Spedifen contains the active ingredient ibuprofen in the form of arginine salt.

This substance relieves pains, exerts an anti-inflammatory effect and lowers fever. Generally, the onset of action occurs after about 30 minutes.

Spedifen is indicated for pains of various origin and in acute inflammations, such as:

•  muscle pain, painful inflammations following surgical interventions or caused by lesions, toothache, headache;

•  period pain;

•  lumbar pain;

•  chronic rheumatic pain, such as joint pain and inflammations and joint morning stiffness, typical of arthrosis.

•  fever, such as during influenza. Spedifen is subject to medical prescription.

Diabetic subjects should take into account that Spedifen granules contain sugar (sucrose). Each 400 and 600 mg sachet contains 1.8 and 1.3 mg sucrose respectively, corresponding to 30 and 22 KJ respectively or 0.18 and 0.13 CU (Carb Units) respectively.

When Spedifen cannot be used Spedifen should not be used:

•  if you are allergic to any of the ingredients of this medicine or if you experienced pseudo allergic skin reactions or respiratory difficulties after the use of acetylsalicylic acid or other painkillers or ant rheumatic agents, i.e. the so-called non-steroidal anti-inflammatory drugs;

•  during the third trimester of pregnancy;

•  if you suffer from gastric and/or duodenal ulcer or gastrointestinal bleeding;

•  in the presence of chronic intesti- nal inflammations (Crohn’s disease, ulcerative colitis);

•  in case of severe renal or hepatic failure;

•  in case of severe heart failure;

•  for the treatment of postoperative pain, after a coronary artery bypass graft surgery (or after use of a heart-lung machine)

When special caution is required while using Spedifen

Ulcerations of the upper gastrointestinal tract, rarely haemorrhages or, in isolated cases, perforations (gastrointestinal perforations) may occur during treatment with Spedifen.

These complications may appear at any time during treatment, also in the absence of warning symptoms. In order to minimize this risk, your doctor prescribes you the lowest effective dose for the shortest duration necessary to control symptoms. Inform your doctor if you have a stomach- ache which you think may be due to this medicine.

An increased risk of heart attack and stroke has been reported for certain painkillers, the so-called COX-2 inhibitors, when used in high doses and for prolonged time periods. It is still unknown whether such increased risk extends also to Spedifen.

If you have already had a heart attack, a stroke or a venous thrombosis, or if you present with some risk factors (such as high blood pressure, diabetes mellitus, high cholesterol levels, ore are a smoker), your doctor will decide if you can still take Spedifen. In any case, tell your doctor about that.

The administration of Spedifen may impair the renal function, and this may lead to an increase in blood pressure and/or water retention (oedemas).

Inform your doctor if you suffer from heart or renal diseases, if you take medicines against hypertension (such as diuretics or ACE-inhibitors) or in case of increased water loss, e.g. heavy transpiration.

This medicine may impair the ability to react and to drive and use tools or machines.

Please tell your doctor or pharmacist if you suffer from other diseases, allergies or use any other medicines (including medicines obtained without a prescription!)

Use of Spedifen during pregnancy or breast-feeding

Pregnancy

If you are pregnant or are planning to have a baby, ask your doctor for advice before taking Spedifen.

Breast-feeding

Spedifen should not be administered during breast-feeding, unless expressly prescribed by your doctor.

For adults and children from 12 years of age, the usual single dose ranges from 400 to 600 mg, but should never exceed 800 mg. The usual daily dose ranges from 1200 to 1800 mg, to be divided into 3 separate administrations. Your doctor may however prescribe for you a daily dose of 2400 mg. Spedifen should not be given to children under 12 years of age.

Dissolve the content of one sachet into a glass of water (do not use sparkling mineral water), shake well and drink. Film- coated tablets are to be taken with some liquid.

Do not change deliberately the prescribed posology. If you think that the effect of this medicine is too weak or too strong, please talk to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist who have at disposal a professional documentation about the medicine.

The following side effects may occur after Spedifen administration: gastrointestinal disorders (heartburn or stomach-ache, nausea, vomiting, diarrhoea, appetite loss or constipation), reactivity impairment (in particular with the concomitant use of alcohol), headache, dizziness, somnolence, anxiety, confusion, ear buzzing, hearing deficiency, visual disturbances. Sometimes also hypersensitivity skin reactions (reddening, itching) have been observed. In all these cases it is suggested to discontinue the treatment and talk to the doctor or the pharmacist.

If during treatment you experience sore throat (angina), high fever and swollen glands in the neck (all symptoms of a very rare disease), upper abdominal pain and/ or black discoloration of the stool, stop taking this medicine and seek immediate medical help.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Store the medicine below 30°C, away from humidity and out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after “EXP”.