Aspimag

Package Leaflet: Information for the Patient

Aspimag, 150 mg + 21 mg, Tablets

Acidum acetylsalicylicum+ Magnesii oxidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Aspimag and what is it used for

Acetylsalicylic acid, when used as directed, reduces the risk of blood clots by selectively inhibiting thromboxane synthesis - a potent platelet aggregator.

Indications for the use of Aspimag

In coronary heart disease and other conditions where there is excessive blood coagulability, after vascular procedures, heart attacks, and ischemic strokes, vascular prostheses and heart valve implants. As a preventive measure in people at high risk of vascular occlusion.

2. Important information before taking Aspimag

When not to take Aspimag:

• if the patient is allergic (hypersensitive) to acetylsalicylic acid, salicylates, magnesium oxide, or any other component of this medicine (listed in section 6);
• during viral infections in children and adolescents (flu, chickenpox);
• if the patient has been diagnosed with a bleeding disorder;
• if the patient has been diagnosed with gastric or duodenal ulcer disease;
• in the third trimester of pregnancy.

Warnings and precautions

Before starting to take Aspimag, the patient should discuss it with their doctor. The patient should consider the risk-to-benefit ratio in case of hypersensitivity to nonsteroidal anti-inflammatory drugs or other substances, when taking other medicines that affect blood clotting, in case of significant liver or kidney failure, and in case of past or current peptic ulcer disease. Due to the possibility of Reye's syndrome - a rare but serious disease - medicines containing acetylsalicylic acid should be used during febrile illnesses in children and adolescents under 12 years of age only on the advice of a doctor. Patients with asthma, chronic respiratory diseases, hay fever, or nasal polyps may react to nonsteroidal anti-inflammatory drugs with asthma attacks, limited skin and mucous membrane edema (angioedema), or urticaria more often than other patients.

Aspimag and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Acetylsalicylic acid enhances the effect of anticoagulant medicines, increases the risk of gastrointestinal bleeding when taken with corticosteroids or alcohol.
• Enhances the effect and side effects of nonsteroidal anti-inflammatory drugs, the effect of sulfonylurea derivatives, methotrexate, sulfonamides, and their combinations, as well as valproic acid.
• Increases the serum concentration of digoxin, barbiturates, and lithium compounds.
• Reduces the effect of aldosterone antagonists and loop diuretics, antihypertensive and anti-gout medicines that increase uric acid excretion.
• Concomitant use of metamizole with acetylsalicylic acid may reduce the anti-clotting effect of acetylsalicylic acid, and the blood-thinning effect may be weaker. Therefore, metamizole should be used with caution in patients taking acetylsalicylic acid in small doses to prevent heart attacks and strokes.

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 before taking this medicine. The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. It should not be used in the third trimester of pregnancy, as it may cause fetal malformations and complications during delivery. Acetylsalicylic acid passes into breast milk in small amounts. Therefore, if possible, the medicine should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Aspimag contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Aspimag

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended doses

Adults:

Unless the doctor has prescribed otherwise, the usual dose is 1 tablet orally with food once a day or 1 tablet every other day.

Taking a higher dose of Aspimag than recommended

Symptoms of overdose may include: rapid breathing, nausea, vomiting, vision and hearing disturbances, headaches and dizziness, disorientation, low blood glucose levels, acid-base and electrolyte disturbances (e.g., potassium loss), skin rashes. In case of acute poisoning, the following symptoms may occur: hallucinations, tremors, shortness of breath, excessive sweating, agitation, high fever, coma.

Missing a dose of Aspimag

The patient should not take a double dose 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, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Rare(occurring in 1 to 10 people out of 10,000):

• nausea;
• diarrhea;
• vomiting;
• gastrointestinal bleeding (black, tarry stools; iron deficiency anemia);
• development of peptic ulcers with bleeding and perforation;
• exacerbation of gout symptoms;
• kidney function disorders;
• shortness of breath;
• skin reactions, including severe skin reactions;
• liver function disorders (increased aminotransferase activity);
• Reye's syndrome, dizziness, and tinnitus (especially in children and elderly patients, may be symptoms of overdose).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Aspimag

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Keep the container tightly closed to protect from moisture. 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. Package contents and other information

What Aspimag contains

• The active substances of the medicine are acetylsalicylic acid and magnesium oxide. One tablet contains 150 mg of acetylsalicylic acid and 21 mg of magnesium oxide.
• The other ingredients (excipients) are: sucrose, potato starch, colloidal anhydrous silica, stearic acid, talc.

What Aspimag looks like and what the package contains

The package contains 50 or 100 tablets.

Marketing authorization holder:

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, Tel. (42) 22 53 100

Manufacturer:

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA, ul. J. Lea 208, 30-133 Kraków, Poland, tel. 12 639 27 27

Date of the last update of the leaflet: