MEFAC 500 mg Film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Mefenamic acid

Dostępny od:

Rowa Pharmaceuticals Limited

Kod ATC:

M01AG; M01AG01

INN (International Nazwa):

Mefenamic acid

Dawkowanie:

500 mg milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Fenamates; mefenamic acid

Status autoryzacji:

Marketed

Data autoryzacji:

1988-04-28

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mefac 500 mg Film‐coated tablets
mefenamic acid
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.
‐ If you have any further questions, ask your doctor or pharmacist.
‐ 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.
‐ If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mefac is and what it is used for
2. What you need to know before you take Mefac
3. How to take Mefac
4. Possible side effects
5. How to store Mefac
6. Contents of the pack and other information
1. WHAT MEFAC IS AND WHAT IT IS USED FOR
Mefac contains an active substance called mefenamic acid. This belongs
to the group of medicines
called NSAIDs (non‐steroidal anti‐inflammatory drugs). Mefac is
used for the relief of mild to
moderate pain and inflammation associated with rheumatic, muscular or
arthritic disorders, trauma,
headache, dental pain, pain following surgery or childbirth. Mefac is
also used for relief of period
pains, management of excessively heavy periods and symptoms of
premenstrual syndrome (PMS).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEFAC
DO NOT TAKE MEFAC
• if you are allergic to mefenamic acid or any of the other
ingredients of this medicine (listed in
section 6)
• if you are allergic to aspirin (acetylsalicylic acid), ibuprofen
or other NSAIDs
• if you are pregnant or breastfeeding
• if you suffer from kidney or liver impairment or heart failure
• if you are seeking pain relief after heart bypass surgery
• if you are taking another medicine known as a
cyclooxygenase‐2‐inhibitor
• if you have ever had a peptic ulceration (ulcer in the stomach or
duodenum) or bleeding in the
digestive tract or inflammatory bowe

Charakterystyka produktu

Health Products Regulatory Authority
22 January 2024
CRN00F0QW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MEFAC 500 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mefenamic acid 500 mg.
Excipients(s) with known effect:
Also contains Sunset Yellow (E110), approximately 0.0625 per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
Yellow oval film coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mefac is indicated in adults only;
- as an anti-inflammatory analgesic for symptomatic relief of mild to
moderate pain associated with rheumatic muscular or
arthritic disorders (including rheumatoid arthritis and
osteoarthritis), trauma, headache, dental pain, post-operative or
post-partum states;
- in the management of dysfunctional menorrhagia;
- primary dysmenorrhoea;
- premenstrual syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults Only_: The usual total daily dose is 1500mg in divided doses.
_Elderly patients_: NSAIDs should be used with particular caution in
elderly patients who are more prone to adverse events,
especially with long-term use. Therefore, the risks versus the
benefits of chronic therapy in the elderly should be carefully
considered. The lowest dose compatible with adequate safe clinical
control should be employed. (See also Section 4.4)
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
_Paediatric population_: Not recommended for children under 12 years
of age.
Do not exceed the stated dose.
METHOD OF ADMINISTRATION
Mefac should be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4)
Health Products Regulatory Authority
22 January 2024
CRN00F0QW
Page 2 of 9
4.3 CONTRAINDICATIONS
- Use in patients with intestinal ulceration or inflammation and in
patients w