Feminax Period Pain Capsules

1. Name Of The Medicinal Product

Feminax Period Pain Capsules

2. Qualitative And Quantitative Composition

Paracetamol 500.0 mg

Codeine Phosphate 8.0 mg

For excipients, see section 6.1.

3. Pharmaceutical Form

Capsule hard

Opaque white hard gelatine capsule with “Feminax” in red along cap and body.

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated for the treatment of period pain, and associated menstrual pain such as headache, and muscular aches and pains.

4.2 Posology And Method Of Administration

For oral administration.

Adults:

1 - 2 capsules. If necessary, the dose may be repeated every 4 - 6 hours with a maximum of 8 capsules in 24 hours.

Elderly

No current evidence for alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.

Children

Children under 12 years, not recommended.

Do not take for more than 3 days continuously without medical review.

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents of Feminax Period Pain Capsules.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

In cases of renal insufficiency the rate of excretion of codeine and paracetamol metabolites may be reduced, and dosage schedules may need to be revised accordingly.

Do not exceed the stated dose.

If symptoms persist, consult your doctor.

Contains paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Keep out of the reach and sight of children.

The leaflet will state in a prominent position in the 'before taking' section:

• If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or health care professional.

• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

• Taking a painkiller for headaches too often or for too long can make them worse.

The label will state (To be displayed prominently on outer pack – not boxed):

• If you need to use this medicine for more than three days at a time, see your doctor or pharmacist. Taking codeine regularly for a long time can lead to addiction.

• Taking a painkiller for headaches too often or for too long can make them worse.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol should be given with care to patients taking other drugs that affect the liver.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone. Concurrent use need not be avoided.

The absorption of paracetamol may possibly be reduced if colestyramine is given at the same time, but the reduction in absorption is small if given an hour later.

The anticoagulatory effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

There is inadequate evidence of safety of codeine in pregnancy. Codeine has been used for many years without apparent ill-consequences, and animal studies have not shown any hazard.

The use of Feminax Period Pain Capsules in pregnancy is therefore acceptable if there is no safer alternative. Use during lactation is also acceptable.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Codeine may sometimes cause constipation.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient:

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts.

Or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Paracetamol, combinations excluding psycholeptics.

ATC code: N02BE51.

Paracetamol is well known for its analgesic and antipyretic actions. Codeine phosphate is an analgesic with uses similar to those of morphine, but only with mild sedative effects, and is much less liable than morphine to produce dependence or toxic effects.

5.2 Pharmacokinetic Properties

Codeine phosphate is well absorbed after oral administration, producing peak plasma concentrations in about one hour. The plasma half-life is between 3 and 4 hours, excretion being mainly in the urine. Paracetamol is also readily absorbed after oral administration, with peak plasma concentrations occurring between 30 minutes and 2 hours after ingestion. The plasma half life varies between 1 and 4 hours. Excretion is mainly via the urine.

5.3 Preclinical Safety Data

There are no additional data of relevance to the prescriber which are not included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Capsules contents

Pregelatinised Maize Starch

Colloidal Silicon Dioxide

Magnesium Stearate (E 572)

Capsule shell

Titanium dioxide (E 571)

Gelatin

Printing ink

Shellac (E 904)

Red Iron Oxide (E172)

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Blisters of white 250 μm PVC/40 gsm PVDC base with 30 μm hard temper aluminium foil lidding.

Pack sizes: 2, 10, 20, 24, 30.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative Data

7. Marketing Authorisation Holder

Bayer Plc

T/A Bayer Plc, Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

8. Marketing Authorisation Number(S)

PL 0010/0373

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 28 October 2005

10. Date Of Revision Of The Text

February 2008