Grypolek

Patient leaflet: information for the patient

Grypolek, coated tablets
Paracetamolum + Guaifenesinum + Pseudoephedrini hydrochloridum + Dextromethorphani
hydrobromidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

1. What Grypolek is and what it is used for
2. What you need to know before taking Grypolek
3. How to take Grypolek
4. Possible side effects
5. How to store Grypolek
6. Contents of the pack and other information

1. What Grypolek is and what it is used for

Grypolek is a combination medicine. It contains four active substances: paracetamol, guaifenesin,
pseudoephedrine hydrochloride and dextromethorphan hydrobromide. Paracetamol has antipyretic and analgesic effects, guaifenesin is an expectorant, dextromethorphan acts as a cough suppressant, and pseudoephedrine restores nasal patency.
The medicine is indicated for the symptomatic treatment of common cold, headache and muscle pain, fever, sore throat, nasal catarrh, and cough associated with the common cold.
Grypolek is indicated for use in adults and adolescents over 12 years of age.
Without consulting a doctor, the medicine should not be used for longer than 3 days.

2. Important information before using Grypolek

When not to use Grypolek

• if the patient is allergic to paracetamol, guaifenesin, hydrochloride of pseudoephedrine, hydrobromide of dextromethorphan, or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• in case of severe liver failure;
• in case of severe, acute or chronic kidney disease or renal failure;
• in case of severe, uncontrolled hypertension;
• in case of severe ischemic heart disease;
• in case of severe hemolytic anemia or congenital deficiency of glucose-6-phosphate dehydrogenase;
• if the patient is taking other medicines containing paracetamol, guaifenesin, pseudoephedrine, dextromethorphan, or other medicines known as sympathomimetics (such as nasal decongestants, appetite suppressants, psychostimulants with amphetamine-like effects);
• if the patient is taking central nervous system depressants (e.g. sedatives, hypnotics);
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) (used, among others, in depression) or certain medicines used in Parkinson's disease, or within 14 days after discontinuation of such treatment;
• in case of cough with large amounts of sputum;
• in bronchial asthma and cough associated with bronchial asthma;
• in cystic fibrosis;
• in alcoholic disease;
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting to use Grypolek, consult your doctor or pharmacist.
Do not use doses higher than recommended.
Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.
Use with caution in patients with hepatic and/or renal impairment.
Use in patients with liver failure, alcohol abuse, or malnutrition increases the risk of liver damage. Alcohol must not be consumed during treatment due to increased risk of toxic liver injury.
During treatment with Grypolek, the patient should immediately inform the doctor if severe diseases occur, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
This medicine should not be used without consulting a doctor if breathing difficulties occur, in emphysema, chronic bronchitis, benign prostatic hyperplasia (enlarged prostate), hyperthyroidism, diabetes, hypertension, ischemic heart disease, vascular disease, increased intraocular pressure, especially in elderly patients or in patients taking CYP2D6 inhibitors.
If the patient is taking medicines such as certain antidepressants or antipsychotics, Grypolek may interact with them, causing changes in mental state (e.g. agitation, hallucinations, stupor) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).
Similarly, particular caution should also be exercised in patients who are poor metabolizers via the CYP2D6 enzyme.
If nervousness, dizziness, or insomnia occur, discontinue the medicine and consult a doctor.
During treatment with Grypolek, sudden abdominal pain or rectal bleeding caused by inflammation of the colon (ischemic colitis) may occur. If these gastrointestinal symptoms appear, stop using Grypolek and contact a doctor or seek immediate medical help (see section 4).
If the patient develops fever with generalized skin redness and blistering rash, stop taking the medicine and contact a doctor or seek immediate medical help (see section 4).
During treatment, reduced blood flow in the optic nerve may occur. In case of sudden vision loss, discontinue the medicine and immediately contact a doctor or seek medical help (see section 4).
Use of this medicine may lead to dependence. The medicine contains two active substances that may be abused: dextromethorphan and pseudoephedrine.
Cases of dextromethorphan abuse have been reported. Therefore, particular caution should be exercised when using the medicine in adolescents and young adults, as well as in patients with a history of drug or other psychoactive substance abuse.
Pseudoephedrine carries a risk of abuse. Use of high doses may be toxic.
Long-term use of the medicine may lead to reduced effectiveness (development of tolerance), which may lead to taking increasingly higher doses and increase the risk of overdose.
Therefore, do not use a dose higher than recommended or exceed the recommended duration of treatment (see section 3).
Several cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported during treatment with medicines containing pseudoephedrine. Discontinue the medicine and seek immediate medical help if the patient experiences the following symptoms: sudden, severe headache or thunderclap headache, nausea, vomiting, confusion, seizures, and/or visual disturbances.
Consult a doctor even if the above warnings relate to conditions that occurred in the past.

Children and adolescents
Use of the medicine in children under 12 years of age is contraindicated (see When not to use Grypolek).

Grypolek and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Interactions of this medicine with other medicines result from the interactions of its active ingredients:

Paracetamol

• Do not use simultaneously with other medicines containing paracetamol.
• Metoclopramide and domperidone (anti-nausea and antiemetic medicines that accelerate gastric emptying) accelerate the absorption of paracetamol.
• Propantheline and all anticholinergic medicines (medicines for abdominal cramps and bladder problems), cholestyramine (a cholesterol-lowering medicine), and certain strong analgesics (pentazocine, pethidine, dimorphine) may delay the absorption of paracetamol.
• Salicylamide prolongs the duration of action of paracetamol.
• Propranolol increases the rate of paracetamol absorption, while oral salbutamol (used in asthma) delays paracetamol absorption.
• Probenecid reduces the elimination of paracetamol from the body.
• Concurrent use with certain hypnotics (e.g. barbiturates) or antiepileptic medicines (e.g. phenobarbital, phenytoin, carbamazepine), as well as with rifampicin (used in tuberculosis treatment), increases the risk of liver damage.
• Concurrent use of a gastric acid secretion-reducing medicine ( nizatidine ) with paracetamol increases paracetamol blood concentration.
• Paracetamol may enhance the effect of oral anticoagulants (coumarin derivatives such as warfarin, acenocoumarol, dicoumarol).
• Antiemetic medicines with 5-HT3 receptor antagonistic action (e.g. tropisetron, granisetron) may reduce the analgesic effect of paracetamol.
• Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may subsequently lead to liver failure.
• 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 require urgent treatment (see section 2).

Pseudoephedrine

• Do not use simultaneously with other medicines containing pseudoephedrine.
• Do not use simultaneously with MAO inhibitors (medicines used in depression treatment) or within 14 days after discontinuation of such treatment (see When not to use Grypolek). Concurrent use may cause increased blood pressure, cardiac arrhythmias, and elevated body temperature.
• Pseudoephedrine used simultaneously with other circulatory stimulants (e.g. containing ephedrine or noradrenaline) or with certain medicines used in hypertension treatment (e.g. guanethidine or methyldopa) may cause increased blood pressure and cardiac arrhythmias.
• Tricyclic antidepressants enhance the effect of pseudoephedrine.
• Concurrent use of pseudoephedrine and tramadol may cause ischemic colitis.
• Antacids, e.g. aluminium hydroxide (used to relieve heartburn and indigestion), may increase the absorption of pseudoephedrine.
• Concurrent use of medicines containing pseudoephedrine and certain dietary supplements containing ephedrine derivatives increases the risk of adverse effects.
• Concurrent use with albuterol (used, among others, in asthma treatment) may intensify vasoconstrictive effects.
• Ammonium chloride may cause pseudoephedrine to act longer in the body, increasing the risk of adverse effects.
• Pseudoephedrine may reduce the effectiveness of antihypertensive medicines and affect the action of digitalis glycosides (used in heart failure).
• Do not use simultaneously with furazolidone (an antibacterial medicine).

Dextromethorphan

• Do not use simultaneously with other medicines containing dextromethorphan.
• Concomitant use with MAO inhibitors (medicines used in depression treatment) is contraindicated.
• Dextromethorphan may enhance the effects of alcohol, antihistamines, and psychotropic medicines on the central nervous system.
• Concurrent use of medicines reducing the activity of enzyme CYP2D6, such as fluoxetine or paroxetine (medicines used in depression treatment), quinidine (used in cardiac arrhythmia treatment), or terbinafine (an antifungal medicine), may increase dextromethorphan concentration in the body. This may lead to intensification of its toxic effects (such as agitation, disorientation, tremors, insomnia, diarrhea, and respiratory depression). At the same time, the risk of serotonin syndrome increases (a serious, potentially life-threatening condition characterized by, among others, severe agitation, confusion, muscle tremors, excessive sweating, fever, rapid heartbeat, and sudden changes in blood pressure).

Guaifenesin
No interactions have been reported.
Guaifenesin may cause falsely elevated results in VMA (vanillylmandelic acid) testing if urine is collected within 24 hours after taking a dose of Grypolek. Inform the doctor about using this medicine.

Use of Grypolek with alcohol
Alcohol must not be consumed during treatment due to increased risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy and breastfeeding (see When not to use Grypolek).
The effect of this medicine on fertility has not been specifically determined.

Driving and operating machinery
The medicine may affect the ability to drive and operate machinery. During treatment, caution should be exercised, as adverse effects on the central nervous system may occur, such as: dizziness, drowsiness, anxiety, irritability, or hallucinations.

Grypolek contains quinoline yellow and orange yellow
The medicine may cause allergic reactions.

Grypolek contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Grypolek

Recommended dose
Adults and adolescents over 12 years of age:
If not otherwise advised by a doctor, 2 tablets every 6 to 8 hours.
Do not take more than 8 tablets per day.
Without consulting a doctor, do not use this medicine for longer than 3 days.
Use in children and adolescents
The use of this medicine in children under 12 years of age is contraindicated (see When not to use Grypolek).
Taking a higher than recommended dose of Grypolek
If a patient has taken more than the recommended dose of Grypolek, seek immediate medical advice
from a doctor or go to hospital.
Paracetamol overdose often does not cause clear symptoms within the first 24 hours, but it may lead to severe liver damage, which becomes apparent after several days (usually 4–6 days). The medicine contains four active substances, so overdose symptoms may result from the effect of one or all of the active substances.
Within a few to several hours after overdose, the following symptoms may occur:
malaise, abdominal pain, nausea, vomiting, diarrhoea, excessive sweating, drowsiness, disturbances of the central nervous system (e.g. mental disturbances, hallucinations, confusion, increased excitability, disorientation (feeling of being lost), involuntary muscle spasms, disturbances of consciousness, or involuntary rapid eye movements).
Heart rhythm disturbances, rapid heartbeat, increased blood pressure which may lead to hypertensive crisis (sudden, life-threatening rise in blood pressure), coordination disturbances, psychosis with visual hallucinations, intracranial haemorrhage, or heart attack may also occur.
In case of severe overdose, the following may occur: coma, severe breathing difficulties, and seizures. These symptoms may resolve the next day, even though liver damage begins to develop and may become apparent later, e.g. with upper abdominal pain, malaise, recurrence of vomiting and nausea, jaundice.
Paracetamol overdose may also cause decreased blood potassium levels (hypokalaemia).
If any of the above symptoms occur, seek immediate medical advice from a doctor or go to hospital. Treatment of overdose should be carried out in hospital.
Missed dose of Grypolek
This medicine is intended for short-term relief of cold symptoms.
If a dose is missed and symptoms persist, take the missed dose as soon as remembered, and take the next dose according to the recommended dosing schedule. Do not exceed the maximum daily dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Grypolek
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions occur, you should immediately
contact your doctor or seek urgent medical help:

• Type I hypersensitivity reactions: allergic swelling (i.e. swelling of the skin and soft tissues, often affecting the face, e.g. lips, tongue, eyelids), anaphylactic reaction (i.e. shortness of breath, sweating, drop in blood pressure up to shock symptoms) (rare);
• Skin allergic reactions, redness of the skin, rash, itching (rare);
• Sudden fever, skin redness, or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of taking Grypolek, see section 2: "Warnings and precautions". If such symptoms occur, treatment should be discontinued and you should contact your doctor or seek urgent medical help (frequency unknown);
• Asthma attack (very rare);
• Liver damage, most commonly due to overdose (very rare);
• Acute kidney failure (very rare); increased risk of kidney failure is associated with prolonged use of the medicine, especially in patients with pre-existing kidney disorders;
• Urinary disorders, urinary retention, particularly in patients with benign prostatic hyperplasia (very rare);
• Ischaemic colitis (inflammation of the large intestine caused by inadequate blood supply) (see section 2: "Warnings and precautions").

Other adverse reactions:
Adverse reactions occurring rarely (less than 1 in 1,000 people):

• Nausea, vomiting, heartburn;
• Dizziness, drowsiness, restlessness, nervousness, irritability, hallucinations, personality disorders, psychomotor agitation.

Adverse reactions occurring very rarely (less than 1 in 10,000 people):

• Blood disorders: anaemia, methaemoglobinaemia (a condition characterized by significant levels of methaemoglobin instead of haemoglobin), thrombocytopenia (reduced number of blood platelets), agranulocytosis (reduced number of granulocytes in the blood).

Adverse reactions with unknown frequency (cannot be estimated from available data):

• Delusions (especially in children);
• Increased heart rate (tachycardia);
• Slight increase in blood pressure;
• Reduced blood flow in the optic nerve (ischaemic optic neuropathy);
• Posterior reversible encephalopathy syndrome (PRES);
• Reversible cerebral vasoconstriction syndrome (RCVS);
• Metabolic acidosis – may occur in patients with specific risk factors during paracetamol use (see section 2: "Warnings and precautions").

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Grypolek

Keep this medicine out of sight and reach of children.
Keep this medicine in a dry place and in the original, tightly closed packaging.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack
following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Grypolek contains

• The active substances in this medicinal product are: paracetamol, guaifenesin, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. Each coated tablet contains: 325 mg paracetamol, 200 mg guaifenesin, 30 mg pseudoephedrine hydrochloride, and 15 mg dextromethorphan hydrobromide.
• Other ingredients are: Tablet core: microcrystalline cellulose (E460), pregelatinized starch, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate. Coating: Opadry Yellow Y-5-12821: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), macrogol (E1521), quinoline yellow, aluminium lake (E104), orange yellow, aluminium lake (E110), carnauba wax (E903).

What Grypolek looks like and contents of the pack
Yellow, elongated, biconvex coated tablets with the imprint P515 on one side.
Packaging: PVC/PVDC/Aluminium foil blister packs in a cardboard box.
Pack sizes:
6 tablets – 1 blister containing 6 tablets
12 tablets – 2 blisters containing 6 tablets each
24 tablets – 4 blisters containing 6 tablets each

Marketing Authorisation Holder and Manufacturer
Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw
Tel.: 22 816 14 50
e-mail: [email protected]