25 mg and 50 mg enteric tablets are 
diclofenac sodium

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

1. What Diclofenac Bluefish is and what it is used for

Diclofenac Bluefish belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines). The drug inhibits inflammation, relieves pain, and lowers fever.

Diclofenac Bluefish is used to treat rheumatic diseases such as rheumatoid arthritis.

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

What you need to know before you take Diclofenac Bluefish

Do not take Diclofenac Bluefish

  • if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had a recurring sore, bleeding, or broken wound in your stomach or duodenum a
  • if you have a history of bleeding or a broken wound in the gastrointestinal tract in connection with the use of painkillers ( NSAIDs )
  • if you have an increased tendency to bleed
  • if you have porphyria (a metabolic disease)
  • if you have severe liver or kidney function
  • if you have previously had allergic reactions such as asthma, runny nose, chest pain, or rash when taking painkillers containing acetylsalicylic acid or other pain/inflammation medicines within the group NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines)
  • during the last 3 months of pregnancy.
  • if you have known heart disease and/or disease of 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
  • if you have or have had problems with blood circulation ( peripheral vascular disease)

Tell your doctor if you have recently had or are about to have surgery on your stomach or intestinal tract before taking Diclofenac Bluefish, as Diclofenac Bluefish can sometimes impair the healing of wounds in the intestines after surgery.

Warnings and cautions

Talk to your doctor or pharmacist before taking Diclofenac Bluefish. Side effects can be minimized by treating with the lowest effective dose for the shortest possible time. In general, higher than recommended doses may increase the risk of side effects.

If you have or have had the following diseases, you should consult a doctor before starting treatment:

  • gastrointestinal upset, heartburn/discomfort in the stomach or previous sores, bleeding, or a broken wound in the stomach or intestines.
  • liver disease or kidney disease
  • asthma, chronic obstructive pulmonary disease (COPD), chronic respiratory infections, or inflammation of the nasal mucosa
  • SLE (connective tissue disease)
  • diseases with an increased tendency to bleed
  • angina, blood clots, high blood pressure
  • ulcerative colitis or Crohn’s disease
  • diabetes

Before you are given diclofenac, tell your doctor

  • if you smoke
  • if you have high cholesterol or triglyceride levels (blood fats).

Elderly people should be aware of the increased risk of side effects that exist in old age.

Like other anti-inflammatory drugs, Diclofenac Bluefish can in rare cases cause allergic reactions, including allergic shock reactions. This can also happen when taking diclofenac for the first time.

Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Diclofenac Bluefish and consult a doctor if you get a rash or other signs of hypersensitivity.

For chickenpox, this medicine should not be used.

Patients who develop gastrointestinal problems should stop taking Diclofenac Bluefish and consult a doctor.

Prolonged use of painkillers for headaches can aggravate the headache. If it is suspected or if so, medical advice should be sought and treatment discontinued.

Like other anti-inflammatory drugs, Diclofenac Bluefish can mask signs or symptoms of infection.

Medicines such as Diclofenac Bluefish may cause a slight increase in the risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time.

Using Diclofenac Bluefish can make it difficult for you to get pregnant. More information about this can be found in the section “Pregnancy and breastfeeding”.

Other medicines and Diclofenac Bluefish

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

Some agents may be affected by treatment with Diclofenac Bluefish, eg:

  • anticoagulants (eg warfarin, ticlopidine, acetylsalicylic acid, heparin ),
  • anti- tumor agents and disorders of the immune system (eg methotrexate),
  • medicines for the treatment of diabetes, except insulin,
  • lithium (used in manic depression),
  • SSRIs (used in depression),
  • digoxin (used for heart problems),
  • ciclosporin (used in transplants, severe psoriasis, and rheumatism),
  • certain medicines for high blood pressure (beta- blocker blockers, angiotensin II antagonists, and ACE inhibitors ),
  • diuretics ( diuretics also used for high blood pressure ),
  • quinolone antibiotics (used in urinary tract infections),
  • zidovudine (used to treat HIV ),
  • corticosteroids (used to treat inflammatory diseases),
  • colestipol or cholestyramine (used in high blood fats). These medicines can be used at the same time as diclofenac if diclofenac is taken at least 1 hour before or 4-6 hours after taking colestipol/cholestyramine.
  • tacrolimus (used in organ transplants, eg liver, kidney, and heart)
  • sulfinpyrazone (used to treat gout )
  • fluconazole or voriconazole (used for fungal infections),
  • rifampicin ( antibiotics for tuberculosis ),
  • carbamazepine (used in epilepsy ),
  • barbiturates (sleeping pills),
  • diazepam (sedatives),
  • pentoxifylline (vasodilators).
  • phenytoin (used in epilepsy ).

Never use several different painkillers at the same time without consulting a doctor or pharmacist.

Diclofenac Bluefish with food and drink

The enteric tablets must be swallowed whole with plenty of drink (at least 1 glass of water). For maximum effect, the tablets should not be taken with or immediately after a meal.

Pregnancy, breastfeeding, and fertility

Pregnant women should not use Diclofenac Bluefish during the last three months of pregnancy. Taking Diclofenac Bluefish should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Small amounts of diclofenac pass into breast milk. Therefore, Diclofenac Bluefish should not be used during breast-feeding.

Using Diclofenac Bluefish can make it harder for you to get pregnant. Talk to your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant. The effect is temporary and stops when you stop taking this type of medicine.

Driving and using machines

Diclofenac Bluefish can cause side effects such as visual disturbances, dizziness, and drowsiness. If you get any of these or other side effects that affect your ability to react, you should refrain from driving or using machines.

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 Bluefish 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.

Diclofenac Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 25 mg and 50 mg tablets respectively, ie essentially ‘sodium-free’.

3. How to take Diclofenac Bluefish

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Rheumatic diseases

The usual dose for adults: 75-150 mg daily in 2-3 divided doses depending on the disease activity.

Note that the total dose for one day should not exceed 6 tablets of 25 mg or 3 tablets of 50 mg.

Gastro-resistant is to be swallowed whole by at least 1½ glasses of water.

If you have the impression that the effect of Diclofenac Bluefish is too strong or too weak, talk to your doctor or pharmacist.

If you take more Diclofenac Bluefish then 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 immediately for assessment of the risk and advice.

Symptoms of overdose may include nausea, vomiting, abdominal pain, stomach ulcers, diarrhea, dizziness, drowsiness, headache, tinnitus, anxiety, hallucinations, cramps, and swelling in the body.

If you forget to take Diclofenac Bluefish

Do not take a double dose to make up for a forgotten 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.

Disorders of the gastrointestinal tract may occur at the beginning of treatment. The problems usually disappear within a few days.

Serious side effects are

If any of the following occur, stop taking Diclofenac Bluefish and seek medical attention immediately.

  • Agranulocytosis (symptoms: fever, sore throat, painful sores in the mouth, sores in the anal, weakened immune system, easier to suffer from bacterial infections ).
  • Steven Johnson syndrome and toxic epidermal necrolysis (life-threatening diseases that cause skin rashes, skin peeling, and sore mucous membranes).
  • Mild cramping and tenderness in the abdomen, which begins shortly after starting treatment with Diclofenac Bluefish 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).
  • Hypersensitivity reaction (spasm of the trachea, hives, allergic shock reaction with a drop in blood pressure).
  • Chest pain, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome.
  • Angioedema (symptoms: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing).

Common (may affect up to 1 in 10 people): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, flatulence, headache, dizziness, skin rash, and elevated liver values.

(These may affect up to 1 in 100):  Tr ötthet, bronchospasm.

Rare (may affect up to 1 in 1,000 people): Hypersensitivity reactions, anaphylactic reactions (severe hypersensitivity reactions which may lead to difficulty breathing and shock (with a drop in blood pressure, pallor, anxiety, weak and fast pulse, sticky skin, and decreased consciousness)), asthma (including shortness of breath), drowsiness, swelling in the body due to fluid retention, inflammation of the stomach, stomach ulcers, stomach bleeding, blood-mixed vomiting, blood in the stool, liver dysfunction (hepatitis, jaundice), hives, impotence (connection uncertain).

Very rare (may affect up to 1 in 10,000 people): Angioneurotic edema (rapid swelling of the skin and mucous membranes), effects on vision (blurred vision, double vision) and hearing (impaired hearing, tinnitus), effects on the blood picture (reduced number of platelets that can cause minor bleeding in the skin and mucous membranes, decreased number of white blood cells that can impair the immune system, decay of red blood cells , anemia ), confusion, depression, difficulty sleeping, nightmares, irritability, anxiety, disturbed perception of reality, abnormal skin reactions (eg tingling) memory disorders, seizures (involuntary muscle cramps), tremors in the hands and arms, taste changes,meningitis (germ), stroke , effects on heart and vascular (e.g., chest pain, palpitations, heart failure , myocardial infarction, high blood pressure , vascular inflammation), pneumonia , colon disorders (including inflammation of the colon or worsening ulcerative colitis and Crohn’s disease ), constipation, inflammation in oral mucosa, tongue or esophagus, inflammation of the pancreas, intestinal stricture, hepatic impairment (including acute hepatitis, hepatocellular death and liver failure), eczema, skin redness, skin inflammation, hair loss, photosensitivity reactions, itching , slight bleeding in the skin (purpura), blister-like skin rash, severe skin reactions such as Steven-Johnson syndrome and toxic epidermal necrolysis , effects on the kidneys ( kidney failure and blood or egg whites in the urine).

Stomach bleeding can occur at any time during treatment with or without warning symptoms. This generally has more serious consequences for the elderly. If this or other unexpected symptoms occur, consult a physician.

In rare cases, severe skin infections are associated with chickenpox.

Diclofenac Bluefish may cause a decrease in the number of white blood cells and reduced resistance to infection. If you suffer from infection with fever and a worsening general condition or fever and local infection symptoms from e.g. throat, pharynx, and mouth or urinary tract, a doctor should be consulted immediately. A blood test is taken to examine a possible decrease in the number of white blood cells( agranulocytosis ). It is important to inform your doctor about your medicine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Diclofenac Bluefish

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

Do not use this medicine after the expiry date which is stated on the carton after 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 diclofenac sodium 25 mg and 50 mg respectively
  • The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, maize starch, macrogol, methacrylic acid ethyl acrylate copolymer, dimethicone, polysorbate 80, sorbic acid and E217; yellow iron oxide E172, titanium dioxide E171).

What the medicine looks like and the contents of the pack

25 mg enteric tablets:  curved, film-coated yellow tablets, diameter 7 mm, marked D 25.

50 mg enteric tablets:  curved, film-coated brown tablets, diameter 8 mm, marked D 50.

Blister packs:

25 mg enteric tablets:  10, 20, 30, 50 and 100 

50 mg enteric tablets:  10, 20, 30, 50 and 100 

Not all pack sizes may be marketed.

Manufacturer

Dragenopharm Apotheker Püschl GmbH

Otto Göllstrasse 1

84529 Tittmoning

Germany

Muhammad Nadeem

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