image description
image description

Relieves stress and mild anxiety

image descriptionRelaxHerb Passionflower Tablets

Passion Flower Extract 425 mg

30 tablets

Traditionally used for:

  • Stress
  • Anxiety
image description
SPECIAL OFFER - UP TO 23% OFF!

Single pack £7.99 (RRP: £9.49) - Save 16%
Triple pack £22.00 (RRP: £28.47) - Save 23%

Free UK delivery over £25
     FREE UK DELIVERY OVER £25
Delivery £3.99 per order or FREE DELIVERY on all UK orders £25 or more.
  • image description
  • image description
  • image description
  • image description
  • image description
  • image description
  • image description

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.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
Passion Flower (Passiflora incarnata L.)
Strength
425mg of dried extract (equivalent to 2125-2975mg of Passion Flower)
Dose
One tablet daily

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.

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 for more information about our company.

About Passion Flower

Passionflower is widely used in remedies for anxiety and nervous tension. Native to South America, this climbing shrub produces wonderful showy flowers.

Visit Herbfacts.co.uk

About stress and mild anxiety

Almost everyone experiences stress and mild anxiety at some point and unfortunately it can sometimes prevent you from enjoying life to the full.

Take a health check

Check your stress levels using this simple questionnaire and get some useful tips on what might help.

What this product is and what is it 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 aqueous ethanolic 50% v/v) 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.This usage is based on traditional use only.

Before you take this product

DO NOT TAKE this product if you are:

  • you are under 18 years of age
  • you are pregnant or breastfeeding
  • you are allergic to any of the ingredients (listed in product description below)

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

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 tablets 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 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.

  • 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 30°C.

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 1PD

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional herbal registration number: THR 23056/0008

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 07/2016

1 Name of the medicinal product

  • RelaxHerb Passion Flower Tablets
  • Higher Nature Passionflower RelaxAid coated tablets
  • Healthspan Passion Flower RelaxAid Tablets

2 Qualitative and quantitative composition

1 coated tablet contains 425mg of extract (as dry extract) from Passion flower (Passiflora incarnata L.)(equivalent to 2125 – 2975 mg of Passion flower). Extraction solvent: Ethanol 50% v/w Each coated tablet contains 187 mg of sucrose and 5 mg of glucose. For full list of excipients, see section 6.1

3 Pharmaceutical form

Coated tablet. Light-yellow, round, biconvex, smooth glossy surface without ruptures.

4 Clinical particulars

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety based on traditional use only

4.2 Posology and method of administration

For oral short term use only. For adults and the elderly, take 1 tablet daily if required. Tablets should be swallowed whole with a little liquid. The tablets should not be chewed. The use in children or adolescents less than 18 years old is not recommended (See ‘Section 4.4 Special Warnings and Precautions for Use’). If symptoms worsen, or do not improve after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Passion flower or to any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose. If the condition worsens, or if symptoms persist for more than four weeks, a doctor or qualified healthcare practitioner should be consulted.. This product contains glucose. 1 coated tablet contains max. 5mg of glucose. This product contains sucrose. 1 coated tablet contains max. 187mg of sucrose or 0,29 carbohydrate units. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 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

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May cause drowsiness and impair the ability to drive and operate machines. Affected patients should not drive or operate machines.

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. The frequency is not known. 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

No case of overdose has been reported. Symptomatic and supportive measures should be taken as appropriate.

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

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. Adequate tests on reproductive toxicity have not been performed. Tests on carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Extract excipients:

  • Maltodextrin
  • Silica, colloidal anhydrous

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:

  • Beeswax, white
  • Carnauba wax
  • Shellac

6.2 Incompatibilities

Not applicable

6.3 Shelf life

5 years

6.4 Special precautions for storage

Do not store above 30°C. Store in the original packaging

6.5 Nature and contents of container

Original packages contain 14 (RelaxHerb Passion Flower tablets only) or 30 (RelaxHerb Passion Flower tablets, Higher Nature Passion Flower Relax Aid coated tablets, Holland & Barrett Passion Flower Stress Relief tablets) coated tablets. The tablets 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 Marketing authorisation holder

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

8 Marketing authorisation number(s)

THR 23056/0008

9 Date of first authorisation/renewal of the authorisation

10/08/2016

10 Date of revision of the text

10/08/2016

image description