caps.Reblaks

Indications for use:

Brand name:

Reblaks

INTERNATIONAL NONPROPRIETARY NAME:

Thiocolchicoside

Description:

Reblaks 4 mg

Hard gelatine capsules, capsule’s cap and body are matt white colour, contained yellow colour powder.

Reblaks 8 mg

Hard gelatine capsules, capsule’s cap and body are matt white colour, contained yellow colour powder.

Composition:

One capsule contains:

Active substance: thiocolchicoside – 4 mg or 8 mg.

Excipients: lactose monohydrate, corn starch, magnesium stearate.

Capsule composition: titanium dioxide, gelatin.

ATC Code: M03BX05

Pharmacotherapeutic group:

Muscle relaxants. Other centrally acting agents

Pharmacological properties

Pharmacodynamics:

Reblaks contains thiocolchicoside as an active substance, a semi-synthetic muscle relaxant obtained from natural glycoside colchicoside. Thiocolchicoside exhibits selective affinity to gamma-aminobutyric acid (GABA) and glycine receptors determining drug effect at various levels of nervous system, both with local spasms and spasms of central origin.

Reblaks does not possess similar to curare effect, thus does not induce paralysis and does not affect cardiovascular and respiratory systems.

Pharmacokinetics:

Distribution

After oral administration thiocolchicoside is metabolized to aglycon 3-demethylthiocolchicide inactive metabolite. This process occurs through intestinal metabolism, which explains the absence of circulating thiocolchicoside in unchanged form in blood plasma. Then, an inactive metabolite undergoes glucuro-conjugation into a pharmacologically active metabolite.

Maximum plasma concentrations of active and inactive metabolites are reached in 1 hour after the drug intake. After 8 mg single oral dose of thiocolchicoside maximum concentration and an active metabolite AUC are approximately 60 ng/ml and 130 ng h/ml respectively. For an inactive metabolite these values are much lower: maximum concentration – approximately 13 ng/ml and AUC varies from 15.5 ng h/ml (up to 3 hours) to 39.7 ng h/ml (up to 24 hours).

Excretion

Reblaks is indicated as an additional drug for painful muscle contractures treatment.

After oral administration 20% of the dose taken is excreted by the kidneys and 75-81% is excreted with feces.

Indications for use:

Reblaks is used in rheumatology for additional treatment of painful muscle contractures.

Contraindications:

- hypersensitivity to the drug components;

- muscle hypotension;

- mild paralysis;

- children under 15 years;

- pregnancy;

- lactation period.

Side effect:

Rarely: skin rash, swelling, allergic and pseudo-allergic reactions (allergic vasculitis), gastralgia and diarrhea.

Very rare: hypotension, irritation and drowsiness.

Dosage and administration:

Used only in adults (over 16)

The drug Reblaks is taken orally. Capsules should be taken orally with a sufficient amount of water.

Maximum drug daily dose is 4 capsules of 4 mg divided into 2 doses (total 16 mg).

Precautionary measures:

Reblaks should be used with caution in case of kidney or liver function impairment. It should be taken with caution in patients with epilepsy or with the risk of seizures.

Effect on ability to drive and use machinery

During the treatment period care should be taken while driving, controlling machinery and engaging in other potentially hazardous activities required increased concentration and psychomotor reactions.

Pregnancy and lactation:

Reblaks is contraindicated in pregnancy and lactation period.

Pediatric Use:

Reblaks is contraindicated in children under 15.

Overdose:

There is no data on overdose.

Symptoms: may increase side effects.

Treatment: symptomatic therapy.

Interaction with other drugs:

There are no data on drug interactions but caution is advised when taken concomitantly with other muscle relaxants.

Concomitant use with drugs that depress the central nervous system, including alcohol, antihypertensive drugs and curare-like drugs can cause muscle relaxation increase and central nervous system depression as well as hypotension aggravation.

Concomitant use of anticoagulants increases the risk of bleeding.

Packaging

Hard gelatine capsules 4 mg or 8 mg.

10 capsules per blister

1 blister with a leaflet in a cardboard box

Storage conditions:

Store at a temperature not higher than 25°С

Keep out of reach of children!

Shelf-life:

Shelf life is 3 years. Do not use after an expiry date indicated on the pack.

PRESCRIPTION STATUS:

By prescription

Manufacturer Information

Foreign production and trade unitary enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, Smilovichi, Sadovaya st., 1, tel./fax: (+375) 17 240 26 35,

e-mail: rebpharma@rebpharma.by, http://www.rebpharma.by