خواص دارویی و گیاهی
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قرص voltaren 50mg
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Brand name
Voltaren (Tablets)
Active ingredient
Diclofenac sodium
Schedule
S4
Please read this leaflet carefully before you start using Voltaren Tablets and Suppositories.
This leaflet answers some common questions about Voltaren tablets and suppositories. 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 final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au.
Those updates may contain important information about the medicine and its use of which you should be aware.
قرص voltaren 50mg
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
Voltaren belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and reduce inflammation (swelling and redness).
Voltaren is used to treat:
It can relieve the symptoms of pain and inflammation but it will not cure your condition.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
Voltaren is only available with a doctor’s prescription. It is not addictive.
Voltaren suppositories should not be used in children under 12 months of age. Because of their strength, Voltaren 100mg suppositories are not suitable for children and adolescents.
There is not enough information to recommend the use of Voltaren tablets in children.
Do not use Voltaren if you are allergic (hypersensitive) to:
If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.
Some of the symptoms of an allergic reaction may include:
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are allergic to aspirin or NSAID medicines and you use Voltaren, these symptoms may be severe.
Do not use Voltaren if you have had any of the following medical conditions:
Do not use Voltaren suppositories if you suffer from inflammation of the rectum (back passage) or if your rectum is painful (sometimes with bleeding or discharge).
Do not use Voltaren during the first 6 months of pregnancy, except on doctor’s advice. Do not use during the last three months of pregnancy.
Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth.
Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when taken close to the time of conception.
Do not use Voltaren after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Tell your doctor if you have any of the following health problems / medical conditions:
Your doctor may want to take special precautions if you have any of the above conditions.
It is generally important to take the lowest dose of Voltaren that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk for cardiovascular side effects as small as possible.
Tell your doctor if you are pregnant or trying to become pregnant.
There is not enough information to recommend the use of Voltaren during the first 6 months of pregnancy and it must not be used during the last 3 months. Voltaren may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you currently have an infection.
If you use Voltaren while you have an infection, some of the signs of the infection such as pain, fever, swelling and redness may be hidden. You may think, mistakenly, that you are better or that the infection is not serious.
Tell your doctor if you are breast-feeding.
Breast-feeding is not recommended while you are using this medicine. The active ingredient in Voltaren passes into breast milk and may affect your baby.
Tell your doctor if you are lactose intolerant.
Voltaren tablets contain lactose.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies, especially if you get skin reactions with redness, itching or rash.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines that are important to mention include:
You may need to take different amounts of your medicines or to take different medicines while you are using Voltaren. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you start using this medicine.
Voltaren Tablets
It is recommended to take the tablets before meals or on an empty stomach. If they upset your stomach, you can take them with food or immediately after food. They will work more quickly if you take them on an empty stomach but they will still work if you have to take them with food to prevent stomach upset.
Voltaren suppositories
Use the suppositories at bedtime to relieve pain during the night and early morning stiffness; or to relieve pain after an operation.
Follow all directions given to you by your doctor and pharmacist carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
There are different ways to take Voltaren tablets and suppositories, depending on your condition. Your doctor will tell you exactly how many tablets or suppositories to take.
Do not exceed the recommended dose.
The usual starting dose of Voltaren tablets is 75mg to 150mg each day. After the early stages of treatment, it is usually possible to reduce the dose to 75mg to 100mg each day.
The tablets are usually taken during each period as soon as cramps begin and continued for a few days until the pain goes away.
The usual starting dose of Voltaren tablets is 50mg to 100mg each day, beginning as soon as cramps begin and continuing until the pain goes away, but for no longer than 3 days.
If necessary, the dose can be raised over several menstrual periods to a maximum of 200mg each day.
Your doctor will advise what strength and dose of Voltaren suppositories is suitable for your child.
Voltaren tablets are usually taken in 2 or 3 doses during the day.
Swallow the tablets whole with a full glass of water or other liquid. Do not chew them.
The tablets have a special coating to keep them from dissolving until they have passed through the stomach into the bowel. Chewing the tablets would destroy the coating.
Do not take suppositories by mouth.
When used in children, the strength of the Voltaren suppository used depends on the weight of the child. Your doctor will decide which strength is suitable for your child and how often it can be used.
If possible, go to the toilet and empty your bowels before using the suppository.
Follow these steps:
Try not to go to the toilet to empty your bowels for at least one hour after using the suppository.
If you are not sure how to use a suppository, ask your pharmacist or doctor.
Do not use Voltaren for longer than your doctor says.
If you are using Voltaren for arthritis, it will not cure your disease but it should help to control pain and inflammation. It usually begins to work within a few hours but several weeks may pass before you feel the full effects of the medicine.
Voltaren suppositories should not be used for more than 3 days in children.
If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have used too much Voltaren. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
If you take too much Voltaren, you may experience:
If you take Voltaren for more than a few weeks, you should make sure to visit your doctor for regular check-ups to ensure that you are not suffering from unnoticed undesirable effects.
If you become pregnant whilst taking or using Voltaren, tell your doctor immediately.
Your doctor can discuss with you the risks of using it while you are pregnant.
Be sure to keep all of your doctor’s appointments so that your progress can be checked.
Your doctor will periodically re-evaluate whether you should continue treatment with Voltaren, if you have established heart disease or significant risks for heart disease, especially in case you are treated for more than 4 weeks.
Your doctor may want to check your kidneys, liver and blood from time to time to help prevent unwanted side effects.
If, at any time while taking Voltaren you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately. These may be signs of cardiovascular toxicity.
If you are going to have surgery, make sure the surgeon and anaesthetist know that you are using Voltaren.
NSAID medicines can slow down blood clotting and affect kidney function.
If you get an infection while using Voltaren, tell your doctor.
This medicine may hide some of the signs of an infection (pain, fever, swelling, redness). You may think, mistakenly, that you are better or that the infection is not serious.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Voltaren.
Tell any other doctor, dentist or pharmacist who treats you that you are using Voltaren.
Do not take any of the following medicines while you are using Voltaren without first telling your doctor:
If you take these medicines together with Voltaren, they may cause unwanted side effects.
If you need to take something for headache or fever, it is usually okay to take paracetamol. If you are not sure, your doctor or pharmacist can advise you.
Do not stop any other forms of treatment for arthritis that your doctor has told you to follow.
This medicine does not replace exercise or rest programs or the use of heat/cold treatments.
Do not give this medicine to anyone else, even if their condition seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Voltaren affects you.
This medicine may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive, use machines, or do anything else that could be dangerous.
Elderly patients should take the minimum number of tablets or suppositories that provides relief of symptoms.
Elderly patients, especially those with a low body weight, may be more sensitive to the effects of Voltaren than other adults.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Voltaren.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor.
As people grow older, they are more likely to get side effects from medicines.
Do not be alarmed by these lists of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
*If symptoms of vision disorders occur during treatment with Voltaren, contact your doctor as an eye examination may be considered to exclude other causes.
If any of the following signs appear, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
Keep the 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 using Voltaren or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
Voltaren tablets
Voltaren 25mg tablets are round, yellow, coated tablets marked “CG” on one side and “BZ” on the other side; blisters of 50.
Voltaren 50mg tablets are round, pale brown, coated tablets marked “CG” on one side and “GT” on the other side; blisters of 50.
Voltaren suppositories
Voltaren suppositories are yellowish-white, torpedo shaped suppositories. The 100mg strength is in packs of 20 and the lower strength suppositories are in packs of 10.
Voltaren tablets
Contain 25mg or 50mg diclofenac sodium as the active ingredient in gastro-resistant tablets.
The tablets also contain:
Voltaren tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.
Voltaren suppositories
Contain either 12.5mg, 25mg, 50mg or 100mg diclofenac sodium as the active ingredient in a triglyceride base.
Voltaren suppositories do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Voltaren is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty LimitedABN 18 004 244 16054 Waterloo RoadMacquarie Park NSW 2113Telephone: 1800 671 203
®= Registered Trademark
This leaflet was prepared in May 2017
Australian Registration Numbers:
25mg tablet blister AUST R 166496
50mg tablet blister AUST R 66880
12.5mg suppository AUST R 96797
25mg suppository AUST R 96810
50mg suppository AUST R 96811
100mg suppository AUST R 37582
(vlt190517c.doc) based on PI (vlt190517i.doc)
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© 2019 NPS MedicineWise. Providing independent, evidence-based information about medicines, medical tests and other health technologies for all Australians.
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Active substance(s): DICLOFENAC SODIUM
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Medical Disclaimer
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Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.
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Home ►
Safety ►
Alerts ►
Archive ► Diclofenac and Cardiovascular
Events
Published: 8 July 2013
Products affected
Information for consumers and caregivers
Information for healthcare professionals
Data summary
What action is Medsafe taking?
How to report
Further information
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used for
the relief of moderate pain and inflammation. Diclofenac provides symptomatic
relief but has not been shown to halt or reverse the underlying disease
process.
Recent publications have suggested an increased risk of cardiovascular
events such as heart attack and stroke with the use of diclofenac. Medsafe
and the Medicines Adverse Reactions Committee (MARC) have concluded there
is a very small increased risk of these effects with diclofenac, when used
at high doses and for long-term therapy.
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However, study limitations make it impossible for Medsafe to determine
whether there is a higher risk of cardiovascular events with diclofenac
treatment compared to treatment with other NSAIDs.
Diclofenac is available under different brand names (refer to product
list at the end of this alert). This alert applies to diclofenac tablets,
suppositories and injections. It does not apply to diclofenac-containing
products applied to the skin or used in the eye.
A list of products containing diclofenac available
in New Zealand can be found below (Further infomation).
The Medicines Adverse Reactions Committee (MARC) reviewed the latest
data in June 2013. The MARC concluded that there was a small increase in
the risk of cardiovascular events with the use of diclofenac.
Many studies had a low number of overall events. This limits risk estimation,
with subsequent risk values only marginally statistically significant. However,
diclofenac is widely used and it is important to highlight the small increase
in risk.
The risk values varied between the different studies. Examples of data
reviewed are shown below:
Table 1: Odds ratios estimated by case-crossover analysis for specific
causes of death associated with exposure to NSAIDs stratified according
to daily dosage1.
Figure 1: Estimate of rate ratio (with 95% confidence interval) for non-steroidal
anti-inflammatory drugs compared with placebo or non-use, for primary outcome
of myocardial infarction2.
Table 2: Estimated relative risk of cardiovascular events according to
risk of underlying cardiovascular disease, compared with non-use3*
*In general, high risk = experienced prior vascular ischaemic events,
low risk = no such history
The limitations of the studies included in the review included a lack
of information on the efficacy of the different medicines in individual
patients, the inability to adjust for some important confounders (eg, smoking
status, alcohol use, body mass index or obesity, over-the-counter non-steroidal
anti-inflammatory drug [NSAID] use and use of other medications), the observational
nature of most studies, and a lack of information in many instances of dosage,
regimen and indication for use.
The MARC noted that other NSAID adverse reactions are also important,
including the risk of gastrointestinal events, renal injury and severe skin
reactions. The MARC also noted that other types of pain relievers also have
undesirable effects.
A previous MARC review (2006/2007) of the risk of cardiovascular events
with the use of NSAIDs determined that all NSAIDs are associated with an
increased risk of serious cardiovascular events. The MARC recommended that
no distinction should be made between individual NSAIDs or dosages, or between
prescription-only and over-the-counter NSAIDs, in terms of the risk management
advice given. Medsafe was unable to determine from the new data a clear
difference in risk between different NSAIDs. Other risks and benefits associated
with NSAIDs and other types of pain relievers also need to be taken into
account.
Medsafe is working with the sponsors of these products to ensure data
sheets, Consumer Medicine Information and package inserts appropriately
outline the safety of diclofenac.
European Medicines Agency decision
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This medication is a nonsteroidal anti-inflammatory drug (NSAID). Typically, it is used for pain or to relieve inflammation and pain. It may also be used for the relief of osteoarthritis, as well as for other uses. Its effects can be felt within 1 hour.
This medication is typically used twice a day. However, your doctor or pharmacist may have suggested a different schedule that is more appropriate for you. Depending on the treated condition, it may be used regularly or only as needed. Follow the instructions provided by your doctor or pharmacist.
Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication may irritate the stomach, and should be taken with food. It is best to avoid coffee, spicy food or alcohol.
In addition to its desired action, this medication may cause some side effects, notably:
Each person may react differently to a treatment. If you think this medication may be causing side effects (including those described here, or others), talk to your doctor or pharmacist. He or she can help you to determine whether or not the medication is the source of the problem.
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As with most medications, this product should be stored at room temperature. Store it in a secure location where it will not be exposed to excessive heat, moisture or direct sunlight. Keep it out of reach of young children. Make sure that any leftover portion is disposed of safely.
It is not recommended to combine this drug with another antiinflammatory. Carefully check for the presence of ibuprofen (Advil, Motrin), naproxen (Aleve) or diclofenac (Voltaren Emulgel) on drug labels.
This medication may interact with other medications or supplements, sometimes significantly. Many interactions, however, may be dealt with by a dosage adjustment or a change in medication schedule. Check with your pharmacist before using this medication in combination with any other medications (including non-prescription products), vitamins or natural products.
It is important to tell the health professionals you consult:
