Informations for option: Diarelax Tablets, show other option

Select option:

1. Diarelax Tablets
2. Diarelax Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

DiaRelax Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

112.5 mg of extract (as dry extract) from Melissa leaf (Melissa officinalis L.) (4-6:1) (equivalent to 450-675 mg of Melissa leaf).

Extraction solvent: Methanol 30% v/v and

125 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3-6:1) (equivalent to 375 - 750 mg of Valerian root).

Extraction solvent: Ethanol 70% v/v, and

80 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5-7:1) (equivalent to 400-560 mg of Passion flower herb).

Extraction solvent: Ethanol 50% v/v

Excipients: each coated tablet also contains:

187 mg of sucrose and 40 mg of glucose.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Light-green, round, biconvex, smooth glossy surface.

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety, to aid sleep and for mild digestive complaints, such as bloating and flatulence, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

For adults and the elderly:

For the temporary relief of symptoms of mild anxiety take 2 tablets two or three times a day.

For the relief of symptoms of mild digestive complaints, such as bloating and flatulence, take 2 tablets two or three times a day.

To aid sleep take 1 to 2 tablets half an hour before bedtime.

Tablets should be swallowed whole with a little liquid. The tablets should not be chewed.

As treatment effects may not be apparent immediately, DiaRelax should be taken for at least

2 weeks continuously.

If symptoms persist or worsen after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

The maximum recommended daily dose is 6 tablets

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions of use).

4.3 Contraindications

Hypersensitivity to the active substances Melissa leaf, Valerian root, Passion flower or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed stated dose

This product contains sucrose and glucose.

1 sugar-coated tablet contains max. 187 mg of sucrose and a max. 40 mg glucose.

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

The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

If symptoms persist or worsen after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.

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

The effect of DiaRelax may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known.

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

There are no known adverse reactions with Melissa leaf.

A mild allergic skin reaction (itching and/or rash) may occur. The frequency is not known.

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

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 35 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

No cases of overdose have been reported for Passion flower or Melissa leaf. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Data from in vitro and animal studies indicate that the water extract of Melissa officinalis may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed on extracts of Melissa leaf, Valerian root or Passion flower.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Excipients of the herbal preparations:

Maltodextrin

Silica, colloidal anhydrous Liquid glucose, spray dried Excipients of the tablet:

Silica, colloidal anhydrous Cellulose, powdered Croscarmellose sodium Stearic acid Talc

Excipients of the coating

Sucrose

Talc

Calcium carbonate E170

Acacia

Tragacanth

Titanium dioxide E 171 Liquid glucose, spray dried Quinoline yellow E 104 Indigotin 85 E 132 Beeswax, white Carnauba wax Shellac

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/03/2010

DATE OF REVISION OF THE TEXT

12/07/2013

10