خواص دارویی و گیاهی
اگر پرسشی درباره این محصول دارید و یا نظری دارید ٬ لطفاْ از طریق فرم زیر ارسال کنید.
فایلهای مربوط به محصول: برای دانلود بر روی فایل مورد نظر کلیک کنید
شرکت داروسازی جالینوس در تیر ماه سال 1356 با نام شرکت ریتا فارم تاسیس و تحت شماره 28987 در اداره ثبت شرکت های تهران با سرمایه اولیه سه میلیون ریال به ثبت رسید و در خیابان ولیعصر نبش بزرگمهر با 6 قلم فرآورده دارویی فعالیت خود را آغاز نمود.
You won’t be able to dismiss this by usual means (escape or
click button), but you can close it programatically based on
user choices or actions.
(S)-3-(Aminomethyl)-5-methylhexansäure (IUPAC)
N03AX16
Antiepileptikum
fest
186–188 °C[1]
قرص pregabalin 150
Gefahr
Pregabalin ist ein Arzneistoff aus der Gruppe der Antikonvulsiva. Zugelassen ist es EU-weit seit 2004 zur Behandlung von neuropathischen Schmerzen, der Epilepsie sowie der generalisierten Angststörung (GAS).
Seit dem 1. Dezember 2014 sind in Deutschland Generika verfügbar.[3]
Pregabalin war 2009 auf Platz 12 der umsatzstärksten patentgeschützten Arzneimittel in Deutschland, mit einem Umsatz von ca. 220 Millionen Euro.[4]
Pregabalin ist ein Derivat der γ-Aminobuttersäure (GABA). Das Pregabalinmolekül ist ein Zwitterion mit einem isoelektrischen Punkt bei 7,4:[5]
In wässrigen Medien ist es bei pH-Werten unterhalb von 3,7 leicht löslich.
Bei der enantioselektiven Synthese von Pregabalin wird zunächst ausgehend von Isobutyraldehyd und Acrylnitril mehrstufig das Salz aus dem tert-Butylammonium-Kation und dem Anion 3-Cyano-5-methyl-3-hexenoat hergestellt, dessen C=C-Doppelbindung dann einer enantioselektiven Hydrierung unterworfen wird und (S)-3-Cyano-5-methylhexansäure liefert. Die Reduktion der Nitrilgruppe liefert dann Pregabalin.[6] Es gibt auch alternative Synthesen bei denen eine Racematspaltung der Schlüsselschritt ist.[6]
Der Wirkmechanismus von Pregabalin wurde erst vor wenigen Jahren entdeckt. Er unterscheidet sich von demjenigen der γ-Aminobuttersäure (GABA), denn Pregabalin wirkt nicht an den GABA-Rezeptoren, sondern die GABA-ähnliche Wirkung wird über andere Mechanismen hervorgerufen.
Pregabalin bindet im zentralen Nervensystem (ZNS) an eine Untereinheit von spannungsabhängigen Calcium-Kanälen vom P/Q-Typ, das bedeutet in den „Purkinje-Zellen“ des Cerebellum und als R-Typ „r“emaining VGCCs vorkommende spannungsgesteuerte Calciumkanälen (Abkürzung VGCCs für voltage-gated Ca2+ channels). Das Einströmen von Calcium in die Nervenendigung wird gedrosselt, so dass eine gesteigerte Freisetzung der Neurotransmitter Glutaminsäure, Noradrenalin und Substanz P normalisiert wird. Dieser Wirkansatz verbindet die so unterschiedlichen Anwendungsgebiete, neuropathischen Schmerz, generalisierte Angststörung und Epilepsie.
Pregabalin wird rasch resorbiert und hat eine geschätzte Bioverfügbarkeit von über 90 Prozent. Es wird so gut wie nicht metabolisiert und unverändert über die Nieren ausgeschieden. Die Plasmahalbwertszeit beträgt 6,3 Stunden.[7]
Pregabalin wird bei Erwachsenen zur Behandlung von Epilepsie (mit und ohne sekundäre Generalisierung), bei peripheren und zentralen neuropathischen Schmerzen (beispielsweise bei Diabetes mellitus, Gürtelrose, Fibromyalgie oder Rückenmarksverletzungen) und generalisierter Angststörung eingesetzt. Es ist in Tagesdosen von 150 bis 300 mg wirksam, eine Steigerung auf bis zu 600 mg pro Tag ist möglich. Die Einstellung der Dosierung erfolgt individuell.
Pregabalin ist in der Lage, Entzugssymptome bei Opiatabhängigkeit zu reduzieren,[8] und wird hierzu aufgrund der relativ einfachen Zugänglichkeit (oft auch über den Schwarzmarkt) von Opiatabhängigen bezogen und angewendet.
Einige Studien haben gezeigt, dass Pregabalin ebenfalls erfolgreich (als Off-Label-Therapie) bei der Behandlung der sozialen Phobie eingesetzt werden kann.[9]
Die Wirksamkeit konnte in Studien bei diabetischer Neuropathie, postherpetischer Neuralgie und nach Rückenmarkverletzung gezeigt werden.
In anderen Modellen zum neuropathischen Schmerz wurde die Wirksamkeit nicht untersucht. Pregabalin wurde in 10 kontrollierten klinischen Studien untersucht, bei zweimal täglicher Gabe bis zu 13 Wochen und bei dreimal täglicher Gabe bis zu 8 Wochen. Insgesamt waren die Sicherheits- und Wirksamkeitsprofile bei zweimaliger und bei dreimaliger Gabe ähnlich. In klinischen Studien über bis zu 12 Wochen wurde sowohl bei peripheren als auch zentralen neuropathischen Schmerzen eine Schmerzverringerung innerhalb der 1. Woche festgestellt und blieb während der gesamten Behandlungsperiode erhalten.
In kontrollierten klinischen Studien bei peripheren neuropathischen Schmerzen kam es bei 35 % der mit Pregabalin behandelten Patienten und bei 18 % der Patienten unter Placebo zu einer 50%igen Verbesserung des Schmerzscores. Unter den Patienten, bei denen es nicht zu Schläfrigkeit kam, kam es bei 33 % der mit Pregabalin behandelten Patienten zu einer derartigen Verbesserung und bei 18 % der Patienten unter Placebo. Bei den Patienten, bei denen es zu Schläfrigkeit kam, betrugen die Responder-Raten unter Pregabalin 48 % und 16 % unter Placebo.
In der kontrollierten klinischen Studie bei zentralen neuropathischen Schmerzen kam es bei 22 % der mit Pregabalin behandelten Patienten und 7 % der Patienten unter Placebo zu einer 50%igen Verbesserung des Schmerzscores.[10]
Pregabalin wurde in drei kontrollierten klinischen Studien sowohl bei zweimal täglicher als auch bei dreimal täglicher Gabe über jeweils 12 Wochen untersucht. Insgesamt war das Verträglichkeits- und Wirksamkeitsprofil bei zweimal und bei dreimal täglicher Gabe ähnlich. Eine Reduktion der Anfallshäufigkeit wurde innerhalb der ersten Woche beobachtet.[11]
Die Wirksamkeit und Sicherheit von Pregabalin als Zusatztherapie von Epilepsie wurden bei pädiatrischen Patienten unter 12 Jahren und Jugendlichen nicht nachgewiesen.
Die Nebenwirkungen, die in einer Studie zur Pharmakokinetik und Verträglichkeit unter Beteiligung von Patienten ab einem Alter von 3 Monaten bis 16 Jahren (n=65) beobachtet wurden, waren jenen, die bei Erwachsenen beobachtet wurden, ähnlich. Die Ergebnisse einer einjährigen unverblindeten Sicherheitsstudie unter Beteiligung von 54 pädiatrischen Epilepsiepatienten ab einem Alter von 3 Monaten bis 16 Jahren zeigen, dass die Nebenwirkungen Fieber und Infektionen der oberen Atemwege häufiger als in Studien bei Erwachsenen beobachtet wurden.
Monotherapie (neu diagnostizierte Patienten): In einer kontrollierten klinischen Studie über 56 Wochen wurde Pregabalin bei zweimal täglicher Gabe untersucht. Bezogen auf den Endpunkt einer sechsmonatigen Anfallsfreiheit zeigte Pregabalin im Vergleich zu Lamotrigin keine Nichtunterlegenheit. Pregabalin und Lamotrigin waren gleichermaßen sicher und gut verträglich.[12]
Pregabalin wurde in 6 kontrollierten Studien über einen Zeitraum von 4 bis 6 Wochen sowie in einer 8-wöchigen Studie mit älteren Patienten und in einer Langzeitstudie zur Rückfallprävention mit einer doppelblinden Rückfallpräventionsphase von 6 Monaten untersucht.
Eine Besserung der Symptome von generalisierten Angststörungen gemäß der Hamilton-Angst-Skala (HAM-A) wurde innerhalb der 1. Woche beobachtet. In kontrollierten klinischen Studien über 4 bis 8 Wochen zeigten 52 % der mit Pregabalin behandelten Patienten und 38 % der Patienten unter Placebo eine im Vergleich zu den Ausgangswerten mindestens 50%ige Verbesserung des HAM-A-Gesamt-Scores.[13]
Zu den häufigsten Nebenwirkungen zählen Schwindel, Müdigkeit, Benommenheit, nachlassende Aufmerksamkeit, Trunkenheitsgefühl, insbesondere zu Beginn der Behandlung. Des Weiteren kann es zu verschwommenem Sehen, Doppeltsehen, Gleichgewichtsstörungen, Erektionsstörungen, Ödemen und Erbrechen kommen. Eine Gewichtszunahme ist häufig. Gelegentliche Nebenwirkungen sind Muskelzucken, Muskelkrämpfe, Herzrhythmusstörungen, Kraftlosigkeit und Stürze. Selten auftretende Nebenwirkungen sind Schluckbeschwerden, hoher Blutzucker, Muskelschäden, Nierenversagen, Brustschmerzen und Veränderungen der Sicht (Tiefenwahrnehmung, Lichtblitze, optische Helligkeit).
Weitere Nebenwirkungen, die nach Markteinführung berichtet wurden und deren Häufigkeit nicht bestimmt werden kann, sind Herzmuskelschwäche (Herzinsuffizienz), Änderung der Aufnahme von elektrischen Veränderungen (EKG) des Herzens, die mit Herzrhythmusstörungen zusammenhängen, Flüssigkeit in der Lunge, Verlust des Bewusstseins, Krampfanfälle sowie Überempfindlichkeits- und allergische Reaktionen.
Nach Absetzen einer Pregabalin-Therapie wurden bei einigen Patienten zum Teil schwere Entzugs-Symptome festgestellt. Pregabalin sollte deshalb nicht plötzlich abgesetzt, sondern ausschleichend dosiert werden, da es sonst auch zu einer Häufung epileptischer Anfälle kommen kann. Benommenheit und Schläfrigkeit können vor allem bei älteren Patienten zu Stürzen führen.
Es bestehen Hinweise auf ein Abhängigkeitspotenzial von Pregabalin, entsprechende Berichte gibt es aus Deutschland[14][15][16] und Schweden.[17]
Die Fachinformationen wurden um den Hinweis erweitert: „Fälle von nicht bestimmungsgemäßem Gebrauch, Missbrauch und Abhängigkeit wurden berichtet. Bei Patienten mit Drogenmissbrauch in der Vorgeschichte ist Vorsicht geboten und der Patient sollte hinsichtlich Symptomen eines nicht bestimmungsgemäßen Gebrauchs, des Missbrauchs oder der Abhängigkeit von Pregabalin (…) überwacht werden.“
Der Wirkstoff Pregabalin kann die Wirkung von ZNS-dämpfenden Substanzen wie Lorazepam und Alkohol verstärken, bis hin zu Atemschwäche (respiratorischer Insuffizienz) und Koma. Er verstärkt vermutlich auch kognitive und grobmotorische Beeinträchtigungen nach Einnahme von Oxycodon.[18]
Eine gleichzeitige Verwendung von Pregabalin und oralen hormonellen Kontrazeptiva („Antibabypille“) ist möglich.
Es liegen keine Untersuchungen zur Anwendung bei Kindern und Jugendlichen unter 18 Jahren vor. Es kann deswegen nicht empfohlen werden, dass diese Personengruppen Pregabalin anwenden.[19]
Es gibt keine kontrollierten klinischen Studien zur Anwendung von Pregabalin bei schwangeren Frauen. Tierversuche lassen jedoch vermuten, dass möglicherweise Gefahren für den Fötus bestehen könnten. Pregabalin sollte deshalb in der Schwangerschaft nur angewendet werden, wenn es unbedingt notwendig ist.[19] Nach Angabe des Herstellers Pfizer ist die Anwendung bei Schwangerschaft ausgeschlossen, es wird explizit darauf hingewiesen, dass gebärfähige Frauen eine „wirksame Verhütungsmethode“ anwenden müssen.[20]
Durch die Einnahme von Pregabalin kann es zu Benommenheit und Schläfrigkeit kommen. Deshalb wird Patienten davon abgeraten, Auto zu fahren, komplexe Maschinen zu bedienen oder andere potenziell gefährliche Tätigkeiten auszuführen, solange nicht bekannt ist, ob die Fähigkeit zur Ausübung solcher Tätigkeiten beeinträchtigt wird.[19]
قرص pregabalin 150
pregabalin
This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pregabalin Mylan.
For practical information about using Pregabalin Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Pregabalin Mylan is a medicine used to treat adults with the following conditions:
Pregabalin Mylan contains the active substance pregabalin.
Pregabalin Mylan is a ‘generic medicine’. This means that Pregabalin Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Lyrica.
Pregabalin Mylan is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription. The recommended starting dose is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased further until the most effective dose is reached. The maximum dose is 600 mg per day. To stop treatment with Pregabalin Mylan the dose should be reduced gradually, over at least a week. Patients who have kidney problems may need to take lower doses.
The active substance in Pregabalin Mylan, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma‑amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan.
As for every medicine, the company provided studies on the quality of Pregabalin Mylan. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Pregabalin Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan has been shown to have comparable quality and to be bioequivalent to Lyrica. Therefore, the CHMP’s view was that, as for Lyrica, the benefit outweighs the identified risk. The Committee recommended that Pregabalin Mylan be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan on 25 June 2015.
For more information about treatment with Pregabalin Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
More detail is available in the summary of product characteristics
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
117 Allee des Parcs69800 Saint-PriestFrance
15/03/2019 Pregabalin Mylan – EMEA/H/C/004078 – N/0012
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antiepileptics
Neuropathic pain Pregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.
EpilepsyPregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety DisorderPregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
An independent peer-reviewed journal providing critical commentary on drugs and therapeutics.
Timely, independent, evidence-based information on new drugs and medical tests, and changes to the PBS and MBS.
Medicine Finder
Find information on medicines by brand name or active ingredient
Receive Email Updates
قرص pregabalin 150
Latest news, evidence and CPD opportunities
Information for consumers on prescription, over-the-counter and complementary medicines.
Provides consumers with a way to report and discuss adverse experiences with medicines
Keep track of medicines and access important health info any time and anywhere, especially in emergencies.
Medicine Finder
Find information on medicines by brand name or active ingredient
Receive Email Updates
Latest news, evidence and CPD opportunities
A primary care data and quality improvement program developed and managed by NPS MedicineWise with funding from the Australian Government Department of Health.
Independent peer-reviewed journal providing critical commentary on drugs and therapeutics for health professionals.
Providing health professionals with timely, independent evidence-based information on new drugs and medical tests and changes to listings on the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule.
Helping the healthcare community and consumers start an important conversation about eliminating the use of unnecessary and sometimes harmful tests, treatments, and procedures.
Relevant, timely and evidence-based information for Australian health professionals and consumers.
Medicine Finder
Find information on medicines by brand name or active ingredient
Receive Email Updates
Latest news, evidence and CPD opportunities
20 years of helping Australians make better decisions about medicines, medical tests and other health technologies
Medicine Finder
Find information on medicines by brand name or active ingredient
Receive Email Updates
Latest news, evidence and CPD opportunities
POPULAR
All fields are required
Brand name
APO-Pregabalin Capsules
Active ingredient
Pregabalin
Schedule
S4
Please read this leaflet carefully before you start using APO-Pregabalin.
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about pregabalin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
قرص pregabalin 150
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
The name of your medicine is APO-Pregabalin. It contains the active ingredient pregabalin.
It is used to:
Pregabalin may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may prescribe pregabalin in addition to your current therapy when your current treatment is no longer working as well as before.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
Pregabalin belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Pregabalin also has analgesic effects (relieves pain).
There is not enough information to recommend the use of this medicine in children under the age of 18 years.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
There have been reported cases of misuse and abuse with pregabalin.
Pregabalin is not recommended for use during pregnancy. However, if you have epilepsy, it is very important to control your fits while you are pregnant. If it is necessary for you to take pregabalin, your doctor can help you decide whether or not to take it during pregnancy.
It is recommended that you do not breast-feed while taking pregabalin, as it passes into breast milk and its safety in infants is unknown.
Some medicines may interact with pregabalin. These include:
Taking these medicines together with pregabalin may increase your chance of experiencing side effects. You may need a different dose or need to take different medicines. Your doctor or pharmacist will advise you.
Other medicines not listed above may also interact with pregabalin.
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
Your doctor will tell you how much of this medicine you should take. This will depend on your age, your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Your doctor may recommend that you start with a low dose of pregabalin and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions or neuropathic pain.
The usual dose range is 150 mg per day to 600 mg per day given in two divided doses.
Swallow the capsules whole with a full glass of water.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine, even if you feel well.
Do not stop taking pregabalin, or lower the dosage, without checking with your doctor.
If you stop taking pregabalin suddenly you may worsen your condition or cause unwanted effects such as sleeplessness, headache, nausea (feeling sick), anxiety, excessive sweating or diarrhoea (runny stools). If appropriate, your doctor will slowly reduce your dose before you can stop taking it completely.
Make sure you have enough pregabalin to last over weekends and holidays.
If it is almost time to take your next dose (within 4 hours), skip the missed dose and take your next dose at the usual time.
Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose with pregabalin may include mood changes, feeling tired, confusion, depression, agitation and restlessness or seizures.
Tell your doctor that you are taking this medicine if:
Some people being treated with anti-epileptics such as pregabalin have had thoughts of harming themselves or taking their life.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicidal risk include:
Mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking pregabalin, contact your doctor or a mental health professional right away.
Tell your doctor if:
If you become pregnant while taking pregabalin, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Do not:
Be careful when driving or operating machinery until you know how this medicine affects you.
As with other anticonvulsant medicines, pregabalin may cause dizziness and drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, symptoms such as dizziness and drowsiness may be worse.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking pregabalin or if you have any questions or concerns.
Pregabalin helps most people with neuropathic pain or epilepsy, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
It can be difficult to tell whether side effects are the result of taking pregabalin, effects of your condition or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.
If you are over 65 years of age you may have an increased chance of getting side effects.
If you get any side effects, do not stop taking pregabalin without first talking to your doctor.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some patients. Some of these side effects (for example, changes in blood pressure) can only be found when your doctor does tests from time to time to check your progress.
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.
25 mg capsules: white body/white cap, imprinted with “APO” and “P25” in black ink.
50 mg capsules: white body/white cap, imprinted with “APO” and “P50” in black ink.
75 mg capsules: white body/orange cap, imprinted with “APO” and “P75” in black ink.
100 mg capsules: orange body/orange cap, imprinted with “APO” and “P100” in black ink.
150 mg capsules: white body/white cap, imprinted with “APO” and “P150” in black ink.
200 mg capsules: light orange body/light orange cap, imprinted with “APO” and “P200” in black ink.
225 mg capsules: white body/light orange cap, imprinted with “APO” and “P225” in black ink.
300 mg capsules: white body/orange cap, imprinted with “APO” and “P300” in black ink.
Available in blister packs of 14, 20, 56 and 60 tablets.
Also available in bottles of 14, 20, 56 and 60 tablets.
Not all strengths, pack types and/or pack sizes may be available.
Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg,
225 mg or 300 mg of pregabalin as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Pregabalin 25 mg capsules (bottle): AUST R 193211
APO-Pregabalin 50 mg capsules (bottle): AUST R 193246
APO-Pregabalin 75 mg capsules (bottle): AUST R 193247
APO-Pregabalin 100 mg capsules (bottle): AUST R 193248
APO-Pregabalin 150 mg capsules (bottle): AUST R 193249
APO-Pregabalin 200 mg capsules (bottle): AUST R 193252
APO-Pregabalin 225 mg capsules (bottle): AUST R 193253
APO-Pregabalin 300 mg capsules (bottle): AUST R 193254
APO-Pregabalin 25 mg capsules (blister pack): AUST R 193255
APO-Pregabalin 50 mg capsules (blister pack): AUST R 193256
APO-Pregabalin 75 mg capsules (blister pack): AUST R 193274
APO-Pregabalin 100 mg capsules (blister pack): AUST R 193275
APO-Pregabalin 150 mg capsules (blister pack): AUST R 193276
APO-Pregabalin 200 mg capsules (blister pack): AUST R 193277
APO-Pregabalin 225 mg capsules (blister pack): AUST R 193278
APO-Pregabalin 300 mg capsules (blister pack): AUST R 193279
Apotex Pty Ltd16 Giffnock AvenueMacquarie Park, NSW 2113
APO and APOTEX are a registered trade mark of Apotex Inc.
This leaflet was prepared in January 2017.
Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer. This website uses cookies. Read our privacy policy.
© 2019 NPS MedicineWise. Providing independent, evidence-based information about medicines, medical tests and other health technologies for all Australians.
PO Box 1147 Strawberry Hills NSW 2012
Level 7, 418A Elizabeth St, Surry Hills NSW 2010
ABN: 61 082 034 393
We are always looking for ways to improve our website
Get medicines information:
Report a problem with medicines, medical devices or vaccines:
Menu Close menu
Back to Medicines A to Z
Pregabalin is used to treat epilepsy and anxiety.
It is also taken to treat nerve pain. Nerve pain can be caused by different illnesses including diabetes and shingles, or an injury.
Pregabalin works in different ways:
قرص pregabalin 150
Pregabalin is only available on prescription. It comes as capsules or a liquid that you drink.
Pregabalin is only for adults. Do not give it to children under the age of 18.
Pregabalin isn’t suitable for some people:
To make sure pregabalin is safe for you, tell your doctor if you:
Pregabalin is a prescription medicine. It’s important to take it as instructed by your doctor.
The usual dose of pregabalin is between 150mg and 600mg a day split into 2 or 3 separate doses.
If you are taking pregabalin as a liquid, 2.5ml is usually the same as taking a single 50mg capsule. Always check the label.
You can take pregabalin with or without food, but it’s best to be consistent each day. Try to space your doses evenly through the day.
Swallow pregabalin capsules whole with a drink of water or juice. Do not chew them.
If you are taking pregabalin as a liquid, it will come with a syringe or spoon to measure your dose. Do not use a kitchen spoon as it will not give the right amount. If you don’t have a measuring spoon or syringe, ask your pharmacist for one.
To prevent side effects, your doctor will prescribe a low dose to start with and then increase it over a few days.
Once you find a dose that suits you, it will usually then stay the same.
If you have epilepsy, it is likely that once your illness is under control you will continue to take pregabalin for many years.
If you are taking pregabalin for nerve pain or anxiety it is likely that once your symptoms have gone you will continue to take it for several months to stop them coming back.
If you forget a dose, take it as soon as you remember. If it is within 2 hours of the next dose, it is better to leave out the missed dose and take your next dose as normal.
Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.
If you have epilepsy, it’s important to take this medicine regularly. Missing doses may trigger a seizure.
If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.
Taking too much pregabalin by accident may cause unpleasant side effects.
Do not drive yourself – get someone else to drive you or call for an ambulance.
If you need to go to hospital, take the pregabalin packet or leaflet inside it plus any remaining medicine with you.
Like all medicines, pregabalin can cause side effects although not everyone gets them.
These common side effects may happen in more than 1 in 100 people. They are usually mild and go away by themselves. Keep taking the medicine but tell your doctor if they bother you or don’t go away:
If you have diabetes, pregabalin can upset your blood sugar control. Monitor your blood sugar more often for the first few weeks of treatment with pregabalin and adjust your diabetes treatment if you need to. Talk to your doctor or diabetes nurse if you want more advice on what to do.
Very few people taking pregabalin have serious problems. Call a doctor straight away if you get:
In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to pregabalin.
These are warning signs of a serious allergic reaction. A serious allergic reaction is an emergency.
These are not all the side effects of pregabalin. For a full list see the leaflet inside your medicines packet.
You can report any suspected side effect to the UK safety scheme.
What to do about:
There is no firm evidence that pregabalin is harmful to an unborn baby but for safety you’re usually only advised to take it in pregnancy if the benefits outweigh the risks.
If you take pregabalin for epilepsy and become pregnant, do not stop the medicine without talking to your doctor first. It’s very important that epilepsy is treated during pregnancy as seizures can harm you and your unborn baby.
If you’re trying to get pregnant or have become pregnant, you’re routinely recommended to take at least 400mcg of a vitamin called folic acid every day. It helps the unborn baby grow normally.
Pregnant women who take pregabalin are recommended to take a higher dose of folic acid. Your doctor might prescribe a high dose of folic acid (5mg a day) for you to take during the first 12 weeks of pregnancy.
قرص pregabalin 150
If you take pregabalin around the time of giving birth, your baby may need extra monitoring for a few days after they’re born. This is because they may have pregabalin withdrawal symptoms.
For more information about how pregabalin can affect you and your baby during pregnancy, visit the Best Use of Medicines in Pregnancy (BUMPS) website.
Tiny amounts of pregabalin can get into breast milk, but it’s not clear whether it can harm the baby.
Talk to your doctor, as other drugs might be better while you’re breastfeeding.
Pregabalin can usually be safely mixed with other medicines.
For safety, tell your doctor if you’re taking these medicines before you start pregabalin:
There are no known problems with taking herbal remedies and supplements with pregabalin.
For safety, tell your doctor or pharmacist if you’re taking any other medicine, including herbal remedies, vitamins or supplements.
It’s not clear exactly how pregabalin works.
In epilepsy, it’s thought that it stops seizures by reducing the abnormal electrical activity in the brain.
With nerve pain, it’s thought to block pain by interfering with pain messages travelling through the brain and down the spine.
In anxiety, it’s thought that it stops your brain from releasing the chemicals that make you feel anxious.
There’s no evidence that pregabalin has lasting harmful effects, even if you take it for many months or years.
Most people don’t have to stay on the same brand of pregabalin as there is very little difference between brands. Talk to your doctor if you have been asked to switch to a different brand and you are worried about that.
If your epilepsy has been hard to control in the past and the brand you are now taking is working well for you, your doctor may recommend you stay on the same one.
Some people have become addicted to pregabalin after taking it for a long time. If this happens, you will have withdrawal symptoms after you stop taking the medicine. Talk to your doctor if you’re concerned you are becoming physically dependant on pregabalin.
Do not stop taking pregabalin suddenly even if you feel fine.
If you have epilepsy, stopping pregabalin suddenly can cause seizures that will not stop.
If you are taking it for any reason and stop suddenly, you may have a severe withdrawal syndrome. This can have unpleasant symptoms, including:
It’s possible to prevent withdrawal seizures and other symptoms by gradually reducing the dose of pregabalin.
Do not stop taking pregabalin without talking to your doctor. Stopping pregabalin suddenly can cause serious problems.
If you have epilepsy, you’re entitled to free prescriptions for all of your medicines (not just your epilepsy ones).
To claim your free prescriptions you’ll need to have a medical
exemption certificate. The application form for the medical exemption certificate is called FP92A. You can get this from your doctor’s surgery.
You will need to fill in the form, then your doctor will sign it and send it off.
Gabapentin
(also called Neurontin) is a medicine that works in a similar way to pregabalin. Like pregabalin, it can also be taken to treat epilepsy and nerve pain. It can also be taken for migraines.
However, there are other differences between pregabalin and gabapentin. Gabapentin is taken in different doses to pregabalin.
If you need to change to gabapentin treatment, your doctor will explain how to safely swap from pregabalin.
Pregabalin has been a controlled medicine since 1 April 2019. This means there are strict rules on how it’s prescribed and dispensed to make sure it’s not given to the wrong person or misused.
When you collect pregabalin your pharmacist will ask for proof of identity such as your passport or driving licence. You’ll also be asked to sign the back of your prescription, to confirm that you’ve received it.
If you’re collecting pregabalin for someone else, you’re legally required to show the pharmacist proof of your identity if asked.
Your pregabalin prescription will probably need to be hand signed by a doctor. This can take longer than normal repeat prescriptions.
It’s best to hand in your repeat prescription request up to five days before you’re due to run out of pregabalin. This will give your doctor enough time to sign it.
Once your prescription has been written, you’ll need to collect your medicine from a pharmacist within 28 days. If you don’t, your prescription will become invalid and you’ll need to get a new one.
If your pharmacist is unable to give you the whole amount prescribed, you’ll need to go again to pick up your remaining medicine.
You’ll need to do this within the 28 days of receiving your prescription otherwise it’ll become invalid. Your pharmacist won’t be able to give you your remaining medicine and you’ll need to get a new prescription again.
Pregabalin doesn’t stop any contraception working. You can safely use any type of contraception, including contraceptive pills and emergency contraception, alongside pregabalin.
There’s no firm evidence to suggest that taking pregabalin will reduce fertility in either men or women.
However, for safety speak to a pharmacist or your doctor before taking it if you’re trying to get pregnant.
Do not drive a car or ride a bike if pregabalin makes you sleepy, gives you blurred vision or makes you feel dizzy, clumsy or unable to concentrate or make decisions. This may be more likely when you first start taking pregabalin but could happen at any time – for example when starting another medicine.
It’s an offence to drive a car if your ability to drive safely is affected. It’s your responsibility to decide if it’s safe to drive. If you’re in any doubt, do not drive.
GOV.UK has more information on the law on drugs and driving. Talk to your doctor or pharmacist if you’re unsure whether it’s safe for you to drive while taking pregabalin.
If you have epilepsy, you’re not allowed to drive until you’ve had no seizures for 1 year, or if you only have seizures while you are asleep. You are also not allowed to drive if your epilepsy medicine has changed and for 6 months after.
You can drink alcohol with pregabalin but it may make you feel sleepy or make you lose your focus.
During the first few days of taking pregabalin, it might be
best to stop drinking alcohol until you see how the medicine affects you.
Pregabalin can intensify the highs of recreational drugs like
cannabis and heroin. So, if you use recreational drugs alongside pregabalin, there may be more chance of unpleasant side effects like panic attacks, anxiety and memory loss.
Page last reviewed: 22 November 2018
Next review due: 22 November 2021
© Crown copyright
%PDF-1.5
%
1 0 obj
>>>
endobj
2 0 obj
>
endobj
3 0 obj
Generic name: PREGABALIN 25mgDosage form: capsule, oral solution
See also:
Medically reviewed by Drugs.com. Last updated on Jun 26, 2019.
LYRICA is given orally with or without food.
When discontinuing LYRICA, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.3)].
قرص pregabalin 150
Because LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].
The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].
The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate LYRICA, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.
The efficacy of adjunctive LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.
The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].
The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].
In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of LYRICA in pediatric patients with compromised renal function has not been studied.
Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient’s CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:
Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.
(For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Other brands: Lyrica CR
Latest: FDA Approves First Generics of Lyrica
gabapentin, prednisone, clonazepam, amitriptyline, Cymbalta, duloxetine, lamotrigine, Lamictal, topiramate, Klonopin
Lyrica reviews
The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.
Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 1 Aug 2019), Cerner Multum™ (updated 1 Aug 2019), Wolters Kluwer™ (updated 31 July 2019) and others.
Third Party Advertising
We comply with the HONcode standard for trustworthy health information – verify here
Copyright © 2000-2019 Drugs.com. All rights reserved.
