Gripblocker

Leaflet included in the packaging: information for the user

GRIPBLOCKER, 500 mg, tablets

Acetylsalicylic acid
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Gripblocker and what is it used for

Gripblocker contains acetylsalicylic acid with anti-inflammatory, analgesic, and antipyretic effects.
Indications for use:

• mild to moderate pain,
• fever.

2. Important information before taking Gripblocker

When not to take Gripblocker:

• if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a bleeding disorder;
• if the patient has active gastric or duodenal ulcer disease;
• if the patient has severe heart, liver, or kidney failure;
• if the patient has a history of asthma attacks triggered by the administration of salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs;
• if the patient is taking methotrexate (used, among other things, in cancer treatment) at doses of 15 mg per week or higher;
• if the patient is in the third trimester of pregnancy;
• in children under 12 years of age with viral infections, due to the risk of developing Reye's syndrome - a rare but severe disease that can cause liver and brain damage.

Warnings and precautions

Before starting to take Gripblocker, you should discuss it with your doctor or pharmacist.
You should be particularly cautious when taking Gripblocker if:

• the patient is in the first or second trimester of pregnancy;
• the patient is breastfeeding;
• the patient has hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergizing substances;
• the patient is taking anticoagulant medications, such as coumarin derivatives, heparin;
• the patient has impaired liver or kidney function;
• the patient has a history of peptic ulcer disease or gastrointestinal bleeding;
• the patient has a genetic disorder characterized by a deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Acetylsalicylic acid can cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and patients who experience allergic reactions to other substances (e.g., skin reactions, hives, itching) are particularly prone to such reactions.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor about taking Gripblocker.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients with a tendency to reduced uric acid excretion, the medicine may trigger a gout attack.

Gripblocker and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
You should be particularly cautious when taking Gripblocker with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be taken at the same time as methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant medications (e.g., coumarin derivatives, heparin), thrombolytic medications (dissolving blood clots, e.g., streptokinase, urokinase), and medications that inhibit platelet aggregation (e.g., ticlopidine), which can increase the risk of prolonged bleeding time and bleeding;
• the risk of developing peptic ulcer disease and gastrointestinal bleeding if taken concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including salicylates in high doses, or if alcohol is consumed during treatment; after discontinuing systemic glucocorticoids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin, as it increases its serum concentration;
• the effect of antidiabetic medications, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid, which in turn enhances the anti-aggregatory effect of acetylsalicylic acid.

You should be particularly cautious when taking Gripblocker with the following medicines, as acetylsalicylic acid reduces the effect:

• medicines used to treat gout, which increase the excretion of uric acid from the body (e.g., benzbromarone, probenecid), which can exacerbate gout symptoms;
• diuretics;
• certain antihypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors, e.g., captopril, enalapril).

Gripblocker can be taken concurrently with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only in consultation with a doctor.

Gripblocker with food, drink, and alcohol

Gripblocker should be taken after a meal, with a large amount of fluid.
Note: Alcohol can increase the risk of adverse reactions from the gastrointestinal tract, such as mucosal erosion or bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine.
Gripblocker is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. In the first and second trimesters, the medicine should be used only after consulting a doctor. Breastfeeding women should consult their doctor before taking the medicine.
Gripblocker belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

Gripblocker has no effect on the ability to drive vehicles and operate machines.

3. How to take Gripblocker

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The medicine should be taken orally.
Adults: 1 to 2 tablets at a time. If necessary, the single dose can be repeated every 4 to 8 hours. Do not take more than 8 tablets per day.

Use in children and adolescents

Children over 12 years of age: 1 tablet at a time. If necessary, the single dose can be repeated every 4 to 8 hours. Do not take more than 3 tablets per day.
Gripblocker is best taken after meals, with a large amount of fluid.
The medicine should not be taken for more than 3 to 5 days without consulting a doctor.

Taking a higher dose of Gripblocker than recommended

Salicylate poisoning can be caused by prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild poisoning are: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (disorders of consciousness with disorientation, disorders of thinking and speech, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, too deep breathing, and symptoms of respiratory alkalosis (darkness before the eyes, fainting).
In the case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiac and vascular disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria to renal failure), increased or decreased blood glucose levels (especially in children), ketoacidosis, gastrointestinal bleeding, coagulation disorders, and neurological disorders manifesting as lethargy, confusion, and even coma and convulsions.
In the event of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist, and in the case of severe poisoning, the patient should be taken to the hospital immediately. Treatment of poisoning involves gastric lavage, administration of activated charcoal, and the use of alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Gripblocker

If a dose of the medicine is missed and the symptoms persist, the next dose of Gripblocker should be taken.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Gripblocker

In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Gastrointestinal disorders

Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (coffee ground vomiting, black tarry stools) or occult (more common with higher doses); gastric or duodenal ulcer disease, perforation.

Liver and biliary disorders

In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported.

Nervous system disorders

Dizziness and tinnitus, usually symptoms of overdose.

Blood and lymphatic system disorders

Increased risk of bleeding, hemorrhages (postoperative, nasal, gastrointestinal, genitourinary), hematomas, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia.
The consequence of bleeding can be the development of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifesting as asthenia, pallor, hypoperfusion (decreased blood flow), as well as abnormal laboratory test results.

Vascular disorders

Cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly taking other anticoagulant medications) potentially life-threatening.

Renal and urinary disorders

In rare cases, after prolonged use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been reported.

Immune system disorders

Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as asthma, mild to moderate reactions involving the skin, respiratory system, and cardiovascular system with symptoms such as: rash, hives, angioedema (including angioedema), respiratory and cardiac disorders, and very rarely severe reactions, including anaphylactic shock.

Respiratory disorders

Asthma.
If coffee ground vomiting or black tarry stools occur, the medicine should be discontinued and a doctor consulted.
A symptom of severe hypersensitivity may be: facial and eyelid edema, laryngeal and pharyngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate medical attention should be sought. These reactions can occur even after the first administration of the medicine.
Prolonged use of medicines containing acetylsalicylic acid can cause headache, which worsens with each subsequent dose.
Prolonged use of painkillers, especially those containing several active substances, can lead to severe kidney dysfunction and kidney failure.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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,
e-mail: [email protected]
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. How to store Gripblocker

Store at a temperature below 25°C. Store in the original packaging to protect from moisture.
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 given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gripblocker contains

• The active substance of the medicine is acetylsalicylic acid. One tablet contains 500 mg of acetylsalicylic acid.
• The other ingredients (excipients) are: microcrystalline cellulose, maize starch, talc.

What Gripblocker looks like and what the package contains

Gripblocker is a white, biconvex tablet with a smooth, uniform surface.
One package of the medicine contains 10 or 50 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, Żmigrodzka 242E
Medicine information
phone: +48 (22) 742 00 22
email: [email protected]

Date of the last update of the leaflet: