Bartal 160 mg Enterotablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

20-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

20-04-2018

Aktiva substanser:
acetylsalicylsyra
Tillgänglig från:
Krka d.d., Novo mesto
ATC-kod:
B01AC06
INN (International namn):
acetylsalicylic acid
Dos:
160 mg
Läkemedelsform:
Enterotablett
Sammansättning:
acetylsalicylsyra 160 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
54354
Tillstånd datum:
2017-01-13

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

24-10-2019

Produktens egenskaper Produktens egenskaper - engelska

24-10-2019

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

13-01-2017

Läs hela dokumentet

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Page 1 of 9

Package leaflet: Information for the user

Bartal 75 mg gastro-resistant tablets

Bartal 100 mg gastro-resistant tablets

Bartal 160 mg gastro-resistant tablets

acetylsalicylic acid

[For medicines available only on prescription:]

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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.

[For medicines available without a prescription: <To be completed nationally>]

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse

has have 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 or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

What <Invented name> is and what it is used for

What you need to know before you take <Invented name>

How to take <Invented name>

Possible side effects

How to store <Invented name>

Contents of the pack and other information

1.

What <Invented name> is and what it is used for

<Invented name> contains acetylsalicylic acid, which in low doses belong to a group of medicines

called anti-platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are

involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off

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Page 2 of 9

the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it

can cause a stroke.

<Invented name> is taken to reduce the risk of blood clots forming and thereby prevent further:

heart attacks

strokes

cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest

pain).

<Invented name> is also used to prevent the formation of blood clots after certain types of heart

surgery in order to widen or to unblock the blood vessels.

[For medicines available without a prescription]

The decision concerning initiation of the therapy and appropriate dosing should be made by a

physician.

This medicinal product is not recommended for emergencies. It can only be used as a preventive

treatment.

2.

What you need to know before you take <Invented name>

Do not take <Invented name>:

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 non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs are often used for arthritis or rheumatism and pain.

if you have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or

tongue (angioedema) after taking salicylates or NSAIDs.

if you currently have or have ever had an ulcer in your stomach or small intestine or any other

type of bleeding like a stroke.

if you have ever had the problem of your blood not clotting properly.

if you have severe liver or kidney problems.

if you have severe heart problems which can cause shortness of breath and ankle swelling

if you are in your last 3 months of pregnancy; you must not use higher doses than 100 mg per

day (see section “Pregnancy and breast-feeding”).

if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in

doses higher than 15 mg per week.

Warnings and precautions

Talk to your doctor or pharmacist before taking <Invented name>.

if you have trouble with your kidneys, liver or heart.

if you have or have ever had problems with your stomach or small intestine.

if you have uncontrolled high blood pressure.

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Page 3 of 9

if you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases;

acetylsalicylic acid may induce an asthma attack.

if you have ever had gout.

if you have heavy menstrual periods.

if you suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)

You must immediately seek medical advice, if your symptoms get worse or if you experience severe

or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of

serious allergy (see section “Possible side effects”).

Inform your doctor if you are planning to have an operation (even a minor one, such as tooth

extraction) since acetylsalicylic acid is blood-thinning there may be an increased risk of bleeding.

You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use

of acetylsalicylic acid at the same time may result in deterioration of kidney function.

This medicinal product is not suitable as a pain killer or fever reducer.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye’s syndrome when given to children. Reye’s syndrome is a very

rare disease which affects the brain and liver and can be live threatening. For this reason, <Invented

name> should not be given to children aged under 16 years, unless on the advice of a doctor.

Other medicines and <Invented name>

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as some

other medicines for:

thinning of the blood/prevention of clots or dissolving (e.g. warfarin, heparin, clopidogrel,

alteplase)

rejection of organ after transplantation (cyclosporine, tacrolimus)

high blood pressure (e.g. diuretics and ACE-inhibitors)

regulation of the heart beat (digoxin)

manic-depressive illness (lithium)

pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)

pain and fever reduction (metamizole), the effect of acetylsalicylic acid on platelet aggregation

may be reduced when coadministered with metamizole

gout (e.g. probenecid)

epilepsy (valproate, phenytoin)

glaucoma (acetazolamide)

cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)

diabetes (e.g. glibenclamide, insulin)

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Page 4 of 9

depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine).

use as hormone replacement therapy when the adrenal glands or pituitary gland have been

destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation

of the intestines (corticosteroids)

<Invented name> with food and drink and alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding

time.

Pregnancy and breast-feeding and fertility

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.

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor.

You should not take <Invented name> if you are in the last 3 months of pregnancy, unless you are

advised to do so by your doctor and then the daily dose should not exceed 100 mg (see section “Do not

take <Invented name>”). Regular or high doses of this medicinal product during late pregnancy can

cause serious complications in the mother or baby.

Breast-feeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

<Invented name> should not affect your ability to drive and use machines.

<Invented name> contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before

taking this medicine.

<Invented name> 75 mg contains sunset-yellow (E110)

which may cause allergic reaction.

<Invented name> 160 mg contains lecithin (soya) (E322)

If you are allergic to peanut or soya, do not use this medicinal product.

3.

How to take <Invented name>

[For medicines available only on prescription:]

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Adults

Prevention of heart attacks:

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Page 5 of 9

The recommended dose is 75-160 mg once daily.

Prevention of strokes:

The recommended dose is 75-325 mg once daily.

Prevention of cardiovascular problems in patients who suffer from stable or unstable angina (a type of

chest pain):

The recommended dose is 75-160 mg once daily.

Prevention formation of blood clots after certain types of heart surgery:

The recommended dose is 75-160 mg once daily.

[For medicines available without a prescription:]

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

Adults

Prevention of heart attacks:

The recommended dose is 75-160 mg once daily.

Prevention of strokes:

The recommended dose is 75-325 mg once daily.

Prevention of cardiovascular problems in patients who suffer from stable or unstable angina (a type of

chest pain):

The recommended dose is 75-160 mg once daily.

Prevention formation of blood clots after certain types of heart surgery:

The recommended dose is 75-160 mg once daily.

This medicine should not be used at higher doses unless advised by a doctor, and then the dose should

not exceed 325 mg a day.

Elderly

As for adults. In general, acetylsalicylic acids should be used with caution in elderly patients who are more

prone to adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid should not be administered to children and adolescents younger than 16 years, unless

prescribed by a doctor (see section “Warnings and precautions”).

Method of administration

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Page 6 of 9

For oral use.

The tablets should be swallowed whole with sufficient fluid (1/2 glass of water). The tablets have a gastro-

resistant coating which prevents irritant effects on the gut, and should therefore not be crushed, broken or

chewed.

If you take more <Invented name> than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or

contact immediately the nearest casualty department. Show any left over medicines or the empty

packet to the doctor.

Symptoms of overdose may include ringing in ears, hearing problems, headache, dizziness, confusion,

nausea, vomiting and abdominal pain. A large overdose can lead to more rapid breathing than normal

(hyperventilation), fever, excess sweating, restlessness, seizures, hallucinations, low blood sugar,

coma and shock.

If you forget to take <Invented name>

If you miss a dose, wait until it is time for your next dose, then go on as normal.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking <Invented name>

Do not stop taking <Invented name> without asking your doctor.

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.

If you notice any of the following serious side effects, stop taking <Invented name> and contact a

doctor immediately:

Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing

(severe allergic reaction)

.

Reddening of the skin with blisters or peeling and may be associated with a high fever and joint

pains. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome.

Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Other side effects include:

Common (may affect up to 1 in 10 people):

Nausea, vomiting, diarrhoea.

Indigestion.

Increased tendency for bleeding.

Uncommon (may affect up to 1 in 100 people):

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Page 7 of 9

Hives.

Runny noses.

Breathing difficulty.

Rare (may affect up to 1 in 1,000 people):

Severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells.

Cramps in the lower respiratory tract, asthma attack.

Inflammation in the blood vessels.

Bruising with purple spots (cutaneous bleeding).

Severe skin reactions such as rash known as erythema multiforme and it’s life threatening forms

Stevens-Johnson syndrome and Lyell’s syndrome.

Hypersensitivity reactions, such as swelling of e.g. lips, face or body, or shock.

Reye’s syndrome (a very rare disease in children which affects the brain and liver (see section 2

“Children and adolescents”))

Abnormal heavy or prolonged menstrual periods

Not known (frequency cannot be estimated from the available data):

Ringing in your ears (tinnitus) or reduced hearing ability.

Headache.

Vertigo.

Ulcers in stomach or small intestine and perforation.

Prolonged bleeding time.

Impaired kidney function, acute renal failure.

Impaired liver function, increased liver enzymes.

High level of uric acid or low levels of sugar

in the blood.

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 the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store <Invented name>

Keep this medicine out of the sight and reach of children.

<Invented name> 75 mg:

Do not store above 25°C.

Store in the original package in order to protect from light.

<Invented name> 100 mg:

Do not store above 30°C.

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<Invented name> 160 mg:

Do not store above 30°C.

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the blister and box after EXP. 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 <Invented name> contains

The active substance is acetylsalicylic acid.

Each gastro-resistant tablet contains 75 mg, 100 mg or 160 mg acetylsalicylic acid.

The other ingredients are for <Invented name> 75 mg:

Tablet core:

lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato

starch, talc, triacetin, methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%, sodium

dodecyl suphate* and polysorbate 80*.

Film-coating:

polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521),

carmine (E120) and sunset yellow aluminium lake (E110).

The other ingredients are for <Invented name> 100 mg:

Tablet core:

lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica and

potato starch.

Film-coating:

talc, triacetin, methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%,

sodium dodecyl suphate* and polysorbate 80*.

The other ingredients are for <Invented name> 160 mg:

Tablet core:

lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato

starch, talc, triacetin, methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%, sodium

dodecyl suphate* and polysorbate 80*.

Film-coating:

polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), soy

lecithin (E322) and iron oxide yellow (E172).

It may contain sodium dodecyl sulfate and polysorbate 80

What <Invented name> looks like and contents of the pack

<Invented name> 75 mg:

pink, round, biconvex film-coated tablet with a diameter of about 7.2 mm.

<Invented name> 100 mg:

white, round, biconvex film-coated tablet with a diameter of about 8.1 mm.

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<Invented name> 160 mg:

yellow, round, biconvex film-coated tablet with a diameter of about

9.2 mm.

Pack sizes:

Blisters: 20,

28, 30, 50, 56, 60, 84, 90 and 100

gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This leaflet was last revised in

24/10/2019

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Page 1 of 15

1.

NAME OF THE MEDICINAL PRODUCT

Bartal 75 mg gastro-resistant tablets

Bartal 100 mg gastro-resistant tablets

Bartal 160 mg gastro-resistant tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gastro-resistant tablet contains 75 mg, 100 mg or 160 mg acetylsalicylic acid.

Excipients with known effect:

75 mg:

Lactose monohydrate .......................................................................................45 mg per tablet.

Sunset yellow (E110) ................................................................................0.0006 mg per tablet.

100 mg:

Lactose monohydrate…………………………………………………………60 mg per tablet

160 mg:

Lactose monohydrate .......................................................................................96 mg per tablet.

Lecithin (soya) (E322) ..................................................................................0.42 mg per tablet.

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Gastro-resistant tablet

<Invented name> 75 mg: pink, round biconvex film-coated tablets with a diameter of about 7.2 mm.

<Invented name> 100 mg: white, round, biconvex film-coated tablets with a diameter of about

8.1 mm.

<Invented name> 160 mg: yellow, round, biconvex film-coated tablets with a diameter of about

9.2 mm.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Secondary prevention of myocardial infarction.

Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris.

History of unstable angina pectoris, except during the acute phase.

Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG).

Coronary angioplasty, except during the acute phase.

Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular

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Page 2 of 15

accidents (CVA), provided intracerebral haemorrhages have been ruled out.

<Invented name> is not recommended in emergency situations. It is restricted to secondary prevention

with chronic treatment.

4.2

Posology and method of administration

Posology

Adults

Secondary prevention of myocardial infarction:

The recommended dose is 75-160 mg once daily.

Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris:

The recommended dose is 75-160 mg once daily.

History of unstable angina pectoris, except during the acute phase:

The recommended dose is 75-160 mg once daily.

Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG):

The recommended dose is 75-160 mg once daily.

Coronary angioplasty, except during the acute phase:

The recommended dose is 75- 160 mg once daily.

Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents

(CVA), provided intracerebral haemorrhages have been ruled out:

The recommended dose is 75-325 mg once daily.

<Invented name> should not be used at higher doses unless advised by a doctor, and the dose should

not exceed 325 mg a day.

For dosage, national and local treatment guidelines should be taken into account.

Elderly

In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to

adverse events. The usual adult dose is recommended in the absence of severe renal or hepatic

insufficiency (see sections 4.3 and 4.4). Treatment should be reviewed at regular intervals.

Paediatric population

Acetylsalicylic acid should not be used in children and adolescents younger than 16 years, except on medical

advice where the benefit outweighs the risk (see section 4.4).

Method of administration

For oral use.

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Page 3 of 15

The tablets should be swallowed whole with sufficient fluid (1/2 glass of water). Due to the gastro resistant

coating the tablets should not be crushed, broken or chewed because coating prevents irritant effects

on the gut.

Duration of administration:

Long-term treatment with the lowest possible dose.

4.3

Contraindications

Hypersensitivity to the active substance or prostaglandin synthetase inhibitors (e.g. certain

asthma patients who may suffer an attack or faint) or to any of the excipients listed in

section 6.1;

Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds

of bleeding such as cerebrovascular haemorrhages;

Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia;

Severe hepatic impairment;

Severe renal impairment;

Severe cardiac insufficiency;

Doses >100 mg/day during the third trimester of pregnancy (see section 4.6);

Methotrexate used at doses >15 mg/week (see section 4.5).

4.4

Special warnings and precautions for use

<Invented name> is not suitable for use as an anti-inflammatory/analgesic/antipyretic.

Recommended for use in adults and adolescents from 16 years of age. This medicinal product is not

recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the

risks. Acetylsalicylic acid may be a contributory factor in the causation of Reye's Syndrome in some

children.

There is an increased risk of haemorrhage and prolongation of bleeding time particularly during or

after surgery(even in cases of minor procedures, e.g. tooth extraction). Use with caution before

surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.

<Invented name> is not recommended during menorrhagia where it may increase menstrual bleeding.

<Invented name> is to be used with caution in cases of uncontrolled hypertension and when patients

have a past history of gastric or duodenal ulcer or haemorrhagic episodes or are undergoing therapy

with anticoagulants.

Patients should report any unusual bleeding symptoms to their physician. If gastrointestinal bleeding

or ulceration occurs the treatment should be withdrawn.

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Page 4 of 15

Acetylsalicylic acid should be used with caution in patients with moderately impaired renal or hepatic

function (contraindicated if severe), or in patients who are dehydrated since the use of NSAIDs may

result in deterioration of renal function. Liver function tests should be performed regularly in patients

presenting slight or moderate hepatic insufficiency.

Acetylsalicylic acid may promote bronchospasm and asthma attacks or other hypersensitivity

reactions. Risk factors are existing asthma, hay fever, nasal polyps or chronic respiratory diseases. The

same applies for patients who also show allergic reaction to other substances (e.g. with skin reactions,

itching or urticaria).

Serious skin reactions, including Stevens-Johnson syndrome, have rarely been reported in association

with the use of acetylsalicylic acid (see section 4.8). The treatment with <Invented name> should be

discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including acetylsalicylic

acid especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Where

prolonged therapy is required, patients should be reviewed regularly.

Concomitant treatment with <Invented name> and other drugs that alter haemostasis (i.e.

anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and

selective serotonin reuptake inhibitors) is not recommended, unless strictly indicated, because they

may enhance the risk of haemorrhage (see section 4.5). If the combination cannot be avoided, close

observation for signs of bleeding is recommended.

Caution should be advised in patients receiving concomitant medications which could increase the risk

of ulceration, such as oral corticosteroids, selective serotonin-reuptake inhibitors and deferasirox (see

section 4.5).

Acetylsalicylic acid in low doses reduces uric acid excretion. Due to this fact, patients who tend to

have reduced uric acid excretion may experience gout attacks (see section 4.5).

<Invented name> should be used with caution in patients with glucose-6-phosphate dehydrogenase

deficiency.

The risk of hypoglycaemic effect with sulfonylureas and insulins may be potentiated with <Invented

name> taken at overdosage (see section 4.5).

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total

lactase deficiency or glucose-galactose malabsorption should not take this medicine.

<Invented name> 75 mg contains sunset yellow aluminium lake (E110) which may cause allergic

reactions.

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<Invented name> 160 mg contains soya lecithin which might be a source of soya protein and should

therefore not be taken in patients allergic to soya or peanut due to the risk of hypersensitivity

reactions.

4.5

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations

Methotrexate (used at doses >15 mg/week):

The combined drugs, methotrexate and acetylsalicylic acid, enhance haematological toxicity of

methotrexate due to the decreased renal clearance of methotrexate by acetylsalicylic acid. Therefore,

the concomitant use of methotrexate (at doses >15 mg/week) with <Invented name> is contraindicated

(see section 4.3).

Not recommended combinations

Uricosuric agents, e.g. probenecid, sulfinpyrazone

Salicylates reverse the effect of probenecid and sulfinpyrazone. The combination should be avoided.

Combinations requiring precautions for use or to be taken into account

Anticoagulants and thrombolytics e.g. coumarin, heparin, warfarin, alteplase

Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and

displacement of oral anticoagulants from their plasma protein binding sites. The bleeding time should

be monitored (see section 4.4).

Particularly, treatment with acetylsalicylic acid should not be initiated within the first 24 hours after

treatment with alteplase in acute stroke patients. Concomitant use is therefore not recommended.

Anti-platelet agents (e.g clopidogrel, ticlopidine, cilostazol and dipyridamole) and selective serotonin

reuptake inhibitors (SSRIs; such as sertraline or paroxetine)

Increased risk of gastrointestinal bleeding (see section 4.4).

Antidiabetics, e.g. sulphonylureas and insulin

Salicylates may increase the hypoglycaemic effect of antidiabetics. Thus, some downward re-

adjustment of the dosage of the antidiabetic may be appropriate if large doses of salicylates are used.

Increased blood glucose controls are recommended.

Digoxin and lithium

Acetylsalicylic acid impairs the renal excretion of digoxin and lithium, resulting in increased plasma

concentrations. Monitoring of plasma concentrations of digoxin and lithium is recommended when

initiating and terminating treatment with acetylsalicylic acid. Dose adjustment may be necessary

Diuretics and antihypertensives

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NSAIDs may decrease the antihypertensive effects of diuretics and other antihypertensive agents.

Blood pressure should be well monitored.

Concomitant administration with ACE-inhibitors,

angiotensin II receptor antagonists and calcium-channel blocker increases the risk of acute renal

insufficiency in combination with high-dose ASA.

Loop diuretics: Risk of acute renal failure due to the decreased glomerual filtration via decreased renal

prostaglandin synthesis. Hydrating the patient and monitoring renal function at the start of the

treatment is recommended. In case of association with verapamil the bleeding time should be

monitored.

Carbonic anhydrase inhibitors (acetazolamide)

May result in severe acidosis and increased central nervous system toxicity

Systemic corticosteroids

The risk of gastrointestinal ulceration and bleeding may be increased when acetylsalicylic acid and

corticosteroids are co-administered (see section 4.4).

Methotrexate (used at doses <15 mg/week):

The combined drugs, methotrexate and acetylsalicylic acid, may increase haematological toxicity of

methotrexate due to decreased renal clearance of methotrexate by acetylsalicylic acid. Weekly blood

count checks should be done during the first weeks of the combination. Enhanced monitoring should

take place in the presence of even mildly impaired renal function, as well, as in elderly.

Other NSAIDs

Increased risk of ulcerations and gastrointestinal bleeding due to synergistic effects.

Ibuprofen

Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on

platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the

uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm

conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be

likely for occasional ibuprofen use (see section 5.1).

Metamizole

Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, when taken

concomitantly. Therefore, this combination should be used with caution in patients taking low dose

acetylsalicylic acid for cardioprotection.

Ciclosporin, tacrolimus

Concomitant use of NSAIDs and ciclosporin or tacrolimus may increase the nephrotoxic effect of

ciclosporin and tacrolimus. The renal function should be monitored in case of concomitant use of these

agents and acetylsalicylic acid.

Valproate

Acetylsalicylic acid has been reported to decrease the binding of valproate to serum albumin, thereby

increasing its free plasma concentrations at steady state.

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Phenytoin

Salicylate diminishes the binding of phenytoin to plasma albumin. This may lead to decreased total

phenytoin levels in plasma, but increased free phenytoin fraction. The unbound concentration, and

thereby the therapeutic effect, does not appear to be significantly altered.

Alcohol

Concomitant administration of alcohol and acetylsalicylic acid increases the risk of gastrointestinal

bleeding.

4.6

Fertility, pregnancy and lactation

Pregnancy

Low doses (up to 100 mg/day):

Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require

specialised monitoring, appear safe.

Doses of 100- 500 mg/day:

There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500

mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this

dose range.

Doses of 500 mg/day and above:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal

development. Data from epidemiological studies suggest an increased risk of miscarriage and of

cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early

pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to

approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals,

administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and

post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various

malformations, including cardiovascular, have been reported in animals given a prostaglandin

synthesis inhibitor during the organogenetic period. During the first and second trimester of

pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is

used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the

dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary

hypertension);

renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

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possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very

low doses.

inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the

third trimester of pregnancy.

Breastfeeding

Low quantities of salicylates and of their metabolites are excreted into the breast milk. Since adverse

effects for the infant have not been reported up to now, short-term use of the recommended dose does

not require suspending lactation. In cases of long-term use and/or administration of higher doses,

breastfeeding should be discontinued.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed with <Invented

name>.

Based on the pharmacodynamic properties and the side effects of acetylsalicylic acid, no influence on

the reactivity and the ability to drive or use machines is expected.

4.8

Undesirable effects

Very common (

1/10)

Common (

1/100 to < 1/10)

Uncommon (

1/1,000 to < 1/100)

Rare (

1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (cannot be estimated from the available data)

Common

Uncommon

Rare

Not known

Blood and

lymphatic system

disorders

Increased

bleeding

tendencies

Thrombocytopenia,

granulocytosis, aplastic

anaemia

Cases of bleeding

with prolonged

bleeding time such

as epistaxis,

gingival bleeding.

Symptoms may

persist for a period

of 4–8 days after

acetylsalicylic acid

discontinuation. As

a result there may

be an increased

risk of bleeding

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during surgical

procedures.

Existing

(haematemesis,

melaena) or occult

gastrointestinal

bleeding, which

may lead to iron

deficiency anaemia

(more common at

higher doses).

Immune system

disorders

Hypersensitivity

reactions, angio-

oedema, allergic

oedema, anaphylactic

reactions including

shock.

Metabolism and

nutrition disorders

Hyperuricemia,

hypoglycaemia

Nervous system

disorders

Intracranial

haemorrhage

Headache, vertigo

Ear and labyrinth

disorders

Reduced hearing

ability; tinnitus

Vascular disorders

Haemorrhagic

vasculitis

Respiratory,

thoracic and

mediastinal

disorders

Rhinitis,

dyspnoea

Bronchospasm, asthma

attacks

Gastrointestinal

disorders

Dyspepsia;

nausea,

vomiting,

diarrhoea

Severe gastrointestinal

haemorrhage,

Gastric or

duodenal ulcers

and perforation

Hepatobiliary

disorders

Reye´s syndrome

Hepatic

insufficiency,

hepatic enzyme

increased

Skin and

subcutaneous

tissue disorders

Urticaria

Stevens-Johnson

syndrome, Lyells

syndrome, purpura,

erythema nodosum,

erythema multiforme

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Renal and urinary

disorders

Impaired renal

function, acute

renal failure

Reproductive

system and breast

disorders

Menorrhagia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.

4.9

Overdose

Although considerable inter-individual variations are involved, it can be considered that the toxic dose

is about 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid is

25-30 grams. Plasma salicylate concentrations above 300 mg/l indicate intoxication. Plasma

concentrations above 500 mg/l in adults and 300 mg/l in children generally cause severe toxicity.

Overdose may be harmful for elderly patients and particularly for small children (therapeutic overdose

or frequent accidental intoxications may be fatal).

Symptoms of moderate intoxications

Tinnitus, hearing disorders, headache, vertigo, confusion and gastrointestinal symptoms (nausea,

vomiting and abdominal pain).

Symptoms of severe intoxications

Symptoms are related to severe disruption of the acid-base balance. In the first instance

hyperventilation occurs, which results in respiratory alkalosis. Respiratory acidosis ensues due to

suppression of the respiratory centre. In addition, metabolic acidosis occurs as a result of the presence

of salicylate.

Since younger children are often not seen until they have reached a late stage of intoxication, they are

usually in the stage of acidosis.

Furthermore, the following symptoms may occur: hyperthermia and perspiration, resulting in

dehydration: feelings of restlessness, convulsions, hallucinations and hypoglycaemia. Depression of

the nervous system may lead to coma, cardiovascular collapse or respiratory arrest.

Management

If a toxic dose has been ingested, hospital admission is required. In the event of moderate intoxication,

inducing the patient to vomit should be attempted.

If this fails, gastric lavage may be attempted during the first hour after ingestion of a substantial amount

of the medicine. Afterwards, administer activated carbon (adsorbent) and sodium sulphate (laxative).

Activated charcoal may be given as a single dose (50 g for an adult, 1 g/kg body weight for a child up

to 12 years).

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Alkalisation of the urine (250 mmol NaHCO

, for three hours) whilst checking urine pH levels.

In the event of severe intoxication, haemodialysis is to be preferred.

Other symptoms to be treated symptomatically.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents: platelet aggregation inhibitors excl. Heparin, ATC

code: B01AC06

Mechanism of action

Acetylsalicylic acid inhibits the platelet activation: blocking the platelet cyclooxygenase by

acetylation, it inhibits thromboxane A

synthesis, a physiological activating substance released by the

platelets and which would play a role in the complications of the atheromatous lesions.

Inhibition of TXA

-synthesis is irreversible, because thrombocytes, which have no nucleus, are not

capable (due to lack of protein synthesis capability) to synthesise new cyclooxygenase, which had

been acetylated by acetylsalicylic acid.

Pharmacodynamic effects

The repeated doses from 20 to 325 mg involve an inhibition of the enzymatic activity from 30 to 95%.

Due to the irreversible nature of the binding, the effect persists for the lifespan of a thrombocyte (7-10

days). The inhibiting effect does not exhaust during prolonged treatments and the enzymatic activity

gradually begins again upon renewal of the platelets 24 to 48 hours after treatment interruption.

Acetylsalicylic acid extends bleeding time on average by approximately 50 to 100%, but individual

variations can be observed.

Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on

platelet aggregation when they are dosed concomitantly.

In one study, when a single dose of ibuprofen 400 mg was taken within 8 h before or within 30 min

after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid

on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these

data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no

firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered

to be likely for occasional ibuprofen use.

5.2

Pharmacokinetic properties

Absorption

After oral administration, acetylsalicylic acid is rapidly and completely absorbed from the

gastrointestinal tract. The principal site of absorption is the proximal small intestine. However, a

significant portion of the dosage is already hydrolysed to salicylic acid in the intestinal wall during the

absorption process. The degree of hydrolysis is dependent on the rate of absorption.

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After intake of <Invented name> gastro-resistant tablets the maximum plasma levels of acetylsalicylic

acid and salicylic acid are reached after about 3.5 and 4.5 hours, respectively, following administration

in the fasted state. If the tablets are taken with food, maximum plasma levels are reached

approximately 3 hours later than in the fasted state.

Distribution

Acetylsalicylic acid as well as the main metabolite salicylic acid, are extensively bound to plasma

proteins, primarily albumin, and distributed rapidly into all parts of the body. The degree of protein

binding of salicylic acid is strongly dependant of both the salicylic acid and albumin concentration.

The volume of distribution of acetylsalicylic acid is ca. 0.16 l/kg of body weight. Salicylic acid slowly

diffuses into the synovial fluid, crosses the placental barrier and passes into breast milk.

Biotransformation

Acetylsalicylic acid is rapidly metabolised to salicylic acid, with a half-life of 15-30 minutes. Salicylic

acid is subsequently predominantly converted into glycine and glucuronic acid conjugates, and traces

of gentisic acid.

Elimination kinetics of salicylic acid is dose-dependent, because the metabolism is limited by liver

enzyme capacity. Thus, elimination half-time varies and is 2-3 hours after low doses, 12 hours after

usual analgetic doses and 15-30 hours after high therapeutic doses or intoxication.

Elimination

Salicylic acid and its metabolites are predominantly excreted via the kidneys.

5.3

Preclinical safety data

The preclinical safety profile of acetylsalicylic acid is well documented.

In experimental animal studies, salicylates have shown no other organ injury than renal damage.

In rat studies, fetotoxicity and teratogenic effects were observed with acetylsalicylic acid at

maternotoxic doses. Clinical relevance is unknown as the doses used in non-clinical studies are much

higher (7 times at least) than the maximal recommended doses in targeted cardiovascular indications.

Acetylsalicylic acid was extensively investigated with regard to mutagenic and carcinogenic effects.

The results as a whole show no relevant signs for any mutagenic or carcinogenic effects in mice and

rat studies.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

<Invented name> 75 mg

Tablet core

lactose monohydrate

cellulose, microcrystalline

silica, colloidal anhydrous

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potato starch

talc

triacetin

methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%

sodium dodecyl suphate*

polysorbate 80*

Film-coating

polyvinyl alcohol (E1203)

titanium dioxide (E171)

macrogol 3350 (E1521)

carmine (E120)

sunset yellow aluminium lake (E110)

<Invented name> 100 mg

Tablet core

lactose monohydrate

cellulose, microcrystalline

silica, colloidal anhydrous

potato starch

Film-coating

talc

triacetin

methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%

sodium dodecyl suphate*

polysorbate 80*

<Invented name> 160 mg

Tablet core

lactose monohydrate

cellulose, microcrystalline

silica, colloidal anhydrous

potato starch

talc

triacetin

methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%

sodium dodecyl suphate*

polysorbate 80*

Film-coating

polyvinyl alcohol (E1203)

titanium dioxide (E171)

macrogol 3350 (E1521)

soy lecithin (E322)

iron oxide yellow (E172)

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It may contain sodium dodecyl sulfate and polysorbate 80

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years

6.4

Special precautions for storage

75 mg:

Do not store above 25°C.

Store in the original package in order to protect from light.

100 mg:

Do not store above 30°C.

160 mg:

Do not store above 30°C.

Store in the original package in order to protect from light.

6.5

Nature and contents of container

75 mg gastro-resistant tablets and 160 mg gastro-resistant tablets:

Blister (PVC/Aluminium).

Pack sizes:

Blisters: 20, 28, 30, 50, 56, 60, 84, 90 and 100

gastro-resistant tablets.

100 mg gastro-resistant tablets:

Blister (PVC/Aluminium)

Pack sizes:

Blisters: 20, 28, 30, 50, 56, 60, 84, 90 and 100

gastro-resistant tablets.

(PVC white - paper/Aluminium foil)

Pack sizes:

Blisters: 20, 28, 30, 50, 56, 60, 84, 90 and 100

gastro-resistant tablets.

(PVC white /Aluminium foil child resistant blister).

Pack sizes:

Blisters: 20, 28, 30, 50, 56, 60, 84, 90 and 100

gastro-resistant tablets.

Not all pack sizes may be marketed.

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6.6

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

24/10/2019

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