THROMBO ASS 50MG TBL N100

ATC code: B01AC06 

Active substances: Acidum Acetylsalicylicum

Vendor, principal: Gl Pharma. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

THROMBO ASS 100MG N30

Package leaflet: Information for the user

Thrombo ASS 75 mg gastro-resistant tablets

Acetylsalicylic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Thrombo ASS is and what it is used for
2.   What you need to know before you take Thrombo ASS
3.   How to take Thrombo ASS
4.   Possible side effects
5.   How to store Thrombo ASS
6.   Contents of the pack and other information

1.   What Thrombo ASS is and what it is used for

The active substance of Thrombo ASS is acetylsalicylic acid, an inhibitor of platelet aggregation that reduces the risk of blood clots (thrombosis).
Thrombo ASS gastro-resistant tablets are used in the following cases:
Prevention of coronary thrombosis (obstruction of the coronary artery)
-   in case of suspected or after a confirmed myocardial infarction;
-   stenocardia (chest pain);
-   after a coronary revascularisation (restoration of blood vessels and circulation) procedure;
-   reduction of the risk of first-time myocardial infarction in case of associated cardiovascular risk factors.
Prevention of brain arterial thrombosis
-   following transient brain ischaemia (insufficient blood flow to the brain);
-   ischaemic stroke (caused by local blood flow insufficiency in the brain).

2.   What you need to know before you take Thrombo ASS Do not take Thrombo ASS

-   if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
-   if you are allergic to other salicylates or similar substances;
-   if you have stomach or intestinal ulcers;
-   if you are susceptible to bleed (haemorrhagic diathesis), have a low platelet count (thrombocytopenia) or haemophilia (blood clotting disorder);
-   if you have renal insufficiency of kidney stones (oxalates in urine);
-   if you have liver insufficiency (severe liver damage);
-   if you have severe and insufficiently investigated heart failure;
-   if you take certain anti-cancer drugs (15 mg or more methotrexate per week);
if you are in the last third of pregnancy (see section 2, “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Thrombo ASS:
-   if you are allergic to other painkillers, anti-inflammatory or antirheumatic medicines;
-   if you have other allergic reactions (e.g., skin reactions, itching, urticaria);
-   if you have asthma, hay fever, nasal swelling (nasal polyps) or other chronic respiratory diseases;
-   if you receive simultaneous treatment against blood clots (e.g. with coumarine derivatives, heparin, except for treatment with small doses of heparin);
-   if you have a rare metabolic disorder (genetic glucose-6-phosphate dehydrogenase deficiency);
-   if you have problems with gastrointestinal tract (e.g. gastritis);
-   if you have a history of gastrointestinal ulcers or gastrointestinal bleeding;
-   if you have renal or liver function problems;
-   if you are scheduled for a surgical procedure (even a minor procedure, such as tooth extraction). The blood clotting time may be longer than usual. Inform your doctor that you are taking Thrombo ASS;
-   if you need to take other salicylates or nonsteroidal anti-inflammatory drugs. This is decided by your doctor;
-   if you have been using large doses of acetylsalicylic acid for many years. Your doctor may test your renal function, because this medicine can cause kidney damage.
Acetylsalicylic acid may increase the risk of bleeding if administered before treatment for blood clots. Pay special attention to potential symptoms of external or internal bleeding (e.g. haemorrhages) during the treatment for blood clots.
Small doses of Thrombo ASS reduce uric acid production. This may provoke acute attacks of gout in predisposed patients.

Children and adolescents

Thrombo ASS is contraindicated in children and adolescents due to reports of rare instances of Reye’s syndrome (potentially fatal complication characterised by persistent vomiting, dehydration or loss of fluid, mental changes and seizures) when using acetylsalicylic acid (the active substance of Thrombo ASS).

Other medicines and Thrombo ASS

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
The effects of treatment may be influenced if Thrombo ASS is taken at the same time as other medicines, such as:
-   medicines for prevention of blood clots (e.g. warfarin and other coumarine derivatives,
heparin, dipyridamole, sulfinpyrazone);
-   medicines reducing organ rejections after transplantation (ciclosporin);
-   medicines for high blood pressure (e.g. diuretics and ACE-inhibitors in combination with Thrombo ASS in doses over 3 g/day);
-   pain and inflammation medicines (e.g. corticosteroids or anti-inflammatory drugs);
-   gout medicines (e.g. probenecid, sulphinpyrazone in combination with Thrombo ASS in doses over 3 g / day);
-   cancer or rheumatoid arthritis medicines (methoxtrexate);
-   diabetes medicines (sulphonylurea);
-   depression medicines (selective serotonin re-uptake inhibitors, e.g. sertraline or paroxetine);
-   infection medicines (sulfonamides and sulfonamide combinations, incl. co-trimoxazole);
-   thyroid medicines (triiodothyronine);
-   seizure medicines (valproic acid);
-   medicines against swelling, e.g. in patients with heart conditions or high blood pressure (spironolactone, canrenone, furosemide in combination with Thrombo ASS in doses over 3 g/day).
The concentration of digoxin, barbiturates and lithium in blood may increase.
If used at the same time with certain infection medicines (tetracyclines), leave a gap of at least 1-3 hours between administrations.
Talk to your doctor before taking this medicine. If you are using acetylsalicylic acid regularly, seek advice from your doctor if you plan to take any other medicines (incl. over-the-counter medicines).

Thrombo ASS with alcohol

Using Thrombo ASS with alcohol may increase the risk of gastrointestinal bleeding.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Only use acetylsalicylic acid in the first 6 months of pregnancy if it is prescribed by your doctor.
Thrombo ASS should not be taken in the last 3 months of pregnancy, as it may extend the bleeding time in the mother and the infant.
Breast-feeding
Use of acetylsalicylic acid during breast-feeding is permitted only if prescribed by your doctor.

Driving and using machines

There should be no effects which would affect your ability to drive and use machines.

Thrombo ASS contains lactose.

If you have intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Thrombo ASS

The tablets should be swallowed whole with sufficient volume of liquid and with or without meals.
The tablets should not be split due to their gastro-resistant coating.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Thrombo ASS gastro-resistant tablets are available with 75 mg and 100 mg.
Recommended dosage:
In stenocardia patients to reduce the risk of myocardial infarction:
75...300 mg acetylsalicylic acid per day.
To reduce the risk of recurrence after myocardial infarction:
75...300 mg acetylsalicylic acid per day.
Prevention of blood clots after a surgery of coronary arteries, e.g. coronary artery bypass:
75...300 mg acetylsalicylic acid per day.
Prevention of transitory brain ischaemia and brain infarction:
75.. .300 mg acetylsalicylic acid per day.
Reduction of the risk of first-time myocardial infarction in case of associated cardiovascular risk factors (e.g. stenocardia or myocardial infarction in diabetes patients):
100.. .300 mg acetylsalicylic acid per day. Your doctor may reduce the dosage if necessary (75 mg acetylsalicylic acid per day).
Children
Acetylsalicylic acid should not be given to children under 12 years of age unless advised by a doctor (see section 2, “Warnings and precautions”).
Note: products with larger doses are available if you need to use acetylsalicylic acid for pain and/or fever.

If you take more Thrombo ASS than you should

The symptoms of overdose include nausea, vomiting, stomach ache, dizziness, ringing in the ears, headache, confusion and hyperventilation (rapid breathing). If you experience any of these symptoms get medical attention immediately.

If you forget to take Thrombo ASS

Do not take a double dose to make up for a forgotten tablet. Administer your next dose at the regular time.

If you stop taking Thrombo ASS

Talk to your doctor before you stop taking Thrombo ASS.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Black stools or blood in vomit can be symptoms of severe bleeding in the gastrointestinal tract. In this case seek immediate medical attention.
Side effects have been classified based on their severity and frequency:
Common (may occur in 1-10 of 100 users)
Gastrointestinal problems, such as heartburn, nausea, vomiting, stomach ache and diarrhoea, as well as gastrointestinal micro-bleeding.
Uncommon (may occur in 1-10 of 1,000 users)
Hypersensitivity reactions, such as bronchospasm and skin reactions.
Gastrointestinal bleeding or ulcers, which can cause perforations in rare instances, as well as gastrointestinal inflammation.
Rare (may occur in 1-10 of 10,000 users)
Extended bleeding times, thrombocytopenia, nosebleed, extended bleeding of gums or skin (these effects can last for 4-8 days from the start of treatment).
Hypersensitivity reactions (in rare cases multiform exudative erythema), possible loss of blood pressure, dyspnoea, anaphylactic reactions and angioneurotic oedema, especially in patients with asthma.
Asthma attacks.
Prolonged use in large doses may cause kidney damage.
Very rare (in less than 1 of 10,000 users)
Severe bleeding, e.g. brain haemorrhage, especially in patients with inadequately controlled hypertension and/or simultaneous antithrombotic treatment; in rare instances can be fatal. Hypoglycaemia.
Increased liver enzyme levels.
Acute renal insufficiency.
Not known (cannot be estimated from the available data)
Haemolysis (unusual rupturing of red blood cells) or haemolytic anaemia (reduced red blood cell count or reduced blood haemoglobin due to haemolysis) has been observed in patients with severe glucose-6-phosphate dehydrogenase deficiency (genetic condition that restricts the biotransformation of red blood cells).
Acetylsalicylic acid reduces production of uric acid. This may provoke acute attacks of gout in predisposed patients.
Headache, vertigo, confusion, hearing problems or ringing in the ears may be symptoms of overdose, especially in children and elderly (see section 3, “If you take more Thrombo ASS than you should”).
Prolonged use of Thrombo ASS may cause iron deficiency anaemia due to gastrointestinal bleeding.
The frequency of side effects depends on dosage.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Thrombo ASS

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25 °C. Keep the blister in the outer carton away from light and humidity.
Do not use Thrombo ASS after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Thrombo ASS contains

-   Active substance is acetylsalicylic acid. One gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
-   Other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, potato starch, talc, glycerol triacetate, metacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%.

What Thrombo ASS looks like and contents of the pack

Thrombo ASS 75 mg gastro-resistant tablets are white, round, biconvex tablets.
The PVC/aluminium blister pack includes 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Covalent OÜ Pämu mnt 102c Tallinn 11312 Estonia
Phone: +372 6600945, fax: +372 6600946
This leaflet was last revised in June 2017.