SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

MigraEeze Feverfew Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 100mg Feverfew herb (Tanacetum

parthenium (L.) Schulz Bip.)

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Round, olive film-coated tablet

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.

For adults and the elderly, take one tablet daily. Tablets should be swallowed whole with water or a little liquid. The tablets should not be chewed.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’)

Duration of use:

If symptoms worsen, or persist longer than 2 months during the use of the product, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Feverfew, other members of the Asteraceae (Compositae) family or to any of the excipients.

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.

The use in children or adolescents under 18 years of age is not recommended due to lack of adequate data.

Each tablet contains dextrose (glucose) 0.7mg (see section 6.1); Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine.

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

Safety during pregnancy and lactation has not been established. In the absence

of sufficient data, the use during pregnancy and lactation is not recommended. Traditional experience suggests that Feverfew may stimulate menstrual flow and induce abortion.

Studies on the effects on fertility have not been carried out.

4.7    Effects on ability to drive and use machines

Studies on the ability to drive and use machines have not been performed.

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 tablet containing dried leaf.

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

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 postmarketing surveillance and the causal relation to Feverfew cannot be established.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

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

A single study with oral administration of feverfew in pregnant rats showed maternal toxicity and embryotoxicity. However, adequate studies on reproductive toxicity have not been performed.

Tests on genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Microcrystalline cellulose

Silica, colloidal hydrated Dicalcium phosphate anhydrous Magnesium stearate Tablet coating:

Croscarmellose sodium Dextrin

Dextrose monohydrate

Lecithin

Sodium citrate dihydrate

6.2    Incompatibilities

Not applicable

6.3    Shelf life

2 years

6.4    Special precautions for storage

There are no special precautions for storage. Store in original packaging.

6.5    Nature and contents of container

Pack sizes of: 30, 60, 90 or 120 film-coated tablets.

Not all pack sizes may be marketed.

MigraEeze Feverfew tablets are packed in: Ph Eur Type III glass bottles, with a polypropylene closure and induction heat seal, packed in outer cartons.

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Natures Aid Ltd

St Georges Park Kirkham

Preston PR4 2DQ

8    MARKETING AUTHORISATION NUMBER(S)

THR 33336/0010

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/09/2015

10    DATE OF REVISION OF THE TEXT

22/09/2015