Gripblocker express

Package leaflet: Information for the user

GRIPBLOCKER EXPRESS
(300 mg + 30 mg + 12 mg), soft capsules
Paracetamolum + Pseudoephedrini hydrochloridum + Dextromethorphani hydrobromidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, you should contact your doctor.

Contents of the leaflet

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

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

Gripblocker Express is a combination medicine intended for short-term treatment of
symptoms of cold and flu. It contains three active substances: paracetamol, pseudoephedrine and
dextromethorphan.
It acts as an analgesic, antipyretic, antitussive, restores patency of nasal passages and sinus ostia, reduces mucus secretion, and relieves nasal mucosal congestion and swelling.
Gripblocker Express is a medicine intended for use in adults, adolescents, and children above 6 years of age.
Indications
Short-term treatment of symptoms of cold, influenza, influenza-like conditions, and sinusitis (fever, nasal congestion, cough, headache, sore throat, muscle and joint pain).

2. Important information before using Gripblocker Express

When not to use Gripblocker Express

• 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 is using other medicines containing paracetamol,
• if the patient is taking monoamine oxidase inhibitors (MAOIs) or has taken these medicines within 2 weeks of stopping treatment,
• in patients with congenital glucose-6-phosphate dehydrogenase deficiency,
• in severe liver failure,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal failure,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in ischemic heart disease,
• in alcoholic liver disease,
• in bronchial asthma,
• during pregnancy and breastfeeding,
• if the patient has hereditary constitutional hyperbilirubinemia (Gilbert's disease),
• in children under 6 years of age.

Warnings and precautions
Before taking Gripblocker Express, talk to your doctor or pharmacist:
if the patient is taking medicines such as certain antidepressants or antipsychotics, Gripblocker Express 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 reflex responses, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Special caution is required when using the medicine in patients:
with kidney failure, hypertension, cardiac arrhythmias, pulmonary emphysema, increased intraocular pressure, benign prostatic hyperplasia, hyperthyroidism, diabetes, and in those taking anxiolytics, tricyclic antidepressants, other sympathomimetic drugs (e.g. decongestants, appetite suppressants, amphetamine-like psychostimulants),
taking anticoagulant medicines,
with liver failure, alcohol abuse, or fasting, as these conditions increase the risk of liver damage.
The medicine should not be used for chronic cough with sputum production.
The medicine should not be used in patients with respiratory insufficiency, bronchial asthma, or in patients at risk of respiratory failure.
Long-term use of painkillers, especially in combination with various analgesics, may cause permanent kidney damage with risk of kidney failure (analgesic nephropathy).
During treatment with Gripblocker Express, inform your doctor immediately:
if the patient has serious illnesses, including severe kidney function disorders 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, vomiting.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be signs of PRES or RCVS, stop using Gripblocker Express immediately and seek immediate medical help (see section 4 "Possible side effects" for symptoms).
Pseudoephedrine – one of the active substances in Gripblocker Express – may be abused, and high doses of pseudoephedrine may be toxic. Continuous use may lead to taking higher doses of Gripblocker Express than the recommended dose to achieve the desired effect, increasing the risk of overdose. Do not take more than the recommended maximum dose or exceed the recommended duration of treatment (see section 3).
Use of this medicine may lead to dependence. Therefore, treatment should be short-term.

Children
Gripblocker Express must not be used in children under 6 years of age.

Gripblocker Express and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
The interaction of Gripblocker Express with other medicines results from the interactions of the active substances contained in the medicine:

Paracetamol
Do not use this medicine simultaneously with other medicines containing paracetamol.
Medicines that accelerate gastric emptying (e.g. metoclopramide) speed up the absorption of paracetamol, while medicines that delay gastric emptying (e.g. propantheline) may delay paracetamol absorption.
Concurrent use of paracetamol with MAO inhibitors (used, among others, in the treatment of depression) and within 2 weeks after discontinuation of these medicines, may cause agitation and fever.
Concurrent use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on bone marrow.
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 the treatment of tuberculosis), may lead to liver damage, even when recommended doses of paracetamol are used.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may subsequently lead to liver failure.
Administration of paracetamol in combination with chloramphenicol (a broad-spectrum antibacterial antibiotic) may increase chloramphenicol concentration in plasma.
Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Pseudoephedrine
Concurrent use with albuterol (used, among others, in asthma treatment) may enhance vasoconstrictive effects.
Do not use simultaneously with amitriptyline (used, among others, in depression) or other sympathomimetics, such as decongestants.
Concurrent use with other sympathomimetics (used, among others, in bronchospasm treatment, e.g. in asthma), appetite suppressants, and amphetamine-like psychostimulants may cause increased blood pressure.
Ammonium chloride, by alkalinizing urine, increases the renal tubular reabsorption of pseudoephedrine metabolites and prolongs its duration of action.
Antacids (used to relieve heartburn and indigestion) may increase the absorption of pseudoephedrine.
MAO inhibitors (used in the treatment of depression) cause slower elimination of pseudoephedrine from the body and increase its bioavailability.
Pseudoephedrine reduces the effect of antihypertensive medicines and may modify the action of cardiac glycosides (used in heart failure).
Do not use simultaneously with furazolidone (an antibacterial medicine).

Dextromethorphan
Do not use with MAO inhibitors (used in the treatment of depression).
Concurrent use of dextromethorphan with serotonin reuptake inhibitors (antidepressants, e.g. fluoxetine, paroxetine), quinidine, terbinafine, tricyclic antidepressants, and H2 receptor antagonists (e.g. cimetidine, ranitidine – used in peptic ulcer disease) may lead to increased concentrations of these drugs and delayed elimination. A similar effect on dextromethorphan metabolism is also caused by amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine.
Concurrent use of dextromethorphan and serotonergic medicines may cause serotonin syndrome (characterized by agitation, increased muscle tone, muscle twitching (myoclonus), stupor, diarrhoea, and fever).
Alcohol may intensify the adverse effects of dextromethorphan.

Gripblocker Express with food, drink, and alcohol
Food does not significantly affect the absorption of the medicine.
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Gripblocker Express during pregnancy and breastfeeding is contraindicated.

Driving and using machines
When taking Gripblocker Express, exercise caution, as this medicine may impair the ability to drive and operate machinery.

Gripblocker Express contains sorbitol
The medicine contains 18.0 mg of sorbitol in one capsule.

Gripblocker Express contains carmine red
The medicine may cause allergic reactions.

Gripblocker Express contains propylene glycol
The medicine contains 55.0 mg of propylene glycol in one capsule.

3. How to use Gripblocker Express

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
Adults and adolescents over 12 years of age: 1 to 2 capsules, 3-4 times daily. Do not exceed 8 capsules per day.
Children aged 6 to 12 years: 1 capsule 3-4 times daily. Do not exceed 4 capsules per day.
If there is no improvement after 3 days of treatment or if the patient's condition worsens, consult a doctor.

Children
In children, overdose may lead to serious adverse effects, including neurological disorders. Caregivers should not administer a dose higher than recommended.

Overdose of Gripblocker Express
This medicine contains three active substances. Symptoms of overdose may result from the effect of one or all of the active substances.
If a patient takes more Gripblocker Express than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, excitation, confusion, drowsiness, disturbances of consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disturbances, psychosis with visual hallucinations, and increased excitability.

Overdose may also cause symptoms within a few or several hours, such as excessive sweating, general weakness, restlessness, tremor. Increased blood pressure, seizures, difficulty urinating, and shortness of breath may occur. These symptoms may subside the next day, even though liver damage may begin to develop, later manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.

Other symptoms of severe overdose may include coma, severe respiratory disturbances, and seizures.

If any of the above symptoms occur, seek immediate medical advice or go to a hospital.
Treatment should be carried out in a hospital and consists of accelerating the elimination of the drug components from the body and maintaining vital functions. In case of paracetamol overdose, administration of an antidote—N-acetylcysteine and (or) methionine—may be necessary. Elimination of pseudoephedrine can be accelerated by forced diuresis or dialysis. To reverse the toxic effect of dextromethorphan on the central nervous system, naloxone may be used.

Missed dose of Gripblocker Express
Gripblocker Express is intended for temporary relief of symptoms of cold, flu, and flu-like conditions. If a dose is missed and symptoms persist, take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency unknown (frequency cannot be determined from available data):
serious conditions affecting the blood vessels in the brain, known as posterior reversible
encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS),
a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Immediately discontinue use of Gripblocker Express and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:
sudden, severe headache,
nausea,
vomiting,
confusion,
seizures,
visual disturbances.

Discontinue the medicine and consult a doctor if any of the following adverse effects occur:
Type I hypersensitivity reaction: allergic swelling (swelling of the skin and soft tissues, often affecting the face, e.g. lips, tongue, eyelids), anaphylactic reaction (shortness of breath, bronchospasm, sweating, nausea, drop in blood pressure),
bronchial asthma attack (difficulty breathing, wheezing),
skin allergic reactions, skin redness, rashes,
granulocytopenia (reduced number of white blood cells – granulocytes in blood), agranulocytosis (absence of granulocytes in blood), symptoms of which include sudden high fever, sore throat and oral ulcers, swollen lymph nodes, general malaise and fatigue,
liver damage (yellowing of the skin and whites of the eyes),
urinary disorders, urinary retention, especially in patients with benign prostatic hyperplasia,
renal colic, renal papillary necrosis,
acute kidney failure: reduced urine output, swelling of legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion,
thrombocytopenia (low platelet count) with symptoms such as bleeding, haemorrhages, easy bruising, petechiae (due to reduced platelet count),
hallucinations.

Other adverse effects may also occur during treatment with Gripblocker Express:
increased heart rate,
slight increase in blood pressure,
urinary stones,
nausea and vomiting,
fatigue and drowsiness,
dizziness.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gripblocker Express

Store in the original packaging, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gripblocker Express contains

• The active substances are: paracetamol, pseudoephedrine, dextromethorphan. One capsule contains 300 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, and 12 mg of dextromethorphan hydrobromide.
• The other ingredients (excipients) are: macrogol 400, glycerol, propylene glycol (E 1520), povidone K17, purified water, gelatin, non-crystallizing liquid sorbitol (E 420), carmine red (E 124).

What Gripblocker Express looks like and contents of the pack
Soft capsules – elongated, with a smooth and glossy surface, red in colour.
One package contains 10 or 20 soft capsules.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. + 48 22 742 00 22
e-mail: [email protected]