ADCO-IBUPROFEN 400 mg TABLET

দেশ: দক্ষিণ আফ্রিকা

ভাষা: ইংরেজি

সূত্র: South African Health Products Regulatory Authority (SAHPRA)

থেকে পাওয়া:

Adcock Ingram Limited

ডোজ:

See ingredients

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

EACH TABLET CONTAINS IBUPROFEN 400 mg

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

1986-07-12

তথ্য লিফলেট

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S1
ADCO-IBUPROFEN 400 MG SUGAR COATED TABLETS
IBUPROFEN
CONTAINS SUGAR:
LACTOSE 0,07266 G
SUCROSE 0,28813 G
CONTAINS TARTRAZINE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
ADCO-IBUPROFEN 400 mg is available without a doctor’s prescription,
for you to treat a mild illness.
Nevertheless, you still need to use ADCO-IBUPROFEN 400 mg carefully to
get the best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ADCO-IBUPROFEN 400 mg with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
7 days.
1. WHAT ADCO-IBUPROFEN 400 MG IS AND WHAT IT IS USED FOR
ADCO-IBUPROFEN 400 mg is indicated in the treatment of mild to
moderate pain of inflammatory
origin and for the emergency treatment of gout attacks.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-IBUPROFEN 400 MG DO NOT TAKE ADCO-IBUPROFEN 400 MG
•
If you are allergic to ibuprofen or any of the other ingredients of
ADCO-IBUPROFEN 400 mg
(listed in section 6.1).
•
If you have bleeding disorder.
•
If you have heart disease.
•
If you have peptic ulceration or a history of such ulceration.
•
If you are pregnant, do not use NSAIDs at 20 weeks or later in your
pregnancy unless
specifically advised to do so by your health care professional because
these medicines may
cause problems in your unborn baby.
•
If you are sensitive to aspirin. WARNINGS AND PRECAUTIONS
Special care should be taken with ADCO-IBUPROFEN 400 mg:
•
Tell your doctor or health care provider if you are pregnant or plan
to become pregnant.
Taking NSAIDs at around 20 weeks of pregnancy or later may harm your
unborn baby. If you
need to take NSAIDs for more than 2 days when you are between 20 and
30 weeks of your
pregnancy, your healthcare provider may need to monitor the amount of
fluid in your w

পণ্য বৈশিষ্ট্য

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PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
1. NAME OF MEDICINE
ADCO-IBUPROFEN 400 mg
STRENGTH
Ibuprofen 400 mg per tablet
PHARMACEUTICAL FORM:
Sugar-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each sugar-coated tablet contains:
Ibuprofen
400 mg
Contains sugars:
Lactose
0,07266 g
Sucrose
0,28813 g
Contains TARTRAZINE
3. PHARMACEUTICAL FORM
Green, sugar-coated tablets
S1
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4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS:
ADCO-IBUPROFEN 400 mg is indicated in the treatment of mild to
moderate pain of
inflammatory origin and for the emergency treatment of gout attacks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Use the lowest effective dose for the shortest possible duration of
treatment.
Adults:
600 mg to 1 200 mg daily in divided doses.
Children:
20 mg/kg body mass per day but not to exceeded 500 mg per day in
children weighing less
than 30 kg.
4.3
CONTRAINDICATIONS:
ADCO-IBUPROFEN 400 mg should not be given to patients with peptic
ulceration or a history
of
such
ulceration,
bleeding
disorders,
cardiovascular
disease
and
those
on
oral
anticoagulants. ADCO-IBUPROFEN 400 mg should not be given to patients
who are
sensitive to aspirin. ADCO-IBUPROFEN 400 mg should not be given to
patients with asthma,
especially those who have developed bronchospasm with other
non-steroidal agents.
Avoid use of NSAIDs in women around 30 weeks gestation and later in
pregnancy due to the
risks of oligohydramnios/ foetal renal dysfunction and premature
closure of the foetal ductus
arteriosus.
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4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Contains tartrazine, which may cause allergic type reactions
(including bronchial asthma) in
certain individuals. The overall incidence of tartrazine sensitivity
is low; it is however
frequently seen in patients who also have aspirin sensitivity.
In view of the product’s inherent potential to cause fluid
retention, heart failure may be
precipitated in some compromised patients.