Gripex 12 tablets

1. What Gripex is and what it is used for

Gripex is a combination medicine to treat symptoms of the common cold and flu. It contains three active substances: paracetamol, pseudoephedrine and dextromethorphan. It has an analgesic, antipyretic and antitussive effect; reduces the secretion and swells the mucous membrane of the nose, which leads to the restoration of the patency of the nasal passages. Gripex is intended for the treatment of adults, adolescents and children over 6 years of age. Gripex is used to treat symptoms of the common cold, flu and flu-like conditions, sinusitis (high fever, runny nose, cough, headache, sore throat, muscle and bone-joint pain).

2. What you need to know before you take Gripex

Do not take Gripex:

if you are allergic to paracetamol, pseudoephedrine, dextromethorphan or any of the other ingredients of this medicine (listed in point 6) if you are taking other medicines that contain paracetamol if you are taking MAO inhibitors and 2 weeks after stopping treatment with them if you have congenital glucose -6-phosphate dehydrogenase deficiency if you have severe kidney or liver failure

if you have severe arterial hypertension if you have ischemic heart disease

in alcoholism

if you have bronchial asthma

during pregnancy and breastfeeding

in children under 6 years of age

Warnings and precautions

This medicine can be addictive. Therefore, the treatment should be of short duration

Talk to your doctor or pharmacist before taking Gripex.

Taking the drug by individuals who suffer from liver failure, abuse alcohol or are fasting is associated with a risk of liver damage.

To be used with caution in patients with renal failure, arterial hypertension, cardiac arrhythmias, pulmonary emphysema, increased intraocular pressure, prostatic hyperplasia, hyperthyroidism (Bazed's disease), diabetes and patients taking anxiolytics, tricyclic antidepressants, other sympathomimetic drugs (t .ie decongestants), appetite suppressants and amphetamine-like psychostimulants.

This medicine should not be used in chronic cough with secretions. It should not be used in patients with respiratory failure, bronchial asthma and patients at risk of developing respiratory failure.

Gripex should be used with caution in patients taking anticoagulants (anti-clotting drugs).

If you are taking medicines, such as some antidepressants or antipsychotics, Gripex may interact with these medicines and you may experience changes in mental status (eg agitation, hallucinations, coma) and other effects, such as body temperature above 38°C, rapid heart rate , unstable blood pressure and increased reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).

If you develop reddening of large areas of the skin with increased temperature and pus bubbles, stop taking Gripex and contact your doctor or seek medical help immediately. See point 4.

Sudden abdominal pain or rectal bleeding may occur when using Gripex due to inflammation of the large intestine (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Gripex and contact your doctor or seek medical attention immediately. See point 4.

A decrease in blood flow to your optic nerve may occur with Gripex. If you experience sudden vision loss, stop taking Gripex and contact your doctor or seek medical help immediately. See point 4.

Because of the reported cases of dextromethorphan overdose, the drug should be given with caution to adolescents, young adults, and patients who abuse drugs or psychotic substances.

Caution should be exercised in patients with delayed metabolism involving the CYP2D6 enzyme or using substances that reduce the activity of the CYP2D6 enzyme (listed in the section "Other drugs and Gripex")

If symptoms worsen or do not improve after three days, you should contact a doctor. You should consult your doctor even if the above warnings refer to circumstances in the past.

Other medicines and Gripex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The interaction of Gripex with other drugs is the result of the action of the active substances contained in this drug.

Paracetamol

Due to the risk of overdose, do not use this medicine at the same time as other medicines containing paracetamol.

Medicinal products that accelerate gastric emptying (eg metoclopramide) accelerate the absorption of paracetamol, while drugs that delay gastric emptying (eg propantheline) may delay the absorption of paracetamol.

More about GRIPEX film-coated tablets * 12, price and information from Fr

The use of paracetamol simultaneously with MAO-inhibitors and 2 weeks after stopping treatment with them is contraindicated, because it can cause a state of agitation and fever. Concomitant use of paracetamol with zidovudine (AZT) may increase the toxic effects of zidovudine on the bone marrow.

Paracetamol can enhance the action of anticoagulants (coumarin derivatives). Concomitant use of paracetamol with medicinal products that increase hepatic metabolism, for example some hypnotic or antiepileptic drugs such as phenobarbital, phenytoin, carbamazepine, as well as rifampicin, can lead to liver damage, even when taking paracetamol in recommended doses.

Alcohol consumption during treatment with paracetamol leads to the formation of a toxic metabolite that causes necrosis of liver cells, which can subsequently lead to liver failure.

Please inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), as there is a serious risk of abnormalities in blood counts and acid-base balance (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with a severe degree of kidney damage, sepsis (when bacteria and their toxins have entered the bloodstream, which leads to organ damage), malnutrition, chronic alcoholism and when using the maximum daily dose of paracetamol.

Pseudoephedrine

Concomitant use with albuterol (used to treat asthma) may increase the vasoconstrictor effect on blood vessels.

Do not use at the same time with amitriptyline (used to treat depression) and sympathomimetic drugs (used to treat bronchospasm, for example to treat asthma). Concomitant use with other sympathomimetics, such as drugs that reduce hyperemia, appetite suppressants, or amphetamine-like psychostimulants may cause an increase in blood pressure.

Ammonium chloride enhances the action of pseudoephedrine.

Antacid drugs (used to treat heartburn and dyspepsia) may increase the absorption of pseudoephedrine.

MAO inhibitors (used to treat depression) slow down the elimination of pseudoephedrine from the body.

Pseudoephedrine reduces the effect of medicines against high blood pressure and may affect the effect of digitalis glycosides (used in heart failure).

Do not use simultaneously with furozolidine (antibacterial drug).

Dextromethorphan

Do not use with MAO inhibitors.

Medicines that reduce the activity of the CYP2D6 enzyme. such as fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine may increase the amount of dextromethorphan in the blood.

Gripex with food, drinks in alcohol

Food has no significant effect on the absorption of this medicine. Alcohol should not be consumed during treatment with this medicine.

Breastfeeding pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Consult your doctor before using any medicine.

Gripex is contraindicated during pregnancy and breastfeeding.

Driving and using machines

During the use of Gripex, special care should be taken when driving and working with machines.

Gripex contains the dye sunset yellow (E 110). May cause allergic reactions.

3. How to take Gripex

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Gripex should be taken orally.

The recommended dose is:

Adults and adolescents over 12 years: 1 to 2 tablets 3-4 times a day. Do not take more than 8 tablets daily.

Children from 6 to 12 years: 1 tablet 3-4 times a day. Do not take more than 4 tablets daily.

Pediatric population (only for products with a pediatric indication under 12 years of age) Serious adverse events may occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

If you have taken more than the required dose of Gripex

Contact your doctor or pharmacist immediately. This medicine contains three active substances. Overdose symptoms may result from the action of one or all of the active substances.

If you take more Gripex than you should for several or ten hours, you may experience the following symptoms: nausea, vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, excessive sweating, disturbances in consciousness, involuntary and rapid eye movements, heart disorders ( rapid heartbeat), coordination disorders, psychosis with visual hallucinations and hyperexcitability, general weakness, restlessness, tremors. Nystagmus, increased blood pressure, convulsions (spasms), difficulty urinating, difficulty breathing, and coma may occur. Contact your doctor or hospital immediately if you experience any of the above symptoms.

These symptoms may disappear the next day, despite the development of liver damage, which may subsequently manifest as a feeling of heaviness in the epigastrium, the recurrence of nausea and jaundice. Treatment should be carried out in a hospital setting. It consists in accelerating the elimination of the components of the drug from the body and maintaining vital functions. In the event of an overdose of paracetamol, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine. Elimination of pseudoephedrine can be accelerated by forced diuresis or dialysis therapy. To neutralize the toxic effect of dextromethorphan on the central nervous system, naloxone can be given.

If you forget to take Gripex

Gripex is indicated for the treatment of symptoms of colds, flu and flu-like conditions.

If you forget to take this medicine and you are still not cured, take another dose of Gripex. Do not take a double dose to make up for a missed dose.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

easy fatigue

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

anaphylactic reaction with allergic edema (severe allergic reaction that causes swelling of the face or throat).

nausea and vomiting

skin allergic reactions, reddening of the skin, rashes

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

granulocytopenia (reduction in the number of granulocytes in the blood), agranulocytosis (absence of granulocytes in the blood), thrombocytopenia (reduction in the number of platelets in the blood)

attacks of bronchial asthma

liver damage

serious skin reactions

renal colic, renal papillary necrosis, acute renal failure, urolithiasis (formation and presence of stones in the urinary tract). Urinary disturbances and urinary retention may occur, especially in patients with prostatic hyperplasia (enlarged prostate gland)

Adverse reactions of unknown frequency (for which an estimate cannot be made from the available data)

hallucinations

drowsiness, vertigo (feeling dizzy or light-headed)

tachycardia (rapid heart rate)

slight increase in blood pressure

inflammation of the colon due to insufficient blood supply (ischemic colitis)

During the first 2 days of treatment with Gripex, you may suddenly have a fever, reddening of the skin or multiple small pus bubbles (possible symptoms of acute generalized exanthematous pustulosis).

See section 2. If you develop these symptoms, stop using Gripex and contact your doctor or seek medical help immediately.

reduced blood flow to the optic nerve (ischemic optic neuropathy)

5. How to store Gripex

To be stored below 25°C.

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the pack. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Gripex contains

The active substances are: paracetamol 325 mg, pseudoephedrine hydrochloride 30 mg, dextromethorphan hydrobromide 10 mg

The other ingredients are: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, stearic acid, povidone, crospovidone.

Coating: Opadry II Orange Y-22-13204: hydroxypropyl methylcellulose, titanium dioxide, polyoxyethylene glycol, polydextrose, glycerol triacetate, sunset yellow (E110), allura red AC (E 129).

Stamping ink: Opacode Black S-l-17823: shellac, iron oxide - black (E-172), N-butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol.

What Grnpex looks like and what it contains

12 film-coated tablets (1 blister), 24 film-coated tablets (2 blisters x 12 tablets), placed in a cardboard box together with a patient leaflet.