Gripostop

Leaflet attached to the packaging: patient information

Grypostop, 325 mg + 30 mg + 15 mg, coated tablets

Paracetamol+ Pseudoephedrine hydrochloride+ Dextromethorphan hydrobromide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Grypostop and what is it used for
• 2. Important information before using Grypostop
• 3. How to use Grypostop
• 4. Possible side effects
• 5. How to store Grypostop
• 6. Contents of the packaging and other information

1. What is Grypostop and what is it used for

A multi-component medicine with analgesic, antipyretic, anti-cough, nasal decongestant, and anti-inflammatory effects, reducing the amount of mucous secretion and congestion and swelling of the nasal mucosa. Indications: Acute treatment of symptoms of colds, flu, flu-like conditions (fever, runny nose, cough, headache, sore throat, muscle and joint pain).

2. Important information before using Grypostop

When not to use Grypostop

• in children under 12 years of age,
• during pregnancy and breastfeeding,

Warnings and precautions

Taking this medicine may lead to dependence. Therefore, treatment should be short-term. Before starting to use Grypostop, the patient should discuss it with their doctor or pharmacist:

• The patient should not use the medicine without consulting their doctor if they have difficulty breathing.
• During the use of Grypostop, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, the patient should stop using Grypostop and seek medical help immediately. See section 4.
• If excessive nervousness, dizziness, insomnia, or other symptoms occur, the patient should stop using the medicine and consult their doctor.
• The patient should not take higher doses than recommended.
• The patient should consult their doctor if symptoms persist for more than 3 days.
• The patient should not drink alcohol while using the medicine, as it may increase the risk of liver damage.
• The patient should not use other medicines that act on the central nervous system (e.g., sedatives, sleeping pills).
• If the patient experiences fever with generalized skin redness and pustular rash, they should stop using Grypostop and consult their doctor or seek medical help immediately. See section 4.
• During the use of Grypostop, a decrease in blood flow to the optic nerve may occur. If sudden vision loss occurs, the patient should stop using Grypostop and consult their doctor or seek medical help immediately. See section 4.

After using medicines containing pseudoephedrine, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain. If symptoms that may be indicative of PRES or RCVS occur, the patient should immediately stop using Grypostop and seek medical help (symptoms, see section 4 "Possible side effects").

Grypostop and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not use Grypostop with other medicines containing paracetamol, dextromethorphan, or pseudoephedrine or other sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with amphetamine-like effects). Medicines that speed up gastric emptying, such as metoclopramide and domperidone, may accelerate the absorption of paracetamol, while medicines that slow down gastric emptying, such as cholestyramine and all anticholinergic medicines, may delay its absorption and effect in the body. Narcotic analgesics (e.g., pentazocine, pethidine, dimorphine) may also delay the absorption of paracetamol into the blood. Salicylamide may prolong the effect of paracetamol. Sedatives and tranquilizers may enhance the analgesic effect of paracetamol. The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, sepsis, malnutrition, chronic alcoholism, and those taking maximum daily doses of paracetamol. The use of medicines such as propranolol (for heart disease), nizatidine (for stomach ulcers), zidovudine (an antiviral medicine), and probenecid (for gout) may increase the harmful effects of paracetamol by increasing its concentration in the blood. Salbutamol taken orally may decrease the rate of paracetamol absorption. Paracetamol may enhance the effects of diabetes medicines and anticoagulants (e.g., warfarin) and increase the effect of caffeine on the nervous system. Paracetamol may increase the harmful effects of chloramphenicol. The concurrent use of paracetamol with rifampicin, antiepileptic medicines, barbiturates, and other medicines that affect liver metabolism may increase the risk of liver damage. Paracetamol taken with MAOIs may cause increased blood pressure, arrhythmias, excitement, and fever. Pseudoephedrine may enhance the effects of other sympathomimetic medicines (e.g., bronchodilators) and may reduce the effects of methyldopa, guanethidine, and reserpine. Tricyclic antidepressants may enhance the effects of pseudoephedrine. The concurrent use of inhaled anesthetics and pseudoephedrine may cause arrhythmias. Propranolol and MAOIs may increase the effects of sympathomimetic medicines, including pseudoephedrine, and cause hypertensive crises (sudden increase in blood pressure); the concurrent use of pseudoephedrine and MAOIs is contraindicated, and the time between stopping MAOIs and taking pseudoephedrine should be at least 14 days. Aluminum hydroxide (used in antacids) may increase the absorption of pseudoephedrine, while kaolin may decrease its absorption. Dextromethorphan may increase the effects of MAOIs, medicines that depress the nervous system, alcohol, and anticholinergic medicines. Medicines such as selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine), quinidine, and terbinafine may increase the concentration of dextromethorphan in the blood. Dextromethorphan taken with lidocaine or nonsteroidal anti-inflammatory medicines may potentiate their effects.

Grypostop with food, drink, or alcohol

Food may delay the absorption of paracetamol. Dextromethorphan may increase the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The use of Grypostop during pregnancy and breastfeeding is contraindicated.

Driving and using machines

Grypostop may affect the patient's ability to drive and use machines. During the use of Grypostop, the patient should be cautious when driving or operating machines.

3. How to use Grypostop

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The medicine is taken orally. The recommended dose is: Adults and adolescents over 12 years of age: 2 tablets, if necessary 3 to 4 times a day, not more often than every 4 hours. The patient should not take more than 8 tablets per day. The medicine should not be used for more than 3 days without consulting a doctor.

Use in children and adolescents

The medicine should not be used in children and adolescents under 12 years of age.

Using a higher dose of Grypostop than recommended

The patient should not use higher doses than recommended, as this may increase the risk of side effects, such as nausea, vomiting, abdominal pain, diarrhea, involuntary muscle contractions, mental disorders, drowsiness, coma, excitement, confusion, visual disturbances, pupil dilation, nystagmus, excessive sweating, arrhythmias, increased blood pressure, and cardiac disorders (rapid heartbeat). The patient may also experience liver or kidney damage and respiratory depression. Other symptoms of a large overdose may include coma, severe respiratory depression, and seizures. If any of these symptoms occur, the patient should immediately consult their doctor or go to the hospital.

Missing a dose of Grypostop

The patient should not take a double dose to make up for a missed dose.

Stopping the use of Grypostop

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Grypostop can cause side effects, although not everybody gets them. The active substances in Grypostop may cause the following side effects: Frequency not known: frequency cannot be estimated from the available data

• severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

The patient should immediately stop using Grypostop and seek medical help if they experience symptoms that may indicate PRES or RCVS, including: severe headache, nausea, vomiting, confusion, seizures, and visual disturbances. Rare (affects 1 to 10 in 10,000 patients): drowsiness, dizziness, euphoria, excessive sedation, feeling of emptiness in the head, anxiety, nervousness, irritability, mood disorders, psychomotor agitation; nausea, vomiting, abdominal pain, constipation; allergic reactions. Very rare (affects less than 1 in 10,000 patients): agranulocytosis (low white blood cell count), thrombocytopenia (low platelet count), neutropenia (low white blood cell count). Frequency not known (cannot be estimated from the available data): sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of using Grypostop. See section 2. Ischemic colitis (inflammatory bowel disease). Decreased blood flow to the optic nerve (ischemic optic neuropathy). If such symptoms occur, the patient should stop using Grypostop and consult their doctor or seek medical help immediately. Additionally, Grypostop may cause: arrhythmias, respiratory depression, rash, itching, changes in blood pressure, liver disorders of varying severity, from minor elevations in liver enzymes to liver damage. Liver damage is more likely in cases of malnutrition, alcoholism, and the presence of other diseases, as well as during the concurrent use of certain medicines. Some symptoms, such as nausea, vomiting, drowsiness, dizziness, and respiratory depression, may occur more frequently and with greater severity in immobilized patients.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, 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, more information can be collected on the safety of the medicine.

5. How to store Grypostop

Store in a temperature below 25°C. Store in a place out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Grypostop contains

1 coated tablet contains: 325 mg paracetamol, 30 mg pseudoephedrine hydrochloride, and 15 mg dextromethorphan hydrobromide.

• The active substances of Grypostop are: paracetamol (Paracetamolum), pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum), and dextromethorphan hydrobromide (Dextromethorphani hydrobromidum).
• The other ingredients are: magnesium stearate, microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), potato starch, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

What Grypostop looks like and contents of the pack

Grypostop, coated tablets, are packaged in blisters containing 12 tablets. The blisters are packaged in cardboard boxes. One box contains 12 tablets (1 blister) or 24 tablets (2 blisters).

Marketing authorization holder and manufacturer

Marketing authorization holder:

Milapharm Sp. z o.o., pl. Gen. Józefa Hallera 5/14A, 03-464 Warsaw

Manufacturer:

Medicofarma S.A., ul. Tarnobrzeska 13, 26-613 Radom

Date of last revision of the leaflet: 09/2024