Gripex hot zatoki

Package leaflet: Information for the patient

Gripex Hot ZATOKI, effervescent powder for oral solution
Paracetamolum + Pseudoephedrini hydrochloridum +
Dextromethorphani hydrobromidum + Chlorphenamini maleas
Please read the entire 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
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please 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, or if you feel worse, you should contact your doctor.

Table of contents:

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

1. What is Gripex Hot ZATOKI and what is it used for

A combination medicine with analgesic, antipyretic, antitussive, and nasal decongestant effects, which helps clear the nasal passages and sinus openings, reduces mucus secretion, and relieves nasal mucosal congestion and swelling.
Indications:
Short-term treatment of symptoms of colds, influenza, influenza-like conditions, and sinusitis (fever, nasal congestion, cough, headache, sore throat, muscle and joint pain).

2. Important information before using Gripex Hot ZATOKI

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

When not to use Gripex Hot ZATOKI:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver failure,
• if the patient has anaemia (reduced number of red blood cells),
• if the patient is simultaneously using other medicines containing paracetamol, dextromethorphan, pseudoephedrine or chlorpheniramine (see section: Gripex Hot ZATOKI and other medicines),
• if the patient is simultaneously using monoamine oxidase inhibitor drugs (MAO inhibitors), such as phenelzine, isocarboxazid, selegiline, moklobemide. Do not use this medicine within two weeks after discontinuing treatment with medicines containing monoamine oxidase inhibitors.
• during pregnancy and breastfeeding,
• if the patient has cough with large amounts of phlegm,
• if the patient has bronchial asthma or cough associated with bronchial asthma,
• if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• if the patient has severe ischaemic heart disease,
• if the patient has cystic fibrosis (a congenital genetic disease characterised, among others, by a tendency to bronchitis and pneumonia),
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Gripex Hot ZATOKI, consult your doctor or pharmacist:

• if the patient has liver and/or kidney failure;
• if the patient is elderly, due to increased risk of adverse effects on the nervous system;
• if the patient is weakened or immobilised for a prolonged period;
• if breathing difficulties occur;
• if the patient has emphysema, asthma, chronic bronchitis, benign prostatic hyperplasia, hyperthyroidism, diabetes, high blood pressure, heart disease, vascular disease, narrow-angle glaucoma, or pheochromocytoma (a tumour of the adrenal gland causing high blood pressure);
• if the patient is taking certain antidepressant or antipsychotic drugs, 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, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). During treatment with Gripex Hot ZATOKI, immediately inform the doctor if the patient has severe illnesses, including severe kidney dysfunction 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 imbalance in blood and body fluids) when taking paracetamol regularly over a long period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
  • Gripex Hot ZATOKI contains paracetamol. Do not exceed the recommended dose. Overdose of paracetamol may lead to severe liver damage or even death. Do not use this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat symptoms of flu and colds.
  • If excessive nervousness, dizziness or insomnia occur, discontinue the medicine and contact a doctor.
  • Do not use doses higher than recommended.
  • Consult a doctor if symptoms persist for more than 3 days.
  • Do not drink alcohol while taking this medicine due to increased risk of liver damage.
  • Do not use other medicines that depress the central nervous system (e.g. sedatives, tranquilisers).
• Due to reported cases of dextromethorphan abuse, particular caution should be exercised when using Gripex Hot ZATOKI in adolescents, young adults, and patients with a history of drug or psychoactive substance abuse.
• Exercise special caution in patients with slow metabolism mediated by the CYP2D6 enzyme or those taking substances that inhibit its activity (listed in the section "Gripex Hot ZATOKI and other medicines").
• If taking medicines that inhibit CYP2D6 enzyme activity, consult a doctor before using this medicine. If it is necessary to use CYP2D6-inhibiting medicines together with dextromethorphan, the patient must be under strict medical supervision. A reduction in the dextromethorphan dose may be required.
• In patients with poor metabolism via this enzyme and in patients simultaneously taking medicines that inhibit CYP2D6 activity, enhanced and/or prolonged effects of dextromethorphan may occur. Concurrent use of strong CYP2D6 inhibitors increases the risk of dextromethorphan poisoning, manifesting as agitation, disorientation, tremor, insomnia, diarrhoea and respiratory depression. It may also lead to the development of a potentially life-threatening serotonin syndrome (rapid heartbeat, disorientation, profuse sweating, hallucinations, involuntary muscle movements, chills, tremors). If the above symptoms occur after taking Gripex Hot ZATOKI, discontinue treatment immediately and seek medical advice without delay.
• If the patient develops fever with generalised skin redness and blistering rash, discontinue use of Gripex Hot ZATOKI and contact a doctor or seek immediate medical help. See section 4.
• During treatment with Gripex Hot ZATOKI, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischaemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue use of Gripex Hot ZATOKI and seek immediate medical advice or help. See section 4.
• During treatment with Gripex Hot ZATOKI, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, discontinue use of Gripex Hot ZATOKI and contact a doctor or seek immediate medical help. See section 4.
• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain. If symptoms suggestive of PRES or RCVS occur, immediately discontinue use of Gripex Hot ZATOKI and seek immediate medical help (symptoms, see section 4 "Possible side effects").

Gripex Hot ZATOKI and other medicines

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

Do not use Gripex Hot ZATOKI with other medicines containing paracetamol, pseudoephedrine or other sympathomimetics (such as nasal decongestants, appetite suppressants or psychostimulants with amphetamine-like action), dextromethorphan and/or chlorpheniramine or other antihistamines (antiallergic medicines).

Medicines that accelerate gastric emptying, such as metoclopramide and domperidone, accelerate the absorption of paracetamol, whereas medicines that delay gastric emptying, such as cholestyramine and all anticholinergic medicines, may delay its absorption and effect in the body. Narcotic painkillers (pentazocine, pethidine, dimorphine) also delay the absorption of paracetamol into the blood.

Salicylamide prolongs the action of paracetamol.

Sleeping and sedative medicines enhance the analgesic effect.

Concomitant use of medicines such as propranolol (for heart conditions), nizatidine (for peptic ulcer), zidovudine (an antiviral medicine), and probenecid (for gout) may increase the harmful effects of paracetamol by increasing its blood concentration.

Oral salbutamol may reduce the rate of paracetamol absorption.

Paracetamol may enhance the effects of antidiabetic medicines and anticoagulants such as warfarin (coumarins), and may enhance the effects of caffeine on the nervous system.

Paracetamol may increase the harmful effects of chloramphenicol.

Concomitant use of paracetamol with rifampicin, antiepileptic drugs, barbiturates, and other medicines affecting liver metabolism increases the risk of liver damage.

Paracetamol taken with MAO inhibitors may cause increased blood pressure, heart rhythm disturbances, agitation, and fever.

Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of disturbances in blood and body fluids (called metabolic acidosis), which require urgent treatment (see section 2).

Pseudoephedrine enhances the effects of other sympathomimetic drugs (bronchodilators), but may reduce the effects of methyldopa, guanethidine, and reserpine.

Tricyclic antidepressants enhance the effects of pseudoephedrine.

Concomitant use of inhaled anaesthetics and pseudoephedrine may lead to heart rhythm disturbances.

Propranolol and MAO inhibitors may enhance the effects of sympathomimetic drugs, including pseudoephedrine, and may cause hypertensive crises (sudden increase in blood pressure); concomitant use of pseudoephedrine and MAO inhibitors is contraindicated, and at least 14 days should elapse between discontinuation of MAO inhibitors and administration of pseudoephedrine.

Aluminium hydroxide (used, for example, in antacids) increases the absorption of pseudoephedrine, whereas kaolin reduces its absorption.

Dextromethorphan may enhance the effects of MAO inhibitors, central nervous system depressants, alcohol, and antidiarrhoeal medicines.

Medicines that inhibit the activity of the CYP2D6 enzyme, such as fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine, may increase the blood concentration of dextromethorphan.

Dextromethorphan taken simultaneously with lidocaine or non-steroidal anti-inflammatory drugs may enhance their effects.

Chlorpheniramine may enhance the effects of MAO inhibitors, sleeping pills and anxiolytics (benzodiazepines), antidepressants, other medicines acting on the nervous system, antimalarial medicines (e.g. chloroquine), and alcohol.

Use of Gripex Hot ZATOKI with food, drink and alcohol

Food may delay the absorption of paracetamol.

Dextromethorphan and chlorpheniramine may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility

Use of Gripex Hot ZATOKI during pregnancy and breastfeeding is contraindicated.

Driving and operating machinery

Gripex Hot ZATOKI may have a significant effect on the ability to drive and operate machinery.

Do not drive or operate machinery while taking this medicine, as Gripex Hot ZATOKI may impair safe driving.

Warnings regarding excipients:

Gripex Hot ZATOKI contains 15 g of sucrose per sachet and glucose (a component of flavoured maltodextrin).

This should be taken into account in patients with diabetes.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Gripex Hot ZATOKI contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
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 of age: 1 sachet. If necessary, the dose may be repeated, but no more frequently than every 4–6 hours. Do not use more than 4 sachets per day. Do not use for longer than 3 days without consulting a doctor.

Use in children
Do not use in children under 12 years of age.
Taking more Gripex Hot ZATOKI than recommended
Due to the presence of paracetamol, if a larger than recommended dose is taken, contact a doctor immediately, even if the patient feels well and no symptoms of poisoning are observed. There is a risk of delayed, severe liver damage, which may result in liver transplantation or death. If a single dose of paracetamol equal to or exceeding 5 g has been taken and less than one hour has passed since ingestion, vomiting may be induced. Administer 60–100 g of activated charcoal orally, preferably mixed with water.
Do not exceed the recommended doses due to the high likelihood of adverse effects.
If a patient takes more than the recommended dose of Gripex Hot ZATOKI, the following symptoms may occur: nausea, vomiting, abdominal pain, diarrhoea, psychiatric disturbances, psychosis with visual hallucinations, confusion, drowsiness, agitation, increased excitability, disturbances of consciousness, coordination disorders, visual disturbances, pupil dilation, nystagmus, involuntary rapid eye movements, profuse sweating, cardiac arrhythmias, and increased blood pressure. Liver and/or kidney damage may also occur, as well as shallow breathing and disturbances in urination.
Other symptoms of severe overdose may include coma, severe respiratory depression, and seizures.
Some symptoms may subside the next day, despite the onset of life-threatening liver damage, which subsequently manifests as discomfort in the upper abdomen, recurrence of nausea, and jaundice.
If a dose higher than recommended is taken or if any of the above symptoms occur, seek immediate medical advice or go to hospital.
If you forget to take Gripex Hot ZATOKI
Do not take a double dose to make up for a forgotten dose.
Stopping Gripex Hot ZATOKI
If you have any further questions about 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 everyone will experience them.
You must stop taking Gripex Hot ZATOKI immediately and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• sudden, severe headache,
• nausea,
• vomiting,
• confusion,
• seizures, visual disturbances.

The active substances in Gripex Hot ZATOKI may cause the following adverse reactions:
Rare (occurs in 1 to 10 out of 10,000 patients):
drowsiness, dizziness, euphoria, excessive sedation, feeling of emptiness in the head, restlessness, anxiety, nervousness, irritability, mood disturbances, psychomotor agitation, nausea, vomiting, abdominal pain, constipation, allergic reactions.
Very rare (occurs in fewer than 1 out of 10,000 patients):
agranulocytosis (lack of white blood cells), thrombocytopenia (lack of platelets), neutropenia (lack of white blood cells).
Frequency not known (frequency cannot be determined from available data): severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS); ischemic colitis (inflammation of the large intestine due to insufficient blood supply); 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 Gripex Hot ZATOKI (see section 2); if such symptoms occur, discontinue use of Gripex Hot ZATOKI and contact a doctor or seek immediate medical help; reduced blood flow to the optic nerve (ischemic optic neuropathy); a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
Additionally, Gripex Hot ZATOKI may cause:

• heart rhythm disturbances,
• shallow breathing,
• rash, itching,
• changes in blood pressure,
• liver-related effects of varying severity, ranging from clinically insignificant elevation of liver enzymes to liver damage. The risk of liver injury is higher in cases of malnutrition, alcoholism, presence of other diseases, and when certain medicines are taken concomitantly.

Some symptoms (e.g., nausea, vomiting, drowsiness, dizziness, shallow breathing) may occur more frequently and be more severe in immobilized patients.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Phone: +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 provide more information on the safety of the medicine.

5. How to store Gripex Hot ZATOKI

Store below 25 ˚C.
Keep the medicine in a place invisible and out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Gripex Hot SINUS contains

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

What Gripex Hot SINUS looks like and contents of the packaging
Gripex Hot SINUS is packed in sachets made of laminated Paper/Polyethylene/Aluminium/Surlyn;
6, 8 or 12 sachets are placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Manufacturer
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00