Thiocolchicoside Injection 4mg/2ml

  1. WHAT THIOCOLCHICOSIDE INJECTION 4MG/2ML IS AND WHAT IT IS USED FOR

This medicine is a muscle relaxant. It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions. It is to be used for acute conditions related to the spinal column.

  • WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIOCOLCHICOSIDE INJECTION 4MG/2ML

Do not take Thiocolchicoside Injection 4mg/2ml if:

  • you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6)
  • you are pregnant, might become pregnant or think you may be pregnant
  • you are a woman of childbearing potential not using contraception
  • you are breastfeeding

Warnings and precautions

Strictly respect the doses and duration of treatment detailed in section 3. You should not use this medicine at a higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms). This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes). This has been shown in studies in animals and in laboratory studies. In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility. Please discuss with your doctor if you have further questions.

Your doctor will inform you about all measures relating to effective contraception and about the potential risk of pregnancy.

Children and adolescents

Do not give this medicine to children and adolescents below 16 years old because of safety concerns.

Pregnancy, breast-feeding and fertility

Do not take this medicine if:

  • you are pregnant, might become pregnant or think you may be pregnant

you are a woman of childbearing potential not using contraception This is because this medicine may harm your unborn child. Do not take this medicine if you are breast-feeding. This is because the medicine passes into your breast-milk.

This medicine might cause problems to male fertility due to potential damage to sperm cells (abnormal number of chromosomes). This is based on laboratory studies (see section 2 ?Warnings and precautions?).

  • HOW TO TAKE THIOCOLCHICOSIDE INJECTION 4MG/2ML

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • For the oral form 4 mg and 8 mg:

The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day). The treatment duration is limited to 7 consecutive days.

  • For intramuscular form:

The recommended and maximal dose is 4 mg every 12 hours (i.e. 8 mg per day). The treatment duration is limited to 5 consecutive days.

  • Both for oral and for intramuscular forms:

Do not exceed the recommended doses and treatment duration.

This medicine should not be used for long-term treatment (see section 2 ?Warnings and precautions?).

Use in children and adolescents

Do not give this medicine to children and adolescents below 16 years old because of safety concerns.

If you take more Thiocolchicoside Injection 4mg/2ml than you should

If you accidentally take more Thiocolchicoside Injection 4mg/2ml than you should talk to your doctor, pharmacist or nurse.

If you forget to take Thiocolchicoside Injection 4mg/2ml

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

  • POSSIBLE SIDE EFFECTS

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

  • CONTENTS OF THE PACK AND OTHER INFORMATION

30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose.

6. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)