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.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Not subject to medical prescription.
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