قرص موتيليوم چيست - کامل (هلپ کده)

خواص دارویی و گیاهی

نشان‌گذاری

عجب سازنده ی این علامت عرب دولاب است
[[رده:نمادهای
نوشتار]]

POM: Preion only medicine

This information is intended for use by health professionals

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Motilium 1 mg film-coated tablets

Each film-coated tablet contains domperidone maleate 12.72 mg equivalent to domperidone 1 mg.

Excipients with known effect:

Each film-coated tablet contains 53.88mg of lactose monohydrate

For the full list of excipients, see section 6.1.

Film-coated tablets – white to faintly cream coloured, circular, biconvex tablets.

Motilium is indicated for the relief of the symptoms of nausea and vomiting.

Motilium should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.

It is recommended to take oral Motilium before meals. If taken after meals, absorption of the drug is somewhat delayed.

Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.

Usually, the maximum treatment duration should not exceed one week.

See section 4.4. for further information.

Adults and adolescents (12 years of age and older and weighing 35 kg or more)

One 1mg tablet up to three times per day with a maximum dose of 3 mg per day.

Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg

Due to the need for accurate dosing, Motilium tablets are unsuitable for use in children and adolescents weighing less than 35 kg.

Hepatic Impairment

Motilium is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).

Renal Impairment

Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Motilium should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2)

Motilium is contraindicated in the following situations:

• Known hypersensitivity to domperidone or any of the excipients

• Prolactin-releasing pituitary tumour (prolactinoma).

• when stimulation of the gastric motility could be harmful e.g in patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation.

• in patients with moderate or severe hepatic impairment (see section 5.2).

• in patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)

• co-administration with QT-prolonging drugs, at the exception of apomorphine (see sections 4.4 and 4.5)

• co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)

Cardiovascular effects

Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).

Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8). A higher risk was observed in patients older than 6 years, patients taking daily doses greater than 3 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.

Domperidone should be used at the lowest effective dose in adults and children.

Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3.). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.

Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.

Patients should be advised to promptly report any cardiac symptoms.

Use with apomorphine

Domperidone is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. Please refer to the apomorphine SmPC.

Use in infants

Although neurological side effects are rare (see section 4.8), the risk of neurological side effects is higher in young children since metabolic s and the blood-brain barrier are not fully developed in the first months of life. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.

Renal impairment

The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of Motilium should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.

Excipients

The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.

Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.

Concomitant use of the following substances is contraindicated

QTc prolonging medicinal products

• anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)

• anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)

• certain anti-psychotics (e.g., haloperidol, pimozide, sertindole)

• certain anti-depressants (e.g., citalopram, escitalopram)

• certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin)

• certain antifungal agents (e.g., pentamidine)

• certain antimalarial agents (in particular halofantrine, lumefantrine)

• certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)

• certain antihistaminics (e.g., mequitazine, mizolastine)

• certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)

• certain other medicines (e.g., bepridil, diphemanil, methadone)

(see section 4.3).

• apomorphine, unless the benefit of the co-administration outweighs the risks, and only if the recommended precautions for co-administration are strictly fulfilled. Please refer to the apomorphine SmPC.

Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e.:

• protease inhibitors

• systemic azole antifungals

• some macrolides (erythromycin, clarithromycin, telithromycin)

(see section 4.3).

Concomitant use of the following substances is not recommended

Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.

(see section 4.3)

Concomitant use of the following substances requires caution in use

Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contra-indicated as it is a potent CYP3A4 inhibitor).

The above list of substances is representative and not exhaustive.

Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of domperidone’s CYP3A4 mediated first pass metabolism by these drugs.

With the combination of oral domperidone 1mg four times daily and ketoconazole 2mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of domperidone 1mg four times daily and oral erythromycin 5mg three times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady state were increased approximately three-fold in each of these interaction studies. In these studies domperidone monotherapy at 1mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (2mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.

Pregnancy

There are limited post-marketing data on the use of domperidone in pregnant women. Studies in animals have shown reproductive toxicity at maternally toxic doses (see section 5.3). Motilium should only be used during pregnancy when justified by the anticipated therapeutic benefit.

Breast-feeding

Domperidone is excreted in human milk and breast-fed infants receive less than .1 % of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.

Motilium has no or negligible influence on the ability to drive and use machines.

Tabulated list of adverse reactions

The safety of Motilium was evaluated in clinical trials and in postmarketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. All patients were at least 15 years old and received at least one dose of Motilium (domperidone base). The median total daily dose was 3 mg (range 1 to 8 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.

The following terms and frequencies are applied:

very common (≥1/1) common (≥1/1 to &lt1/1) uncommon (≥1/1, to &lt1/1) rare (≥1/1, to &lt1/1,) very rare (&lt1/1,), Where frequency can not be estimated from clinical trials data, it is recorded as “Not known.

System Organ Class

Adverse Drug Reaction

Frequency

Common

Uncommon

Not known

Immune system disorders

Anaphylactic reaction (including anaphylactic shock)

Psychiatric disorders

Loss of libido

Anxiety

Agitation

Nervousness

Nervous system disorders

Somnolence

Headache

Convulsion

Extrapyramidal disorder

Eye disorders

Oculogyric crisis

Cardiac disorders (see section 4.4)

Ventricular arrhythmias

Sudden cardiac death

QTc prolongation

Torsade de Pointes

Gastrointestinal disorders

Dry mouth

Diarrhoea

Skin and subcutaneous tissue disorder

Rash

Pruritus

Urticaria

Angioedema

Renal and urinary disorders

Urinary retention

Reproductive system and breast disorders

Galactorrhoea

Breast pain

Breast tenderness

Gynaecomastia

Amenorrhoea

General disorders and administration site conditions

Asthenia

Investigations

Liver test abnormal

Blood prolactin increased

In 45 studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher. This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.

Paediatric population

Extrapyramidal disorder occurs primarily in neonates and infants

Other central nervous system-related effects of convulsionand agitation alsoare primarily reported in infants and children.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Symptoms

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions,disorientation, somnolence and extrapyramidal reactions.

Treatment

There is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.

Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

Pharmacotherapeutic group: Propulsives, ATC code: A3F A 3

Mechanism of action

Domperidone is a dopamine antagonist with anti-emetic properties, Domperidone does not readily cross the blood-brain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors.

Studies in man have shown oral domperidone to increase lower oesophaegeal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.

In accordance with ICH—E14 guidelines, a thorough QT study was performed. This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 8 mg per day 1 or 2 mg administered 4 times a day of domperidone. This study found a maximal difference of QTc between domperidone and placebo in LS-means in the change from baseline of 3.4 msec for 2 mg domperidone administered 4 times a day on Day 4. The 2-sided 9 % CI (1. to 5.9 msec) did not exceed 1 msec. No clinically relevant QTc effects were observed in this study when domperidone was administered at up to 8 mg/day (i.e., more than twice the maximum recommended dosing).

However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (1 mg 4 times a day).The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5 msec (95 % CI: .6 to 14.4), respectively.

Absorption

Domperidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1hr after dosing. The Cmax and AUC values of domperidone increased proportionally with dose in the 1 mg to 2 mg dose range. A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.

The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone’s bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15-3 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when the oral drug is taken after a meal.

Distribution

Metabolism

Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-45 involved in the N-dealkylation of domperidone, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone aromatic hydroxylation.

Excretion

Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively. The proportion of the drug excreted unchanged is small (1% of faecal excretion and approximately 1% of urinary excretion). The plasma half-life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

Hepatic impairment

In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5-fold higher, respectively, than in healthy subjects. The unbound fraction is increased by 25%, and the terminal elimination half-life is prolonged from 15 to 23 hours. Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life. Subjects with severe hepatic impairment were not studied. Motilium is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).

Renal impairment

In subjects with severe renal insufficiency (creatinine clearance &lt3ml/min/1.73m2) the elimination half-life of domperidone is increased from 7.4 to 2.8 hours, but plasma drug levels are lower than in healthy volunteers. Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.

However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.

Paediatric population

No pharmacokinetic data are available in the paediatric population.

Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes, exposure ratios ranged between 26- 47-fold, based on IC5 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 1 mg administered 3 times a day. Safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by 45-fold. Safety margins in in vitro pro-arrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by 9- up to 45-fold. In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively. In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4 ng/mL, which are 3-fold higher than the total plasma levels in humans at maximum daily dose (1 mg administered 3 times a day). The relevance of the latter study for humans following exposure to orally administered domperidone is uncertain.

In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3-fold.

At a high, maternally toxic dose (more than 4 times the recommended human dose), teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.

Lactose monohydrate

Maize starch

Microcrystalline cellulose

Pregelatinised starch

Povidone K9

Magnesium stearate

Silica colloidal hydrated

Polysorbate 2

Hypromellose

Propylene glycol.

Not applicable.

3 years.

Do not store above 25°C.

Blister packs consisting of aluminium foil and PVC genotherm clear glass.

Pack sizes of 4, 1, 28, 3 and 1 tablets.

HDPE (Duma) containers

Pack size 5 tablets.

Not all pack sizes may be marketed.

No special requirements.

Zentiva Pharma UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

PL 1778/3

1 July 27

31st July 218

One Onslow Street, Guildford, Surrey, GU1 4YS

+44 () 1483 554831

UK-medicalinformation@sanofi.com

+44 ()1483 55 515

+44 ()845 372 711

To bookmark a medicine you must sign up and log in.

To email a medicine you must sign up and log in.

To view the changes to a medicine you must sign up and log in.

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.
Continue

POM: Preion only medicine

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet.
The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD.
For further information call RNIB Medicine Leaflet Line on 8 198 5.
The product code(s) for this leaflet is: PL 1778/3.

Motilium 1mg Film-Coated Tablets

MOTILIUM 1 mg FILM-COATED TABLETS

Domperidone

PATIENT INFORMATION LEAFLET

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine.

In this leaflet:

1. What Motilium is and what it is used for
2. What you need to know before you take Motilium
3. How to take Motilium
4. Possible side effects
5. How to store Motilium
6. Contents of the pack and other information

1. WHAT MOTILIUM IS AND WHAT IT IS USED FOR

The name of your medicine is Motilium 1mg Film-Coated Tablets (called Motilium in this leaflet). Motilium contains a medicine called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.

This medicine is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTILIUM

Do not take Motilium tablets if:

Do not take Motilium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Motilium.

Warnings and precautions

Before taking this medicine contact your doctor if:

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Motilium. Do this even if they have applied in the past.

Motilium may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 6 years old or taking doses higher than 3 mg per day. The risk also increases when Motilium is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see “Other medicines and Motilium).

Motilium should be used at the lowest effective dose in adults and children.

While taking Motilium, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with Motilium should be stopped.

Other medicines and Motilium

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without a preion, including herbal medicines. This is because Motilium can affect the way some other medicines work. Also, some medicines can affect the way Motilium works.

Do not take Motilium if you are taking medicine to treat:

Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.

Motilium and apomorphine

Before you use Motilium and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet.

It is important to ask your doctor or pharmacist if Motilium is safe for you when you are taking any other medicines, including medicines obtained without preion.

Taking Motilium with food and drink

It is recommended to take Motilium before meals, as when taken after meals the absorption of the medicine is slightly delayed.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Motilium if:

Small amounts of Motilium have been detected in breast-milk. Motilium may cause unwanted side effects affecting the heart in a breast-fed baby. Motilium should be used during breast feeding only if your physician considers this clearly necessary. Ask your doctor for advice before taking this medicine.

Driving and using machines:

Motilium does not affect your ability to drive or use machines.

Important information about some of the ingredients of Motilium tablets

This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Motilium.

3. HOW TO TAKE MOTILIUM

Follow these instructions closely unless your doctor has advised you otherwise. You should check with your doctor or pharmacist if you are not sure.

Duration of treatment

Your doctor will decide how long you will need to take this medicine.

Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Motilium for longer than 7 days without consulting your doctor.

Taking this medicine

The usual dose is:

People with kidney problems

Your doctor may tell you to take a lower dose or to take the medicine less often.

If you take more Motilium than you should:

If you forget to take Motilium:

4. POSSIBLE SIDE EFFECTS

Like all medicines, Motilium can have side effects, although not everybody gets them.

Stop taking Motilium and see your doctor or go to a hospital straightaway if:

Other side effects include:

Common (affects less than 1 in 1 people)

Uncommon (affects less than 1 in 1, people)

Not known (Frequency cannot be estimated from the available data)

Some patients who have used Motilium for conditions and dosages requiring longer term medical supervision have experienced the following unwanted effects:

Restlessness swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.

Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOTILIUM

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Motilium 1mg Film-Coated Tablets contain

Each Motilium Tablet contains 1mg of domperidone (the active ingredient). It also contains lactose, maize starch, microcrystalline cellulose, hypromellose, pregelatinised starch, povidone, propylene glycol, magnesium stearate, silica colloidal hydrated and polysorbate 2.

What Motilium 1mg Film-Coated Tablets look like and contents of the pack

Each pack contains 3 or 1 white to cream coloured, film-coated tablets with Motilium
stamped on one side.

Marketing Authorisation Holder:

Manufacturer:

This leaflet was last revised in: July 218

One Onslow Street, Guildford, Surrey, GU1 4YS

+44 () 1483 554831

UK-medicalinformation@sanofi.com

+44 ()1483 55 515

+44 ()845 372 711

To bookmark a medicine you must sign up and log in.

To email a medicine you must sign up and log in.

To view the changes to a medicine you must sign up and log in.

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.
Continue

Loading

Working

Loading

Working

Loading

Assalam o alikum nawaz khan live The name of your medicine is Motilium 1mg Film-Coated Tablets (called Motilium in this leaflet). Motilium contains a medicine called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.This medicine is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick). ki saat hazir ho