Description

Modafen Extra Grip is an analgesic, anti-inflammatory, and antipyretic drug that reduces mucous membrane congestion and unclogs the nose and sinuses.

Composition

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, maize starch, pregelatinized starch, sodium lauryl sulfate, povidone 25, stearic acid, sodium starch glycolate (type C), colloidal anhydrous silica; coating composition: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, simethicone emulsion SE4.

Dosage

The drug should be taken orally.

Adults and adolescents 12 years of age and over: initial dose: 2 tablets, then 1 to 2 tablets every 4 to 6 hours as needed. Maximum daily dose: 6 tablets.

Elderly patients: No dosage adjustment is necessary unless hepatic or renal function is impaired. In these patients, dosage should be individually adjusted.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.

This medicine should not be used for longer than 3 days without consulting a doctor. If you need to use this medicine for longer than 3 days or if your symptoms worsen, consult your doctor.

The coated tablets should be swallowed whole, without chewing, and with a sufficient amount of water.

Indications

Modafen Extra Grip is used on an ad hoc basis to relieve the symptoms of flu and colds, such as:

• fever
• headache
• nasal obstruction (runny nose) and paranasal sinuses
• joint and muscle pain

Contraindications

When not to use Modafen Extra Grip:

• if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine 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 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 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 hemorrhagic stroke or have risk factors that may increase the likelihood of hemorrhagic stroke, for example, patients taking vasoconstrictor drugs or other oral or nasal decongestants.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (less than 1 in 10 patients, but more than 1 in 100 patients) side effects: drowsiness, dizziness.

Uncommon (less than 1 in 100 patients but more than 1 in 1,000 patients) side effects: hypersensitivity reactions such as hives and itching; anxiety, insomnia, restlessness, hallucinations, headaches; collapse; taste disturbances; palpitations; abdominal pain, nausea and indigestion.

Rare (less than 1 in 1,000 patients, but more than 1 in 10,000 patients) side effects: blurred vision, tear flow disorders; diarrhea, flatulence, constipation, vomiting.

Very rare (in less than 1 in 10,000 patients and in isolated cases) side effects: changes in blood count - anemia, leukopenia (reduction in the number of white blood cells), thrombocytopenia (reduction in the number of platelets), pancytopenia (reduction in the number of all types of blood cells, i.e. white, red and platelets), agranulocytosis (significant reduction in the number of a certain type of white blood cells - granulocytes or absence of granulocytes in the blood) - the first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, nosebleeds or subcutaneous bruising; in patients with autoimmune diseases (such as systemic lupus erythematosus, mixed connective tissue disease) during the use of ibuprofen, isolated cases of aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever, disorientation have been observed; Severe hypersensitivity reactions – swelling of the face, tongue and larynx, shortness of breath, increased heart rate, hypotension (lowering of blood pressure), anaphylactic reaction, angioedema or severe shock; worsening of asthma and bronchospasm; rapid muscle fatigue; hypertension, tachycardia, vasodilation; tarry stools, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; gastric and/or duodenal ulcer, perforation or gastrointestinal bleeding; liver disorders (especially during long-term use); severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis; painful or difficult urination; decreased urine output, edema, acute renal failure, renal papillary necrosis (especially during long-term use), increased urea concentration in the blood serum.

Side effects occurring with unknown frequency (frequency cannot be estimated from the available data): acute generalized pustular eruption, manic symptoms such as insomnia, elevated mood or irritability, inflated self-esteem, increased activity or restlessness, racing thoughts, accelerated speech rate, impaired concentration, tachycardia, urinary retention.
Sudden fever, skin redness, or many small pimples (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of taking Modafen Extra Grip.

A serious skin reaction known as DRESS syndrome can occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).

Edema, hypertension and heart failure have been reported in association with NSAID treatment.

Taking medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Due to the presence of pseudoephedrine in the drug, gastrointestinal disorders, dyspepsia, nausea, vomiting, ischemic colitis, excessive sweating, dizziness, increased thirst, increased heart rate, heart rhythm disturbances, anxiety and insomnia, flushing and rashes may occur. Rarely, urinary disorders, decreased muscle tone, tremor, anxiety, disorientation, and thrombocytopenia may occur. Unknown frequency (frequency cannot be estimated based on available data): urinary retention may occur, mainly in men with prostatic hyperplasia.

Warnings and precautions

• Modafen Extra Grip contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Modafen Extra Grip.
• Keep out of the sight and reach of children.
• Store below 25°C.

Use of other medications

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

Modafen Extra Grip may affect how other medicines work, or other medicines may affect how Modafen Extra Grip works. For example:

• medicines with anticoagulant activity (i.e. blood thinning/preventing clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine).
• medicines to lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Modafen Extra Grip should not be used concomitantly with monoamine oxidase inhibitors or within 14 days after their discontinuation (hypertensive crises may occur).

Pregnancy and breastfeeding

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.

The drug is contraindicated for use during pregnancy and breastfeeding.

Use of the drug in children and adolescents

This medicine is not intended for use in children under 12 years of age. There is a risk of kidney problems in dehydrated children and adolescents.

Driving and operating machinery

While taking this medicine, caution should be exercised when driving or operating machinery.