Heptaminol Hydrochloride 187.8mg Arrow. Box of 20 tablets

1. NAME OF THE MEDICINAL PRODUCT

HEPTAMINOL CHLORYDRATE ARROW 187.8 mg, tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Heptaminol chloride................................................................................................... 0, 1878 g

Quantity corresponding to heptaminol................................................................................. 0, 1500 g

For one tablet.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

4. CLINICAL DATA

4.1 Therapeutic indications

Proposed for the symptomatic treatment of orthostatic hypotension, particularly during psychotropic treatment.

4.2. Dosage and method of administration

Dosage

Adult: 1 to 2 tablets, three times daily.

Pediatric population

Not applicable.

Method of administration

Oral use.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1.

Severe arterial hypertension.

Hyperthyroidism.

4.4. Special warnings and precautions for use

The attention of sportsmen and women should be drawn to the fact that this speciality contains an active ingredient which may induce a positive reaction in tests carried out during anti-doping controls.

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable.

4.6. Fertility, pregnancy and lactation

Not applicable.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Not applicable.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after approval of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Health 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 Centres - Website: www.ansm.sante.fr.

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: CARDIOVASCULAR ANALEPTIC, ATC code: not yet assigned.

(C: cardiovascular system)

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Gelling corn starch (STA-Rx 1500), magnesium trisilicate, magnesium stearate, wheat starch.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

No special precautions for storage.

6.5. Nature and contents of outer packaging

20, 500 or 1000 tablets in blister packs (PVC/ Aluminium).

6.6. Special precautions for disposal and handling

No special requirements for disposal.

7. MARKETING AUTHORIZATION HOLDER

H2 PHARMA

21 RUE JACQUES TATI

ZAC LA CROIX BONNET

78390 BOIS D'ARCY

8. MARKETING AUTHORIZATION NUMBER(S)

-34009339 278 5: 20 tablets in blister pack (PVC/ Aluminium)

-34009559 377 2: 500 tablets in blister packs (PVC/ Aluminium)

34009559 378 9: 1000 tablets in blister packs (PVC/ Aluminium)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

[To be completed later by the holder] Date of first authorisation

Date of first authorisation:{ DD Month YYYY}

10. DATE OF UPDATE OF THE TEXT

[To be completed later by the holder] {D months YYYY}

{ DD Month YYYY}

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.