Paracetamol + Pseudoephedrine Hydrochloride
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.
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.
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.
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:
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).
Due to the presence of pseudoephedrine, the medication should not be used in children under 12 years of age without a doctor's recommendation.
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
Pseudoephedrine
Alcohol should not be consumed during treatment with Gripblocker Zatoki.
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.
Gripblocker Zatoki has no or negligible influence on the ability to drive and use machines.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medication.
The medication may cause allergic reactions.
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:
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.
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.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medication, a doctor or pharmacist should be consulted.
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:
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.
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.
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.
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.
Hasco-Lek S.A., 51-131 Wrocław, ul. Żmigrodzka 242E, phone: +48 (71) 352 95 22
phone: (22) 742 00 22, e-mail: informacjaoleku@hasco-lek.pl
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