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Diclofenac T Ratiopharm

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Package leaflet: Information for the patient


Diclofenac T ratiopharm 25 mg film-coated tablets


Diclofenac potassium


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet

1. What Diclofenac T ratiopharm is and what it is used for

2. What you need to know before you take Diclofenac T ratiopharm

3. How to take Diclofenac T ratiopharm

4. Possible side effects

5. How to store Diclofenac T ratiopharm

6. Contents of the pack and other information


1. What Diclofenac T ratiopharm is and what it is used for


Diclofenac T ratiopharm contains diclofenac potassium.

Diclofenac T ratiopharm acts against pain(is an analgesic) and inflammation(an anti-inflammatory). Medicinal products with this or similar properties are also called “non-steroidal anti-inflammatory drugs”, or NSAIDs.


Diclofenac T ratiopharm is used for:

Adults and adolescents over 16 years

Short-term treatment of following conditions

Acute treatment of migraine with or without aura.


Children and adolescents

Short-term treatment of


Diclofenac T ratiopharm 25 mg shall not be used in children under 9 years of age.



2. What you need to know before you take Diclofenac T ratiopharm


Do not take Diclofenac T ratiopharm:


Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac T ratiopharm


Side effects may be minimised by using the lowest effective dose for the shortest time necessary to control the symptoms.


Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.


Laboratory tests

When taking Diclofenac T ratiopharm for a long period of time your doctor will regularly check your liver values, your kidney function and your blood count.


Bleeding of the gastrointestinal tract, ulcers and perforation

Treatment with any non-steroidal anti-inflammatory drug (NSAID) can cause bleeding of the gastrointestinal tract, ulcers and perforation, possibly with a fatal outcome. The risk of becoming ill is higher


If you have one of these risk factors and/or if you are additionally being treated with

your doctor may possibly prescribe a gastroprotective drug in addition.


If you havepreviously had gastrointestinal side effects you should report any unusual abdominal symptoms to your doctor. This particularly applies to bleeding from the stomach or bowels. Such bleeding is recognisable by the vomit or stool being coloured black. The elderly are particularly at risk.

If you have gastrointestinal bleeding or ulcers while taking Diclofenac T ratiopharm the treatment must be discontinued.


Effects on the cardiovascular and cerebrovascular system

Medicinal products like Diclofenac T ratiopharm are possibly related to a slightly increased risk of heart attack (cardiac infarct) or stroke. The risk is greater with high doses and longer periods of treatment. Do not exceed the recommended dose or period of treatment.


Skin reactions

There have very rarely been reports of serious skin reactions, when taking an NSAID, involving erythema and blistering, sometimes with a fatal outcome. At the first signs of a disorderaffecting the skin or mucous membranes you should discontinuetaking Diclofenac T ratiopharm and inform yourdoctor without delay. This also applies to other signs of a sensitivity reaction (see also section 4.).


Elderly patients

Side effects appear more frequently in elderly or frail elderly patients taking NSAIDs. Bleeding and perforation of the gastric and intestinal regions are the effects particularly concerned, which in some circumstances can be life-threatening.


Children and adolescents

Diclofenac T ratiopharm 25 mg shall not be used in children under 9 years of age.


Other medicines and Diclofenac T ratiopharm

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.


You should avoid taking Diclofenac T ratiopharm at the same time as:


Your doctor will decide this on a case to case basis.


Particular caution is required when taking Diclofenac T ratiopharm with:


Pregnancy

You must not take Diclofenac T ratiopharm in the last three months of a pregnancy. It represents a danger for the health of the mother and the child. In the 1st and 2nd trimesters of pregnancy you should only take Diclofenac T ratiopharm after consultation with your doctor.


Breast-feeding

The active substance, diclofenac, passes in small quantities into the maternal milk. Therefore Diclofenac T ratiopharm should not be administered during breast-feeding.


Female fertility

Like other medicinal products that inhibit prostaglandin synthesis (the formation of certain tissue hormones) Diclofenac T ratiopharm may make it more difficult to become pregnant. You should inform your doctorif you plan to become pregnant or have had problems becoming pregnant.


Driving and using machines

Diclofenac T ratiopharm can induce side effects such as visual disturbances, vertigo, dizziness and drowsiness. As a result your capacity to react may be altered and your ability to drive and use machines can be impaired.


Diclofenac T ratiopharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


3. Howtotake Diclofenac T ratiopharm


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Method of administration

Take Diclofenac T ratiopharm without chewing and with a small amount of fluid preferably before a meal.


Duration of use

The doctor treating you will decide the duration of use.


The recommended dose is


Adultsand adolescents over 16 years:

The starting dose is generally 4-6 tablets of Diclofenac T ratiopharm 25 mg per day. In milder cases a dose of 3-4 tablets of Diclofenac T ratiopharm 25 mg per day is usually sufficient.

The daily dose should be taken in two or three separate doses.


Period pain:

2-6 tablets of Diclofenac T ratiopharm 25 mgper day taken in two to three doses.

The dose should be adapted to the individual case. A lower dose (2-4 tablets per day) should be taken at the start which may be increased in stages from period to period.

The treatment begins when the first symptoms of pain occur and continues for a few days depending on the intensity of the pain.


Migraine:

Take 2 tablets Diclofenac T ratiopharm 25 mg at the first signs of an attack.

In cases where pain relief in the 2 hours after the first tablets is not sufficient two further tablets can be taken. If necessary two additional Diclofenac T ratiopharm 25 mgtablets can be taken at 4 to 6 hour intervals. Do not take more than 8 tablets Diclofenac T ratiopharm 25 mgper day!


Use in children and adolescents:

For the short term treatment of pain related to infections of the ear, nose or throat and post-operative pain the following dosage should be given:

Usual dose for adolescents 12-16 years (45-55 kg): 1 tablet to be taken as required, maximum 3-4 times in a 24-hours period.

Usual dose for children 9-11 years (35-44 kg): 1 tablet to be taken as required, maximum 3 times in a 24-hours period.

Diclofenac T ratiopharm 25 mgshall not be used in children younger than 9 years of age.


If you take more Diclofenac T ratiopharm than you should

If an overdose with Diclofenac T ratiopharm is suspected, please inform your doctor immediately.


If you forget to take Diclofenac T ratiopharm

Do not take a double dose to make up for a forgotten dose but continue the treatment with the next dose.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.



4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Side effects of medicines are as a rule dose-dependent and differ from patient to patient. The risk particularly of gastrointestinal bleeding (ulcers, damage to the mucosa, inflammation of the gastric mucosa) depends on the dose range and period of use.


For evaluating side effects the following degrees of frequency have been established:


Serious side effects and countermeasures

Stop taking Diclofenac T ratiopharm and tell your doctor straight away if you notice:

If the following side effects appear you must inform a doctor as soon as possible:

Urticaria (a kind of skin rash with pale red, raised, itchy bumps). This is rare.


Other side effects

The following side effects may occur during treatment with Diclofenac T ratiopharm:


Common (may affect up to 1 in 10 users):


Rare (may affect up to 1 in 1,000 users):


Very rare (may affect up to 1 in 10,000 users):


Medicinal products like Diclofenac T ratiopharm are possibly related to a slightly increased risk of heart attack (cardiac infarct) or stroke.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.


5. How to store Diclofenac T ratiopharm


Keep this medicine out of the sight and reach of children.


Do not use the medicine after the expiry date which is stated on the outer carton and the blister after EXP. The expiry date refers to the last day of that month.


Do not store above 25 °C.


6. Contents of the pack and other information


What Diclofenac T ratiopharm contains


The active substance is diclofenac potassium.

Each film-coated tablet contains 25 mg of diclofenac potassium.


The other ingredients are:

Microcrystalline cellulose, lactose monohydrate, maize starch, carmellose sodium, magnesium stearate, anhydrous colloidal silica, hypromellose, glycerol 85 %, titanium dioxide (E171), red and yellow ferric oxide (E172).


What Diclofenac T ratiopharm looks like and contents the pack


Diclofenac T ratiopharm 25 mg is a red-brown, round, film-coated tablet with a diameter of 9.1 mm.


Diclofenac T ratiopharm 25 mg is available in packs with 10, 20, 30, 30x1, 100, 100x1 film-coated tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Marketing authorisation holder

[To be completed nationally]


Manufacturer

[To be completed nationally]


This leaflet was last revised in {month YYYY}.


2016-10-06

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