INTRODUCTION

BAKFLEX INJECTIONcontains Thiocolchicoside, which belongs to the group of medicines called Muscle relaxants. It is used in adults and adolescents 16 years of age and older as an add-on therapy for painful muscle contractions and acute painful conditions related to the spine.

Muscle spasms (muscle cramps) are painful contractions and tightening of your muscles. They’re usually common, involuntary, and unpredictable. The symptoms may include swelling, pain, stiffness, tenderness, and fatigue.

Before receiving BAKFLEX INJECTION inform your doctor if you have flaccid paralysis (sagging of the face), muscular hypotonia (weak muscles), diarrhoea, lactose intolerance, seizure or epilepsy. BAKFLEX INJECTION is not recommended for use in pregnant or breastfeeding women.

BAKFLEX INJECTION is not recommended for use in children and adolescents below 16 years of age. The most common side effects of receiving BAKFLEX INJECTION are skin allergic reactions, drowsiness, diarrhea and gastric symptoms. Consult your doctor if any of your symptoms get worse or persist.

USES OF BAKFLEX INJECTION

• Treats painful muscle contractions
• Treats acute painful conditions related to the spine

HOW BAKFLEX INJECTION WORKS

BAKFLEX INJECTION works through selective binding to the GABA-A receptor (neurotransmitter). It prevents muscle contractions by activating the GABA-inhibitory motor pathway and inhibiting the glycine receptors (neurotransmitters). Thus, relaxing the muscle pain and spasms.

DIRECTIONS FOR USE

BAKFLEX INJECTION will be given to you only by a doctor or a nurse into the muscles (intramuscularly). Your doctor will decide the right dose and duration depending on your age, body weight and disease condition.

SIDE EFFECTS OF BAKFLEX INJECTION

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try to take BAKFLEX INJECTION with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your symptom gets worse.

Itchy skin:

Avoid taking hot showers as they can irritate the skin. Do not scratch the affected area. Use sunscreen and protective clothing when going outdoors or use unscented moisturizers to soothe and hydrate the skin. Consult your doctor if your symptom gets worse.

Diarrhoea:

Drink plenty of water or fruit juices to keep yourself hydrated. Don’t take any medicine on your own to treat diarrhoea. Consult your doctor if your symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before receiving BAKFLEX INJECTION, inform your doctor if you are taking any of the following medicine:

• taking or have taken any other medicines, muscle relaxants or central nervous system sedatives

Overdosage:

BAKFLEX INJECTION will be administered to you only by a doctor or a nurse in a hospital, so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.

SYNOPSIS

MORE INFORMATION

• Keep BAKFLEX INJECTION out of reach from children
• Store at room temperature

FAQs ABOUT BAKFLEX INJECTION

What is BAKFLEX INJECTION used for?

BAKFLEX INJECTION is used in adults and adolescents 16 years of age and older as an add-on therapy for painful muscle contractions and acute painful conditions related to the spine.

Can children receive BAKFLEX INJECTION?

No, BAKFLEX INJECTION is not recommended for use in children below 16 years of age. Consult your doctor before receiving BAKFLEX INJECTION.

How does BAKFLEX INJECTION work?

BAKFLEX INJECTION works through selective binding to the GABA-A receptor (neurotransmitter). It prevents muscle contractions by activating the GABA-inhibitory motor pathway and inhibiting the glycine receptors (neurotransmitters). Thus, relaxing the muscle pain and spasms.

When is BAKFLEX INJECTION contraindicated?

BAKFLEX INJECTION is not recommended for use in patients with flaccid paralysis, muscular hypotonia and hypersensitivity to this medicine. Consult your doctor before receiving BAKFLEX INJECTION.

Can a pregnant woman receive BAKFLEX INJECTION?

BAKFLEX INJECTION is not recommended for use in pregnant women, planning to have a baby or women of childbearing potential not taking contraceptives. Consult your doctor before receiving BAKFLEX INJECTION.

REFERENCES

1. KD Tripathi. Skeletal Muscle Relaxants. Essentials of medical pharmacology. Eighth Edition. 2019. Page –383-384.

2. Marco Gervasi, Davide Sisti, Piero Benelli, Eneko Fernández-Peña, Cinzia Calcabrini, Marco B.L. Rocchi, Luigi Lanata, Michela Bagnasco, Andrea Tonti, Stocchi Vilberto, and Piero Sestili. The effect of topical thiocolchicoside in preventing and reducing the increase of muscle tone, stiffness, and soreness. [Accessed on 6th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627858/

3. A.R Umarkar, S.R Bavaskar & P.N.Yewale. Thiocolchicoside as Muscle Relaxant: A Review. [Revised in September 2011] [Accessed on 6th July 2022] http://www.ijpbsonline.com/uploads/1/2/1/8/12183777/364-371.pdf

4. Iasis Pharma Hellas s.a. Thiocolchicoside [Revised in October 2014] [Accessed on 6th July 2022] https://iasispharma.com/wp-content/uploads/pdf/RELIEF_PIL_ENG.pdf

5. European Medical Agency. Thiocolchicoside. [Revised on November 2013] [Accessed on] https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-annex-iii_en.pdf

6. Thiocolchicoside. Pubchem. [Revised in July 2022] [Accessed on 6th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Thiocolchicoside#section=Associated-Disorders-and-Diseases

7. Thiocolchicoside. Clevelandclinic. [Revised in March 2021] [Accessed on 6th July 2022] https://my.clevelandclinic.org/health/diseases/15466-muscle-spasms