Gripex Pro Mucus

Package Leaflet: Information for the Patient

Gripex Pro MUCUS

250 mg + 100 mg + 5 mg

coated tablets
Paracetamol + Guaifenesin + Phenylephrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in the case of fever or 5 days in the case of pain, there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

1. What is Gripex Pro MUCUS and what is it used for

2. Important information before taking Gripex Pro MUCUS

3. How to take Gripex Pro MUCUS

4. Possible side effects

5. How to store Gripex Pro MUCUS

6. Contents of the pack and other information

1. What is Gripex Pro MUCUS and what is it used for

Gripex Pro MUCUS is a multi-component medicine that treats many symptoms of colds and flu. It contains three active substances: paracetamol, phenylephrine, and guaifenesin. It acts as an analgesic, antipyretic, expectorant, and restores the patency of nasal passages and paranasal sinuses. Gripex Pro MUCUS is intended for adults and adolescents over 12 years old. The indication for use of Gripex Pro MUCUS is the short-term treatment of flu and cold symptoms, such as: fever, muscle and joint pain, headache, sore throat, pain and congestion of paranasal sinuses, rhinitis and paranasal sinuses, cough.

2. Important information before taking Gripex Pro MUCUS

When not to take Gripex Pro MUCUS:

• in the case of taking monoamine oxidase inhibitors (IMAO, used in the treatment of arterial hypotension and depression) and within 14 days of stopping their use,
• in the case of taking tricyclic antidepressants (used in mental disorders) or zidovudine (AZT, a medicine used in HIV infection),
• during pregnancy or breastfeeding,
• in children under 12 years old.

Warnings and precautions

Before starting treatment with the medicine, consult a doctor or pharmacist. The medicine contains paracetamol. Due to the risk of overdose, check if other medicines being taken do not contain paracetamol. During treatment with the medicine, do not drink alcohol. Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals poses a risk of toxic liver damage. Use with caution in people with liver or kidney failure (monitor liver enzyme activity and kidney function), with vascular disease, with Raynaud's syndrome (manifested by pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often under the influence of cold or emotions), with stable coronary heart disease, with respiratory failure, with asthma, taking beta-adrenergic receptor antagonist drugs (used, for example, in the treatment of hypertension), taking anticoagulant drugs (it is recommended to adjust their dose based on blood coagulation tests).

During treatment with Gripex Pro MUCUS, immediately inform your doctor if the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in standard doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting. Due to the content of guaifenesin, use with caution in people with chronic or persistent cough in the course of asthma, chronic bronchitis, emphysema, and chronic cough in smokers. If symptoms worsen or do not improve after 5 days, consult a doctor. Consult a doctor even if the above warnings concern situations that occurred in the past.

Other medicines and Gripex Pro MUCUS

Tell your doctor or pharmacist about all medicines being taken currently or recently, as well as about medicines that the patient plans to take.

Interaction of Gripex Pro MUCUS with other medicines results from the interaction of the active substances contained in the medicine:

Paracetamol The medicine should not be taken simultaneously with other medicines containing paracetamol. Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol. Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol. Taking paracetamol simultaneously with monoamine oxidase inhibitors (IMAO, used in the treatment of, among other things, arterial hypotension and depression) and within 14 days of stopping their use may cause a state of excitement and fever (see also "When not to take Gripex Pro MUCUS"). Simultaneous use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow. Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives). Simultaneous use of paracetamol and medicines that increase liver metabolism, i.e., certain sedatives or antiepileptic drugs, e.g., phenobarbital, phenytoin, carbamazepine, as well as rifampicin (used in the treatment of, among other things, tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol. Therefore, before using the medicine, consult a pharmacist or doctor. Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which can ultimately lead to liver failure. Cholestyramine reduces the absorption of paracetamol and should not be taken within the first hour after paracetamol administration. Probenecid prolongs the half-life of paracetamol. Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2). Phenylephrine Monoamine oxidase inhibitors (IMAO, medicines used in arterial hypotension and depression) may enhance the effect of phenylephrine (see also "When not to take Gripex Pro MUCUS"). Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants (medicines used in mental disorders). Avoid their simultaneous use with phenylephrine or administer phenylephrine at least 14 days after discontinuation of tricyclic antidepressants. Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, reserpine (medicines used in the treatment of hypertension). Phenylephrine used simultaneously with indomethacin (a pain and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of hypertension), or methyldopa (a medicine used, for example, in the treatment of hypertension) may cause a hypertensive crisis. Guaifenesin No significant interactions of guaifenesin with other medicines have been found. Guaifenesin and/or its metabolites may affect the results of measurements of 5-hydroxyindoleacetic acid and vanillylmandelic acid, but do not cause false positive results in healthy individuals.

Gripex Pro MUCUS with food, drinks, and alcohol

Food does not significantly affect the absorption of the medicine. During treatment with the medicine, do not drink alcohol. Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which can ultimately lead to liver failure.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before taking this medicine. The medicine should not be taken during pregnancy. The medicine should not be taken during breastfeeding.

Driving and using machines

During treatment with Gripex Pro MUCUS, exercise caution when driving vehicles and operating moving machinery.

3. How to take Gripex Pro MUCUS

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Gripex Pro MUCUS should be taken orally. Adults and adolescents over 12 years old: if necessary, 2 tablets, the dose can be repeated no more than every 4 hours. Do not take more than 8 tablets in 24 hours. The medicine should not be taken for longer than 3 days in the case of fever or 5 days in the case of pain without consulting a doctor.

Overdose of Gripex Pro MUCUS

In case of accidental ingestion of an excessive dose of the medicine, immediately consult a doctor or pharmacist. The medicine contains three active substances. Symptoms of overdose may result from the action of one or all of the active substances. Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, within a few or several hours. Oculogyric crisis, increased blood pressure, seizures, urinary retention, and shortness of breath may occur. Even if the symptoms have subsided the next day, life-threatening liver damage may develop, which manifests as abdominal distension, return of nausea, and jaundice. In every case of taking paracetamol in a dose of 5 g or more, vomiting should be induced if it has not been more than an hour since ingestion. It is worth administering 60-100 g of activated carbon orally, preferably mixed with water. Then, consult a doctor, as treatment should be carried out in a hospital. Treatment involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. It may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missed dose of Gripex Pro MUCUS

In case of missing a dose of the medicine and persistence of symptoms, take the next dose of Gripex Pro MUCUS. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Gripex Pro MUCUS can cause side effects, although not everybody gets them. If the following symptoms occur, stop treatment and immediately consult a doctor: severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), laryngeal edema, and anaphylactic shock (frequency not known). Possible side effects of the medicine due to the presence of paracetamol: Rare(may occur in less than 1 in 1,000 people):

• blood and lymphatic system disorders: anemia, bone marrow suppression, thrombocytopenia, agranulocytosis, leukopenia, neutropenia,
• cardiovascular disorders: edema,
• gastrointestinal disorders: acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice,
• skin and subcutaneous tissue disorders: itching, rash, sweating, purpura, angioedema, urticaria,
• renal and urinary disorders: nephropathy and tubulopathy.

Frequency not known(cannot be estimated from the available data):

• a serious condition that can cause acidification of the blood (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of chronic use of the medicine. Single cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock, and dizziness have been observed. Possible side effects of the medicine due to the presence of phenylephrine: Common(may occur in less than 1 in 10 people):

• gastrointestinal disorders: nausea, vomiting, digestive disorders, anorexia. Rare(may occur in less than 1 in 1,000 people):
• skin and subcutaneous tissue disorders: itching, urticaria,
• immune system disorders: allergic reactions and hypersensitivity up to anaphylactic shock and bronchospasm,
• cardiovascular disorders: increased blood pressure, tachycardia, arrhythmias, palpitations, pallor.

Very rare(may occur in less than 1 in 10,000 people):

• nervous system disorders: anxiety, agitation, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations. Frequency not known(cannot be estimated from the available data): urinary retention.

Possible side effects of the medicine due to the presence of guaifenesin: Rare(may occur in less than 1 in 1,000 people):

• nervous system disorders: headaches, dizziness,
• gastrointestinal disorders: gastrointestinal disorders, nausea, vomiting, and diarrhea.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Gripex Pro MUCUS

Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What Gripex Pro MUCUS contains

• The active substances of the medicine are paracetamol, guaifenesin, and phenylephrine hydrochloride.
• The other ingredients are: povidone, microcrystalline cellulose, stearic acid, hypromellose (Methocel E5), hypromellose (Methocel E15), polyethylene glycol.

What Gripex Pro MUCUS looks like and contents of the pack

White, oblong, coated tablets with the imprint PGP, intended for oral use. Blisters of PVC/Aluminum/Paper in a cardboard box. Pack sizes:8 tablets; 16 tablets; 12 tablets; 24 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław. For more detailed information on this medicine, please contact the representative of the marketing authorization holder: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.

Date of last revision of the leaflet: