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For relief of Premenstrual Syndrome symptoms

image descriptionPremHerb PMS Relief

Agnus castus fruit extract 4mg

30 tablets

Traditionally used for:

  • Premenstrual Syndrome symptoms, including
  • Irritability
  • Mood swings
  • Breast tenderness
  • Bloating
  • Menstrual cramps
3.67 out of 5 based on 3 customer ratings
Rated 3.67 stars See reviews
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A traditional herbal medicinal product used for the relief of the symptoms associated with premenstrual syndrome, exclusively based on long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal Active
Agnus Castus (Vitex agnus castus L.)
Strength
4mg of dried fruit extract (equivalent to 28-52mg of Agnus Castus)
Dose
One tablet daily

‘PMT DROVE ME NUTS’

You may have read recently in the Daily Mail, Good Health section, about the benefits of agnus castus- now experience all of the benefits in these easy to swallow tablets. Now available direct from the manufacturer, Schwabe Pharma UK, these unique tablets contain 4mg of agnus castus extract (7-13:1), equivalent to 28-52mg of pure agnus castus.

A licensed herbal medicine means a safe, high quality product

PremHerb PMS Relief has 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:

  • PremHerb is a regulated herbal product and meets specific standards of safety and quality
  • PremHerb 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. PremHerb’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 PremHerb has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Try it for yourself

PremHerb is a traditional herbal medicinal product used for the relief of the symptoms associated with premenstrual syndrome, exclusively based on long-standing use as a traditional remedy. PremHerb is one of the few natural remedies for PMS that contains agnus castus; each pharmaceutical grade coated tablet is foiled blister packed to retain its freshness and maintain its potency.

PremHerb contains 4mg of agnus castus extract, a large shrub native to southern Europe. The plant produces small, fragment white of lilac coloured flowers in the height of the summer and after pollination develops dark reddish-brown fruits the size of peppercorns.

Further Information

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.

Also available from…

Holland & Barrett, Ocado and other leading independent pharmacies and health food stores nationwide.

About Agnus Castus

Agnus Castus has been used since ancient times as a female remedy.

Visit Vitfacts.co.uk

About Premenstrual Syndrome

PMS effects women between their late 20s and early 40s and symptoms can vary greatly.

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Agnus castus fruit. 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.

PremHerb PMS Relief is a traditional herbal medicinal product used to help relieve symptoms  of premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps. This usage is based on traditional use only.

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 (see product description below)
  • 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.

How to take this product

For women experiencing premenstrual symptoms

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.

Do not exceed the stated dose.

Do not give to children or adolescents under 18 years old.

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. A small overdose (up to 8 tablets) may not cause any symptoms. In the event of a large overdose (more than 8 tablets) advice should be sought from a doctor.

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.

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:

Side-effects

  • 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 thisproduct. 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.

Other side-effects

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

You can help to make medicines safer by reporting any side-effects tothe Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am–2pm Monday –Friday).

How to store this product

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

This medicinal product does not require any special storage conditions.

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

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

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.

This product also contains the following 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.

Each pack contains 30 film-coated tablets.

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 23056/0002

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 401 980
Email: info@schwabepharma.co.uk

This leaflet was revised 01/2013.

1 Name of the medicinal product

  • PremHerb PMS Relief Tablets
  • Higher Nature Agnus Castus PMS Relief film-coated tablets
  • Healthspan Agnus Castus Premenstrual Relief Tablets
  • Boots PMS Relief Agnus Castus Tablets

2 Qualitative and quantitative composition

Each film-coated tablet contains: 4.0 mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1)(equivalent to 28-52 mg of Agnus castus). Extraction solvent: Ethanol 60% m/m.

Excipients: 1 film-coated tablet contains 124 mg of lactose monohydrate and 36 mg of liquid glucose.

For full list of excipients, see section 6.1

3 Pharmaceutical form

Film-coated tablet. Salmon pink, round, convex, scored tablet.

4 Clinical particulars

4.1 Therapeutic indications

A traditional herbal medicinal product used to help relieve symptoms associated with premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

For women experiencing premenstrual symptoms, take 1 tablet daily. Tablets should be taken at the same time of day if possible (morning or evening) and swallowed whole with plenty of liquid. Some individuals may need to take PremHerb for up to 3 months for maximum benefit to occur.

Women suffering from a current pituitary disorder should not take PremHerb.

Not for children and adolescents under 18 years.

4.3 Contraindications

Hypersensitivity to dry extract of Agnus castus fruit, or any of the other ingredients in the drug.

This product is not recommended for use in children, adolescents under 18 years or for patients with a current pituitary disorder.

4.4 Special warnings and precautions for use

Agnus castus is thought to act on the pituitary-hypothalamic axis and therefore patients with a history of a pituitary disorder should consult with a doctor before using this product.

This product contains glucose:

1 film-coated tablet contains max. 36 mg glucose

This product contains lactose:

1 film-coated tablet contains max. 124 mg lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

There are no published data available on drug interactions with extracts of Agnus castus.

Animal experiments have shown that that the drug has a dopaminergic effect and so, theoretically, there could be a reduction in the effectiveness of dopamine-receptor antagonists, and/or a potentiation of dopamine-receptor agonists.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established, therefore it should be avoided during pregnancy or while breastfeeding. Additionally, because of the potential for the product to have hormone-like actions the product should also be avoided by women who are trying to become pregnant.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Mild and reversible, transient side-effects are associated with Agnus castus use. Postmarketing surveillance studies suggest that the approximate incidence of adverse effects is between 1.9 – 5 %. Most frequently these are:

  • Nausea
  • Stomach disturbances
  • Headache
  • Diarrhoea
  • Allergic skin reactions.

If there are signs of an allergic reaction the product should be withdrawn.

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

4.9 Overdose

In the event of an overdose, patients are advised to contact a doctor, pharmacist or healthcare professional. A small overdose (up to 8 tablets) may not cause any symptoms. In the event of a large overdose (more than 8 tablets), advice should be sought from a doctor.

Management of an overdose should include appropriate symptomatic and supportive treatment as warranted by the clinical situation.

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 non-clinical toxicology data available are limited. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Tablet core:

  • Liquid glucose (dry substance)
  • 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 E171
  • Iron(III)-oxide E172 (==red iron oxide)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life is 3 years

6.4 Special precautions for storage

This product does not require any special storage instructions

6.5 Nature and contents of container

Original packages containing 30 (Premherb PMS Relief tablets, Higher Nature Agnus Castus PMS Relief Film-coated Tablets, Boots PMS Relief Agnus Castus Tablets only) or 60 (Healthspan Agnus Castus Premenstrual Relief Tablets only) film-coated tablets.

The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton.

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 Registration number

THR 23056/0002

9 Date of first registration

16th October 2007

10 Date of revision of text

8th March 2013

3 reviews for PremHerb PMS Relief

  1. 4 out of 5

    :

    I am lucky in the fact that I don’t suffer mood swings but have always suffered such immense breast pain for 3 out of 4 weeks each month.

    The sales person in Holland barret – Sale -Cheshire was so honest and extremely knowledgeable. He told me because these tablets were herbal they would probably stop working after 4 months, he was absolutely right but unfortunately they didn’t last as long with me.

    I started the tablets in November 2014 having experienced several months prior to this of breast pain that seemed to be getting worse and worse.

    I could not believe the difference I had a completely pain free Xmas and New year and it lasted until mid January. Unfortunately all my pain is back but at the time he did recommend alternatives that might last a bit longer but may not work as well.

    I am willing to have whatever break it takes for this amazing product to be effective on me again even if it only lasts 2 months at a time.

    Premherb is amazing I would just give anything for it to last longer than 2.5 months. I was fully warned about the fact that the effects would wear off, still don’t fully know why that is the case.

    I would have given this product 10 /10 if it had lasted longer before becoming ineffective. Maybe it would be different for different people and different symptoms, I took it purely for breast tenderness.

  2. 3 out of 5

    :

    Have been taking PremHerb PMS Relief for 3 months my husband says he has noticed a difference with my mood swings and irratibility. I feel a little better.

  3. 4 out of 5

    :

    I no longer behave like a “bunny boiler” once every month thanks to PremHerb.

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