Bartal 160 mg Enterotablett

Țară: Suedia

Limbă: suedeză

Sursă: Läkemedelsverket (Medical Products Agency)

Ingredient activ:

acetylsalicylsyra

Disponibil de la:

Krka d.d., Novo mesto

Codul ATC:

B01AC06

INN (nume internaţional):

acetylsalicylic acid

Dozare:

160 mg

Forma farmaceutică:

Enterotablett

Compoziție:

acetylsalicylsyra 160 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne

Tip de prescriptie medicala:

Receptbelagt

Statutul autorizaţiei:

Avregistrerad

Data de autorizare:

2017-01-13

Prospect

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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: ]_
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
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible s

Caracteristicilor produsului

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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
75 mg: pink, round biconvex film-coated tablets with a
diameter of about 7.2 mm.
100 mg: white, round, biconvex film-coated tablets
with a diameter of about
8.1 mm.
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.
-
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