DEXOFEN 25MG 10 TABLETS

• Dexofen is used to treat mild to moderate pain such as musculoskeletal pain, painful menstruation (dysmenorrhoea), and toothache.

Do not take Dexofen if:

• you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other ingredients of Dexofen;
• you are allergic to aspirin or other NSAIDs;
• you have asthma or if you have experienced asthma attacks, acute allergic rhinitis (inflammation of the nose for a short time), nasal polyps (growths in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking aspirin or other NSAIDs;
• are suffering from or have had a peptic ulcer, stomach or intestinal bleeding or have chronic digestive disorders (eg. indigestion, heartburn);
• you had a stomach or intestinal bleeding or perforation due to previous administration of nonsteroidal anti-inflammatory drugs (NSAIDs) for pain;
• have an intestinal disorder with chronic inflammation (Crohn's disease or ulcerative colitis);
• suffer from severe heart failure, moderate to severe renal impairment or severe hepatic impairment;
• have disorders related to bleeding;
• you are pregnant or breastfeeding;
• you are under 18 years old.

Take special care with Dexofen, if:

• If you are allergic or you have had allergic reactions;
• have kidney, liver or heart disorders (hypertension and/or heart failure) as well as fluid retention, or if you have suffered from any of these disorders in the past;
• you are taking diuretics or are dehydrated and have low blood volume due to excessive loss of fluids (such as frequent urination, diarrhea or vomiting);
• You have heart problems, a previous stroke or think that you might be at risk of these conditions (eg. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist. Drugs such as Dexofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose and duration of treatment;
• you are elderly as you may be more prone to side effects. If you experience any adverse reaction, consult your doctor;
• you are a woman who has trouble conceiving (Dexofen may impair your reproductive capacity. Therefore, it should not be taken if you are trying to become pregnant or are doing fertility tests);
• suffer from a disorder in blood formation or the formation of blood cells;
• you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
• if you have ever had a chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• have or have suffered in the past from other stomach or intestinal disorders;
• taking other drugs that increase the risk of ulceration or bleeding, for example. oral corticosteroids, some antidepressants (those of the SSRI type, ie. pomegranate. inhibitors of serotonin reuptake inhibitors), anti-clotting drugs, e. aspirin or anticoagulants such as warfarin. In these cases, consult your doctor before taking Dexofen. They may advise you to take extra medicine to protect the stomach (eg. Misoprostol or medicines that suppress gastric acid secretion).

Taking other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines should not be taken with others, or a change in dosage is required if administered simultaneously.

Always tell your doctor, dentist, or pharmacist if you are simultaneously using Dexofen and taking any of the following medications:

Combinations not recommended:

• acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs;
• warfarin, heparin or other anti-clotting drugs;
• Lithium used to treat certain mood disorders;
• methotrexate, used in cancer or rheumatoid arthritis;
• hydantoin and phenytoin, used for epilepsy;
• sulfamethoxazole used for bacterial infections.
• Combinations requiring special precautions:
• ACE inhibitors, diuretics, beta blockers and angiotensin-II antagonists, used for high blood pressure and heart problems;
• pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• zidovudine used to treat viral infections;
• aminoglycoside antibiotics used to treat bacterial infections;
• chlorpropamide and glibenclamide used for diabetes.

Combinations that must be applied with caution:

• quinolone antibiotics (eg. ciprofloxacin, levofloxacin) used for bacterial infections;
• cyclosporin or tacrolimus used to treat immune system diseases and in organ transplantation;
• streptokinase and other thrombolytic or fibrinolytic medicines, ie drugs for the destruction of blood clots;
• probenecid, used in gout;
• digoxin applied in the treatment of chronic heart failure;
• mifepristone, used to induce abortion (termination of pregnancy);
• antidepressants of the selective serotonin reuptake inhibitors of serotonin (SSRIs);
• antiplatelet drugs used for the inhibition of platelet aggregation, reduction of the concentration of the blood and blood clots.

If you have any doubts about taking other medicines with Dexofen, consult your doctor or pharmacist.

Taking Dexofen with food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food as this can reduce the risk of side effects from the stomach or of intestinal origin. However, if you are experiencing acute pain, take the tablets on an empty stomach, for example at least 30 minutes before a meal, as it will slightly accelerate the effect.

Children and adolescents

Do not take Dexofen, if you are under 18 years old.

Pregnancy and lactation

Do not take Dexofen during pregnancy and lactation.

Ask your doctor or pharmacist before taking any medicine.

Tell your doctor if you are pregnant or planning to become pregnant, as Dexofen may not be suitable for you.

If you are not sure you should take Dexofen while breastfeeding, consult your doctor.

Driving and operating machines

Dexofen may slightly affect your ability to drive and operate machines due to possible induction of dizziness or drowsiness as side effects. If you notice such effects, do not drive or operate machinery until your symptoms have resolved.

Keep out of reach of children!

Manufacturer: Berlin-Chemie, Germany

How to take Dexofen?

Always take Dexofen exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.

The dose of Dexofen depends on the type, intensity and duration of pain. Your doctor will determine how many tablets a day should be taken and the duration of therapy.

The recommended dose is generally 1 tablet (25 mg) every 8 hours but not more than 3 tablets per day (75 mg).

If you are elderly or if you suffer from impaired renal or hepatic function, you should start a treatment with a total daily dose of no more than 2 tablets (50 mg).

In elderly patients, the initial dose may be increased to the total recommended daily dose (75 mg), if Dexofen 25 mg was well tolerated.

If the pain is intense and you need fast relief, take the tablets on an empty stomach (at least 30 minutes before meals), as this would facilitate their absorption (see section. 2 Taking Dexofen 25 mg with food and drinks).

If you take too much Dexofen, tell your doctor or pharmacist or go to the emergency department of the nearest hospital. 

Do not take a double dose to make up for a missed one. Take the next regular dose as scheduled.

If you have any questions about using this medicine, ask your doctor or pharmacist.

The active substance is dexketoprofen trometamol (36,90 mg), corresponding to dexketoprofen (INN) 25 mg.

Other ingredients are: corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol palmitostearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000.