Consumer medicine information

Femin 250 mg Capsules

Mefenamic acid

BRAND INFORMATION

Brand name

Femin

Active ingredient

Mefenamic acid

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Femin 250 mg Capsules.

1. Why am I using FEMIN?


FEMIN contains the active ingredient mefenamic acid. FEMIN is used to relieve the symptoms of period pain and treat heavy periods. It also provides short term relief of pain in conditions such as muscle and joint injuries such as sprains, strains and tendonitis; dental pain.
For more information, see Section 1. Why am I using FEMIN? in the full CMI.

2. What should I know before I use FEMIN?


Do not use if you have ever had an allergic reaction to mefenamic acid, aspirin, any other NSAID, or any of the ingredients listed at the end of the CMI. Do NOT also use if you have any of the conditions listed in Section 2. What should I know before I use FEMIN? in the full 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 FEMIN? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with FEMIN 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 FEMIN?

  • Swallow FEMIN capsules whole with a full glass of water.
  • Do not chew the capsules.
  • Take FEMIN with or after food. This may help reduce the possibility of stomach upset.

More instructions can be found in Section 4. How do I use FEMIN? in the full CMI.

5. What should I know while using FEMIN?

Things you should do
  • Remind any doctor or dentist you visit that you are using FEMIN.
  • Call your doctor immediately if you become pregnant while taking FEMIN.
Things you should not do
  • Do not give FEMIN to anyone else, even if they have the same condition as you.
  • Do not take FEMIN to treat any other complaints unless your doctor tells you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how FEMIN affects you. FEMIN may cause dizziness or light-headedness in some people. If this occurs do not drive.
Drinking alcohol
  • If you drink alcohol, it may increase your risk of developing gastrointestinal complications.
Looking after your medicine
  • Store it in a cool dry place away from moisture, heat or sunlight, below 25°C.

For more information, see Section 5. What should I know while using FEMIN? in the full CMI.

6. Are there any side effects?


Common side effects may include stomach upset, diarrhoea or constipation, vomiting or light headedness. More serious side effects may include severe allergic reaction, black stools or vomit that looks like coffee grounds, bleeding or bruising more easily than usual, swollen ankles, bleeding from the back passage or a stiff neck.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Femin

Active ingredient

Mefenamic acid

Schedule

S4

 

1 Name of Medicine

Mefenamic acid.

2 Qualitative and Quantitative Composition

Femin capsules contain the active ingredient mefenamic acid 250 mg/capsule.
Excipients with known effect. 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

4.9 Overdose

Symptoms. Symptoms of overdosage are related to the amount of drug ingested and range from gastrointestinal discomfort and diarrhoea to seizures, acute renal failure, confusional state, vertigo, hallucination, coma and death. Plasma levels of up to 210 microgram/mL (therapeutic range 1 to 10 microgram/mL) have been reported resulting in repeated generalised convulsions, but are not generally useful for evaluation and management of overdosage.
Treatment. There is no specific antidote for mefenamic acid overdose. Treatment is symptomatic and supportive, including fluid replacement and IV access especially to patients who are dehydrated or unable to ingest adequate fluids. Avoiding intravascular fluid depletion will help prevent development of renal failure.
In cases of severe toxicity, activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube ensuring that the airway is protected.
In clinically severe overdoses, full blood count, electrolytes, glucose, renal function, liver function tests, arterial blood gases and coagulation studies should be monitored for abnormalities.
Because mefenamic acid and its metabolites are firmly bound to plasma proteins, haemodialysis, haemoperfusion and peritoneal dialysis may be of little value.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Mefenamic acid is one of the fenamate series of non-steroidal anti-inflammatory agents. It is a white or almost white, crystalline powder. The drug soluble in solutions of alkali hydroxides; sparingly soluble in chloroform slightly soluble in alcohol and in methanol, practically insoluble in water.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMEFACI.gif Chemical name: N-(2,3, xylyl)-anthranilic acid.
Molecular formula: C15H15NO2.
Molecular weight: 241.3.
CAS number. 61-68-7.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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