Description

Gripex Night is a multi-component medicinal product with comprehensive analgesic, antipyretic and antitussive effects.

Composition

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

Each film-coated tablet contains 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, 15 mg of dextromethorphan hydrobromide and 2 mg of chlorpheniramine maleate.

The other ingredients are: tablet core: pregelatinized starch, povidone, stearic acid, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, brilliant blue (E 133), indigo carmine lake (E 132); film-coating: polydextrose, titanium dioxide (E 171), hypromellose, brilliant blue lake (E 133), triacetin, Macrogol 8000, Macrogol 400; 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 : 1 to 2 tablets orally, before bedtime.

Do not use more than 8 tablets per day.

Action

Gripex Night reduces swelling of the nasal mucosa and paranasal sinuses, unclogs the nasal passages, and reduces mucus secretions. It has a mild sedative and hypnotic effect, making it easier to fall asleep.

Indications

Gripex Noc is used to relieve the symptoms of colds, flu and flu-like conditions such as: fever, runny nose, sneezing, swelling of the nasal mucosa and paranasal sinuses, dry cough, headache, sore throat, muscle and bone and joint pain.

Contraindications

When not to use Gripex Noc :

• if you are allergic to the active substances or any of the other ingredients of this medicine;
• in case of congenital glucose-6-phosphate dehydrogenase deficiency;
• in patients with severe hepatic or renal failure;
• in case of viral hepatitis;
• in case of severe hypertension;
• in case of unstable coronary artery disease;
• in case of alcoholism;
• when using MAO inhibitors (drugs used, among others, for depression) or zidovudine.
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Side effects

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

Paracetamol:

Rare side effects (affect 1 to 10 people in 10,000):

• Blood and lymphatic system disorders: non-hemolytic anemia (not related to the breakdown of red blood cells), bone marrow suppression, thrombocytopenia;
• Cardiac and/or vascular disorders: edema;
• Gastrointestinal disorders: acute and chronic pancreatitis, hemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice;
• Skin and subcutaneous tissue disorders: pruritus, rash, sweating, purpura, angioedema, urticaria;
• Kidney and urinary tract disorders: nephropathies (kidney diseases) and tubulopathies (diseases causing dysfunction of the renal tubules);
• Paracetamol is a widely used drug, and reports of adverse effects are rare and usually associated with overdose. Isolated cases have been reported: severe skin reactions manifested by the formation of erythematous-edematous lesions (erythema multiforme), blistering and necrosis of the epidermis (Stevens-Johnson syndrome), and even necrosis and desquamation of large areas of the epidermis (epidermal necrolysis), laryngeal edema, anaphylactic shock (a severe allergic reaction characterized by a drop in blood pressure, pale skin, sweating, altered consciousness, low urine output, rapid breathing, and edema), and dizziness.
• Effects causing kidney damage (nephrotoxicity) are rare and have not been associated with therapeutic doses, except in cases of chronic use of the drug.

Pseudoephedrine:

• Adverse reactions resulting from the presence of pseudoephedrine in the medicinal product: dyspepsia, gastrointestinal disorders, redness and rashes, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia (increased heart rate), heart rhythm disorders, anxiety, insomnia, rarely uncontrolled urination, muscle weakness, tremors, fear, hallucinations, thrombocytopenia (reduction in the number of blood platelets).

Frequency unknown:

• Sudden fever, skin redness, or many small pimples (possible symptoms of acute generalized exanthematous pustulosis (AGEP)) may occur within the first 2 days of using Gripex Noc. If these symptoms occur, stop using Gripex Noc and contact your doctor or seek medical attention immediately.

Dextromethorphan:

Uncommon side effects (more than 1 in 1000 but less than 1 in 100 people taking the medicine):

• Nervous system disorders: moderate fatigue, dizziness;
• Gastrointestinal disorders: nausea, gastrointestinal problems, vomiting;

Very rare side effects (affecting less than 1 in 10,000 people):

• Immune system disorders: hypersensitivity reactions;
• Nervous system disorders: drowsiness, hallucinations, development of addiction in case of abuse;

Chlorpheniramine maleate:

• Common side effects (affect 1 to 10 people in 100):
• Nervous system disorders: central nervous system depression in the form of drowsiness, nausea and muscle weakness, which in some patients disappear after 2-3 days of treatment; facial dyskinesia, coordination disorders (rigidity), tremor, paresthesia;
• Eye disorders: blurred vision, double vision;
• Respiratory, thoracic and mediastinal disorders: dryness of the nasal mucosa and throat, drying of the mucous membranes;
• Gastrointestinal disorders: dry mouth, loss of appetite, changes in the sense of taste and smell, gastrointestinal complaints (nausea, vomiting, diarrhea, constipation, epigastric pain), which may be reduced when taken with food;
• Skin and subcutaneous tissue disorders: increased sweating;
• Kidney and urinary tract disorders: urinary retention and/or difficulty urinating;

Uncommon (affects 1 to 10 people in 1,000) or rare (affects 1 to 10 people in 10,000) side effects:

• Blood and lymphatic system disorders: rarely, blood count disorders (agranulocytosis - a significant reduction in the number of certain types of white blood cells, leukopenia - a reduction in the number of white blood cells, aplastic anemia - resulting from impaired bone marrow function or thrombocytopenia - a reduction in the number of blood platelets), with symptoms such as unusual bleeding, sore throat or fatigue;
• Immune system disorders: hypersensitivity reactions, anaphylactic reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face, tongue, shortness of breath, fatigue, etc.), photosensitivity, cross-sensitivity to similar drugs;
• Nervous system disorders: sometimes paradoxical agitation, especially when high doses are used in children or the elderly, characterized by anxiety, insomnia, nervousness, delirium, palpitations and convulsions;
• Cardiac disorders: generally in overdose; cardiac arrhythmias, palpitations, tachycardia (rapid heartbeat);
• Ear and labyrinth disorders: tinnitus, acute labyrinthitis;
• Vascular disorders: hypotension, hypertension, edema;
• Respiratory, thoracic and mediastinal disorders: chest tightness, wheezing;
• Hepatobiliary disorders: rarely, cholestasis (bile stasis), hepatitis or other liver disorders (including epigastric or abdominal pain, dark urine, etc.) may develop;
• Reproductive system and breast disorders: impotence, intermenstrual bleeding.

Warnings and precautions

• Do not store at temperatures above 25 ^o C.
• Keep the medicine out of the sight and reach of children.
• Do not use with other medicines containing paracetamol, dextromethorphan, pseudoephedrine or chlorpheniramine;

Use of other medications

Gripex Noc may interact with:

• MAO inhibitors and within 2 weeks after stopping treatment with these drugs,
• zidovudine,
• anticoagulants (warfarin, coumarin),
• antihypertensive drugs and digitalis glycosides,
• oral antidiabetic drugs,
• central nervous system depressants (hypnotics, opioid painkillers)
• neuroleptic drugs (haloperidol and other butyrophenone derivatives)
• antidepressants (fluoxetine, paroxetine)
• drugs inhibiting the activity of cytochrome P450IID6,
• drugs that induce liver enzymes (e.g. phenytoin, carbamazepine, rifampicin, phenobarbital),
• dihydroergotamine.

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.

Do not use during pregnancy or breastfeeding.

Use of the drug in children and adolescents

Do not use in children under 12 years of age.

Driving and operating machinery

While taking the medicine, you should not drive or operate machinery.