Description

Gripex is a multi-ingredient drug intended for the short-term treatment of cold and flu symptoms.

Composition

The active substances of the drug are paracetamol ( Paracetamolum ), pseudoephedrine hydrochloride ( Pseudoephedrini hydrochloridum ) and dextromethorphan hydrobromide ( Dextromethorphani hydrobromidum ).

One film-coated tablet contains: 325 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 10 mg of dextromethorphan hydrobromide.

Excipients: Tablet core: microcrystalline cellulose, pregelatinized starch, colloidal silica, stearic acid, povidone, crospovidone. Film-coating: (Opadry II Orange Y-22-13204): hypromellose, titanium dioxide (E 171), macrogol, polydextrose, triacetin, sunset yellow (E 110), Allura red AC (E 129). Printing ink: (Opacode Black S-1-17823): shellac, black iron oxide (E 172), N-butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol.

Dosage

This is a medicine. For safety, use it according to the package leaflet. Do not exceed the maximum dose. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age: 2 tablets orally 3 to 4 times daily. Do not exceed 8 tablets daily.

Children aged 6 to 12 years: 1 tablet orally 3-4 times daily. Do not exceed 4 tablets daily.

Action

Gripex is a drug that has analgesic, antipyretic, and antitussive properties, clears the nasal passages, reduces the amount of mucous secretions and reduces congestion and swelling of the nasal mucosa.

Indications

Gripex is indicated for the temporary treatment of symptoms of colds, flu, flu-like conditions, and inflammation of the paranasal sinuses (fever, runny nose, cough, headache, sore throat, muscle and bone pain).

Contraindications

When not to use Gripex :

• if you are allergic to paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide or any of the other ingredients of this medicine;
• if you are taking other medicines containing paracetamol; if you are taking medicines from the MAO inhibitor group (medicines used, among others, for depression), and also within 2 weeks of stopping their use;
• in patients with congenital glucose-6-phosphate dehydrogenase deficiency;
• if you have severe kidney or liver failure;
• if you have severe hypertension;
• if you have coronary heart disease;
• in patients with alcoholism;
• in patients with bronchial asthma;
• during pregnancy and breastfeeding;
• in children under 6 years of age.

Side effects

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

Uncommon side effects (affecting 1 to 10 in 1,000 patients taking the medicine):

• fatigue, dizziness;
• nausea and vomiting.

Rare side effects (affecting 1 to 10 out of 10,000 patients taking the medicine):

• type I hypersensitivity reactions: allergic edema (i.e. swelling of the skin and soft tissues, often in the face, e.g. lips, tongue, eyelids), anaphylactic reaction (i.e. shortness of breath, sweating, lowering of blood pressure up to symptoms of shock);
• allergic skin reactions, skin redness, rash.

Very rare side effects (occurring in less than 1 in 10,000 patients taking the medicine):

• disorders of blood cell production: granulocytopenia (decrease in the number of granulocytes in the blood), agranulocytosis (lack of granulocytes in the blood), thrombocytopenia (decrease in the number of platelets);
• attack of bronchial asthma;
• liver damage most often occurring as a result of overdose;
• renal colic, renal papillary necrosis, acute renal failure, urolithiasis;
• hallucinations.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• somnolence;
• increased heart rate (tachycardia);
• slight increase in blood pressure;
• urinary disorders, urinary retention, especially in patients with prostatic hyperplasia.

Warnings and precautions

• Gripex contains sunset yellow (E 110) and Allura red AC (E 129), which may cause allergic reactions.
• Do not store at temperatures above 25 ^o C.
• Keep out of the sight and reach of children.

Use of other medications

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

Gripex may interact with:

• other medicines containing paracetamol,
• metoclopramide, propantheline, zidovudine,
• MAO inhibitors (used to treat depression) also 2 weeks after the end of therapy,
• anticoagulants,
• drugs that increase hepatic metabolism (some sleeping pills, antiepileptic drugs, rifampicin)
• chloramphenicol, albuterol, amitriptyline,
• sympathomimetic drugs (drugs that decongest, suppress appetite or have psychostimulant effects)
• antacids,
• antihypertensive drugs, digitalis glycosides,
• fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, thioridazine, furazolidine.

Taking the medicine with food and drink

• Food does not significantly alter the absorption of the drug.
• You cannot drink alcohol while taking the drug.

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.

Gripex is contraindicated for use during pregnancy and breastfeeding.

Use of the drug in children and adolescents

The medicine should not be used in children under 6 years of age.

Driving and operating machinery

While taking Gripex , be careful when driving or operating machinery.