Gripblocker

Package leaflet: Information for the user

GRIPBLOCKER, 500 mg, tablets
Acidum acetylsalicylicum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for possible future reference.
• 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 or if your condition worsens after 3–5 days, consult your doctor.

Table of contents

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

1. What GRIPBLOCKER is and what it is used for

GRIPBLOCKER contains acetylsalicylic acid, which has antipyretic, analgesic, and anti-inflammatory properties.
Indications:

• Mild to moderate pain,
• Fever.

2. Important information before using Gripblocker

When not to use 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 tendency;
• if the patient has active gastric or duodenal ulcer;
• if the patient has severe heart failure, severe liver failure, or severe kidney failure;
• if the patient has a history of bronchial asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient is concurrently receiving methotrexate (used, among others, in cancer treatment) at doses of 15 mg per week or higher;
• if the patient is in the last three months of pregnancy, doses exceeding 100 mg per day must not be used (see section "Pregnancy and breastfeeding");
• in children under 12 years of age with viral infections, due to the risk of Reye's syndrome—a rare but serious condition causing liver and brain damage.

Warnings and precautions
Before starting to use Gripblocker, discuss this with your doctor or pharmacist.
Exercise particular caution when using 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 allergenic substances;
• the patient is concurrently using anticoagulants, e.g. coumarin derivatives, heparins;
• the patient has impaired liver or kidney function;
• the patient has a history of peptic ulcer or gastrointestinal bleeding;
• the patient has a genetic disorder involving glucose-6-phosphate dehydrogenase deficiency.

Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients particularly at risk include those with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, and patients who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
Patients scheduled for surgical procedures (including minor procedures such as 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 predisposed to reduced uric acid excretion, the drug may trigger an attack of gout.

Gripblocker and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Exercise special caution when using Gripblocker with the following medicines, as acetylsalicylic acid increases:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
• the effect of anticoagulants (e.g. coumarin derivatives, heparin), thrombolytic drugs (clot-dissolving agents, e.g. streptokinase, urokinase), and drugs inhibiting platelet aggregation (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including high-dose salicylates, or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin, as it increases its plasma concentration;
• the effect of antidiabetic drugs, e.g. insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid, which in turn enhances the antiplatelet effect of acetylsalicylic acid.

Exercise special caution when using Gripblocker with the following medicines, as acetylsalicylic acid reduces the effect of:

• anti-gout drugs used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretics;
• certain antihypertensive drugs (angiotensin-converting enzyme inhibitors, e.g. captopril, enalapril).

Gripblocker may be used concurrently with the above-mentioned medicines (except methotrexate at doses of 15 mg per week or higher) only under the supervision of a doctor.

Gripblocker with food, drink, and alcohol
Gripblocker should be taken after meals, with plenty of fluid.
Caution: Alcohol may increase the risk of adverse gastrointestinal effects, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
If the patient continues or starts treatment with Gripblocker during pregnancy, she should use Gripblocker according to the doctor's recommendations and should not take a higher dose than advised.
Gripblocker is contraindicated in the last trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn. In the first and second trimesters, consult a doctor before using the medicine.

Pregnancy – last trimester
Do not use acetylsalicylic acid doses exceeding 100 mg per day if the patient is in the last three months of pregnancy, as this may harm the unborn child or cause complications during delivery. Use of acetylsalicylic acid may cause disturbances in kidney and heart function in the unborn child. This may affect the tendency to bleed in both the mother and her child and may cause delay or prolongation of labor.
If the patient uses acetylsalicylic acid in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Pregnity – first and second trimester
Do not use Gripblocker during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. Gripblocker taken for longer than a few days, starting from week 20 of pregnancy, may cause kidney dysfunction in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Women who are breastfeeding should consult their doctor before using the medicine.
Gripblocker belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Gripblocker has no influence on the ability to drive vehicles or operate machinery.

3. How to use Gripblocker

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine should be taken orally.
Adults: single dose of 1 to 2 tablets. The single dose may be repeated every 4 to 8 hours if necessary. Do not take more than 8 tablets per day.
Use in children and adolescents
Children over 12 years of age: single dose of 1 tablet. The single dose may be repeated every 4 to 8 hours if necessary. Do not take more than 3 tablets per day.
Gripblocker is best taken after meals, with a large amount of fluid.
Do not use this medicine for longer than 3 to 5 days without consulting a doctor.
Taking more Gripblocker than recommended
Salicylic acid poisoning may result from prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which may be life-threatening, for example following accidental ingestion by children or elderly persons.
Symptoms of mild poisoning include: dizziness (including vertigo), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, confusion (disorders of consciousness with disorientation, disturbances in thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, and symptoms of respiratory alkalosis (visual disturbances such as spots before the eyes, fainting).
In cases of severe poisoning, additional symptoms may include: high fever, respiratory disorders (up to respiratory arrest and suffocation), disturbances in heart and blood vessel function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss [due to dehydration, oliguria (reduced daily urine output below 400–500 ml in adults) up to kidney failure], increased or decreased blood glucose levels (especially in children), ketosis, gastrointestinal bleeding, blood coagulation disorders, and neurological disturbances manifesting as lethargy, confusion, up to coma and convulsions.
If more than the recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist, and in case of severe poisoning, the patient must be immediately taken to hospital. Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.
Missed dose of Gripblocker
If a dose is missed and symptoms persist, take the next dose of Gripblocker as scheduled.
Do not take a double dose to make up for a missed dose.
Stopping Gripblocker treatment
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Gastrointestinal disorders
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomit, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulceration, perforation.

Hepatobiliary and biliary tract disorders
Rarely, transient disturbances in liver function (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, haemorrhages (postoperative, epistaxis, gingival bleeding, urogenital bleeding), bruising, prolonged bleeding time and prothrombin time, thrombocytopenia.
Bleeding may lead to acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion (reduced blood flow), as well as abnormal laboratory test results.

Vascular disorders
Intracranial haemorrhage (particularly in patients with uncontrolled arterial hypertension and/or concomitant use of other antithrombotic drugs), potentially life-threatening.

Renal and urinary disorders
Rarely, with long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been observed.

Immune system disorders
Hypersensitivity reactions with clinical symptoms and abnormal results of relevant laboratory tests, such as asthma, mild to moderate skin, respiratory, and cardiovascular system reactions with symptoms including: rash, urticaria, angioedema (including vasomotor type), respiratory and cardiac disturbances, and very rarely severe reactions, including anaphylactic shock.

Respiratory system disorders
Bronchial asthma.

If coffee-ground vomit or black, tarry stools occur, the medicine should be discontinued and medical advice sought immediately.

Symptoms of severe hypersensitivity may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, breathing difficulties, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate professional medical assistance must be sought. These reactions may occur even after the first dose of the medicine.

Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with continued dosing.

Prolonged use of analgesics, especially those containing multiple active substances, may lead to severe kidney dysfunction and renal failure.

Reporting of adverse effects
If any adverse effects occur, including those 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 responsible entity.

Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Gripblocker

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

6. Contents of the pack and other information

What Gripblocker contains

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

What Gripblocker looks like and contents of the pack
Gripblocker is in the form of white, biconvex tablets with a smooth, uniform surface.
One pack contains 10 or 50 tablets.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel. +48 (22) 742 00 22
email: [email protected]