Ibuprofen 400mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Ibuprofen

可用日期:

Relonchem Ltd

ATC代码:

M01AE01

INN（国际名称）:

Ibuprofen

剂量:

400mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 10010100; GTIN: 5055144200866 5055144200859

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 400 MG COATED TABLETS
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.
•
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.
•
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.
•
You must talk to your doctor if you do not feel better
or if you feel worse after 10 days.
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen 400 mg Coated Tablets are and what
they are used for
2.
What you need to know before you take Ibuprofen
400 mg Coated Tablets
3. How to take Ibuprofen 400 mg Coated Tablets
4. Possible side effects
5. How to store Ibuprofen 400 mg Coated Tablets
6. Contents of the pack and other information
1. WHAT IBUPROFEN 400 MG COATED TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Ibuprofen 400 mg Coated
Tablets. They contain the active ingredient called
Ibuprofen. Ibuprofen belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
These drugs are pain killers and reduce inflammation.
Ibuprofen 400 mg Coated Tablets are used for:
•
Rheumatic or muscular pain
•
Pain of non-serious arthritic conditions (characterised
by pain and stiffness in your body)
•
Back pain
•
Neuralgia (painful disorder of the nerves)
•
Headache including migraine
•
Toothache
•
Period pain
•
Feverishness
•
Symptoms of cold & influenza.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN
400 MG COATED TABLETS
DO NOT TAKE IBUPROFEN 400 MG COATED TABLETS IF YOU:
•
are allergic to Ibuprofen or any of the other ingredients
(see section 6)
•
have (or have had two or more episodes of) a stomach
ulcer, perforation or bleeding
•
have had asth

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400 mg Tablets
Ibuprofen 400mg Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg Ibuprofen
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink biconvex film coated tablets (tablets) marked with “I 400” on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of migraine-headaches, backache, dental pain, neuralgia
and
period pains as well as rheumatic and muscular pains, and pain of non-
serious arthritic conditions.
Ibuprofen relieves pain and reduces inflammation and temperature as
well
as relieving headaches and other types of pain. It also relieves cold
and flu
symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only. To be taken
preferably with or after
food, with plenty of fluid.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4). The patient should consult a doctor if
symptoms persist or
worsen if the product is required for more than 10 days.
_ADULTS AND CHILDREN OVER 12 YEARS _
The recommended dosage of Ibuprofen is 1200 -1800 mg daily in divided
doses. Some
patients can be maintained on 600 -1200 mg daily. In severe or acute
conditions, it can
be advantageous to increase the dosage until the acute phase is
brought under control,
provided that the total daily dose does not exceed 2400 mg in divided
doses.
_CHILDREN_
The daily dosage of Ibuprofen is 20 mg/kg of body weight in divided
doses.
Not to be administered to children weighing less than 7 kg.
In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily
in divided doses
may be taken.
_ELDERLY_
The elderly are at increased risk of serious consequences of adverse
reactions. If an
NSAID is considered necessary, the lowest effective dose should be
used and for the
shortest possible duration. The patient should be monitored regularly
for GI bleeding
during NSAID therapy. If renal