Gripblocker Express

Leaflet attached to the packaging: patient information

GRIPBLOCKER EXPRESS

(300 mg + 30 mg + 12 mg), soft capsules
Paracetamol + Pseudoephedrine hydrochloride + Dextromethorphan hydrobromide

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 advised by a doctor or pharmacist.

• This 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, 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 consult a doctor.

Table of contents of the leaflet

• 1. What is Gripblocker Express and what is it 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 packaging and other information

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

Gripblocker Express is a combination medicine for the short-term treatment of cold and flu symptoms. It contains three active substances: paracetamol, pseudoephedrine, and dextromethorphan.
It has analgesic, antipyretic, antitussive, and decongestant effects, reducing the amount of mucous discharge and relieving nasal congestion.
Gripblocker Express is intended for the treatment of adults, adolescents, and children over 6 years of age.

Indications for use

For the symptomatic treatment of colds, flu, and flu-like conditions, including sinusitis (fever, runny nose, cough, headache, sore throat, muscle and joint pain).

2. Important information before taking Gripblocker Express

When not to take 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 taking other medicines containing paracetamol,
• if the patient is taking monoamine oxidase inhibitors (MAOIs) or has taken them within the last 2 weeks,
• in patients with congenital glucose-6-phosphate dehydrogenase deficiency,
• in severe liver failure,
• if the patient has severe acute or chronic kidney disease or kidney failure,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in coronary heart disease,
• in alcoholism,
• in asthma,
• in pregnancy and breastfeeding,
• if the patient has been diagnosed with hereditary constitutional hyperbilirubinemia (Gilbert's syndrome),
• in children under 6 years of age.

Warnings and precautions

Before taking Gripblocker Express, the patient should talk to their doctor or pharmacist:
if the patient is taking certain antidepressants or antipsychotics, as Gripblocker Express may interact with them, causing changes in mental state (e.g., excitement, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Particular caution should be exercised when taking the medicine in patients with kidney failure, hypertension, heart rhythm disorders, chronic obstructive pulmonary disease (COPD), increased intraocular pressure, prostatic hyperplasia, hyperthyroidism, diabetes, and those taking anxiolytics, tricyclic antidepressants, other sympathomimetic medicines (e.g., decongestants, appetite suppressants, and psychostimulants similar to amphetamines),
those taking anticoagulants,
those with liver failure, alcohol abusers, and fasting patients, as this may increase the risk of liver damage.
The medicine should not be taken in the case of chronic cough with expectoration.
The medicine should not be taken in patients with respiratory failure, asthma, or those at risk of respiratory failure.
Long-term use of painkillers, especially in combination with different painkillers, may lead to permanent kidney damage (analgesic nephropathy).
During treatment with Gripblocker Express, the patient should immediately inform their doctor:
if they have severe illnesses, 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 developed a severe condition called metabolic acidosis (a blood and body fluid disorder), which must be treated promptly (see section 2).
After taking medicines containing pseudoephedrine, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, the patient should immediately stop taking Gripblocker Express and seek medical help (symptoms, see section 4 "Possible side effects").
Pseudoephedrine, one of the active substances of Gripblocker Express, may be abused, and large doses of pseudoephedrine may be toxic. Continuous use may lead to taking larger doses of Gripblocker Express than the recommended dose to achieve the desired effect, increasing the risk of overdose. The patient should not take a dose larger than the recommended maximum dose or exceed the treatment duration (see section 3).
Taking this medicine may lead to dependence. Therefore, treatment should be short-term.

Children

The medicine should not be taken in children under 6 years of age.

Gripblocker Express and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The interaction of Gripblocker Express with other medicines results from the interaction of the active substances in the medicine:
Paracetamol
The medicine should not be taken at the same time as other medicines containing paracetamol.
Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol, while medicines that delay its emptying (e.g., propanteline) may delay the absorption of paracetamol.
Taking paracetamol at the same time as monoamine oxidase inhibitors (MAOIs) used to treat depression and within 2 weeks after stopping treatment with these medicines may cause excitement and fever.
Taking paracetamol with zidovudine (AZT, a medicine used to treat HIV infection) may enhance the toxic effects of zidovudine on the bone marrow.
Paracetamol may enhance the effects of anticoagulant medicines (coumarin derivatives).
Taking paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used to treat tuberculosis), may lead to liver damage, even when taking the recommended doses of paracetamol.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that causes liver cell necrosis, which may eventually lead to liver failure.
Administering paracetamol in combination with chloramphenicol (a broad-spectrum antibacterial antibiotic) may increase the concentration of chloramphenicol in the blood.
The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the risk of serious blood and body fluid disorders (metabolic acidosis), which must be treated promptly (see section 2).
Pseudoephedrine
Taking pseudoephedrine at the same time as albuterol (used to treat asthma) may enhance its vasoconstrictive effect.
Pseudoephedrine should not be taken at the same time as amitriptyline (used to treat depression) and sympathomimetics (e.g., decongestants).
Taking pseudoephedrine with other sympathomimetics (used to treat bronchospasm, e.g., in asthma), appetite suppressants, and psychostimulants similar to amphetamines may cause increased blood pressure.
Ammonium chloride, by alkalizing the urine, increases the renal reabsorption of pseudoephedrine metabolites and prolongs its action.
Antacids (used to relieve heartburn and indigestion) may increase the absorption of pseudoephedrine.
MAOIs (used to treat depression) cause slower elimination of pseudoephedrine from the body and increase its bioavailability.
Pseudoephedrine reduces the effects of antihypertensive medicines and may modify the effects of digitalis glycosides (used to treat heart failure).
Pseudoephedrine should not be taken at the same time as furazolidone (an antibacterial medicine).
Dextromethorphan
Dextromethorphan should not be taken with MAOIs (used to treat depression).
Taking dextromethorphan with serotonin reuptake inhibitors (antidepressants, e.g., fluoxetine, paroxetine), quinidine, and terbinafine, tricyclic antidepressants, and H2 receptor antagonists (e.g., cimetidine and ranitidine, used to treat stomach ulcers) may lead to increased levels of these medicines and delayed elimination. Similar effects on dextromethorphan metabolism are also caused by amiodarone, flecainide, and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine.
Taking dextromethorphan with serotonergic medicines may cause serotonin syndrome (characterized by agitation, increased muscle tone, myoclonus, somnolence, diarrhea, and fever).
Alcohol may enhance the adverse effects of dextromethorphan.

Gripblocker Express with food, drink, and alcohol

Food does not significantly affect the absorption of the medicine.
Alcohol should not be consumed during treatment with Gripblocker Express.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking Gripblocker Express during pregnancy and breastfeeding is contraindicated.

Driving and using machines

When taking Gripblocker Express, the patient should be cautious, as the medicine may impair the ability to drive vehicles and operate machinery.

Gripblocker Express contains sorbitol

The medicine contains 18.0 mg of sorbitol in one capsule.

Gripblocker Express contains cochineal 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 take Gripblocker Express

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Adults and adolescents over 12 years of age: 1-2 capsules, 3-4 times a day. Do not take more than 8 capsules per day.
Children 6-12 years of age: 1 capsule, 3-4 times a day. Do not take more than 4 capsules per day.
If there is no improvement after 3 days of treatment or if the patient feels worse, they should consult a doctor.
Children
In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give a dose larger than recommended.

Taking a higher dose of Gripblocker Express than recommended

The medicine contains three active substances. Overdose symptoms may result from the action of one or all of the active substances.
If the patient takes a higher dose of Gripblocker Express than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, excitement, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability.
Overdose may also cause symptoms such as excessive sweating, general weakness, anxiety, tremors, increased blood pressure, seizures, difficulty urinating, and shortness of breath within a few or several hours. These symptoms may resolve the next day, despite the onset of liver damage, which will then become apparent with abdominal distension, return of nausea, and jaundice.
Other symptoms of large overdose may include coma, severe respiratory disorders, and seizures.
If any of these symptoms occur, the patient should immediately consult a doctor or go to the hospital.
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 case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine. The elimination of pseudoephedrine can be accelerated by forced diuresis or dialysis therapy. To counteract the toxic effects of dextromethorphan on the central nervous system, naloxone can be used.

Missing a dose of Gripblocker Express

Gripblocker Express is used for the symptomatic treatment of colds, flu, and flu-like conditions. If a dose is missed and symptoms persist, the next dose should be taken.
A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gripblocker Express can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):
severe 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 can cause blood acidification (metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).
The patient should immediately stop taking Gripblocker Express and seek medical help if they experience symptoms indicating PRES or RCVS, including:
severe headache with a sudden onset,
nausea,
vomiting,
confusion,
seizures,
vision changes.
The patient should stop taking the medicine and consult their doctor if they experience the following side effects:
type I hypersensitivity reaction: allergic edema (swelling of the skin and soft tissues, often on the face, e.g., lips, tongue, eyelids), anaphylactic reaction (shortness of breath, bronchospasm, sweating, nausea, decreased blood pressure),
asthma attack (difficulty breathing, wheezing),
allergic skin reactions, redness, rash,
granulocytopenia (decreased number of white blood cells - granulocytes in the blood), agranulocytosis (absence of granulocytes in the blood), whose symptoms include sudden high fever, sore throat, and oral ulcers, enlarged lymph nodes, general decreased well-being, and fatigue,
liver damage (yellowing of the skin and whites of the eyes),
urinary disorders, urinary retention, especially in patients with prostatic hyperplasia,
renal colic, renal papillary necrosis,
acute renal failure: decreased urine output, swelling of the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion,
thrombocytopenia (low platelet count) with symptoms such as bleeding, hemorrhages, easy bruising, and petechiae (due to decreased platelet count),
hallucinations.
Other side effects may also occur during treatment with Gripblocker Express:
increased heart rate,
mild increase in blood pressure,
kidney stones,
nausea and vomiting,
fatigue and drowsiness,
dizziness.

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:
Jerozolimskie Avenue 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.
Reporting side effects will help gather 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.
The medicine should be stored out of 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gripblocker Express contains

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

What Gripblocker Express looks like and what the packaging contains

Soft capsules - oblong, with a smooth and shiny surface, red in color.
One packaging of the medicine contains 10 or 20 soft capsules.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E

Information about the medicine

phone: +48 22 742 00 22
e-mail: [email protected]

Date of last update of the leaflet: