Synaptol SR 450mg Tablet 10'S

Introduction About SYNAPTOL SR 450MG TABLET

SYNAPTOL SR 450MG TABLET contains Tolperisone which belongs to the group of
medicines called Muscle Relaxants. It is used to relieve painful muscle spasms
of the skeletal muscles. Muscle spasms (muscle cramps) are painful contractions
and tightening of the muscles. Symptoms include muscular weakness, tingling or
prickling sensation, pain or discomfort.

SYNAPTOL SR 450MG TABLET is not recommended for use in patients with severe
liver or kidney impairment, galactose intolerance, the Lapp lactase deficiency
or glucose-galactose-malabsor
TABLET should be used with caution in patients with liver or kidney impairment.

SYNAPTOL SR 450MG TABLET should be used with caution during pregnancy only if
clearly advised by the doctor and it is not recommended for use in breastfeeding
women. SYNAPTOL SR 450MG TABLET should be used with caution in children (from 3
months to 14 years of age) and in elderly patients.

The most common side effects of taking SYNAPTOL SR 450MG TABLET are muscle
weakness, headache, nausea, indigestion and dry mouth. Consult your doctor if
any of the above side effects worsen.

Uses Of SYNAPTOL SR 450MG TABLET

• Relieves painful muscle spasms of the skeletal muscles

How SYNAPTOL SR 450MG TABLET Works

SYNAPTOL SR 450MG TABLET works by blocking the voltage-gated sodium channel in
the brain stem thereby causing muscle relaxation and stopping the pain signals
between nerve and brain. It also relieves pain by increasing the blood supply to
skeletal muscles.

How to use SYNAPTOL SR 450MG TABLET

Take SYNAPTOL SR 450MG TABLET as advised by your physician. Swallow the medicine
with plenty of water. Do not crush or chew the medicine. Your physician will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition. Do not stop taking SYNAPTOL SR 450MG TABLET unless
your doctor advises you to stop.

Side Effects Of SYNAPTOL SR 450MG TABLET

Common

• muscle weakness
• headache
• low blood pressure
• nausea, vomiting, indigestion, dry mouth

Uncommon

• sleepiness, dizziness
• abdominal discomfort or pain
• fatigue
• lassitude (physical or mental tiredness)
• weakness

Rare

• constipation, gastrointestinal disturbance, diarrhea
• increased sweating
• sleep disturbance

Stop taking SYNAPTOL SR 450MG TABLET and contact your doctor immediately if you
experience this side effect:

• hypersensitivity reactions (signs include rash, redness of the skin, itching, shortness of breath, swelling underneath the skin, increased heart rate or low blood pressure)

How To Manage Side Effects

Nausea or vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried
or spicy foods. Do not lie down or sleep immediately after eating. Consult your
doctor if the symptom does not improve.

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to
be relaxed and stress-free. Apply pain relieving balm on your forehead if
necessary. Consult your doctor if the symptom does not improve.

Constipation:

Eat plenty of fibre-rich foods such as fresh fruits, vegetables and cereals and
drink plenty of water. Exercise more regularly. If the symptom does not improve,
consult your doctor.

Stomach pain:

Try to take rest and relax. Eat and drink slowly or try to have smaller and more
frequent meals. Keep a heating pad on your stomach. If the symptom does not
improve, consult your doctor.

Dry mouth:

Sip water regularly and other sugar-free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does not improve.

Warning & Precautions

!### Pregnancy

SYNAPTOL SR 450MG TABLET should be used with caution during pregnancy only if
considered clearly necessary. Consult your doctor before taking SYNAPTOL SR
450MG TABLET.

!### Breastfeeding

SYNAPTOL SR 450MG TABLET is not recommended for use in breastfeeding women.
Consult your doctor before taking SYNAPTOL SR 450MG TABLET.

!### Driving and Using Machines

SYNAPTOL SR 450MG TABLET may cause dizziness, sleepiness, attention disturbance,
muscle weakness, fits or blurred vision after taking SYNAPTOL SR 450MG TABLET.
If you experience any such side effects consult your doctor for advice.

!### Kidney

SYNAPTOL SR 450MG TABLET is not recommended for use in patients with severe
kidney impairment. It should be used with caution in patients with kidney
impairment due to increased risk of adverse events and dose may be adjusted by
monitoring the patient’s condition and kidney function in patients with moderate
kidney impairment. Consult your doctor before taking SYNAPTOL SR 450MG TABLET.

!### Liver

SYNAPTOL SR 450MG TABLET is not recommended for use in patients with severe
liver impairment. It should be used with caution in patients with liver
impairment due to increased risk of adverse events and the dose may be adjusted
by monitoring the patient’s condition and liver function in patients with
moderate liver impairment. Consult your doctor before taking SYNAPTOL SR 450MG
TABLET.

!### Allergy

SYNAPTOL SR 450MG TABLET is not recommended for use if you are allergic to
Tolperisone or any other ingredients of this medicine. It should be used with
caution in patients who are allergic to lidocaine (due to cross-reactions).

Others

SYNAPTOL SR 450MG TABLET is not recommended for use if you have:

• galactose intolerance
• the Lapp lactase deficiency or glucose-galactose-malabsor
• myasthenia gravis

Use in pediatrics:

SYNAPTOL SR 450MG TABLET should be used with caution in children (from 3 months
to 14 years of age). Your child’s doctor may adjust the dose depending upon age
and body weight. Consult your child’s doctor for advice.

Use in geriatrics:

The dose of the SYNAPTOL SR 450MG TABLET should be adjusted in the
elderly. Consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking SYNAPTOL SR 450MG TABLET, inform your doctor if you are taking any
of the following medicines:

• benzodiazepines such alprazolam, diazepam (used to manage anxiety and insomnia)
• medicines used to manage pain and inflammation (ibuprofen, diclofenac, niflumic acid)
• medicines used to manage schizophrenia (Ex. thioridazine, perphenazine)
• tolterodine (used to manage overactive bladder)
• atomoxetine (used in attention deficit hyperactivity disorder)
• desipramine, venlafaxine (used to manage depression)
• dextromethorphan (used to relieve cough and cold)
• medicines used to manage high blood pressure (Ex. metoprolol, nebivolol)

Overdosage:

If you or anyone else accidentally take too much of SYNAPTOL SR 450MG TABLET,
consult your doctor immediately or visit the nearby hospital. Overdosage
symptoms of SYNAPTOL SR 450MG TABLET are sleepiness, gastrointestinal symptoms
(nausea, vomiting and epigastric pain), increased heart rate, low blood
pressure, slow movements, vertigo, seizures and coma.

Synopsis

Drug	:	Tolperisone
Pharmacological Category	:	Muscle Relaxant
Therapeutic Indication	:	Muscle spasm of skeletal muscles
Dosage Forms	:	Tablet

More Information

• Keep SYNAPTOL SR 450MG TABLET out of reach of children
• Store at room temperature

FAQs About SYNAPTOL SR 450MG TABLET

How doesSYNAPTOL SR 450MG TABLET work?

SYNAPTOL SR 450MG TABLET works by blocking the voltage-gated sodium channel in
the brain stem thereby causing muscle relaxation and stopping the pain signals
between nerve and brain. It also relieves pain by increasing the blood supply to
skeletal muscles.

Can SYNAPTOL SR 450MG TABLET be used in pregnant women?

SYNAPTOL SR 450MG TABLET should be used with caution during pregnancy only if
clearly advised by the doctor. Consult your doctor before taking SYNAPTOL SR
450MG TABLET if you are pregnant or planning to get pregnant.

Does SYNAPTOL SR 450MG TABLET cause dry mouth?

Yes, SYNAPTOL SR 450MG TABLET may cause dry mouth in some individuals. To manage
this effect, sip water regularly and other sugar-free liquids. Do not use
mouthwashes that contain alcohol because they can make your mouth dry, use
mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid
smoking or using tobacco products. Consult your doctor if the symptom does not
improve.

Can SYNAPTOL SR 450MG TABLET be taken by patients with liver disease?

SYNAPTOL SR 450MG TABLET is not recommended for use in patients with severe
liver impairment. It should be used with caution in patients with liver
impairment due to increased risk of adverse events and the dose may be adjusted
by monitoring the patient’s condition and liver function in patients with
moderate liver impairment. Consult your doctor before taking SYNAPTOL SR 450MG
TABLET.

What if I forget to take a dose of SYNAPTOL SR 450MG TABLET?

If you forget to take a dose of SYNAPTOL SR 450MG TABLET, take it as soon as you
remember. However, omit the missed dose if it is almost time for the next one.
Do not take medicine two times to make up for the missed dose.

Useful Diagnostic Tests

• Liver function test
• Kidney function test