25 mg and 50 mg film-coated tablets 
diclofenac potassium

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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 take Diclofenac T ratiopharm to be stored 
6. Contents of the packaging and other information 

What Diclofenac T ratiopharm is and what it is used for

Diclofenac T ratiopharm 25 mg and 50 mg contain diclofenac potassium.

Diclofenac T ratiopharm acts against pain (is an analgesic) and inflammation (is an anti-inflammatory). Drugs with these or similar properties are also called “non-steroidal anti-inflammatory drugs” or NSAIDs – preparations.

Diclofenac T ratiopharm is used for:

Adults and young people over 16 years

Short-term treatment of the following conditions:

  • rheumatic diseases of the soft tissues (eg bursitis or tendinitis)
  • pain or inflammation after injury and surgery (including dental surgery)
  • menstrual pain (primary dysmenorrhea )
  • acute treatment of migraine with or without aura.

Children and young people

Diclofenac T ratiopharm 25 mg: short-term treatment of symptoms in:

  • pain caused by an inflammatory infection in your ear, nose, or throat
  • acute pain after minor surgery.

Diclofenac T ratiopharm 25 mg: Diclofenac T ratiopharm should not be given to children under 9 years of age.

Diclofenac T ratiopharm 50 mg: Diclofenac T ratiopharm should not be given to children under 16 years of age.

Diclofenac contained in Diclofenac T ratiopharm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Diclofenac T ratiopharm

Do not take Diclofenac T ratiopharm

  • if you think you may be allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the ingredients of this medicine (listed in section 6 at the end of this leaflet). Signs of a hypersensitivity reaction may include swelling of the face and mouth ( angioedema ), difficulty breathing, chest pain, runny nose, rash, or any other type of allergic reaction.
  • If you have bleeding or perforation ulcers in the stomach or duodenum a
  • if you have had bleeding or a broken wound in the stomach or intestines in connection with previous use of painkillers ( NSAIDs )
  • if you have had ulcers or bleeding in your stomach on two or more occasions
  • during the last three months of pregnancy
  • if you have severe liver or kidney function
  • if you have known heart disease and/or disease in the blood vessels of the brain e.g. heart attack, stroke, “mini-stroke” ( transient ischemic attack, TIA ). You may also have had narrowing of the blood vessels to the heart or brain, or have had surgery for such narrowing by clearing blood vessels one or through a bypass operation you have or have had problems with blood circulation ( peripheral vascular disease)
  • if you have hepatic porphyria (a specific hemoglobin-forming disease)
  • if you have bleeding disorders and an increased tendency to bleed
  • if you have previously had an allergic reaction, such as asthma attacks, sneezing, or rash, when using acetylsalicylic acid (ASA) or other pain/inflammation medications within the NSAID group.

Warnings and cautions

Talk to your doctor or pharmacist before taking Diclofenac T ratiopharm:

  • if you have recently had surgery or are about to have surgery on your stomach or intestinal tract, diclofenac can sometimes impair wound healing in the intestines after surgery.
  • if you suffer from asthma (a respiratory disease with shortness of breath), seasonal allergic rhinitis (hay fever), swelling of the mucous membranes of the nose, chronic lung disease, or respiratory infection
  • if you have a blood clotting disease
  • if you have impaired kidney function
  • if you have lost a lot of fluid (eg before or after a major operation)
  • if you have liver disease
  • if you have ulcerative colitis or Crohn’s disease (a certain intestinal disease)
  • if you are at risk of infection
  • if you smoke
  • if you have diabetes
  • if you have angina, blood clots, high blood pressure, high cholesterol, or triglyceride levels (blood fats).

Side effects can be minimized by treating with the lowest effective dose for the shortest possible time needed to keep symptoms under control.

Prolonged use of all types of painkillers for headaches can aggravate the headache. If you have or think you may have such a headache, you should seek medical advice and stop treatment.

Laboratory test

When you take Diclofenac T ratiopharm for a long time, your doctor will regularly check your liver values, your kidney function, and your blood value.

Bleeding in the gastrointestinal tract, ulcers, and perforation

Treatment with non-steroidal anti-inflammatory drugs ( NSAIDs ) can cause gastrointestinal bleeding, ulcers, and perforation, possibly fatal. The risk of becoming ill is higher:

  • at higher dose s of NSAID -preparat
  • in patients who have already had stomach ulcers, especially if they have involved bleeding or perforation
  • in elderly patients.

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

  • low dose acetylsalicylic acid (ASA) as a blood thinner
  • other drugs that increase the risk of gastrointestinal disease

Your doctor may prescribe a medicine to protect your stomach.

If you have previously had any side effects from the gastrointestinal tract, you should report any unusual abdominal symptoms to your doctor. This is especially true of bleeding from the stomach or intestines. Such bleeding is recognized on black vomit or feces. Older people are at greater risk.

If you have bleeding or ulcers in the gastrointestinal tract while taking Diclofenac T ratiopharm, treatment must be stopped.

Effects on blood vessels in the heart and brain

Drugs such as Diclofenac T ratiopharm may be associated with a slightly increased risk of heart attack (heart attack) or stroke. The risk is greater with high doses and longer treatment periods. Do not exceed the recommended dose or the duration of treatment.

Skin reactions

There have been very rare reports of serious skin reactions, when treated with NSAIDs, with skin redness and blistering, sometimes with fatal outcomes. At the first symptoms that affect the skin or mucous membranes, stop using Diclofenac T ratiopharm and tell your doctor immediately. This also applies to other signs of a sensitivity reaction (see also section 4).

Elderly patients

An adverse reaction is occurring more frequently in elderly or physically frail elderly patients who take NSAIDs preparation. Bleeding and perforation of the gastrointestinal tract are particularly worrying conditions, which in some cases can be life-threatening.

Children and young people

Diclofenac T ratiopharm 25 mg: Diclofenac T ratiopharm tablets should not be used by children under 9 years of age.

Diclofenac T ratiopharm 50 mg: Diclofenac T ratiopharm tablets should not be used by children under 16 years of age.

Other medicines and Diclofenac T ratiopharm

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

You should avoid taking Diclofenac T ratiopharm while:

  • other anti-inflammatory and analgesic drugs from the non-steroidal anti-inflammatory drug group ( NSAID )
  • COX ‑ 2 inhibitors (which are also anti-inflammatory substances).
  • glucocorticosteroid s (antiinflammatory drugs/cortisone)

Your doctor will decide this on a case-by-case basis.

Take special care with Diclofenac T ratiopharm when taking:

  • digoxin (a drug to increase strength and power in the heart)
  • lithium (a medicine for the treatment of mental/emotional disorders)
  • drugs that act against fluid retention ( diuretics )
  • drugs that increase potassium levels in the blood
  • drugs to lower blood pressure et including beta-blockers, ACE inhibitors, and angiotensin -II receptor antagonist s (although they are drugs for the treatment of heart failure and blood pressure lowering)
  • certain antidepressants (selective serotonin reuptake inhibitors / SSRIs)
  • methotrexate (another medicine for rheumatism)
  • blood thinners such as warfarin (to prevent blood clots)
  • cyclosporine (inhibits the body’s immune system)
  • medicines that lower blood sugar (antidiabetic)
  • quinolone antibiotics (a medicine for bacterial infections )
  • cholesterol / cholestyramine (lipid-lowering drug).
  • phenytoin (a medicine used to treat epilepsy )
  • voriconazole (a medicine used to treat fungal infections)
  • sulfinpyrazone (anti-gout medicine )

Pregnancy

You must not take Diclofenac T ratiopharm during the last three months of pregnancy. It poses a danger to the health of the mother and the child. During the first 6 months of pregnancy, you should only take Diclofenac T ratiopharm after consulting your doctor.

Breast-feeding

The active substance, diclofenac, passes in small amounts into breast milk. Therefore, diclofenac T ratiopharm should not be used during breast-feeding.

Female fertility

Like other drugs that inhibit prostaglandin synthesis (formation of certain tissue hormones), Diclofenac T ratiopharm may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or have had problems getting pregnant.

Driving and using machines

Diclofenac T ratiopharm can cause side effects such as vision changes, dizziness, dizziness, and drowsiness. As a result, your ability to react may change and your ability to drive and use machines may deteriorate.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Diclofenac T ratiopharm contains

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 medicine.

This medicine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie it is essentially ‘sodium-free’.

3. How to take Diclofenac T ratiopharm

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Method of administration

Take Diclofenac T ratiopharm without chewing the tablet and with a small amount of liquid, preferably before a meal.

Treatment time

The doctor who treats you will decide how long the treatment should last.

The recommended dose is

Adults and adolescents over 16 years:

Diclofenac T ratiopharm 25 mg: The starting dose is usually 4-6 tablets 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.

Diclofenac T ratiopharm 50 mg: The starting dose is usually 2-3 tablets Diclofenac T ratiopharm 50 mg per day. In milder cases, a dose of 1-2 tablets of Diclofenac T ratiopharm 50 mg per day is usually sufficient. The daily dose should be taken in two or three separate doses.

Menstrual pain:

Diclofenac T ratiopharm 25 mg: 2-6 tablets Diclofenac T ratiopharm 25 mg per day is taken in two to three doses.

Dose one should be adapted to the individual case. A lower dose (2-4 tablets per day) should be taken at the beginning, which can then be increased gradually from menstruation to menstruation.

Treatment begins when the first pain symptoms appear and continues for a few days depending on the intensity of the pain.

Diclofenac T ratiopharm 50 mg: 1-3 tablets Diclofenac T ratiopharm 50 mg per day is taken in two to three doses.

Dose one should be adapted to the individual case. A lower dose (1-2 tablets per day) should be taken at the beginning, which can then be increased gradually from menstruation to menstruation.

Treatment begins when the first pain symptoms appear and continues for a few days depending on the intensity of the pain.

Migraine:

Diclofenac T ratiopharm 25 mg: Take 2 tablets Diclofenac T ratiopharm 25 mg at the first signs of an attack. In cases where pain relief within 2 hours after the first tablets is not sufficient, two more tablets can be taken. If needed, two additional Diclofenac T ratiopharm 25 mg tablets can be taken at 4 to 6-hour intervals.

Do not take more than 8 tablets of Diclofenac T ratiopharm 25 mg per day!

Diclofenac T ratiopharm 50 mg: Take 1 tablet Diclofenac T ratiopharm 50 mg at the first signs of an attack. In cases where pain relief within 2 hours after the first tablet is not sufficient, another tablet may be taken. If needed, additional Diclofenac T ratiopharm 50 mg tablets can be taken at 4 to 6-hour intervals.

Do not take more than 4 tablets of Diclofenac T ratiopharm 50 mg per day!

Use for children and adolescents

Diclofenac T ratiopharm 25 mg: For short-term treatment of pain caused by an infection in the ear, nose, or throat and pain after surgery, the following dose should be given:

The usual dose for adolescents 12-16 years (45-55 kg): 1 tablet is taken as needed, no more than 3-4 times during a 24 hour period.

The usual dose for children 9-11 years (35-44 kg): 1 tablet is taken as needed, no more than 3 times during a 24 hour period.

Diclofenac T ratiopharm should not be used by children under 9 years of age.

Diclofenac T ratiopharm 50 mg: Diclofenac T ratiopharm should not be used in children under 16 years of age.

If you take more Diclofenac T ratiopharm than you should:

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Diclofenac T ratiopharm

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

If you have any further questions on the use of this product, 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 drugs are usually dose-dependent and vary from patient to patient. The risk, especially for bleeding in the gastrointestinal tract (ulcers, damage to the mucous membranes, inflammation of the lining of the stomach ), depends on the dose range and duration of treatment.

Serious side effects and countermeasures

Stop taking Diclofenac T ratiopharm and tell your doctor immediately if you notice the following :

  • Increased heart rate, a drop in blood pressure with shock (signs of severe hypersensitivity reactions ). This can happen when you take Diclofenac T ratiopharm for the first time, but it is rare.
  • Swelling of the face, lips, mouth, tongue, or throat may cause difficulty in swallowing or breathing ( angioedema ), but it is very rare.
  • Severe skin reactions with blisters, red or purple marks, or flaking of the skin. It can also affect the mouth, eyes, and other mucous membranes. ( Stevens-Johnson syndrome, toxic epidermal necrolysis, or Erythema multiforme). This is very rare.
  • Severe pain in the upper abdomen, vomiting, blood-mixed vomiting, blood-mixed diarrhea, and black stools (signs of gastrointestinal bleeding or gastric ulcer). This is rare. 
  • Mild cramping and tenderness in the abdomen, which begins shortly after starting treatment with Diclofenac T ratiopharm and is followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (reported, occurring in an unknown number of users).
  • Superficial damage to the mouth, fever, sore throat, nosebleeds and bruising, flu-like symptoms, severe fatigue (signs of blood clotting, decreased number of different types of blood cells). This is very rare. Do not take painkillers or medicines to lower the fever.
  • Severe headache, nausea, vomiting, fever, stiff neck, or loss of consciousness (signs of meningitis ). This is very rare.
  • Decreased urinary excretion, retention of water in the body, and general malaise (signs of kidney disease or kidney failure ). This is very rare.

If you get any side effects, talk to your doctor as soon as possible:

  • Urticaria (a type of skin rash with light red, raised, itchy lumps). This is rare.

Other side effects are

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

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

  • Headache, dizziness
  • The sensation of spinning or swaying (dizziness)
  • Upper abdominal pain, nausea, vomiting, diarrhea, indigestion, flatulence, loss of appetite
  • Elevated liver enzyme levels in the blood
  • Skin rash and irritation

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

  • Drowsiness
  • Wheezing and shortness of breath ( asthma )
  • Liver disease including inflammation of the liver with or without jaundice
  • Inflammation of the gastric mucosa, gastric and duodenal ulcers (optionally with bleeding and perforation )
  • Fluid retention in the body, symptoms include swollen ankles ( edema )

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

  • Mental/emotional disorders, depression, anxiety, nightmares
  • Mental and emotional illnesses, disorders of the normal perception of time and space, insomnia, irritability, seizures, tremors
  • Disorders of the taste buds
  • Tingling and numbness in fingers
  • Visual disturbances, (blurred vision or double vision)
  • Tinnitus and hearing loss
  • Palpitations or irregular heartbeat, chest pain, heart failure, heart attack, high blood pressure
  • Inflammation of blood vessels ( vasculitis )
  • Pneumonia ( pneumonitis )
  • Symptoms of the lower abdomen such as bleeding in the gastrointestinal tract and inflammation, worsening of Crohn’s disease / ulcerative colitis
  • Inflammation of the mouth or tongue, damage to the esophagus, constipation.
  • Inflammation of the pancreas
  • Very severe progressive hepatitis B ( inflammation of the liver) and severe liver disease
  • Slight spotting under the skin (purpura, also caused by allergies ), rash, eczema, photosensitivity, reddening of the skin, itching
  • Hair loss
  • Acute renal dysfunction, protein in the urine, blood in the urine, nephrotic syndrome (retention of water in the body and greater excretion of protein ), damage to the kidney tissue
  • Difficulty getting an erection ( impotence )

No known frequency (cannot be calculated from the available data):

  • Chest pain, which can be a sign of a potentially serious allergic reaction called Kuoni’s syndrome. Talk to your doctor immediately if you notice chest pain.

Drugs such as Diclofenac T ratiopharm may be associated with a slightly increased risk of heart attack (heart attack) or stroke.

5. How to store Diclofenac T ratiopharm

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. / EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is 25 mg and 50 mg of diclofenac potassium respectively.
  • The other ingredients for 25 mg are microcrystalline cellulose, lactose monohydrate, maize starch, carmellose sodium, magnesium stearate, anhydrous colloidal silica, hypromellose, glycerol 85%, titanium dioxide (E171), red and yellow iron dioxide (E172).
  • The other ingredients for 50 mg are microcrystalline cellulose, lactose monohydrate, maize starch, croscarmellose sodium, magnesium stearate, anhydrous colloidal silica, hypromellose, glycerol 85%, talc, titanium dioxide (E171), red and yellow iron dioxide (E172).

What the medicine looks like and the contents of the pack

Diclofenac T ratiopharm 25 mg tablets are reddish-brown, round, film-coated tablets, 9.1 mm in diameter.

Diclofenac T ratiopharm 25 mg is available in packs of 10, 20, 30, 30×1, 100, 100×1 film-coated tablets. Not all pack sizes may be marketed.

Diclofenac T ratiopharm 50 mg tablets are reddish-brown, round, biconvex, film-coated tablets, 11.1 mm in diameter.

Diclofenac T ratiopharm 50 mg is available in packs of 10, 20, 20×1, 30, 50, 50×1, 100, 100×1 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany

Muhammad Nadeem

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