Modafen (Extra Grip), 12 coated tablets

Indications for use:

Modafen is used on an occasional basis to relieve symptoms of flu and colds, such as:

■ fever,

■ headache,

■ nasal and sinus obstruction,

■ joint and muscle pain.

The active substances of the drug are ibuprofen and pseudoephedrine hydrochloride. One film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch, pregelatinized starch, sodium lauryl sulfate, povidone 25, stearic acid, sodium starch glycolate (type C), colloidal anhydrous silica; shell composition: hypromellose, talc, titanium dioxide (E171), macrogol 6000, simethicone emulsion SE4.

Before use, read the leaflet, which contains indications, contraindications, data on adverse effects and dosage, and information on the use of the medicinal product, or consult a doctor or pharmacist, as any drug used improperly may threaten your life or health.

The medicine should be taken orally.
Adults and adolescents aged 12 years and over : the initial dose is 2 tablets, then, if necessary, 1 to 2 tablets every 4 to 6 hours. The maximum daily dose is 6 tablets.
The medicine should not be used in children under 12 years of age.
Elderly patients : it is not necessary to adjust the dosage, unless there is impaired liver or kidney function. In these patients, the dosage should be determined individually.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.
The medicine should not be used for longer than 3 days without a doctor’s recommendation. If it is necessary to use the medicine for longer than 3 days or if symptoms worsen, consult a doctor.
The film-coated tablets should be swallowed whole, without chewing, and with an adequate amount of water.
Taking a higher dose of Modafen Extra Grip than recommended
If you have taken a higher dose than recommended, contact a doctor or pharmacist immediately.
An overdose of ibuprofen may cause central nervous system disorders – headaches, dizziness, nystagmus, convulsions, which may even lead to loss of consciousness. Abdominal pain, nausea and vomiting may also occur. In severe cases, a decrease in blood pressure, acidosis, respiratory arrest and blue discoloration of the skin and mucous membranes have been observed. In addition, an overdose of pseudoephedrine may cause increased blood pressure (hypertensive crisis).
In the event of an overdose or accidental ingestion of a larger number of tablets, consult a doctor. The doctor will apply symptomatic and supportive treatment. Within the first hour of taking the drug, activated charcoal may be administered (adults: 50 g; children: 1 g/kg b.w.).
In all cases with symptoms of overdose, electrolyte levels should be checked and an electrocardiogram should be performed.
Missed use of Modafen Extra Grip
Do not take a double dose of the drug to make up for the missed dose.

When not to use Modafen Extra Grip

• if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs,
• in patients who have ever had allergy symptoms such as rhinitis, urticaria or asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• in case of stomach ulcer and/or active duodenum ulcer or history of perforation or bleeding, also after the use of NSAIDs,
• in case of severe circulatory system disease such as ischemic heart disease, severe hypertension, tachycardia,
• in the case of narrow-angle glaucoma,
• in case of severe liver failure,
• in case of severe renal failure,
• in case of concomitant use of other NSAIDs, including COX-2 inhibitors (increased risk of side effects),
• in case of urinary retention,
• in case of hyperthyroidism,
• in case of bleeding diathesis,
• if you have a history of haemorrhagic stroke or have risk factors that may increase the likelihood of haemorrhagic stroke, for example patients taking vasoconstrictor drugs or other oral or nasal decongestants.

The drug is contraindicated for use during pregnancy and breastfeeding.