Atrosan Devil's Claw Tablets

The Medicines and Healthcare products  Regulatory Agency (MHRA) granted a Traditional Herbal Registration certificate  for the traditional herbal medicinal product Atrosan Devil’s Claw tablets (Traditional Herbal Registration number: THR 13668/0012). 

This product is available without  prescription.

The active ingredient of Atrosan Devil’s Claw tablets comes from the roots of the plant  Harpagophytum procumbens  DE CANDOLLE, also known as Devil’s claw. 

Devil’s claw is a traditional herbal medicine used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints.

Before you take this product

DO NOT TAKE this product if you:

• are pregnant or breastfeeding
• are allergic to Devil's claw or any of the ingredients in this product (see Product description below)
• have intolerance to lactose
• have an ulcer ( gastric and/or duodenal ulcer)
• are under 18 years of age

Dosage

Use one tablet twice daily immediately after food. The dose can be increased to two tablets twice daily if relief is not obtained after 3 to 5 days.

Side effects

Like all Devil’s Claw products, Atrosan may cause side effects, although not everybody gets them.

Minor side effects 
Digestive symptoms

• Stomach discomfort
• Feeling sick
• Digestive upsets such as sickness or diarrhoea

Other side effects 

• Rash
• Itching
• Headache
• Dizziness

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.

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

Product description

Each film-coated tablet contains 480 mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne.) (1.5-3.0:1). Extraction solvent: Ethanol 60% V/V.
Other ingredients found in Atrosan^® Devil’s Claw tablets are lactose, maize starch, microcrystalline cellulose, precipitated silica, colloidal silica and magnesium stearate (vegetable source). The tablet coating contains talc, titanium dioxide, macrogol and hypromellose.

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NiteHerb Tablets

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product NiteHerb Tablets (Traditional Herbal Registration number: THR 23056/0006).


The active ingredient of NiteHerb Tablets comes from the roots of the plant Valeriana 
officinalis L., also known as Valerian. 

Valerian is a traditional herbal medicine used for the temporary relief of sleep disturbances due to symptoms of mild anxiety.

Before you take this product

DO NOT TAKE this product if you are:

• pregnant or breastfeeding
• allergic to any of the ingredients (see Product description below)
• already taking a medicine which makes you drowsy
• under 18 years of age

Tell your doctor before taking this product if you have an intolerance to some sugars (see Product description below)

The effects of this product may be increased by alcohol. Excessive use of alcohol should therefore be avoided.

Dosage

Adults and the elderly

Take 1 to 2 tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets. As the effects of this product may not occur immediately, the tablets should be taken continuously for 2-4 weeks.
Do not exceed the stated dose.

Side effects

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

• abdominal cramps

• nausea

If these persist for more than a few days, or become troublesome, stop taking this product.

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

This product may cause drowsiness. If you are affected do not drive or operate machines.

After taking this product

You must speak to a healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if side-effects not mentioned in this leaflet occur.

Product description

Each coated tablet of this product contains 150mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 450- 900mg of Valerian root. Extraction solvent: ethanol 70%v|v.

Other ingredients: Liquid glucose, silica colloidal anhydrous, cellulose powdered, croscarmellose sodium, stearic acid, talc, sucrose, calcium carbonate (E170), acacia, tragacanth, white beeswax, carnauba wax, shellac.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each tablet contains 35mg of glucose and 136mg of sucrose.

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PremHerb Tablets

A traditional herbal medicine with the  Traditional Herbal Registration number: 23056/0002), is used for the relief of the symptoms associated with premenstrual syndrome, exclusively based on long-standing use as a traditional remedy.

PremHerb Film-coated Tablets are used for  the relief of premenstral symptoms. 

The tablets’ active ingredient comes from the fruit of the plant  Vitex agnus castus L., also known as the chaste tree.

Before you take this product

DO NOT TAKE this product if you are:

• lactose-intolerant (react badly to lactose or milk)

• pregnant or trying to become pregnant

• breastfeeding

• allergic to any of the ingredients (see Product description below)

• suffering from a pituitary disorder

• under 18 years of age

Tell your doctor before taking this product if you have: 

• an intolerance to some sugars
• had a pituitary disorder in the past

If you are taking a dopamine-receptor antagonist or agonist-type drug, there is a theoretical risk that this product may affect the way they work.

Dosage

Take 1 tablet daily.

Try to take the tablets at the same time each day, either in the morning or evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets. You can take the tablets with or without food. The maximum beneficial effect of this product may take up to 3 months to develop in some women.

Side-effects

Like all medicines this product can have side-effects. Any side-effects are usually mild and disappear in a few days. Side-effects that have been reported are listed below:

• nausea or feeling sick
• indigestion
• digestive upsets such as wind, bloating or diarrhoea
• headache

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

• allergic skin reactions itching and/or rash of the skin

Stop taking this product immediately if you experience any allergic skin reaction.

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

Product description 

Each film-coated tablet contains 4mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1) (equivalent to 28-52mg of Agnus castus). Extraction solvent: Ethanol 60% v|v.

Other ingredients:Tablet core: Liquid glucose, silica colloidal anhydrous, lactose monohydrate, magnesium stearate, maize starch, cellulose microcrystalline, sodium starch glycolate (type A).

Film-coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron (III)-oxide (E 172).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 124mg of lactose and 36mg of liquid glucose.

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MenoHerb Tablets

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product Menoherb® Film-coated Tablets (Traditional Herbal Registration number: THR 
23056/0003). 

This product is available without prescription.

The active ingredient of Menoherb® Film-coated Tablets comes from the root of the plant Cimicifuga racemosa, also known as black cohosh. 

Menoherb® Film-coated Tablets is a traditional herbal medicinal product used for  the relief of symptoms of the menopause, such as hot flushes, night sweats or temporary changes of mood.

Before you take this product

DO NOT TAKE this product if you:

• have ever had or are suffering from liver or kidney disease (e.g. hepatitis, jaundice or cirrhosis)
• have ever had or are suffering from an oestrogen dependent tumour
• are of childbearing potential and do not use contraception
• are lactose-intolerant (react badly to lactose or milk)
• are pregnant or breastfeeding
• are allergic to any of the ingredients (see Product description below)
• are under 18 years of age

Tell your doctor before taking this product if you:

> have a persistent history of menstrual disorders

> are currently taking a medicine containing oestrogen

Dosage

Take 1 tablet daily.

Tablets should be taken at the same time of day if possible (morning or evening). Swallow the tablet whole with some water or other liquid. Do not chew the tablets.

Do not exceed the stated dose.

Side effects

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

Uncommon side-effects (affecting fewer than 1 in 1000 people)

• digestive upsets such as indigestion or diarrhoea
• facial swelling
• allergic skin reactions such as nettle rash, itching of the skin

If these persist for more than a few days, or become troublesome, stop taking this product. These uncommon side-effects are often only temporary. Stop taking this product immediately if you experience any allergic skin reaction.

Other side effects

Black Cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice.

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

Product description

Each film-coated tablet contains 6.5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 29.25-55.25mg of Black Cohosh). Extraction solvent: Ethanol 60% v/v.

This product also contains the following ingredients:

Tablet core: Cellulose powdered, lactose monohydrate, silica colloidal anhydrous, magnesium stearate, maize starch, cellulose microcrystalline, sodium starch glycolate (type A).

Film-coating: hypromellose, macrogol 4000, titanium dioxide (E171).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 142mg of lactose.

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MigraHerb Capsules

Migraherb Capsules
The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product  MigraHerb Hard capsules (Traditional Herbal Registration number: THR 23056/0004). 

This product is available without prescription.

The active ingredient of MigraHerb Hard capsules comes from the aerial parts of the plant Tanacetum parthenium, also known as Feverfew. 

MigraHerb  Hard capsules is a traditional herbal medicinal product used for the prevention of migraine headaches.

Migraherb Capsules

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 or artichokes (see Product description below)
• 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.

Migraherb Capsules

Dosage

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.

Migraherb Capsules

Side effects

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.

After taking this product:

You must speak to a healthcare practitioner if your symptoms worsen, if they do not improve after 12 weeks, or if side-effects not mentioned in this leaflet occur.

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 healthcare professional before stopping treatment.

Migraherb Capsules

Product description

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

This product also contains the following ingredients:

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

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FlexiHerb Tablets

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product Flexiherb Film-coated Tablets (Traditional Herbal Registration number: THR 23056/0001). 

This product is available without prescription. 

The active ingredient of Flexiherb Film-coated Tablets comes from the roots of the plant Harpagophytum procumbens, also known as Devil’s claw. 

Flexiherb Film-coated Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints.

Before you take this product

DO NOT TAKE this product if you:
>  have a stomach ulcer or duodenal ulcer
> are lactose-intolerant (react badly to lactose or milk)
> are pregnant or breastfeeding
> are allergic to any of the ingredients (see Product description below)
> are under 18 years of age

Tell your doctor before taking this product if you have:

• an intolerance to some sugars 
• your joint pain is accompanied by swelling of the joint, redness or fever.

Dosage

Take 1 tablet twice daily – the dose can be increased to 2 tablets twice daily if you do not obtain relief after 3-5 days.

Take one dose in the morning and one dose in the evening. You can take the tablets with or without food. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

Side effects

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

Common side-effects (affecting approximately 1 in 20 people)

> nausea or feeling sick

> diarrhoea

> abdominal pain

> headache, dizziness

> mild allergic skin reactions, itching and/or rash of the skin

If these persist for more than a few days, or become troublesome, stop taking this product. These common side-effects are often only temporary.  Stop taking this product immediately if you experience any allergic skin reaction.

Devil’s Claw may make you feel dizzy. If you are affected do not drive or operate machines.

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

Product description

Each film-coated tablet contains 600mg of a dry aqueous extract of Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500mg of Devil’s Claw root)

This product also contains the following ingredients:

Powdered cellulose, lactose monohydrate, sodium starch glycolate (Type A), silica colloidal anhydrous, magnesium stearate, sucrose, titanium dioxide (E171), hypromellose, microcrystalline cellulose, stearic acid.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 170mg of lactose and 20mg of sucrose.

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Atrogel Arnica Gel

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product Atrogel Arnica Gel (Traditional Herbal Registration number: THR 13668/0009). 

This product is available without prescription.

The active ingredient of Atrogel Arnica Gel is an extract obtained from the fresh flower heads of the Arnica montana plant.  

Atrogel Arnica Gel is a traditional herbal medicinal product used for the symptomatic relief of muscular aches, pains and stiffness and sprains, bruises and swelling. 

Before you take this medicine

Don’t use Atrogel if:

•  you have broken or irritated skin,
• if you are allergic to arnica preparations or other members of the daisy (Asteraceae / Compositae) family or any of the other ingredients (see Product description below).

Dosage

Atrogel Arnica gel may be used to relieve pain and bruising in adults, children and the elderly. Apply 2 to 10 cm of the gel gently to the affected area. Use between 2 and 4 times daily for pain relief.

Atrogel Arnica gel may be used by those who are pregnant. 

Side effects

Like all arnica products used externally, Atrogel Arnica gel can cause side effects, although not everybody gets them. Minor side effects can occur when using Atrogel Arnica gel. These are likely to affect less than 1 in every 10 people and may take the form of skin reactions (itching, skin rash, dry skin, contact dermatitis).

Discontinue the use of arnica gel if you find these side effects are troubling you. If they persist, become serious or are worrying to you, or if you notice any side effects not listed in this leaflet, talk to a doctor, pharmacist or healthcare practitioner.

If Atrogel Arnica gel is swallowed by mistake contact your doctor, pharmacist or healthcare practitioner immediately.

Product description

1g of gel contains 500mg of arnica extract, equivalent (on average) to 160mg fresh arnica flowers. 

Other ingredients are ethanol, purified water, glycerol (derived from plants) and hypromellose (a thickening agent). 

The product is free from genetically modified ingredients.

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Traditional Herbal Medicines

List of Products Granted a Traditional Herbal Registration (THR)

Granted from October 2006 to 19 November 2012