MODAFEN 12 FILM-COATED TABLETS

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Composition:
- Active substances are: ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.
- The other ingredients are: core: lactose monohydrate, corn starch, microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate (type C), sodium lauryl sulfate, povidone K25, stearic acid, colloidal anhydrous silicon dioxide. Film: hypromellose 2910/3, talc, titanium dioxide (E 171), macrogol 6000, simethicone emulsion SE4.

Indications:
Modafen belongs to the group of nasal decongestant drugs for systemic use, sympathomimetics, combinations, used to relieve the unpleasant symptoms of flu and colds, such as nasal and sinus congestion, headache, fever, muscle and joint pain. It contains ibuprofen, which is effective in relieving pain (analgesic drug), inflammation (anti-inflammatory drug) and reducing fever in case of fever (antipyretic drug). The other active substance, pseudoephedrine hydrochloride, reduces edema of the mucous membranes of the upper respiratory tract (decongestant drug).

Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy. Do not take Modafen if you are pregnant or breastfeeding.

Driving and using machines
Due to the adverse reactions it can cause (eg: visual disturbances, dizziness), the drug may affect the ability to drive or operate machinery.

Dosage and method of administration:

Adults and adolescents: the initial dose is 2 film-coated tablets; subsequently, if necessary, 1-2 film-coated tablets every 4-6 hours for the duration of the symptoms - usually 3-5 days. A daily dose of 6 film-coated tablets should not be exceeded. It is recommended to administer the film-coated tablets with a small amount of food or with milk; the tablets are swallowed whole, unchewed. In the elderly, no specific dose reduction is necessary, except in cases where renal or hepatic function is impaired. In the case of hepatic or renal disorders, the dose must be adjusted individually. If symptoms worsen or persist for more than 3 days, it is necessary to re-evaluate the diagnosis and treatment.

Contraindications:
Do not use Modafen - if you are allergic (hypersensitive) to ibuprofen, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, pseudoephedrine hydrochloride or any of the other ingredients of Modafen,
- If you have had bronchospasm attacks (feeling of chest tightness, wheezing and shortness of breath), rhinitis or urticaria to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
- If you have or have had gastric and duodenal ulcer, gastrointestinal bleeding, ulcerative colitis (two or more distinct episodes of ulceration or bleeding),
- If you have or have had a stroke.
- If you have severe heart failure (decreased pumping capacity).
- If you have high or uncontrolled blood pressure.
- If you have angina pectoris (chest pain).
- If you have increased thyroid gland activity.
- If you have diabetes.
- If you have pheochromocytoma.
- If you have epilepsy.
- If you have a form of closed-angle glaucoma.
- If you have prostatic hyperplasia.
- If you have severe renal failure.
- If you have severe hepatic failure.,
- If you have systemic lupus erythematosus.
- If you are taking certain antidepressants (called tricyclic antidepressants and monoamine oxidase inhibitors).
- If you are under 12 years old.
- If you are pregnant or breastfeeding.

Adverse reactions:
Like all medicines, Modafen can cause side effects, although not everybody gets them. Medicines such as Modafen may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. The following adverse reactions have been observed during the administration of ibuprofen: Gastrointestinal disorders: abdominal pain, nausea, vomiting, intestinal transit disorders and dyspepsia (difficult digestion). Very rarely, active ulcer and gastrointestinal bleeding may occur.
Immune system disorders
Pseudoephedrine adverse reactions include: dyspepsia (difficult digestion), gastrointestinal disorders, bleeding, nausea, vomiting, diarrhea, polydipsia (excessive thirst), allergic reactions, hyperhidrosis, headache, dizziness, palpitations, tachycardia (abnormally fast heartbeat), arrhythmias (abnormal heart rhythm), hypertensive crises, closed-angle glaucoma attacks, restlessness, insomnia, urinary problems (painful and difficult urination to the point of inability to urinate) especially in case of pre-existing urethro-prostatic conditions.