LENAFEN TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS IBUPROFEN 200 mg

Authorization status:

Registered

Authorization date:

1979-06-08

Patient Information leaflet

Date of approval: 20/06/2023
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
LENAFEN, EACH TABLET CONTAINS 200 MG OF THE ACTIVE SUBSTANCE
IBUPROFEN.
CONTAINS SUGAR: LACTOSE MONOHYDRATE 274,625 MG
WHAT IS IN THIS LEAFLET
1. What LENAFEN is and what it is used for
2. What you need to know before you take LENAFEN
3. How to take LENAFEN
4.Possible side effects
5. How to store LENAFEN
6. Contents of the pack and other information
1. WHAT LENAFEN IS AND WHAT IT IS USED FOR
A 2.7 Antipyretic and anti-inflammatory analgesic
LENAFEN is used for:
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
LENAFEN is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use LENAFEN carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share LENAFEN with any other person.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
10 days.
Date of approval: 20/06/2023
Page 2 of 12
•
The treatment of mild to moderate pain and fever of inflammatory
origin for a
treatment period not exceeding 10 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LENAFEN.
DO NOT TAKE LENAFEN:
•
If you are allergic to or have had an allergic reaction (e.g., asthma,
rhinitis,
angioedema, urticaria) to ibuprofen or any other ingredient in LENAFEN
(listed in
section 6), aspirin or other related painkillers.
•
If you have or have ever had a stomach ulcer, perforation or bleeding
due to NSAIDs.
•
If you suffer from severe liver, kidney or from heart failure.
•
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 taking other NSAIDs or aspirin.
WARNINGS AND PRECAUTIONS
Special care should be taken with LENAFEN:
•
If you develop a fever, skin rash, sw

Summary of Product characteristics

Date of approval: 20/06/2023
Page 1 of 17
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S1
1. NAME OF THE MEDICINE
LENAFEN
STRENGTH
Each tablet of LENAFEN contains:
200 mg of ibuprofen
PHARMACEUTICAL FORM
Tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of LENAFEN contains:
200 mg of ibuprofen.
CONTAINS SUGAR: Lactose monohydrate 274,625 mg
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
A white, film-coated biconvex tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
LENAFEN is indicated for the treatment of mild to moderate pain and
fever of inflammatory
origin for a treatment period not exceeding 10 days.
Date of approval: 20/06/2023
Page 2 of 17
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment (see Special
warnings and precautions for use).
ADULTS AND CHILDREN OVER 12 YEARS:
Take 1 or 2 tablets every four to six hours after food or milk.
DO NOT EXCEED 6 TABLETS IN ANY 24 HOURS.
Not to be given to children under 12 years.
LENAFEN should not be used continuously for fever for more than 3 days
or for more than
10 days for pain without consulting a doctor.
SPECIAL POPULATIONS
No information available.
PAEDIATRIC POPULATION
The safety and efficacy of LENAFEN in children under 12 years has not
been established.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS:
•
Patients with hypersensitivity to ibuprofen or to any of the
excipients in LENAFEN (see
Composition).
•
LENAFEN should not be used in patients who have previously shown
hypersensitivity
reactions (e.g., asthma, urticaria, angioedema or rhinitis) after
taking LENAFEN, aspirin
or other NSAIDs.
•
History of gastrointestinal perforation, ulceration and bleeding (PUB)
related to previous
Date of approval: 20/06/2023
Page 3 of 17
NSAID therapy.
•
Active or history of, recurrent peptic ulcer or haemorrhage or
perforations.
•
History of recurrent haemorrhage/perforations or in patients with
conditions involving a