MEFENAMIC ACID MLabs mefenamic acid 250 mg capsule bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

mefenamic acid, Quantity: 250 mg

Disponível em:

Micro Labs Pty Ltd

DCI (Denominação Comum Internacional):

Mefenamic acid

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: lactose monohydrate; titanium dioxide; purified water; quinoline yellow; Gelatin; sodium lauryl sulfate; brilliant scarlet 4R

Via de administração:

Oral

Unidades em pacote:

HDPE container pack of 30's with CR polypropylene cap, HDPE container pack of 100's with CR polypropylene cap, HDPE container pack of 50's with CR polypropylene cap

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Treatment of primary dysmenorrhoea and primary menorrhagia.,Short-term relief of mild to moderate pain such as dental pain and soft tissue pain.

Resumo do produto:

Visual Identification: Yellow-Yellow coloured, size '1' hard gelatin capsules imprinted with 'ML' on cap and '250' on body.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

2017-07-07

Folheto informativo - Bula

PR:CTDV5
MEFENAMIC ACID MLABS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about this medicine, speak to
a doctor
1. WHY AM I USING MEFENAMIC ACID MLABS?
Each Mefenamic acid capsule contains 250 mg mefenamic acid. Inactive
ingredients are lactose
monohydrate, iron oxide yellow, brilliant blue, gelatin and carbon
black. MEFENAMIC ACID
MLabs does not contain sucrose, gluten, tartrazine or any other azo
dyes.
2. WHAT SHOULD I KNOW BEFORE I USE MEFENAMIC ACID MLABS?
Do not use if you have ever had an allergic reaction to Mefenamic acid
or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
MEFENAMIC ACID
MLabs?
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mefenamic acid and affect how it
works.
A list of these medicines is in section 3.What if I am taking other
medicines? In the full CMI.
4. HOW DO I USE MEFENAMIC ACID MLABS?
THE USUAL DOSE OF MEFENAMIC ACID MLABS IS 2 CAPSULES (500 MG) THREE
TIMES DAILY
WITH MEALS.
•
Your doctor may recommend a different dose. This may depend on your
age, your condition
and whether or not you are taking any other medicines.
•
Swallow MEFENAMIC ACID MLabs capsules whole with a full glass of
water.
•
Do not chew them.
•
Take MEFENAMIC ACID MLabs with or after food.
TAKE MEFENAMIC ACID MLABS EXACTLY AS YOUR DOCTOR HAS PRESCRIBED.
PR:CTDV5
More instructions can be found in Section 4. How do I use MEFENAMIC
ACID MLabs in the
full CMI.
5. WHAT SHOULD I KNOW WHILE USING MEFENAMIC ACID MLABS?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you
are using
THINGS YOU SHOULD NOT DO
•
Do not stop using this medicine suddenly
DRIVING OR USING MACHINES
•
As with other NSAIDS medicines, MEFENAMIC ACID
MLabs may cause dizziness or light-headed

Características técnicas

PR:CTDV5 1
AUSTRALIAN PRODUCT INFORMATION
MEFENAMIC ACID MLABS (MEFENAMIC ACID) CAPSULES
1.
NAME OF THE MEDICINE
Mefenamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MEFENAMIC ACID MLabs
capsules contain the active ingredient mefenamic acid
250 mg/capsule.
EXCIPEINT(S) WITH KNOWN EFFECT:
contains sugars (as lactose)
For a full list of excipients, see section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
MEFENAMIC ACID 250 MG, HARD GELATIN CAPSULE
Yellow-Yellow colored, size‘1’ hard gelatin capsules imprinted
with ‘ML’ on cap and ‘250’ on
body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of primary dysmenorrhoea and primary menorrhagia.
Short-term relief of mild to moderate pain such as dental pain and
soft tissue pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk factors
and ongoing need for treatment.
Pregnancy: see Section 4.6 Fertility, Pregnancy and Lactation.
DYSMENORRHOEA
2 capsules (500 mg) three times daily with meals from the onset of
pain and continued for the
usual duration of pain.
PR:CTDV5 2
MENORRHAGIA
2 capsules (500 mg) three times daily with meals and from the onset of
menses and continued
according to the judgement of the physician. Therapy should not be
continued for more than
7 days except on the advice of a physician.
OTHER INDICATIONS
2 capsules (500 mg) three times daily, with meals.
4.3
CONTRAINDICATIONS
1.
Patients showing evidence of chronic inflammation and/or active
ulceration of either the
upper or lower gastrointestinal tract and patients with pre-existing
renal disease.
2.
Patients in whom aspirin and/or other NSAIDs have induced symptoms of
bronchospasm,
allergic rhinitis or urticaria, because the potential exists for cross
sensitivity.
3.
Patients with impaired renal function.
4.
Patients with severe hepatic impairment.
5.
Patients