Gripex Hot Zatoki

Leaflet attached to the packaging: patient information

Gripex Hot ZATOKI, powder for oral solution

Paracetamol+ Pseudoephedrine hydrochloride+
Dextromethorphan hydrobromide + Chlorphenamine maleate

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 this patient leaflet or as directed by your 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Gripex Hot ZATOKI 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 of the nasal mucosa.
Indications:
For the symptomatic treatment of colds, flu, flu-like conditions, and sinusitis (fever, runny nose, cough, headache, sore throat, muscle and joint pain).

2. Important information before using Gripex Hot ZATOKI

Taking this medicine may lead to dependence. Therefore, treatment should be short-term.

When not to use Gripex Hot ZATOKI:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver failure,
• if you have anemia (low red blood cell count),
• if you are taking other medicines containing paracetamol, dextromethorphan, pseudoephedrine, or chlorphenamine (see subsection: Gripex Hot ZATOKI and other medicines),
• if you are taking medicines that inhibit the enzyme monoamine oxidase (MAOIs), such as phenelzine, isocarboxazid, selegiline, or moclobemide. You should not take this medicine for 2 weeks after stopping MAOIs.
• in pregnancy and breastfeeding,
• if you have a cough with a large amount of mucus,
• if you have asthma and cough associated with asthma,
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if you have severe acute or chronic kidney disease or kidney failure,
• if you have severe coronary heart disease,
• if you have cystic fibrosis (a genetic disorder characterized by respiratory and pancreatic problems),
• in children under 12 years of age.

Warnings and precautions

Before starting to use Gripex Hot ZATOKI, you should discuss it with your doctor or pharmacist:

• if you have liver or kidney failure;
• if you are elderly, due to the increased risk of adverse effects on the nervous system;
• if you are weakened or immobilized for a longer period;
• if you experience breathing difficulties;
• if you have pulmonary emphysema, asthma, chronic bronchitis, prostate enlargement, hyperthyroidism, diabetes, high blood pressure, heart disease, vascular disease, glaucoma, or pheochromocytoma (a tumor of the adrenal gland);
• if you are taking certain antidepressants or antipsychotics, Gripex Hot ZATOKI may interact with them, causing changes in mental state (e.g., agitation, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). If you experience any of these symptoms while taking Gripex Hot ZATOKI, you should immediately inform your doctor.

Gripex Hot ZATOKI and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
You should not take Gripex Hot ZATOKI with other medicines containing paracetamol, pseudoephedrine, or other sympathomimetics (e.g., nasal decongestants, appetite suppressants, or psychostimulants similar to amphetamines), dextromethorphan, or chlorphenamine or other antihistamines (anti-allergic medicines).
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 painkillers (e.g., pentazocine, pethidine, and diamorphine) 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.
Taking 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.
Taking 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, heart rhythm disturbances, agitation, and fever.
You should inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the risk of serious blood and fluid disorders (metabolic acidosis), which require immediate treatment (see section 2).
Pseudoephedrine may enhance the effects of other sympathomimetic medicines (e.g., bronchodilators), while it may weaken the effects of methyldopa, guanethidine, and reserpine.
Tricyclic antidepressants may enhance the effects of pseudoephedrine.
Concomitant use of inhaled anesthetics and pseudoephedrine may cause heart rhythm disturbances.
Propranolol and MAOIs may increase the effects of sympathomimetic medicines, including pseudoephedrine, and cause hypertensive crises (sudden increase in blood pressure); concomitant 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, central nervous system depressants, alcohol, and anti-diarrheal medicines.
Medicines that inhibit the enzyme CYP2D6, such as fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine, may increase the concentration of dextromethorphan in the blood.
Dextromethorphan taken with lidocaine or nonsteroidal anti-inflammatory medicines may potentiate their effects.
Chlorphenamine may increase the effects of MAOIs, sedatives, and anxiolytics (benzodiazepines), antidepressants, other central nervous system medicines, anti-malarial medicines (e.g., chloroquine), and alcohol.

Using Gripex Hot ZATOKI with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Using Gripex Hot ZATOKI during pregnancy and breastfeeding is contraindicated.

Driving and using machines

Gripex Hot ZATOKI may have a significant impact on your ability to drive and use machines.
You should not drive or operate machinery while taking this medicine, as it may impair your ability to drive safely.

Warnings about excipients:

Gripex Hot ZATOKI contains 15 g of sucrose in one sachet and glucose (a component of maltodextrin with flavor).

This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Gripex Hot ZATOKI contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is considered "sodium-free".

3. How to use Gripex Hot ZATOKI

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
The medicine is taken orally.
You should dissolve the contents of the sachet in a glass of hot water. Drink the hot liquid in small sips.
The recommended dose is:

• adults and adolescents over 12 years: 1 sachet, which can be repeated if necessary, but not more often than every 4-6 hours. Do not take more than 4 sachets per day. Do not use for more than 3 days without consulting a doctor.

Use in children

Do not use in children under 12 years of age.

Using a higher dose of Gripex Hot ZATOKI than recommended

Due to the presence of paracetamol, in any case of taking a higher dose than recommended, you should immediately contact a doctor, even if you feel well and have not observed any symptoms of poisoning. There is a risk of delayed, severe liver damage, which can lead to liver transplantation or death. In any case of taking paracetamol in a dose of 5 g or more and if it has not been more than an hour since ingestion, you can induce vomiting. Give 60-100 g of activated charcoal orally, preferably mixed with water.
Do not take higher doses than recommended, due to the high probability of adverse effects.
If you take a higher dose of Gripex Hot ZATOKI than recommended, you may experience the following symptoms: nausea, vomiting, abdominal pain, diarrhea, mental disorders, psychosis with visual hallucinations, confusion, sleepiness, agitation, increased excitability, impaired consciousness, impaired coordination, impaired vision, pupil dilation, nystagmus, involuntary rapid eye movements, excessive sweating, heart rhythm disturbances, increased blood pressure. You may also experience liver and/or kidney damage and respiratory depression.

Missing a dose of Gripex Hot ZATOKI

Do not take a double dose to make up for a missed dose.

Stopping the use of Gripex Hot ZATOKI

In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately stop using Gripex Hot ZATOKI and seek medical help if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures, changes in vision

The active substances in Gripex Hot ZATOKI may cause the following side effects:
Rare (affects 1 to 10 in 10,000 patients):
drowsiness, dizziness, euphoria, excessive sedation, feeling of emptiness in the head, anxiety, nervousness, irritability, mood disturbances, 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): severe vascular disorders in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), ischemic colitis (inflammation of the colon due to insufficient blood flow); 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 Gripex Hot ZATOKI (see section 2); if you experience any of these symptoms, you should stop using Gripex Hot ZATOKI and consult your doctor or seek medical help; decreased blood flow in the optic nerve (ischemic optic neuropathy); a serious condition that can cause acidosis (metabolic acidosis), in patients with severe underlying disease taking paracetamol (see section 2).
Additionally, Gripex Hot ZATOKI may cause:

• heart rhythm disturbances,
• shallow breathing,
• rash, itching,
• changes in blood pressure,
• liver disorders of varying severity, from clinically insignificant elevations of liver enzymes to liver damage. The harmful effect on the liver is greater in cases of malnutrition, alcoholism, and the presence of other diseases, as well as during concomitant use of certain medicines.

Some symptoms (e.g., nausea, vomiting, drowsiness, dizziness, shallow breathing) may occur more frequently and with greater severity in immobilized patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides), 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Gripex Hot ZATOKI

Store in a temperature below 25°C.
Medicines should be kept out of the 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. You should ask your 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 Gripex Hot ZATOKI contains

• The active substances of the medicine are: paracetamol (Paracetamolum), pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum), dextromethorphan hydrobromide (Dextromethorphani hydrobromidum), and chlorphenamine maleate (Chlorphenamini maleas). One sachet contains: 650 mg of paracetamol, 60 mg of pseudoephedrine hydrochloride, 20 mg of dextromethorphan hydrobromide, and 4 mg of chlorphenamine maleate.
• Other ingredients are: ascorbic acid, citric acid, lemon flavor (lemon oil, including limonene, citral, and linalool), maltodextrin (containing glucose), gum arabic (E 414), povidone, sodium citrate, cornstarch, stearic acid, sucrose, titanium dioxide, calcium phosphate, and quinoline yellow (E 104).

What Gripex Hot ZATOKI looks like and what the pack contains

Gripex Hot ZATOKI is packaged in sachets made of a laminate of paper/polyethylene/aluminum/Surlyn; 6, 8, or 12 sachets are placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00

Date of last revision of the leaflet: