image description
image description

RelaxHerb – SPC

Summary of Product Characteristics

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

A Guide to Herbal Medicines

Download our comprehensive guide to popular traditional herbal medicines and food supplements for minor ailments.

image description

Visit Herbfacts

Everything you need to know about herbal medicines and food supplements. image description

Nature's Way

Visit Nature’s Way - our sister-site for vitamins, minerals and food supplements. image description

Take a FREE health check

Try one of our quick health checkers.

image description

Email Sign Up

Receive email updates on product offers and natural health news.


image description