GRIPEXPRO OPTIMA

Package leaflet: Information for the user

Gripex ZATOKI Caps
500 mg + 25 mg + 6.1 mg
hard capsules
Paracetamolum + Coffeinum + Phenylephrini hydrochloridum
Please read the entire leaflet carefully 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 a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects 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, contact your doctor.

Table of contents

1. What Gripex ZATOKI Caps is and what it is 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. Contents of the pack and other information

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

Gripex ZATOKI Caps is a combination medicine. It contains three active substances: paracetamol, caffeine, and phenylephrine. Paracetamol has antipyretic and analgesic effects, phenylephrine restores nasal and sinus patency. Caffeine exerts a stimulant effect on the central nervous system, resulting in a subjective feeling of reduced fatigue and improved coordination and mental speed.
Gripex ZATOKI Caps is indicated for the short-term treatment of symptoms associated with rhinitis and sinusitis, such as nasal and sinus congestion, mucosal hyperemia and edema, nasal stuffiness, runny nose, headache, pain related to sinus obstruction, fever, general malaise, and fatigue.
Gripex ZATOKI Caps is an analgesic and antipyretic medicine intended for use in colds and influenza.

2. Important information before taking Gripex ZATOKI Caps

When not to use Gripex ZATOKI Caps:

• if you are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine, other medicines with similar action, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver or kidney impairment,
• if you have a history of peptic ulcer disease,
• if you have cardiovascular disorders,
• if you have cardiac arrhythmias,
• if you have hypertension,
• if you have diabetes,
• if you have been diagnosed with pheochromocytoma,
• if you have closed-angle glaucoma,
• if you have hyperthyroidism,
• if you have been diagnosed with benign prostatic hyperplasia,
• if you have congenital glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency,
• if you are taking monoamine oxidase inhibitors (MAO inhibitors) (used in the treatment of hypotension and depression), or within 14 days after discontinuation of such treatment,
• if you are taking tricyclic antidepressants (medicines used for psychiatric 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 treatment, consult your doctor or pharmacist.
This medicine contains paracetamol. Due to the risk of overdose, check whether other medicines you are taking also contain paracetamol.
Do not drink alcohol while taking this medicine. Use of this medicine in patients with liver impairment, chronic alcohol abuse, or fasting increases the risk of hepatotoxic damage.
Use with caution in patients:

• with liver or kidney impairment (liver enzyme activity and kidney function should be monitored),
• with peripheral vascular disease,
• with Raynaud's syndrome (characterized by pallor followed by cyanosis of fingers, toes, earlobes, and nose tip, often triggered by cold or stress),
• with stable coronary artery disease,
• with respiratory insufficiency,
• with bronchial asthma,
• with increased intraocular pressure,
• taking anxiolytic medicines,
• taking beta-adrenolytic agents (medicines used, e.g., for hypertension),
• taking anticoagulant medicines.

If symptoms worsen or do not improve within 3 days, contact your doctor.
Consult your doctor even if the above warnings refer to conditions previously experienced.

Gripex ZATOKI Caps and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
The interaction of Gripex ZATOKI Caps with other medicines results from the effects of its active ingredients:

Paracetamol

• Do not take this medicine simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) increase the rate of paracetamol absorption.
• Medicines that delay gastric emptying (e.g., propantheline) may delay paracetamol absorption.
• Concomitant use of paracetamol with MAO inhibitors (used, among others, in the treatment of hypotension and depression) and within 14 days after discontinuation of such treatment may cause excitation and fever.
• Concurrent use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the myelotoxic effect of zidovudine.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Concurrent use of paracetamol with medicines that increase hepatic metabolism, such as certain sedatives or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used, among others, in tuberculosis treatment), may lead to liver damage, even when recommended doses of paracetamol are used. Therefore, consult your pharmacist or doctor before using this medicine.
• Alcohol consumption during paracetamol treatment may lead to liver failure.
• Cholestyramine reduces paracetamol absorption; therefore, it should not be taken within the first hour after paracetamol administration.
• Concurrent use of probenecid reduces paracetamol excretion and prolongs its duration of action.
• Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of fluid and electrolyte imbalance (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal impairment, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or in patients taking maximum daily doses of paracetamol.

Caffeine
Exercise particular caution when using Gripex ZATOKI Caps with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamines), as caffeine may inhibit their effects,
• medicines causing tachycardia (e.g., thyroxine), as caffeine may enhance their effects,
• theophylline (a medicine used in asthma and allergic conditions), as caffeine may inhibit its excretion,
• oral contraceptives, cimetidine, and disulfiram, as they inhibit caffeine metabolism in the liver,
• barbituric acid derivatives (hypnotic medicines), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine and its metabolite excretion.

Smoking accelerates caffeine metabolism.
Caffeine increases the risk of dependence on substances with ephedrine-like action (contained in cardiac medicines).

Phenylephrine

• MAO inhibitors (medicines used in hypotension and depression) may enhance the effect of phenylephrine. Avoid concomitant use of MAO inhibitors with phenylephrine or administer phenylephrine at least 14 days after discontinuation of tricyclic antidepressants.
• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants (medicines used in psychiatric disorders).
• Phenylephrine may reduce the antihypertensive effect of guanethidine, mecamylamine, methyldopa, and reserpine (medicines used in hypertension treatment).
• Phenylephrine used concomitantly with indomethacin (an analgesic and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used, e.g., for hypertension), or methyldopa (a medicine used, e.g., for hypertension) may cause hypertensive crisis.

Children and adolescents
Do not use in children under 12 years of age.

Gripex ZATOKI Caps with food, drink, and alcohol
This medicine can be taken regardless of meals.
Do not consume alcohol while taking this medicine.
Alcohol consumption during paracetamol treatment leads to the formation of a toxic metabolite causing hepatocyte necrosis, which may ultimately result in liver failure.

Pregnancy and breastfeeding
Do not use during pregnancy.
Do not use during breastfeeding.

Driving and operating machinery
Exercise caution when driving or operating machinery while taking Gripex ZATOKI Caps.

Gripex ZATOKI Caps contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., it is considered "sodium-free".

3. How to take Gripex SINUS Caps

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Gripex SINUS Caps should be taken orally.
Adults and adolescents over 12 years of age: 1 to 2 capsules, 3 - 4 times daily.
Do not exceed 8 capsules per day.
This medicine should not be used in children under 12 years of age.

Taking more Gripex SINUS Caps than recommended
Seek immediate advice from a doctor or pharmacist. The medicine contains three active substances.
Symptoms of overdose may result from the effect of one or all of the active substances.
Accidental or intentional overdose may cause, within a few to several hours, symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, restlessness, tremor. Nystagmus, elevated blood pressure, seizures, difficulty in urinating, and shortness of breath may also occur. These symptoms may resolve the following day, even though liver damage may have started to develop, which subsequently manifests as abdominal discomfort, recurrence of nausea, and jaundice.
In case of overdose, seek medical help immediately.
Treatment should be carried out in a hospital. It consists of accelerating the elimination of the drug components from the body and supporting vital functions. In case of paracetamol overdose, administration of an antidote (N-acetylcysteine and/or methionine) may be necessary.

If you forget to take Gripex SINUS Caps
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The frequency of adverse effects has been classified as follows:

• Frequent – may occur in 1 to 10 out of 100 treated patients;
• Rare – may occur in 1 to 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 based on available data.

If any of the adverse effects occur or worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor.

Possible adverse effects of the medicine due to the presence of paracetamol:
Rare:

• anaemia, bone marrow suppression, thrombocytopenia (deficiency of blood platelets), agranulocytosis (lack of granulocytes in the blood), leukopenia (reduced number of leukocytes), neutropenia (reduced number of neutrophils),
• oedema,
• acute and chronic pancreatitis, haemorrhage, abdominal pain, diarrhoea, nausea, vomiting, liver failure, hepatic necrosis, jaundice,
• itching, rash, sweating, purpura, angioedema, urticaria,
• nephropathies and tubulopathies (kidney and urinary tract disorders).

Nephrotoxic effects are rare; no association with therapeutic doses has been reported, except in cases of chronic use.
Very rare cases of severe skin reactions have been reported, including single cases of epidermal necrolysis (toxic epidermal necrolysis), Stevens-Johnson syndrome, erythema multiforme, laryngeal oedema, anaphylactic shock, and dizziness.

Possible adverse effects of the medicine due to the presence of phenylephrine:
Frequent:

• nausea, vomiting, digestive disturbances, loss of appetite.
  Rare:

• itching, urticaria,

• allergic reactions and hypersensitivity up to symptoms of anaphylactic shock and bronchospasm,

• increased arterial blood pressure, tachycardia, cardiac arrhythmias, palpitations, pallor.
  Very rare:

• anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness and headache, hallucinations.
  Frequency not known:

• urinary retention.

Following administration of caffeine, the following occurred: palpitations, sudden flushing, high arterial blood pressure, tachycardia.

Reporting of adverse effects
If any adverse effects occur, including all possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting of adverse effects allows further information on the safety of the medicine to be collected.

5. How to store GripexPro Optima SINUS Caps

Store the medicinal product below 25 °C.
Keep the medicinal product out of sight and reach of children.
Do not use after the expiry date stated on the carton and on the immediate packaging (month/year).
Blister labelling: EXP - expiry date, Lot - batch number.
The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Gripex SINUS Caps contains
The active substances are: paracetamol, caffeine, and phenylephrine hydrochloride.
The other excipients are: maize starch, sodium croscarmellose, 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 SINUS Caps looks like and contents of the pack
A two-coloured, yellow-red hard gelatin capsule intended for oral use.
Packaging: 6, 8, 10, 12, 16, 20 hard capsules.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40,
50-507 Wrocław
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
tel. +48 (22) 543 60 00