Active ingredients: Heparin (Heparin sulfate)
CLAREMA® 120 mg prolonged-release tablets
Indications Why is Clarema used? What is it for?
Pharmacotherapeutic group
Antithrombotic.
Therapeutic indications
Clarema 120 mg prolonged-release tablets are indicated in vascular disease with thrombotic risk.
Contraindications When Clarema should not be used
Hypersensitivity to the active substance or to any of the excipients listed in "Composition"
Hypersensitivity to heparin and heparinoids.
Syndromes with hyperfibrinolysis.
Diathesis and hemorrhagic syndromes.
Precautions for use What you need to know before taking Clarema
The association with anticoagulants and / or antiplatelet agents must be carried out with caution, only in cases of absolute necessity, under strict medical supervision and monitoring the blood coagulation parameters.
In the event of skin rashes and other manifestations of hypersensitivity ", discontinue treatment and institute appropriate therapy.
Interactions Which drugs or foods can change the effect of Clarema
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Since heparan sulfate is a heparin-like molecule, CLAREMA® 120 mg prolonged-release tablets can increase the anticoagulant effects of heparin itself and / or of other anticoagulants and antiplatelet agents, if administered simultaneously. In case of concomitant administration of other drugs affecting haemocoagulability (non-steroidal anti-inflammatory drugs), mutual enhancement of activity must be taken into account. No interactions with other drugs are known so far.
Warnings It is important to know that:
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Animal studies show no reproductive toxicity (see section 5.3). The use of CLAREMA 120 mg prolonged release tablets during pregnancy can be considered, if necessary and in any case under medical supervision.
Feeding time
There is insufficient information on the excretion of CLAREMA 120 mg prolonged-release tablets in breast milk. The use of CLAREMA 120 mg prolonged-release tablets during breastfeeding should only be performed if clearly needed and under medical supervision.
CLAREMA 120 mg prolonged-release tablets have no or negligible influence on the ability to drive or use machines.
Dosage and method of use How to use Clarema: Dosage
1 tablet a day, or according to medical opinion, by mouth, between meals. The duration of the treatment is in the opinion of the doctor
Overdose What to do if you have taken too much Clarema
There are no known acute incidents with heparan sulfate. In case of overdose, as a specific antidote is not known, it is advisable to implement the usual emergency measures such as induction of vomiting and gastric lavage. In case of accidental ingestion / intake of an excessive dose of CLAREMA 120 mg prolonged-release tablets, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of CLAREMA 120 mg prolonged release tablets, ask your doctor or pharmacist.
Side Effects What are the side effects of Clarema
Like all medicines, CLAREMA 120 mg prolonged-release tablets can cause side effects, although not everybody gets them.
The undesirable effects associated with heparan sulfate treatment are listed below, organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.
Gastrointestinal disorders
Disorders of the gastro-enteric system with nausea, vomiting and epigastralgia.
Skin and subcutaneous tissue disorders
Skin rashes
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Composition and pharmaceutical form
Composition
One prolonged-release tablet contains:
Active ingredient: heparan sulfate 120 mg
Excipients: cetyl alcohol; microcrystalline cellulose; sucrose; methacrylic acid copolymer (Eudragit L); talc; titanium dioxide; triethyl citrate; polyvinylpyrrolidone; hydroxypropylmethylcellulose; magnesium stearate; precipitated silica.
Pharmaceutical form and content
Prolonged-release tablets.
Blister packs of 10 tablets containing 120 mg of heparan sulfate.
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
CLAREMA 120 MG PROLONGED RELEASE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One controlled-release tablet contains:
Heparin sulfate 120 mg
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Prolonged-release tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Vascular pathology with thrombotic risk.
04.2 Posology and method of administration
CLAREMA® 120 mg prolonged-release tablets: 1 tablet per day, or according to medical opinion, by mouth, between meals.
The duration of the treatment is in the opinion of the doctor.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to heparin and heparinoids.
Syndromes with hyperfibrinolysis.
Diathesis and hemorrhagic syndromes.
04.4 Special warnings and appropriate precautions for use
The association with anticoagulants and / or antiplatelet agents, although not contraindicated in an absolute sense, should be carried out with caution, only in cases of absolute necessity, under strict medical supervision and monitoring blood coagulation parameters.
In the event of skin rashes and other manifestations of hypersensitivity, discontinue treatment and institute appropriate therapy.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Since heparan sulfate is a heparin-like molecule, CLAREMA® 120 mg prolonged-release tablets can increase the anticoagulant effects of heparin itself and / or other anticoagulants, if administered simultaneously. No interactions with other drugs are known so far.
04.6 Pregnancy and lactation
Although all reproductive toxicology studies have ruled out any effects on pregnancy and peri- and postnatal development of the fetus, the use of CLAREMA® 120 mg prolonged-release tablets in pregnancy is only recommended in cases of real need and under direct supervision. doctor's check.
04.7 Effects on ability to drive and use machines
CLAREMA® 120 mg prolonged-release tablets does not affect the ability to drive or use machines.
04.8 Undesirable effects
Occasionally reported gastrointestinal disorders with nausea, vomiting and epigastralgia.
04.9 Overdose
There have been no reported cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antithrombotics. ATC code: B01AB49.
The heparan sulfate, an active extracting principle of animal origin, is a mucopolysaccharide variously sulfated with repetitive dimeric units, consisting of a glycuronic acid and more or less N-acetylated glucosamine; it is present in the arterial and venous vascular endothelium, to which it can confer profibrinolytic and anticoagulant properties, correlated to some chemical parameters (position and degrees of sulfation, molecular weight, etc.). The type of heparan sulphate used in the specialty in question, obtained thanks to specific extraction and purification methods, is endowed with marked antithrombotic properties, resulting from an intense profibrinolytic activity and from the activation of ATIII. It has been shown, in pharmacodynamic studies, to inhibit thrombinogenesis and to activate the fibrinolytic process both by the intrinsic and extrinsic pathways. The mechanism of action includes interactions at the level of other steps of the fibrinolytic process by activating the proactivators and antagonizing the plasmin inhibitors, exerting antiXa and anticomplementary activities. Consequently, as an indirect effect, an increased respiratory activity of the aortic tissue, a decreased blood viscosity and a reduced platelet adhesiveness.
05.2 "Pharmacokinetic properties
CLAREMA® 120 mg prolonged-release tablets: the pharmacokinetic studies conducted in humans, with the new prolonged-release formulation, demonstrate a rapid gastrointestinal absorption which results in a "fibrinolytic activity that reaches its maximum after about 4 hours, to maintain plateau up to about 14 hours; this activity then decreases in plasma with return to baseline values within 18 hours.
05.3 Preclinical safety data
Non-clinical data reveal no risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cetyl alcohol; microcrystalline cellulose; sucrose; methacrylic acid copolymer (Eudragit L); talc; titanium dioxide; triethyl citrate; polyvinylpyrrolidone; hydroxypropylmethylcellulose; magnesium stearate; precipitated silica.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Box of 10 tablets, in blisters, containing 120 mg of heparan sulphate.
06.6 Instructions for use and handling
The product is administered orally between meals.
Unused product and waste derived from this medicine must be disposed of in accordance with local legal requirements.
07.0 MARKETING AUTHORIZATION HOLDER
FARMACEUTICI DAMOR S.p.A.
Via E. Scaglione, 27 - 80145 Naples
08.0 MARKETING AUTHORIZATION NUMBER
AIC: 027456021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
February 2005
10.0 DATE OF REVISION OF THE TEXT
September 2007
