MENAMIC MLabs mefenamic acid 250 mg capsule bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

mefenamic acid, Quantity: 250 mg

Dostupné z:

Micro Labs Pty Ltd

INN (Medzinárodný Name):

Mefenamic acid

Forma lieku:

Capsule, hard

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

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

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2017-07-07

Súhrn charakteristických

PR:CTDV5 1
AUSTRALIAN PRODUCT INFORMATION
MENAMIC MLABS (MEFENAMIC ACID) CAPSULES
1.
NAME OF THE MEDICINE
Mefenamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENAMIC 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 previously exp