Gripex Zatoki Caps

Leaflet attached to the packaging: patient information

Gripex ZATOKI Caps

500 mg + 25 mg + 6.1 mg

Hard capsules
Paracetamol+ Caffeine+ Phenylephrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform 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 Gripex ZATOKI Caps and what is it used for
• 2. Important information before taking Gripex ZATOKI Caps
• 3. How to take Gripex ZATOKI Caps
• 4. Possible side effects
• 5. How to store Gripex ZATOKI Caps
• 6. Package contents and other information

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

Gripex ZATOKI Caps is a combination medicine. It contains three active substances: paracetamol, caffeine, and phenylephrine. Paracetamol acts as an antipyretic and analgesic, phenylephrine restores nasal and sinus patency. Caffeine has a stimulating effect on the central nervous system, which causes a subjective feeling of relief from fatigue, improved coordination, and speed of association.
The indication for using Gripex ZATOKI Caps is the short-term treatment of symptoms associated with nasal and sinus mucosa inflammation, such as nasal and sinus congestion, hyperemia and edema of the mucosa, feeling of a blocked nose, runny nose, headache, pains related to sinus congestion, and fever, feeling of general malaise, fatigue.
Gripex ZATOKI Caps is a pain reliever and antipyretic for use in colds and flu.

2. Important information before taking Gripex ZATOKI Caps

When not to take Gripex ZATOKI Caps:

• if the patient is allergic (hypersensitive) to paracetamol, caffeine, phenylephrine, or other medicines with similar effects or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has had stomach ulcers,
• if the patient has been diagnosed with cardiovascular disorders,
• if the patient has arrhythmias,
• if the patient has hypertension,
• if the patient has diabetes,
• if the patient has been diagnosed with a pheochromocytoma of the adrenal gland,
• if the patient has been diagnosed with angle-closure glaucoma,
• if the patient has hyperthyroidism,
• if the patient has been diagnosed with prostatic hyperplasia,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• in the case of using monoamine oxidase inhibitors (MAOIs) (used in the treatment of hypertension and depression) and during the 14 days after discontinuation of their use,
• in the case of using tricyclic antidepressants (used in mental disorders) or zidovudine (AZT, a medicine used in HIV infection),
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Warnings and precautions

Before starting to take the medicine, consult a doctor or pharmacist.
The medicine contains paracetamol. Due to the risk of overdose, check if other medicines being taken contain paracetamol.
Do not drink alcohol while taking the medicine. Taking the medicine by people with liver failure, alcohol abuse, or starvation creates a risk of toxic liver damage.

Use with caution in:

• patients with liver or kidney failure (monitor liver enzyme activity and kidney function),
• patients with arteriosclerotic disease,
• patients with Raynaud's syndrome (manifested by blanching, followed by cyanosis of the fingers, toes, earlobes, and tip of the nose, often under the influence of cold or emotions),
• patients with stable coronary artery disease,
• patients with respiratory failure,
• patients with asthma,
• patients with increased intraocular pressure,
• patients taking anxiolytics,
• patients taking beta-adrenergic blockers (medicines used, for example, in the treatment of hypertension),
• patients taking anticoagulants.

If symptoms worsen or do not improve after 3 days, consult a doctor.
Consult a doctor even if the above warnings concern situations that have occurred in the past.

Gripex ZATOKI Caps and other medicines

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

Interaction of Gripex ZATOKI Caps with other medicines results from the interaction of the active substances contained in the medicine:

Paracetamol

• The medicine should not be taken simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol.
• Taking paracetamol simultaneously with MAO inhibitors (used in the treatment of, among other things, hypertension and depression) and during the 14 days after discontinuation of their use may cause a state of excitement and fever.
• Concomitant use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Concomitant use of paracetamol and medicines that increase liver metabolism, i.e., certain sedatives or antiepileptic medicines, e.g., phenobarbital, phenytoin, carbamazepine, as well as rifampicin (used in the treatment of, among other things, tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol. Therefore, before using the medicine, consult a pharmacist or doctor.
• Drinking alcohol during paracetamol treatment may lead to liver failure.
• Cholestyramine reduces the absorption of paracetamol and should not be taken within the first hour after paracetamol administration.
• Concomitant use of probenecid reduces the excretion of paracetamol and prolongs its action.
• Tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (metabolic acidosis with a large anion gap), which should be treated urgently and may occur especially in patients with severe kidney function disorders, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking the maximum daily doses of paracetamol.

Caffeine
Particular caution should be exercised when taking Gripex ZATOKI Caps with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamines), as caffeine inhibits their action,
• medicines that cause more frequent heart contractions (e.g., thyroxine), as caffeine enhances their action,
• theophylline (a medicine used in the treatment of asthma and allergic conditions), as caffeine inhibits its excretion,
• oral contraceptives, cimetidine, and disulfiram, as they inhibit caffeine metabolism in the liver,
• barbituric acid derivatives (sedatives), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine excretion and its metabolite.

Smoking accelerates caffeine metabolism.
Caffeine increases the risk of dependence on substances with effects similar to ephedrine (contained in heart medicines).
Phenylephrine

• MAO inhibitors (medicines used in hypertension and depression) may enhance the effect of phenylephrine. Their concomitant use should be avoided

or phenylephrine should be administered at least 14 days after discontinuation of tricyclic antidepressants.

• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants (medicines used in mental disorders).
• Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, reserpine (medicines used in the treatment of hypertension).
• Phenylephrine used concomitantly with indomethacin (a pain reliever and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of hypertension), or methyldopa (a medicine used, for example, in the treatment of hypertension) may cause a hypertensive crisis.

Children and adolescents

Do not use in children under 12 years of age.

Gripex ZATOKI Caps with food, drink, and alcohol

The medicine can be taken regardless of meals.
Do not drink alcohol while taking the medicine.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which may subsequently lead to liver failure.

Pregnancy and breastfeeding

Do not use during pregnancy.
Do not use during breastfeeding.

Driving and using machines

While taking Gripex ZATOKI Caps, be cautious when driving vehicles and operating machines.

Gripex ZATOKI Caps contains sodium

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

3. How to take Gripex ZATOKI Caps

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of any doubts, consult a doctor or pharmacist.
Gripex ZATOKI Caps should be taken orally.
Adults and adolescents over 12 years of age: 1 to 2 capsules, 3 to 4 times a day.
Do not take more than 8 capsules per day.
Do not use in children under 12 years of age.

Taking a higher dose of Gripex ZATOKI Caps than recommended

Consult a doctor or pharmacist immediately. The medicine contains three active substances.
Symptoms of overdose may result from the action of one or all of the active substances.
Accidental or intentional overdose of the medicine may cause, within a few or several hours, symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors. There may be nystagmus, increased blood pressure, seizures, difficulty urinating, and shortness of breath. These symptoms may resolve the next day, even though liver damage is beginning to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.
In case of overdose, consult a doctor immediately.
Treatment should be carried out in a hospital and involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. In the case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missing a dose of Gripex ZATOKI Caps

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects has been classified as follows:
Common - may occur in 1-10 out of 100 treated patients;
Rare - may occur in 1-10 out of 10,000 treated patients;
Very rare - may occur in less than 1 out of 10,000 patients;
Frequency not known - cannot be estimated from the available data.

If any of the side effects get worse or if any side effects not listed in the leaflet occur, tell your doctor.

Possible side effects of the medicine due to the presence of paracetamol:

Rare:

• anemia, bone marrow suppression, thrombocytopenia (low platelet count), agranulocytosis (absence of granulocytes in the blood), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count),
• edema,
• acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice,
• itching, rash, sweating, erythema, angioedema, urticaria,
• nephropathy and tubulopathy (kidney and urinary tract diseases).

Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of chronic use of the medicine.
Very rare cases of severe skin reactions have been reported, including single cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock, and dizziness.
Possible side effects of the medicine due to the presence of phenylephrine:

Common:

• nausea, vomiting, digestive disorders, anorexia.

Rare:

• itching, urticaria,
• allergic reactions and hypersensitivity up to anaphylactic shock and bronchospasm,
• increased blood pressure, tachycardia, arrhythmias, palpitations, pallor.

Very rare:

• anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations.

Frequency not known:

• urinary retention.

After taking caffeine, the following have been reported: palpitations, sudden flushing, high blood pressure.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C

• 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 the medicine.

5. How to store Gripex ZATOKI Caps

Store the medicine at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.
The expiry date stated is the last day of the specified month.

6. Package contents and other information

What Gripex ZATOKI Caps contains

The active substances of the medicine are: paracetamol, caffeine, and phenylephrine hydrochloride.
The other excipients are: cornstarch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, talc, gelatin, erythrosine (E 127), titanium dioxide (E 171), quinoline yellow (E 104), patent blue V (E 131).

What Gripex ZATOKI Caps looks like and what the pack contains

Bicolor yellow-red hard capsule, gelatinous, intended for oral use.
Packaging:6, 8, 10, 12, 16, 20 hard capsules.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel. +48 (22) 543 60 00

Date of the last update of the leaflet: