Package leaflet: information for the patient

Gripex Pro MUCUS
250 mg + 100 mg + 5 mg
film-coated tablets
Paracetamolum + Guaifenesinum + Phenylephrini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days of treatment for fever or after 5 days for pain, or if you feel worse, consult your doctor.

Leaflet contents
1. What Gripex Pro MUCUS is and what it is 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 Gripex Pro MUCUS is and what it is used for
Gripex Pro MUCUS is a combination medicine used to treat multiple symptoms of cold and flu. It contains three active substances: paracetamol, guaifenesin and phenylephrine hydrochloride. It provides analgesic, antipyretic, expectorant effects, and helps restore patency of the nasal passages and paranasal sinus openings.
Gripex Pro MUCUS is intended for use in adults and adolescents aged 12 years and older.
Indications for Gripex Pro MUCUS include short-term treatment of cold and flu symptoms such as: fever, joint and muscle pain, headache, sore throat, pain and nasal sinus congestion, nasal and paranasal sinus mucosal inflammation (rhinitis), and cough.

2. Important information before taking Gripex Pro MUCUS

When not to take Gripex Pro MUCUS:

if you are allergic (hypersensitive) to paracetamol, guaifenesin, phenylephrine or other similarly acting drugs, or to any of the excipients listed in section 6,
if you have severe liver or kidney failure,
if you have cardiovascular disorders,
if you have cardiac arrhythmias,
if you have arterial hypertension,
if you have diabetes,
if you have been diagnosed with pheochromocytoma,
if you have been diagnosed with narrow-angle glaucoma,
if you have hyperthyroidism,
if you have benign prostatic hyperplasia,
if you have congenital glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency,
if you suffer from porphyria, a congenital disorder characterized by excessive pigment content in urine,
if you are taking monoamine oxidase inhibitors (MAOIs, used in the treatment of hypotension and depression) or within 14 days after discontinuation of such treatment,
if you are taking tricyclic antidepressants (medicines used for psychiatric disorders) or zidovudine (AZT, a medicine used in HIV infection),
during pregnancy or breastfeeding,
in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before starting treatment.
This medicine contains paracetamol. Due to the risk of overdose, check whether other medicines you are taking also contain paracetamol.
Do not drink alcohol while taking this medicine. Use in patients with liver impairment, chronic alcohol abuse, or malnutrition increases the risk of hepatotoxic liver damage.
Use with caution in patients:

with liver or kidney impairment (liver enzyme activity and kidney function should be monitored),
with peripheral vascular disease,
with Raynaud's syndrome (characterized by pallor followed by cyanosis of fingers, toes, earlobes and nose tip, often triggered by cold or emotional stress),
with stable coronary artery disease,
with respiratory insufficiency,
with bronchial asthma,
taking beta-adrenergic receptor antagonists (medicines used e.g. in hypertension treatment),
taking anticoagulant medicines (dose adjustment may be required based on coagulation tests).

During treatment with Gripex Pro MUCUS, immediately inform your doctor if you have severe medical conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
In such cases, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluid composition) when taking paracetamol at standard doses for prolonged periods or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Due to the presence of guaifenesin, use with caution in patients with chronic or persistent cough associated with bronchial asthma, chronic bronchitis, pulmonary emphysema, or chronic cough in smokers.
If symptoms worsen or do not improve after 5 days, consult your doctor.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Other medicines and Gripex Pro MUCUS
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions of Gripex Pro MUCUS with other medicines result from the effects of its active ingredients:

Paracetamol
Do not take this medicine simultaneously with other medicines containing paracetamol.
Medicines that accelerate gastric emptying (e.g. metoclopramide) increase the absorption rate of paracetamol.
Medicines that delay gastric emptying (e.g. propantheline) may delay paracetamol absorption.
Concomitant use of paracetamol with monoamine oxidase inhibitors (MAOIs, used in the treatment of e.g. hypotension and depression) or within 14 days after discontinuation of such treatment may cause excitation and fever (see also "When not to take Gripex Pro MUCUS").
Concurrent use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on bone marrow.
Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives). Concurrent use of paracetamol with drugs that increase hepatic metabolism, such as certain sedatives or anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), or rifampicin (used e.g. in tuberculosis treatment), may lead to liver damage, even when recommended doses of paracetamol are used. Therefore, consult your pharmacist or doctor before taking this medicine.
Alcohol consumption during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may eventually result in liver failure.
Cholestyramine reduces paracetamol absorption; therefore, it should not be taken within the first hour after paracetamol administration.
Probenecid prolongs the half-life of paracetamol.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Phenylephrine
Monoamine oxidase inhibitors (MAOIs, used in 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 psychiatric disorders). Concomitant use with phenylephrine should be avoided, or phenylephrine should be administered at least 14 days after discontinuation of tricyclic antidepressants.
Phenylephrine may reduce the antihypertensive effect of guanethidine, mecamylamine, methyldopa, and reserpine (medicines used in hypertension treatment).
Phenylephrine used concomitantly with indomethacin (a pain-relieving and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used e.g. in hypertension treatment), or methyldopa (a medicine used e.g. in hypertension treatment) may cause hypertensive crisis.

Guaifenesin
No significant interactions between guaifenesin and other medicines have been reported.
Guaifenesin and/or its metabolites may affect test results for 5-hydroxyindoleacetic acid and vanillylmandelic acid, but do not cause false positive results in healthy individuals.

Gripex Pro MUCUS with food, drink and alcohol
Food does not significantly affect the absorption of the medicine.
Do not consume alcohol during treatment with this medicine.
Alcohol consumption during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may eventually result in liver failure.

Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if you suspect you may be pregnant or are planning pregnancy, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
Do not use during breastfeeding.

Driving and operating machinery
Exercise caution when driving or operating machinery while taking Gripex Pro MUCUS.

3. How to use Gripex Pro MUCUS

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Gripex Pro MUCUS should be taken orally.
Adults and adolescents over 12 years of age: 2 tablets as needed, which may be repeated no more frequently than every 4 hours.
Do not take more than 8 tablets within 24 hours.
Do not use the medicine for longer than 3 days in case of fever or 5 days in case of pain without consulting a doctor.

Overdose of Gripex Pro MUCUS
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist.
The medicine contains three active substances. Symptoms of overdose may result from the effect of one or all of the active substances. Accidental or intentional overdose may cause symptoms within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, general weakness, restlessness, tremor. Nystagmus, increased blood pressure, seizures, difficulty in urination, and shortness of breath may also occur.
Even if symptoms subside by the next day, potentially life-threatening liver damage may develop, characterized by upper abdominal discomfort, recurrence of nausea, and jaundice.
In every case where a single dose of paracetamol of 5 g or more has been ingested, vomiting should be induced if less than one hour has passed since ingestion. It is advisable to administer 60–100 g of activated charcoal orally, preferably mixed with water.
Afterwards, medical attention must be sought immediately, as treatment should be carried out in a hospital. Treatment consists of accelerating the elimination of the drug components from the body and supporting vital functions. Administration of an antidote may be necessary: N-acetylcysteine and/or methionine.

Missed dose of Gripex Pro MUCUS
If a dose is missed and symptoms persist, take the next dose of Gripex Pro MUCUS as scheduled. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Gripex Pro MUCUS may cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, treatment should be discontinued immediately and a doctor should be contacted without delay:
severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), laryngeal edema and anaphylactic shock (frequency unknown).

Possible adverse effects of the medicine due to the presence of paracetamol:
Rare (may occur in fewer than 1 in 1,000 people):

Blood and lymphatic system disorders: anaemia, bone marrow suppression, thrombocytopenia, agranulocytosis (lack of granulocytes in the blood), leucopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils),
Cardiac disorders / vascular disorders: oedema,
Gastrointestinal disorders: acute and chronic pancreatitis, haemorrhage, abdominal pain, diarrhoea, nausea, vomiting, liver failure, hepatic necrosis, jaundice,
Skin and subcutaneous tissue disorders: itching, rash, sweating, purpura, angioedema, urticaria,
Renal and urinary disorders: nephropathies and tubulopathies.

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

Serious condition which may lead to blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Nephrotoxic effects are rare; no association has been observed with therapeutic doses, except in cases of chronic use of the medicine.
Isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, laryngeal oedema, anaphylactic shock and dizziness have been observed.

Possible adverse effects of the medicine due to the presence of phenylephrine:
Common (may occur in up to 1 in 10 people):

Gastrointestinal disorders: nausea, vomiting, digestive disturbances, loss of appetite.
Rare (may occur in fewer than 1 in 1,000 people):
Skin and subcutaneous tissue disorders: itching, urticaria,
Immune system disorders: allergic reactions and hypersensitivity up to symptoms of anaphylactic shock and bronchospasm,
Cardiac disorders: increased blood pressure, tachycardia, cardiac arrhythmia, palpitations, pallor.

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

Nervous system disorders: anxiety, restlessness, tremor, nervousness, insomnia, irritability, dizziness and headache, hallucinations.
Frequency not known (cannot be estimated from the available data): renal and urinary disorders in the form of urinary retention.

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

Nervous system disorders: headache and dizziness,
Gastrointestinal disorders: gastrointestinal discomfort, nausea, vomiting and diarrhoea.

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

5. How to store Gripex Pro MUCUS

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use after the expiry date stated on the cardboard box and primary packaging (month/year). The blister labelling used: EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What Gripex Pro MUCUS contains

The active substances are paracetamol, guaifenesin, 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, film-coated tablets with the embossed marking PGP, for oral use.
Blister packs made of PVC/Aluminum/Paper in cardboard boxes.
Pack sizes: 8 tablets; 16 tablets; 12 tablets; 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40 Street, 50-507 Wrocław
For further information about this medicinal product, please contact the marketing authorisation holder's representative:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw
tel. +48 (22) 543 60 00