FORTÉ PHARMA DORMICALM - 30 Coated tablets

ANSM - Updated on : 14/06/2013

IN THIS APPENDIX, THE TERM "MARKETING AUTHORIZATION" IS UNDERSTOOD TO MEAN "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND THE TERM "AUTHORIZATION" IS UNDERSTOOD TO MEAN "REGISTRATION"

1. DRUG NAME

DORMICALM, coated tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Valerian(Valeriana officinalis L.) (dried root extract)..................................................... 125 mg

On liquid glucose nebulisate and anhydrous colloidal silica

Extraction solvent: 70%(V/V) ethanol

Drug:native extract ratio: 3 - 6:1

Lemon balm (Melissa officinalis L.) (dried leaf extract)....................................................... 112.5 mg

On liquid glucose nebulisate and anhydrous colloidal silica

Extraction solvent: 30% (V/V) methanol

Drug:native extract ratio: 4 6 : 1

Passion flower (Passiflora incarnata L.) (dry extract of aerial parts of)................................... 80 mg

On maltodextrin and colloidal anhydrous silica

Extraction solvent: 50% (V/V) ethanol

Drug:native extract ratio: 5 7 :

For one coated tablet.

Notable excipients: this drug contains 192.172 mg sucrose, 35.313 mg glucose

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Coated tablet.

Light green, round, biconvex tablet with a smooth, shiny surface

4. CLINICAL DATA

4.1. therapeutic indications

Traditional herbal medicine used to relieve mild nervous tension and sleep disorders.

Its use is restricted to the specified indication, based exclusively on the length of time it has been used

4.2. Dosage and administration

Dosage

For adults and adolescents over 12 years of age

Sleep disorders: 2 tablets half an hour before bedtime.

If necessary, 2 additional tablets may be taken.

Mild nervous tension: 1 tablet three times a day.

The maximum dose is 6 tablets per day

Pediatric population

Use in children under 12 years of age is not recommended (see section 4.4.)

Method of administration

Oral administration.

Swallow tablets whole with a little liquid.

not chew.

Duration of treatment

As the effects of treatment may not appear immediately, DORMICALM, coated tablet should be taken for at least 2 weeks without interruption

The maximum duration of treatment is 1 month

If symptoms persist during treatment, a doctor should be consulted

4.3. Contraindications

This medicine is contraindicated in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

Warnings :

This medicine contains glucose. Its use is not recommended in patients with glucose-galactose malabsorption syndrome

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency

If symptoms worsen during treatment, a doctor or qualified healthcare professional should be consulted

Pediatric population

Use in children under 12 years of age is not recommended, due to lack of data in this population

4.5. Interactions with other drugs and other forms of interaction

Limited data are available on pharmacological interactions with other drugs. No clinically relevant interactions have been observed with drugs metabolized by the cytochrome pathways CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1.

Although no clinical data are available on interactions with synthetic sedatives, concomitant use with such drugs (e.g. benzodiazepines) is not recommended unless advised by a physician

4.6. Fertility, pregnancy and breast-feeding

Pregnancy

Safety in pregnant women has not been established. In the absence of sufficient data, the use of this drug is not recommended during pregnancy.

Breast-feeding

Safety in nursing mothers has not been established. In the absence of sufficient data, this drug should not be used during breast-feeding

Fertility

No data on fertility are available.

4.7. Effects on ability to drive and use machines

DORMICALM, coated tablet may impair the ability to drive or operate machinery. Affected patients should not drive or operate machinery.

4.8. Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. Their frequency is unknown.

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported in association with passionflower. Their frequency is unknown.

known adverse reactions to lemon balm leaf.

Reporting suspected adverse reactions

The reporting of suspected adverse reactions after drug registration is important. It enables ongoing monitoring of the drug's benefit/risk ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

Valerian root, at a dose of around 20 g, caused mild symptoms (fatigue, abdominal cramps, chest tightness, dizziness, hand tremor and mydriasis) which disappeared within 24 hours. If such symptoms occur, symptomatic treatment should be initiated

Symptomatic and supportive measures should be taken as required

No cases of overdosage have been reported with passionflower and lemon balm

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Not applicable.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Data from in vitro and animal studies indicate that aqueous extract of lemon balm may inhibit TSH (thyrotropin)activity . The clinical relevance of these observations is unknown

Standard in vitro genotoxicity tests on extracts of lemon balm leaf, valerian root and passionflower revealed no mutagenic potential

No reproductive toxicity or carcinogenicity tests were performed on extracts of lemon balm leaf, valerian root or passionflower aerial parts

6. PHARMACEUTICAL DATA

6.1. List of excipients

Colloidal anhydrous silica, cellulose powder, croscarmellose sodium, stearic acid, talc, sucrose, calcium carbonate, gum arabic nebulisate, tragacanth, titanium dioxide (E171), liquid glucose nebulisate, sucrose, quinoline yellow (E104), indigotine (E132), beeswax, carnauba wax, shellac, maltodextrin.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special storage precautions

No special storage precautions.

6.5. Nature and contents of outer packaging

Box of 30 coated tablets in blister packs (PVC/PVDC-aluminium).

6.6. Special precautions for use and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

LABORATOIRES FORTE PHARMA

41, AVENUE HECTOR OTTO

LE PATIO PALACE

98000 MONACO

8. MARKETING AUTHORIZATION NUMBER(S)

- 224 474-6 or 34009 224 474 6 9: 30 coated tablets in PVC/PVDC-Aluminium blister packs.

9. DATE OF FIRST AUTHORIZATION/AUTHORIZATION RENEWAL

to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder

10. TEXT UPDATE DATE

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.