1 NAME OF THE MEDICINAL PRODUCT

MigraHerb Migraine Relief Capsules

Higher Nature Feverfew Migraine Relief Hard Capsules

Healthspan Feverfew Migraine Relief Capsules

Boots Migraine Relief Feverfew Capsules

Holland & Barrett Feverfew Migraine Relief Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 hard capsule contains

100mg Feverfew herb (Tanacetumparthenium (L.) Schultz Bip.)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Hard white capsule

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the prevention of migraine headaches based on traditional use only.

4.2 Posology and method of administration

For oral short term use only. The patient should consult a doctor if symptoms worsen or do not improve after 12 weeks.

For adults and the elderly, take one capsule daily. Capsules should be swallowed whole with water or a little liquid. The capsules should not be chewed.

This product should be taken continuously for three months in order to achieve maximum benefit.

This product is not indicated for use in patients less than 18 years old.

Hypersensitivity to any of the ingredients or to Feverfew, chrysanthemums, daisies, marigolds, or other members of the Asteraceae (Compositae) family, including ragweed.

Due to lack of data this product is contraindicated in children and adolescents under 18 years.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Patients who take Feverfew for migraine should have been previously diagnosed by a doctor of this condition. If the patient experiences changes in the migraines (i.e. increase in attacks, worsening of pain, new symptoms) they should be instructed to consult their doctor.

Long-term Feverfew users who stop treatment suddenly may experience withdrawal symptoms, including rebound headaches, anxiety, difficulty sleeping, muscle stiffness, and joint pain. Patients who are on long term therapy with

Feverfew should be instructed to seek professional advice before stopping treatment.

Evidence from a limited number of in vitro studies suggests that feverfew may inhibit platelet function, the relevance of this in humans is unknown.

4.5 Interaction with other medicinal products and other forms of interaction

Drugs that affect coagulation and bleeding:

Feverfew theoretically may increase the risk of bleeding when taken with drugs that affect coagulation and bleeding. Some examples include aspirin, anticoagulants such as warfarin or heparin, anti-platelet drugs such as clopidogrel, and non-steroidal antiinflammatory drugs such as aspirin, ibuprofen and naproxen.

4.6 Fertility, pregnancy and lactation

There are no adequate data of the use of Feverfew in pregnancy and lactation. However, traditional experience suggests that Feverfew may stimulate menstrual flow and induce abortion. As a general precaution, use is not recommended in pregnancy.

It is not known whether Feverfew is excreted in the milk or not. As a general precaution use is not recommended during lactation.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No data on the effects on the ability to drive and use machines are available.

4.8 Undesirable effects

The review of the adverse drug reactions reported in clinical trials indicate that most side-effects are mild and reversible.

Mouth inflammation or ulcers, including swelling of the lips, tongue irritation, bleeding of the gums, and loss of taste have been reported, usually after direct contact of the mouth with the leaves, although some people report burning after swallowing a capsule containing dried leaf.

Photosensitivity (sensitivity to sunlight or sunlamps) has been reported with other herbs in the Asteraceae (Compositae) plant family (see Section 4.4).

Indigestion, nausea, flatulence, constipation, diarrhoea, abdominal bloating, and heartburn have been reported rarely.

Feverfew can also cause allergic rashes.

Increased heart rate in some patients has been reported in one small study.

Other side effects that have been reported spontaneously are eosinophilia, abnormal liver function tests, arthritis, renal failure, Raynaud’s phenomenon and hypertension. These were spontaneously generated adverse drug reactions during post-marketing surveillance and the causal relation to Feverfew cannot be established.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

There are well documented cases of overdose with Feverfew. In cases of overdose the treatment should be supportive. Since there is a theoretical increased risk of bleeding, patients should be closely monitored for signs of bleeding

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

The preclinical toxicology data available are limited. There are no repeat-dose toxicity data available. Appropriate tests on genotoxicity and carcinogenicity have not been performed.

In two small teratogenicity studies, pregnant rats were administered very high doses of Feverfew (0.86 g/kg/day) as an ethanolic extract; this dose represents the highest possible for which ethanol remained below the the teratogenic threshold. Results showed that extracts of Feverfew induced both maternal and embryotoxic effects of reduced foetal weights with Feverfew administered from day 8 to 15 of gestation, and enlarged placentae on administration of Feverfew from day 1 to 8, or day 8 to 15. However, the percentages of implantation loss and litter size were not significantly different from controls.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dextrin, white

Silica, colloidal anhydrous Talc

Magnesium stearate Titanium dioxide E 171

Hypromellose

6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf life is 3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Original packages contain 30, 60 or 90 Migraherb Migraine Relief Capsules. Not all pack sizes may be marketed. Also original packages containing 30 ( Higher Nature Feverfew Migraine Relief Hard Capsules, Holland & Barrett Feverfew Migraine Relief Capsules and Boots Migraine Relief Feverfew Capsules only) and 60 (Healthspan Feverfew Migraine Relief Capsules and Holland & Barrett Feverfew Migraine Relief Capsules) hard capsules.

The capsules are packed in PVC/ PVDC- aluminium blisters and inserted into a carton together with the package leaflet.

6.6 Special precautions for disposal

No special requirements

7. REGISTRATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8 MARKETING AUTHORISATION NUMBER(S)

THR 23056/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

03/04/2007

10 DATE OF REVISION OF THE TEXT

26/03/2014