Aspirin 75mg Gastro-resistant Tablets Caprin 75mg Gastro-resistant Tablets

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

ACETYLSALICYLIC ACID

Доступна с:

Wockhardt UK Limited

код АТС:

B01AC06

ИНН (Международная Имя):

ACETYLSALICYLIC ACID

Фармацевтическая форма:

GASTRO-RESISTANT TABLET

состав:

ACETYLSALICYLIC ACID 75 mg

Тип рецепта:

OTC

Терапевтические области:

ANTITHROMBOTIC AGENTS

Статус Авторизация:

Authorised

Дата Авторизация:

2006-05-26

тонкая брошюра

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN 75MG GASTRO-RESISTANT TABLETS
Aspirin
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, pharmacist or
nurse 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, 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 after 3 days.
The name of your medicine is Aspirin 75 mg Gastro-resistant Tablets.
In the rest of this
leaflet, it is called Aspirin Tablets.
WHAT IS IN THIS LEAFLET
1. What Aspirin Tablets are and what they are used for
2. What you need to know before you take Aspirin Tablets
3. How to take Aspirin Tablets
4. Possible side effects
5. How to store Aspirin Tablets
6. Contents of the pack and other information
1. WHAT ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your medicine is Aspirin. Aspirin belongs to
a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin thins
the blood which helps
to reduce the likelihood of having a heart attack.
These tablets have been specially coated (enteric coating) to help
minimise stomach upset
and feeling sick (sometimes experienced as side effects of these
tablets – see Section 4).
Aspirin Tablets are used to reduce the likelihood of further heart
attacks or strokes in patients
with a previous history of these conditions, when taken regularly.
They can also be taken
following bypass surgery. Due to the slow release of Aspirin, this
product is not useful for
relieving acute pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN TABLETS
2. BEFORE YOU TAKE ASPIRIN TABLETS
THERE IS A POSSIBLE ASSOCIATION BETWEEN ASPIRIN AND REYE’S SYNDROME
WHEN GIVEN TO
C

Характеристики продукта

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 75mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin 75mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
White circular tablet, plain on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the secondary prevention of thrombotic cerebrovascular or
cardiovascular
disease and following by-pass surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The advice of a doctor should be sought before commencing therapy for
the
first time. The usual dosage, for long-term use, is 75mg-150mg once
daily. In
some circumstances a higher dose may be appropriate, especially in the
short
term, and up to 300mg a day may be used on the advice of a doctor.
Method of administration
Take the tablet with water, do not cut, chew or crush the tablet.
Swallow whole.
_ Paediatric population _
Do not give to children aged under 16 years, unless specifically
indicated (e.g.
for Kawasaki’s disease).
Gastro-intestinal irritation may be reduced by taking aspirin with or
immediately after food.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed
in section 6.1.
Page 2 of 10
In patients with a history of hypersensitivity to aspirin (or any of
the
excipients) or any other NSAIDs and in patients in whom attacks of
asthma, angioedema, urticaria or rhinitis have been precipitated by
aspirin
or other NSAIDs.

Active peptic ulceration or history of peptic ulceration

Haemophilia, other coagulopathies or concurrent anticoagulant therapy

Gout

Do not give to children aged under 16 years, unless specifically
indicated (e.g. for Kawasaki’s disease).

Doses > 100mg/day during the third trimester of pregnancy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised in patients with asthma, allergic disease,
,
impairment of hepatic or renal function (avoid if severe), impaired
cardiac
function,