SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
HIPOSEM, 340 mg, tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 340 mg of Aesculus hippocastanum L., semen (horse chestnut seed)
1 tablet contains at least 10 mg of aescin.
See below for full list of excipients.
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
Traditional herbal medicinal product intended for traditional use for stated indications. Its efficacy is based solely on long-term use and experience.
4.1. Indications for use
Traditionally used in the treatment of symptoms of chronic venous insufficiency and varicosity.
4.2. Posology and method of administration
Posology:
Adults: 2 tablets 3 times a day.
Children and adolescents: Not intended for use.
Method of administration:
Oral.
4.3. Contraindications:
Hypersensitivity to active substance or any excipient listed in 6.1. Kidney or liver failure.
4.4. Special warnings and precautions for use
If symptoms persist after 3-4 weeks, worsen or there occur dermititis, thrombophlebitis or subcutaneous sclerosis, acute pain, ulceration, sudden edema of one or both lower limbs, heart or kidney failure, consult a doctor.
4.5 Drug interactions and other interactions
No data.
Literature on aescin suggests that there is a possibility of interaction with nonsteroidal anti-inflammatories, oral anticoagulants and heparin. Concomitant use with aminoglycoside antibiotics may have a nephrotoxic effect. Horse chestnut seed may intensify the hypoglycemic activity of oral anti-diabetics and insulin.
4.6. Impact on fertility, pregnancy and lactation
Due to insufficient safety data, do not use during pregnancy and lactation.
4.7. Impact on ability to drive vehicles and operate machinery
No data.
4.8. Adverse effects
May rarely cause irritation of stomach and intestinal mucosa and allergic reactions.
Reporting suspected adverse effects
After a medicinal product receives marketing authorization, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
4.9. Overdose
No data.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamics
Pharmacodynamic properties of powdered horse chestnut have not been examined. All literature data on aescin (exclusively preclinical data) and horse chestnut seed extracts, standardized for aescin content (preclinical and clinical data).
5.2. Pharmacokinetics
No data.
5.3. Preclinical safety data
No studies on powdered horse chestnut seed have been conducted.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium starch glycolate (type C)
Potato starch
Colloidal anhydrous silica
6.2. Incompatibilities
No data.
6.3. Expiry date
2 years
6.4. Special precautions for storage
Store closed in max. 25° C, keep away from children.
6.5. Box type and contents
Glass containers with polytethylene caps, polyethylene or polypropylene containers with polyethylene caps, with 30, 60 or 90 tablets.
Not all types of packaging need to be marketed.
6.6. Special precautions for disposal and preparation of medicinal product for use
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
Laboratorium Farmaceutyczne Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
fax 58 561 20 16
e-mail: poczta@labofarm.com.pl
- MARKETING AUTHORIZATION NUMBER
10360
- FIRST MARKETING AUTHORIZATION ISSUE DATE AND RENEWAL DATE
First marketing authorization issue date: 08.04.2004
Last marketing authorization renewal date: 07.01.2013
- DATE OF APPROVAL OR PARTIAL CHANGE OF
SUMMARY OF PRODUCT CHARACTERISTICS
09.06.2017
PL