RelaxHerb Passionflower Tablets

Passion Flower Extract 425 mg

30 tablets

Traditionally used for:

• Stress
• Anxiety

RelaxHerb Passionflower Tablets. A traditional herbal medicinal product used for the relief of the symptoms associated with stress, such as mild anxiety, exclusively based on long-standing use as a traditional remedy. Always read the label.

RelaxHerb contains Passion Flower, a climbing shrub native to South America, which can grow as high as 9m and is widely cultivated throughout Europe. It produces wonderful showy flowers with white petals surrounded by a crown of pink or violet filaments and large stamens with orange coloured sacs.

A licensed herbal medicine means a safe, high quality product

RelaxHerb Passion Flower Tablets 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:

• RelaxHerb is a regulated herbal product and meets specific standards of safety and quality
• RelaxHerb 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. RelaxHerb’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 RelaxHerb 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 coated tablet is foiled blister packed to retain its freshness and maintain its potency.

Taking one tablet daily can help to relieve symptoms associated with stress, such as mild anxiety. If symptoms worsen or do not improve after 4 weeks you should consult a healthcare practitioner.

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Using RelaxHerb

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Passion flower. Each coated tablet of this product contains 425mg of extract (as dry extract) from Passion flower (Passiflora incarnata L.) (equivalent to 2125–2975mg of Passion flower).

RelaxHerb Passion Flower is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as mild anxiety based on traditional use only.

Before you take this product

DO NOT TAKE this product if you are:

• under 18 years of age
• pregnant or breast-feeding
• taking any other medicines for anxiety, or to help you sleep such as benzodiazepines
• allergic to any of the ingredients

Tell your doctor before taking this product if you have an intolerance to some sugars.

Taking this product with other medicines

Tell your doctor or pharmacist about any medicines you are taking including any bought without a prescription.

Driving and using machines

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

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

How to take this product

Adults and the elderly

Take 1 tablet daily if required. Swallow the tablet whole with a little liquid. Do not chew the tablet.

Do not exceed the stated dose.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified 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 qualified healthcare practitioner.

Possible side-effects

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

• nausea or feeling sick

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

Other side-effects

There has been one report of tachycardia (increased heart beat) and one report of hypersensitivity (vasculitis) in patients using Passion flower.

Tell your doctor or pharmacist if you notice any other side-effect not mentioned in this leaflet.

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 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.

Store in the original packaging.

Do not store the tablets in a place where the temperature goes above 30oC.

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.

Further information

Each coated tablet of this product contains 425mg of extract (as dry extract) from Passion flower (Passiflora incarnata L.) (equivalent to 2125-2975mg of Passion flower). The extraction solvent is ethanol 50% v/v.

This product also contains the following ingredients:

Tablet core: Maltodextrin, silica colloidal anhydrous, cellulose powdered, croscarmellose sodium, magnesium stearate, stearic acid, talc.

Coating: Sucrose, talc, calcium carbonate (E170), acacia, tragacanth, titanium dioxide (E171), liquid glucose spray dried, iron oxide hydrate (E172 = yellow iron oxide), hypromellose, Capol 600 T.S. containing: 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 coated tablet contains 187 mg of sucrose and 5 mg of glucose.

Each pack contains 14 or 30 coated tablets. 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 23056/0008

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