Active ingredients: Total triterpene fraction of Centella asiatica
Centellase 30 mg tablets
Why is Centellase used? What is it for?
Centellase is a medicine based on Centella asiatica, a drug used to protect the veins.
Centellase is indicated in the treatment of:
- swelling in the ankles and legs due to venous insufficiency, feeling of heaviness in the legs, tingling and itching in the legs, nocturnal leg cramps and visible capillaries;
- fragility of capillaries.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Centellase should not be used
Do not take Centellase
- if you are allergic to the active substance or any of the other ingredients of this medicine
Precautions for use What you need to know before taking Centellase
There are no particular precautions for the use of this medicine.
Interactions Which drugs or foods can modify the effect of Centellase
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
Do not use this medicine during pregnancy and breastfeeding because its effects are not known.
if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Centellase does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Centellase: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 to 2 tablets a day preferably at mealtimes.
How to use: the tablets must be swallowed whole with water
Duration of treatment: Use this medicine only for short periods of treatment. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Side Effects What are the side effects of Centellase
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of the medicine can cause itching or give rise to phenomena of sensitivity to the sun and UV rays (photosensitization) with the appearance of redness and red and / or swollen spots (skin rashes).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Centellase contains
- The active ingredient is: total triterpene fraction of Centella asiatica
- The other ingredients are: dibasic calcium phosphate dihydrate, docusate sodium, povidone, croscarmellose sodium, carmellose sodium, magnesium stearate.
What Centellase looks like and contents of the pack
Centellase comes in a cardboard box containing 30 tablets packed in blisters.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CENTELLASE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains: total triterpene fraction of gotu kola (asiaticoside 40% - asiatic acid + madecassic acid 60%) 30 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptoms attributable to venous insufficiency; states of capillary fragility.
04.2 Posology and method of administration
Dosage
1 to 2 tablets per day, preferably at mealtimes.
The medicine should only be used for a short period of treatment.
Method of administration: oral use.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
No particular precautions for the use of the product.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions with other drugs.
04.6 Pregnancy and lactation
Studies in animals have not shown reproductive toxicity. There are no adequate data from the use of the drug in pregnant or breastfeeding women. Centellase should not be used during pregnancy and lactation.
04.7 Effects on ability to drive and use machines
Centellase does not affect the ability to drive or use machines.
04.8 Undesirable effects
Cases of itching and photosensitivity reactions with the appearance of redness and rashes have been reported after oral administration of the drug.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: vasoprotectors.
ATC code: C05CX.
Mechanism of action
The triterpene fraction of Centella asiatica (FTTCA) has modulating properties on the development of connective tissue, which results in an improvement in the tone and elasticity of the venous wall. This allows, with the reduction of endothelial permeability (decrease in stasis and diapedesis at the capillary level), to restore over time the hemodynamic equilibrium at the level of the tissue micro-vascular system, the alteration of which is the cause of the symptomatology accompanying the varicose syndrome.
05.2 Pharmacokinetic properties
Absorption
The FTTCA after oral administration is rapidly absorbed reaching the maximum plasma level around 4 hours. After epicutaneous administration, the product shows a blood peak between the 6th and 12th hour.
Biotransformation and elimination
The active ingredients are not metabolized by the body and are eliminated as such by the fecal route.
An entero-hepatic circulation has been demonstrated.
05.3 Preclinical safety data
There is no information, deriving from preclinical data, of significant importance to the physician that has not already been reported in the other sections of the Summary of Product Characteristics.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Calcium dibasic phosphate dihydrate, docusate sodium, povidone, croscarmellose sodium, carmellose sodium, magnesium stearate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
The tablets are enclosed in plastic material heat-sealed with aluminum (blister) and placed in a cardboard box, together with the package leaflet.
Box of 30 tablets.
06.6 Instructions for use and handling
No special instructions for disposal.
07.0 MARKETING AUTHORIZATION HOLDER
Pharmaceutical Laboratory SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
08.0 MARKETING AUTHORIZATION NUMBER
AIC: 016222073
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: November 1982.
Date of most recent renewal: May 2010.
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 21 July 2014.
