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Migraine Relief

image descriptionMigraHerb Feverfew Migraine Relief Capsules

Feverfew herb 100mg

30 capsules

Traditionally used for:

  • Migraine headaches
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MigraHerb Feverfew Migraine Relief. A traditional herbal medicinal product used for the prevention of migraine headaches exclusively based upon long-standing use as a traditional remedy. MigraHerb should only be taken by patients who have been diagnosed with migraine by their doctor. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
Feverfew (Tanacetum parthenium L. Schultz Bip.)
Strength
100mg of Feverfew herb
Dose
One capsule daily

A licensed herbal medicine means a safe, high quality product

MigraHerb Migraine Relief Capsules have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • MigraHerb is a regulated herbal product and meets specific standards of safety and quality
  • MigraHerb is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. MigraHerb’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that MigraHerb has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade capsule is foiled blister packed to retain its freshness and maintain its potency.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe to see why we’re the leaders in traditional herbal medicine, worldwide.

MigraHerb contains Feverfew, a member of the daisy family and looks somewhat similar to camomile at first glance. It has a strong distinctive smell and is particularly disliked by bees. It grows wild in many parts of Europe and the British Isles.

About Feverfew

Feverfew is a herb with a long history of traditional use going back to the Middle Ages.

Visit Herbfacts.co.uk

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Feverfew herb. Each hard capsule of this product contains 100mg of dry Feverfew herb (Tanacetum parthenium) (L.) Schultz Bip.).

MigraHerb is a traditional herbal medicinal product used for the prevention of migraine headaches This usage is based on traditional use only.

Before you take this product

Patients who take this product for migraine should have been previously diagnosed by a doctor of this condition. If you experience changes in your symptoms (increase in attacks, worsening of pain, new symptoms), you should consult your doctor.

DO NOT TAKE this product if you:

  • are pregnant or breastfeeding
  • are allergic to any of the ingredients or to plants from the Asteraceae (Compositae) family such as daisies, marigolds, artichokes, chrysanthemums or ragweed (see Further Information)
  • are under 18 years of age

If you are already taking warfarin, clopidogrel, aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs, there is a theoretical risk that taking this product may increase the risk of bleeding.

Tell your doctor or pharmacist if you are taking any of these medicines or any other medicines, including any bought without a prescription.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after 2 months, or if side-effects not mentioned here occur.

How to take this product

Adults and the elderly

Take 1 capsule daily – try to take the capsule at the same time each day. Swallow the capsules whole with some water or other liquid. Do not chew the capsules. You can take the capsules with or without food. The maximum beneficial effect of this product may take several months to develop for some people.
Do not exceed the stated dose.

Long-term Feverfew users who stop treatment suddenly may experience withdrawal symptoms, including rebound headaches, anxiety, insomnia, muscle stiffness and joint pain. Patients who are on long-term therapy with this product should seek advice from their doctor, pharmacist or qualified healthcare professional before stopping treatment.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or healthcare practitioner and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner.

Possible side-effects

Like all medicines, this product can have side-effects. These are listed below.

Common side-effects (affecting up to 1 in 20 people)

  • abdominal bloating
  • indigestion
  • heartburn
  • digestive upsets such as wind, bloating, nausea, constipation or diarrhoea

If these side-effects persist for more than a few days, or become troublesome, stop taking this product. These common side-effects are often only temporary.

Uncommon side-effects (affecting fewer than 1 in 300 people)

  • mouth inflammation or mouth ulcers
  • mild allergic skin reactions itching and/or rash of the skin

Stop taking this product immediately if you experience any of these side-effects.

Other side-effects

These include increased heart rate, raised blood pressure, eosinophilia, abnormal liver function tests, arthritis, renal failure and Raynaud’s phenomenon.

Tell your doctor or pharmacist, if you notice any other side-effect.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

 

How to store this product

Do not use your capsules after the expiry date. Return any out-of-date capsules to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the capsules in a cool dry place below 25°C. Store in the original packaging.

Keep the capsules out of the reach and sight of children.

Keep your capsules in the blister pack until it is time to take them.

Product description

Each hard capsule contains 100 mg of dry Feverfew herb (Tanacetum parthenium) (L.) Schultz Bip.).

This product also contains the following ingredients:

Dextrin white, silica colloidal anhydrous, talc, magnesium stearate, hypromellose, titanium dioxide E171.

Each pack contains 30, 60 or 90 hard capsules. Not all pack sizes may be marketed.

Registration holder for this product

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1FX

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional herbal registration number: THR 23056/0004

If you would like further information about this product, please contact:

Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX
Telephone: 01628 401980
Email: info@schwabepharma.co.uk

Leaflet last revised 12/2015.

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

Each hard capsule contains 100mg Feverfew herb (Tanacetum parthenium (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 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 than 18 years old is not recommended. (See section 4.4 ‘Special warnings and precautions for use’)

4.3 Contraindications

Hypersensitivity to Feverfew, 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 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 aspirin, anticoagulants such as warfarin or heparin, 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. 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 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

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 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

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

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

THR 23056/0004

9 Date of the first authorisation/renewal of the authorisation

30/06/2016

10 Date of revision of the text

30/06/2016

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