Gripblocker Zatoki

Package Leaflet: Information for the Patient

Gripblocker Zatoki

250 mg + 30 mg, Soft Capsules

Paracetamol + Pseudoephedrine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

Table of Contents of the Leaflet

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

1. What is Gripblocker Zatoki and what is it used for

Gripblocker Zatoki is a combination medication containing two active substances – paracetamol and pseudoephedrine hydrochloride. The medication has analgesic, antipyretic, and decongestant effects on the upper respiratory tract.

Indications

Gripblocker Zatoki is used to treat symptoms of flu and flu-like infections, accompanied by fever, headache, muscle and bone pain, as well as to treat symptoms of rhinitis and sinusitis. The medication can be used in patients for whom the use of nonsteroidal anti-inflammatory drugs and acetylsalicylic acid derivatives is contraindicated.

2. Important information before taking Gripblocker Zatoki

Contraindications:

• if the patient is hypersensitive to paracetamol, pseudoephedrine hydrochloride, or any other component of the medication (listed in section 6),
• in the case of using monoamine oxidase inhibitors (a group of medications used to treat depression and hypertension) and up to 2 weeks after discontinuing their use,
• in the case of severe liver dysfunction,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• in the case of glucose-6-phosphate dehydrogenase deficiency (possibility of hemolysis),
• in the case of anemia,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in the case of ischemic heart disease,
• in the case of alcoholism.

Warnings and precautions

Before starting treatment with Gripblocker Zatoki, the patient should discuss it with a doctor or pharmacist. Special caution should be exercised when taking Gripblocker Zatoki:

• in patients with jaundice, as well as in patients who are fasting,
• in patients taking blood pressure-lowering medications, tricyclic antidepressants, and other sympathomimetic medications (vasoconstrictor medications for nasal mucosa, appetite suppressants, psychostimulants similar to amphetamine),
• in patients with diabetes, hyperthyroidism, prostatic hyperplasia, arrhythmias, and increased intraocular pressure,
• in elderly patients.

During treatment with Gripblocker Zatoki, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), which requires urgent treatment (see section 2).

Children

Due to the presence of pseudoephedrine, the medication should not be used in children under 12 years of age without a doctor's recommendation.

Gripblocker Zatoki and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The interaction of Gripblocker Zatoki with other medications is due to the interaction of the active substances in the medication:

Paracetamol

• concomitant use of Gripblocker Zatoki and nonsteroidal anti-inflammatory medications (e.g., ibuprofen, naproxen, acetylsalicylic acid) increases the risk of kidney dysfunction;
• paracetamol enhances the anticoagulant effect of coumarin derivatives (e.g., warfarin, acenocoumarol) and may prolong bleeding time;
• metoclopramide accelerates, and anticholinergics (e.g., pirenzepine, telenzepine) reduce the absorption of paracetamol;
• concomitant use of paracetamol with rifampicin, antiepileptic medications (phenobarbital, phenytoin, carbamazepine), barbiturates (e.g., phenobarbital), and ethanol may lead to liver cell necrosis;
• using paracetamol with monoamine oxidase inhibitors and within 2 weeks after discontinuing treatment with these medications may cause excitement and high fever;
• the patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the risk of blood and body fluid disorders (metabolic acidosis), which require urgent treatment (see section 2).

Pseudoephedrine

• the antibacterial medication furazolidone has a dose-dependent inhibitory effect on monoamine oxidase activity. Although there are no reports of hypertensive crises caused by concomitant use of pseudoephedrine and furazolidone, it is not recommended to take them together;
• concomitant use of Gripblocker Zatoki and tricyclic antidepressants, sympathomimetic medications (such as vasoconstrictor medications for nasal mucosa, appetite suppressants, psychostimulants similar to amphetamine), and monoamine oxidase inhibitors that disrupt the catabolism of sympathomimetic medications may cause an increase in blood pressure;
• concomitant use of Gripblocker Zatoki with digitalis glycosides may increase the risk of cardiac arrhythmias. Caution and electrocardiographic monitoring are recommended;
• pseudoephedrine used with blood pressure-lowering medications and beta-adrenergic receptor blockers may reduce their effect;
• antacids may increase the absorption of pseudoephedrine;
• monoamine oxidase inhibitors cause slower elimination of pseudoephedrine from the body and increase its bioavailability.

Gripblocker Zatoki and alcohol

Alcohol should not be consumed during treatment with Gripblocker Zatoki.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult a doctor or pharmacist before taking this medication. The medication can be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. The active substances in Gripblocker Zatoki pass into breast milk in small amounts. Breastfeeding women should not take Gripblocker Zatoki.

Driving and using machines

Gripblocker Zatoki has no or negligible influence on the ability to drive and use machines.

Gripblocker Zatoki contains sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medication.

Gripblocker Zatoki contains cochineal red (E124) and quinoline yellow (E104)

The medication may cause allergic reactions.

3. How to take Gripblocker Zatoki

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. The recommended dose is:

• Adults and adolescents over 12 years of age
• 2 capsules every 4-6 hours, maximum 8 capsules per day
• Children 6-12 years of age
• 1 capsule every 6 hours, maximum 4 capsules per day

The medication should not be used in children under 12 years of age without a doctor's recommendation. The medication is taken orally. If there is no improvement or the patient feels worse after 3 days of treatment, a doctor should be consulted.

Overdose of Gripblocker Zatoki

Accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, which later manifests as abdominal distension, return of nausea, and jaundice. Symptoms of pseudoephedrine overdose include: irritability, restlessness, tremors, seizures, tachycardia, difficulty urinating, ventricular arrhythmia, and increased pulmonary blood pressure. In case of taking a higher dose than recommended, a doctor or pharmacist should be consulted immediately.

Missed dose of Gripblocker Zatoki

A double dose should not be taken to make up for a missed dose.

Discontinuation of Gripblocker Zatoki

In case of any further doubts about taking this medication, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Gripblocker Zatoki can cause side effects, although not everybody gets them. The patient should stop taking Gripblocker Zatoki and seek medical help immediately if they experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

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

Side effects of paracetamol used in therapeutic doses are rare and include transient gastrointestinal disorders, skin allergic reactions (rash, flushing, itching). Very rare side effects include: thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), agranulocytosis (decreased granulocyte count), and nephrotoxicity (toxic effect on the kidneys; mainly in combination with nonsteroidal anti-inflammatory medications). With an unknown frequency (cannot be estimated from available data), a serious condition that can cause acidosis of the blood (metabolic acidosis) has been observed in patients with severe disease taking paracetamol (see section 2). Pseudoephedrine rarely causes side effects. With an unknown frequency, serious conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), have been observed. The most common side effects include tachycardia (rapid heart rate), restlessness, and insomnia. Skin rash, urinary retention, and symptoms of central nervous system stimulation (such as sleep disturbances and hallucinations), especially in children, may also occur. Urinary retention has been observed in men. Very rare side effects include cardiovascular disorders – increased pulmonary blood pressure and ventricular arrhythmias, also after therapeutic doses. With an unknown frequency, ischemic colitis (inflammation of the colon caused by insufficient blood flow) has been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: +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 medication.

5. How to store Gripblocker Zatoki

The medication should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging. The medication should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.

6. Contents of the pack and other information

What Gripblocker Zatoki contains

• The active substances of the medication are paracetamol and pseudoephedrine hydrochloride. One capsule contains 250 mg of paracetamol and 30 mg of pseudoephedrine hydrochloride.
• The other ingredients (excipients) are: macrogol 400, glycerol, propylene glycol, povidone K-15/17, purified water, and the capsule shell: gelatin, glycerol, non-crystallizing sorbitol syrup, cochineal red (E124), quinoline yellow (E104), purified water.

What Gripblocker Zatoki looks like and contents of the pack

Gripblocker Zatoki is a capsule-shaped, smooth, and shiny medication with an orange color. One pack of the medication contains 12 or 24 soft capsules in blisters in a cardboard box.

Marketing authorization holder and manufacturer

Hasco-Lek S.A., 51-131 Wrocław, ul. Żmigrodzka 242E, phone: +48 (71) 352 95 22

Medication information

phone: (22) 742 00 22, e-mail: [email protected]

Date of the last revision of the leaflet: