HERZ ASS-RATIOPHARM 100 TBL N100

ATC code: B01AC06 

Active substances: Acidum Acetylsalicylicum

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

HERZASS-RATIOPHARM 100MG N100

Package leaflet: information for the user

HerzAss-ratiopharm 100 mg tablets

Acetylsalicylic acid

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

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

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

1.   What HerzAss-ratiopharm is and what it is used for

HerzAss-ratiopharm 100 mg is a medicine of the anti-thrombotic group.
Indications
Prophylaxis of coronary thrombosis (coronary artery blockage):
-   in case of suspected myocardial infarction and post-myocardial infarction;
-   in case of stenocardia (chest pain);
-   after a coronary revascularisation (restoration of blood vessels and blood flow) procedure;
-   reducing the risk of primary myocardial infarction in case of concomitant cardiovascular risk factors.
Prophylaxis of cerebral thrombosis:
-   after a transient cerebral ischemic attack (lack of blood flow to the brain);
-   after an ischemic stroke (due to topical lack of blood flow).

2.   What you need to know before you use HerzAss-ratiopharm Do not use HerzASS-ratiopharm 100 mg:

-   if you have hypersensitivity, asthma, allergic rhinitis, or hives due to to acetylsalicylic acid, other salicylates, prostaglandin synthesis inhibitors or any excipients of the medicine;
-   if you have previously had an asthma attack or angioedema (facial and mucous membrane swelling) after using acetylsalicylic acid (aspirin) or other anti-inflammatory analgesic;
-   if you currently have or have recently had peptic or duodenal ulcers;
-   if you    have recently had a cerebral haemorrhage;
-   if you have a predilection for haemorrhage    (thrombocytopenia, vitamin K deficiency, haemophilia);
-   if you    have severe liver failure, hepatic    cirrhosis;
-   if you    have severe renal failure;
-   if you have severe heart failure;
-   if you are receiving treatment with methotrexate in doses of 15 mg per week or more;
if you are in the last trimester of pregnancy.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using HerzASS-ratiopharm 100 mg if any of the following applies to you:
-   concomitant use of anticoagulants (agents inhibiting blood coagulation);
-   if you have mild to moderate kidney, liver or heart failure;
-   if you have a severe liver disease;
-   if you have a gastrointestinal disease;
-   if you have previously had a gastrointestinal ulcer or gastrointestinal haemorrhage;
-   if you have previously had symptoms of hypersensitivity, such as rash or rhinitis occurring after the use of an anti-inflammatory analgesic;.
- if you have bronchial asthma or chronic obstructive pulmonary disease (use of acetylsalicylic acid can cause an asthma attack).
The long-term concomitant use of HerzAss-ratiopharm 100 mg with non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided due to increased risk of side effects.
Small doses of acetylsalicylic acid reduce the secretion of uric acid and can cause gout attacks in patients with a predilection for such attacks.
Doses should be reduced or dosage intervals increased in patients with impaired hepatic and/or renal function.
Talk to your doctor before administering the medicine if you suffer from any of the listed conditions.
Acetylsalicylic acid has an anticoagulant effect occurring already after using very small doses and lasting for several days. As a result, you may have an increased risk of bleeding during surgical procedures, even if they are minor procedures, such as tooth extraction.
Acetylsalicylic acid is not recommended to be used in children and adolescents under the age of 16 for febrile viral infections (incl. chickenpox, the flu), as it may induce Reye’s syndrome (extended vomiting, liver function disorders, encephalopathy, coma).
Acetylsalicylic acid should not be continuously used in patients with an increased risk of cerebral haemorrhage, such as patients with hypertension.
If you develop long-lasting vomiting, loss of consciousness or behavioural changes during the treatment, stop using the medicine and talk to a doctor.
Note: HerzAss-ratiopharm 100 mg is not suitable as an analgesic.

Fertility, pregnancy, and breast-feeding

Tell your doctor if you are pregnant, planning to have a baby, or breast-feeding.
In case the patient becomes pregnant during extended use of HerzAss-ratiopharm, they must talk to their doctor about this.
In the third trimester of pregnancy, acetylsalicylic acid is contraindicated in doses exceeding 100 mg/day.
Low quantities of acetylsalicylic acid and its metabolites are secreted into breast milk. Even though no harmful effects on the infant have been reported, it is not recommended to exceed the daily dose of 150 mg of acetylsalicylic acid during breast-feeding. In case of doses exceeding 150 mg per day, breastfeeding must be discontinued.
Talk to your doctor or pharmacist before using the medicine.
Acetylsalicylic acid can reduce female fertility. If you are planning to have a baby or if you are having problems conceiving, you should consider discontinuing acetylsalicylic acid.

Other medicines and HerzAss-ratiopharm 100 mg

Concomitant use of other medicines can affect the activity of acetylsalicylic acid.
-   Oral anticoagulants (agents preventing coagulation): increased risk of bleeding. Your doctor can determine the time of bleeding by using blood analyses.
-   Ticlopidine, clopidogrel: increased risk of bleeding. Treatment under a doctor’s supervision.
-   Other non-steroidal anti-inflammatory drugs: increased gastrointestinal side effects.
-   Metotrexate: contraindicated.
-   Corticosteroids: increased risk of gastrointestinal    haemorrhage.
-   Acetazolamide: acetylsalicylic acid increases acetazolamide levels in the blood, thereby increasing the risk of severe metabolic deviations (metabolic acidosis.
-   Sodium valproate / valproic acid: acetylsalicylic acid increases blood valproate levels. Increased drug effect and side effects.
-   Diabetes medicines (insulin, sulfonylurea preparations): increased blood sugar-reducing effect.
-   Phenytoin: reduced blood phenytoin levels.
-   Digoxine, barbiturates, lithium: increased blood levels.
-   Aldosterone antagonists, loop diuretics (certain medicines increasing water excretion) and probenecid: reduced effect.
-   Diuretics (medicines increasing water excretion), ACE inhibitors and angiotensin II antagonists (cardiac and blood pressure medicines): decreased blood pressure-reducing effect, development of renal damage (leading to renal failure) in patients with reduced renal function (elderly, in the case of fluid deficiency). Concomitant treatment must be carried out under a doctor’s supervision. Sufficient liquid consumption required.
-   Probenecid (gout medicine): decreased uric acid level-reducing effect.
-   Alcohol: increased risk of gastrointestinal bleeding. Do not consume alcohol during treatment.
-   Ibuprofen: reduced anticoagulant effect in case of regular use.
Tell your doctor if you are taking, have recently taken or might take any other medicines.

3. How to use HerzAss-ratiopharm

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The following dosage scheme usually applies:
-   stenocardia, acute myocardial infarction, prophylaxis of infarctions, as well as after vascular surgery, 100-300 mg per day as a single dose.
-   inhibition of thrombocyte aggregation, transient cerebral blood supply disorders (transient ischemic attacks), and prophylaxis of cerebral infarction, 50-300 mg per day as a single dose.
Take the tablets with a copious amount of liquid. It is recommended to let the tablets dissolve in a small amount of liquid. Administer the tablets with food or after a meal.
HerzAss-ratiopharm is designed for extended use. Commence treatment after talking to a doctor.

Use in children and adolescents

see “Warnings and precautions”.
If you feel that the effect of HerzAss-ratiopharm 100 mg is too strong or too weak, talk to a doctor or pharmacist.

If you take more HerzAss-ratiopharm 100 mg than you should

Overdose can cause dizziness and murmur in the ears (especially in children and elderly patients), which are signs of severe poisoning. In case of the occurrence of overdose symptoms, immediately call an ambulance or go to an emergency department of a hospital. You may be in need of immediate medical assistance.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Incidence is reported as follows:
Very common:   more than 1 person in 10
Common:   up to    1    person in 10
Uncommon:   up to    1    person in 100
Rare:   up to    1    person in 1,000
Very rare:   up to    1    person in    10,000
Blood and lymphatic system disorders Common:    Increased risk of bleeding
Rare:   Intracranial bleeding (inside the skull), thrombocytopenia (low blood cell count),
agranulocytosis (low count of certain white blood cells), aplastic anaemia (not enough blood cells are produced in bone marrow)
Immune system disorders
Rare:   Anaphylactic (strong hypersensitivity) reactions
Metabolic and nutritional disorders Very rare:    Reduced blood sugar levels
Nervous system disorders
Rare:   Headache, dizziness, confusion, impaired hearing, tinnitus (buzzing sound in ears)
Vascular disorders
Rare:   Haemorrhagic vasculitis (blood vessel inflammation accompanied by a rash)
Respiratory, chest, and mediastinal disorders
Uncommon:   Rhinitis, dyspnoea
Rare:   Bronchospasm, asthma attack
Gastrointestinal disorders
Common:   Indigestion, stomach pain, nausea, vomiting, heartburn, diarrhoea
Rare:   Strong gastrointestinal haemorrhage, gastric or intestinal ulcers, which can, in very rare
cases, result in gastric or intestinal perforation
Hepatic and biliary duct disorders
Very rare:   Increased liver enzyme activity (visible in blood analyses)
Skin and subcutaneous tissue disorders Uncommon:    Hives
Rare:   severe bullous skin reactions (Stevens-Johnson syndrome, Lyell’s syndrome), purpura,
erythema nodosum, erythema multiforme, Quincke’s oedema
Renal and urinary disorders
Very rare:   Renal function disorders
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 HerzAss-ratiopharm

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
Store in the original package in order to protect from moisture.
Do not use HerzAss-ratiopharm 100 mg 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 HerzAss-ratiopharm 100 mg contains

-   The active ingredient is acetylsalicylic acid. One tablet contains 100 mg of acetylsalicylic acid.
-   The other ingredients are corn starch, microcrystalline cellulose, powdered cellulose.

What HerzAss-ratiopharm 100 mg looks like and contents of the pack

White round biconvex tablet, 7 mm in diameter and 3.2 mm in length, with a score line dividing the convex surface on one side and the marking “100” on the other side. The tablet may be divided into equal doses.
PVC/aluminium blister pack containing 50 tablets.
PVC/aluminium blister pack containing 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
ratiopharm GmbH,
Graf-Arco-Str.3,
89079 Ulm,
Germany
Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn
Phone: +372 661 0801
This leaflet was last revised in September 2017