MIOFREE 4 Injection 2ml

Introduction About MIOFREE 4 INJECTION

MIOFREE 4 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 MIOFREE 4 INJECTION inform your doctor if you have flaccid
paralysis (sagging of the face), muscular hypotonia (weak muscles), diarrhoea,
lactose intolerance, seizure or epilepsy. MIOFREE 4 INJECTION is not recommended
for use in pregnant or breastfeeding women.

MIOFREE 4 INJECTION is not recommended for use in children and adolescents below
16 years of age. The most common side effects of receiving MIOFREE 4 INJECTION
are skin allergic reactions, drowsiness, diarrhea and gastric symptoms. Consult
your doctor if any of your symptoms get worse or persist.

Uses Of MIOFREE 4 INJECTION

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

How MIOFREE 4 INJECTION Works

MIOFREE 4 INJECTION works through selective binding to the GABA-A receptor
(neurotransmitter). It manages muscle contractions by activating the
GABA-inhibitory motor pathway and inhibiting the glycine receptors
(neurotransmitters). Thus, relaxing the muscle pain and spasms.

How to use MIOFREE 4 INJECTION

MIOFREE 4 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 MIOFREE 4 INJECTION

Common

• digestive disorders such as diarrhoea and stomach pain
• gastralgia
• drowsiness
• pain at the injection site

Uncommon

• itching, redness, bumps, vesicles or blisters on the skin
• allergic skin reaction
• nausea and vomiting

Rare

• allergic skin reactions like hives/urticaria

Stop receiving MIOFREE 4 INJECTION and contact your doctor immediately if you
experience any of the following side effects:

• seizures
• signs of a liver problem (loss of appetite, nausea or vomiting, abdominal discomfort, unexplained fatigue, dark-coloured urine, jaundice, fever, itching)
• angioedema (sudden swelling of the neck and face, possibly causing difficulty breathing)
• anaphylactic shock (drop in blood pressure, possibly preceded by an eru

How To Manage Side Effects

Nausea:

Try to take MIOFREE 4 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 manage diarrhoea. Consult your doctor if your symptom
gets worse.

Warning & Precautions

!### Pregnancy

MIOFREE 4 INJECTION is not recommended for use in pregnant women, planning to
have a baby or women of childbearing potential not taking contrace
Consult your doctor before receiving MIOFREE 4 INJECTION.

!### Breastfeeding

MIOFREE 4 INJECTION is not recommended for use in breastfeeding women. Consult
your doctor before receiving MIOFREE 4 INJECTION.

!### Driving and Using Machines

Do not drive or use machines while receiving MIOFREE 4 INJECTION as it can make
you drowsy. Consult your doctor.

!### Allergy

Before receiving MIOFREE 4 INJECTION inform your doctor if you are allergic to
Thiocolchicoside or any other ingredients of this medicine.

Others

MIOFREE 4 INJECTION is not recommended for use if you:

• flaccid paralysis (sagging face)
• muscular hypotonia (muscle weakness)

Before receiving MIOFREE 4 INJECTION, inform your doctor if you:

• have diarrhoea
• have epilepsy or risk of seizure
• lactose intolerant

Use in pediatrics:

MIOFREE 4 INJECTION is not recommended for use in children below 16 years of
age. Consult your doctor before receiving MIOFREE 4 INJECTION.

Interactions

A. Drug-Drug interactions:

Before receiving MIOFREE 4 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:

MIOFREE 4 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

Drug	:	Thiocolchicoside
Pharmacological Category	:	Muscle relaxant
Therapeutic Indication	:	Painful muscle contractions, Acute painful conditions related to the spine
Dosage Forms	:	Gel, Tablet, Capsule, Injection

More Information

• Keep MIOFREE 4 INJECTION out of reach from children
• Store at room temperature

FAQs About MIOFREE 4 INJECTION

What is MIOFREE 4 INJECTION used for?

MIOFREE 4 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 MIOFREE 4 INJECTION?

No, MIOFREE 4 INJECTION is not recommended for use in children below 16 years of
age. Consult your doctor before receiving MIOFREE 4 INJECTION.

How does MIOFREE 4 INJECTION work?

MIOFREE 4 INJECTION works through selective binding to the GABA-A receptor
(neurotransmitter). It manages muscle contractions by activating the
GABA-inhibitory motor pathway and inhibiting the glycine receptors
(neurotransmitters). Thus, relaxing the muscle pain and spasms.

When is MIOFREE 4 INJECTION contraindicated?

MIOFREE 4 INJECTION is not recommended for use in patients with flaccid
paralysis, muscular hypotonia and hypersensitivity to this medicine. Consult
your doctor before receiving MIOFREE 4 INJECTION.

Can a pregnant woman receive MIOFREE 4 INJECTION?

MIOFREE 4 INJECTION is not recommended for use in pregnant women, planning to
have a baby or women of childbearing potential not taking contrace
Consult your doctor before receiving MIOFREE 4 INJECTION.