NIDALAN SR 40MG TABLET 10'S

Introduction About NIDALAN SR

NIDALAN SR contains Isoxsuprine which belongs to the group of medicines called
Vasodilators. It is used in the management of premature labor (when the uterus
starts contracting for birth too early than usual), cerebral vascular
insufficiency (poor blood flow to the brain) and arteriosclerosis obliterans
(hardening of the arteries).

NIDALAN SR can also be used to manage Buerger's disease (blood vessels become
inflamed, swollen and can become blocked with blood clots), Raynaud’s phenomenon
(decreased blood flow to the nose, ears, fingers, toes, nipples or knees) and
dysmenorrhea (painful menstrual cramps).

NIDALAN SR should not be used immediately after delivering a baby or if you have
a bleeding disorder. NIDALAN SR is not recommended for use if you have any heart
disease (especially arrhythmias), hyperthyroidism, chorioamnionitis, bleeding,
eclampsia or pre-eclampsia.

Avoid smoking and consuming alcohol while taking NIDALAN SR as it may cause
dizziness. Do not take NIDALAN SR if you are pregnant or breastfeeding without
consulting your doctor. Safety and effectiveness of NIDALAN SR in children have
not been established.

Your doctor may want you to take blood tests or other medical evaluations during
management with NIDALAN SR to monitor progress and side effects. The most common
side effects of taking NIDALAN SR are chest pain or an irregular heartbeat,
nausea, vomiting, dizziness or weakness. Contact your physician if any of the
symptoms deteriorate.

Uses Of NIDALAN SR

Manage:

• premature labor
• cerebral vascular insufficiency
• arteriosclerosis obliterans
• thromboangitis obliterans (Buerger's disease)
• Raynaud’s phenomenon
• dysmeorrhea

How NIDALAN SR Works

NIDALAN SR manages premature labor by managing the contractions of the smooth
muscles in the uterus. In peripheral vascular disease, it helps in widening of
blood vessels to increase blood flow, thereby improving blood circulation to
certain parts of the body (such as the hands/feet and brain).

How to use NIDALAN SR

Take NIDALAN SR as advised by your physician. Swallow the medicines with enough
water. Do not crush or chew it. The correct dose and duration will be decided by
your physician for you according to your age, body weight and disease condition.

Side Effects Of NIDALAN SR

Common

• chest pain
• nausea, vomiting, upset stomach
• dizziness, weakness
• shaking
• fast heartbeat
• low blood pressure
• excessive fluid in the lungs

Rare

• chest pain
• shortness of breath

Stop taking NIDALAN SR and contact your doctor immediately if you experience any
of the following side effects:

• allergic reaction (symptoms like difficulty breathing, closing of the throat, swelling of the lips, tongue or face, hives)
• rash
• restarting of contractions or breaking of water

How To Manage Side Effects

Nausea or vomiting:

Take NIDALAN SR with or just after meals. Stick to simple meals. Avoid eating
oily or spicy foods. If symptom persists, contact your doctor.

Dizziness:

Lie or sit down promptly when you feel dizzy. If you're feeling severe episode
of spinning, lie in a dark and quite place and close your eyes. Try to avoid
vehicle driving. If symptom persists, contact your doctor.

Skin rash:

Avoid hot showers as it can irritate your skin more. Do not scratch the affected
area. Use protective clothing when going outdoors and moisturize your skin
regularly. If symptom persists, contact your doctor.

Warning & Precautions

!### Pregnancy

NIDALAN SR is not recommended for use in pregnant women unless considered
clearly necessary as it is not known whether this medicine will be harmful to an
unborn baby. Consult your doctor before taking it.

!### Breastfeeding

NIDALAN SR is not recommended for use in breastfeeding women unless considered
clearly necessary as it is not known whether this medicine passes into breast
milk. Consult your doctor before taking it.

!### Driving and Using Machines

Do not drive, use any machines or do anything that needs attention if you feel
sleepy or dizzy after taking NIDALAN SR.

!### Allergy

Do not take NIDALAN SR if you are allergic to Isoxsuprine, lactose or some
sugars or to any of the other ingredients of this medicine.

!### Heart Disease

NIDALAN SR is not recommended for use in patients having heart diseases,
especially arrhythmias (irregular heartbeat). Consult your physician before
taking it.

Others

NIDALAN SR is not recommended for use if you:

• have hyperthyroidism (overactive thyroid)
• have chorioamnionitis (infection of the amniotic fluid and tissue around the baby during pregnancy)
• have bleeding problems
• have eclampsia or preeclampsia (high blood pressure problems during pregnancy)
• just had a baby (immediately postpartum)

Before taking NIDALAN SR, inform your doctor if you:

• smoke tobacco
• have glaucoma (increased eye pressure)

Use in pediatrics:

Safety and effectiveness of NIDALAN SR in children have not been established.
Consult your child’s doctor for advice.

Use in geriatrics:

No specific information is available on the use of NIDALAN SR in elderly
patients. It may reduce tolerance to cold temperatures in these patients.
Consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking NIDALAN SR, inform your doctor if you are taking any of the
following medicines:

• other medicines used to manage low blood pressure (Ex. cilnidipine, phenylephrine)
• other vasodilators (Ex. hydralazine, minoxidil)

Overdosage:

If you or anyone else accidentally take too much of NIDALAN SR, consult your
doctor immediately or visit the nearby hospital. The symptoms of overdosage may
include weakness, lightheadedness, fainting, nausea and vomiting.

Synopsis

Drug	:	Isoxsuprine
Pharmacological Category	:	Vasodilators
Therapeutic Indication	:	Premature labor, to improve blood flow
Dosage Forms	:	Tablet, Capsule, Injection

More Information

• Keep NIDALAN SR out of reach of children
• Store NIDALAN SR below 30°C

FAQs About NIDALAN SR

Does NIDALAN SR affect the ability to drive?

NIDALAN SR causes dizziness and sleepiness. So, avoid driving, doing machinery
work or anything that needs attention. Consult your physician for advice.

Can NIDALAN SR cause bleeding?

NIDALAN SR might worsen the bleeding and thus it is not recommended for use in
patients having bleeding disorders. Consult your doctor if you experience any
kind of bleeding and it bothers you.

Can I have alcohol after taking NIDALAN SR?

Avoid consum
dizziness and affect your ability to perform activities that need alertness.
Consult your physician for advice.

Is it safe to take NIDALAN SR in patients with heart problems?

NIDALAN SR is not recommended for use in patients having heart problems,
especially arrhythmias (slow or fast heartbeat). Consult your doctor for advice.
The doctor will determine a proper dose of NIDALAN SR or select a suitable
alternative management for you.

Can NIDALAN SR be used in pregnant women?

NIDALAN SR is generally not recommended for use in pregnant women unless
considered clearly necessary as it is not known whether this medicine will be
harmful to an unborn baby. If you are pregnant, think you may be pregnant or are
planning to have a baby, consult your doctor before taking it.