DIAFEVERFEW HARD CAPSULES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

DiaFeverfew Hard capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 hard capsule contains:

100 mg Feverfew herb (Tanacetum parthenium).

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 use only.

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.

If symptoms worsen, or persist longer than 2 months, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents less than18 years old is not recommended. (See section 4.4 ‘Special warnings and precautions for use’)

4.3 Contraindications

Hypersensitivity to the active ingredient , or 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.

If symptoms worsen, or persist longer than 2 months, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents less than 18 years old is not recommended due to lack of adequate data.

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 anticoagulants such as warfarin, acenocoumarol, phenindione, apixaban, edoxaban, dabigatran, rivaroxaban or parenteral anticoagulants such as heparin, dalteparin, enoxaparin and tinzaparin; anti-platelet drugs such as clopidogrel; and non-steroidal anti-inflammatory 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. However, traditional experience suggests that Feverfew may stimulate menstrual flow and induce abortion.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

Studies on the effect 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 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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The preclinical toxicology data available are limited. There are no repeat-dose toxicity data available.

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102 and TA 1535) mutation assays with or without metabolic activation.

Adequate tests on reproductive toxicity have not been performed. Tests on 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 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.

6.1

Dextrin, white

Silica, colloidal anhydrous

Talc

Magnesium stearate

Titanium dioxide E171

Hypromellose

6.2

Not applicable

6.3

Shelf life

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original packaging.

6.5 Nature and contents of container

Original packages containing 30, 60, 90 or 100 hard capsules

DiaFeverfew capsules are packed in PVC/ PVDC aluminium blisters and inserted into a carton.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road, Marlow SL7 1FX

8 MARKETING AUTHORISATION NUMBER(S)

THR 23056/0018