Nifedine 10mg Tablet 10'S

Introduction About NIFEDINE

NIFEDINE contains Nifedipine, which belongs to the group of medicines called
Antihypertensive drugs. It is used in the management of high blood pressure
(hypertension) and angina. Hypertension is a condition in which the force of the
blood against the blood vessel walls is too high and is characterised by
headache, irregular heartbeat, vision changes, a feeling of overtiredness,
nausea, vomiting, confusion, anxiety, and chest pain. Angina is a type of chest
pain caused by reduced blood flow to the heart and characterised by a squeezing
type of pain, pressure, heaviness, and tightness in the chest.

NIFEDINE is not recommended for use in patients with liver and heart disease and
should be used with caution with patients having kidney dialysis, improper liver
function, or poor cardiac reserve. It should be used with caution in pregnant
women, and it is not recommended in a breast-feeding woman; consult your doctor
for advice.

NIFEDINE is not recommended for use by children and adolescents below 18 years
of age. The most common side effects of taking NIFEDINE are headache, flushing,
a general feeling of being unwell, constipation, and swelling, particularly of
the ankles and legs. Consult your doctor if the symptom worsens.

Uses Of NIFEDINE

• Manage high blood pressure (hypertension) and angina (chest pain)

How NIFEDINE Works

NIFEDINE reduces blood pressure by relaxing and expanding the blood vessels for
easy blood flow and thereby lowers the blood pressure, which reduces the strain
on the heart. It also works by relaxing and expanding the blood vessels
supplying the heart, which allows more blood and oxygen to reach the heart and
decreases the strain on it. This reduces the severity and frequency of angina
attacks.

How to use NIFEDINE

Take NIFEDINE as advised by your physician. Swallow this medicine, do not crush,
or chew the medicine. Your doctor will decide the correct dose and duration for
you depending on your age, body weight and disease condition.

Side Effects Of NIFEDINE

Common

• headache
• flushing
• general feeling of being unwell
• constipation
• swelling, especially of legs and ankle

Uncommon

• stomach pain
• unspecific pain
• chills
• low blood pressure when standing up showing symptoms of fainting, dizziness, lightheadedness, occasional palpitations, blurred vision, confusion
• fainting
• irregular heartbeat
• dry mouth
• indigestion
• wind (flatulence)
• feeling sick (nausea)
• muscle cramps
• joint swelling
• sleep disorders
• anxiety or nervousness
• reddening of the skin
• nose bleeds
• nasal congestion
• feeling of spinning (vertigo)
• migraine (one side headache)
• dizziness
• trembling (involuntary shaky movements)
• increased urge to urinate
• painful or difficult urination
• erection dysfunction (impotence)
• blurred vision

Rare

• pins and needles feeling
• gum inflammation, with swollen, tender or bleeding gums

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

• generalised allergic reaction including very rarely life-threatening shock (Ex. difficulty in breathing, drop of blood pressure, fast pulse, swelling including airway
• other allergic reactions like swelling of the skin (sometimes severe which includes swelling of the larynx)
• fast heartbeat (tachycardia)
• shortness of breath or difficulty breathing
• mild to moderate allergic reactions
• itching, a rash or hives

How To Manage Side Effects

Constipation:

Eat plenty of fiber-rich foods, such as fresh fruits, vegetables, and cereals,
and drink plenty of water. Exercise more regularly.

Dizziness

When you feel dizzy, lie down or sit down immediately. If you're experiencing a
severe episode of vertigo, lie in a dark, quiet place with your eyes closed.
Vehicle driving should be avoided if you experience frequent dizziness without
warning. Talk to your doctor if the symptom worsens.

Headache:

Apply a hot or cold-water bag to your head. Try to take a rest in a quiet, dark
environment. Drink tea or coffee. Massage with mild pressure on the scalp or
head.

Dry mouth:

A dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free
hard candies to stimulate the flow of saliva. Drink water at regular intervals.
Do not use mouthwashes that contain alcohol because they can be drying.

Warning & Precautions

!### Pregnancy

NIFEDINE should be used with caution during pregnancy but only after special
consideration done by your doctor. Consult your doctor before taking NIFEDINE.

!### Breastfeeding

NIFEDINE should be used with caution during pregnancy but only after special
consideration done by your doctor. Consult your doctor before taking NIFEDINE.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy or sleepy, extremely
tired, faint, or have visual disturbances after taking NIFEDINE. Consult your
doctor before taking NIFEDINE.

!### Alcohol

Avoid consuming alcohol as it may cause dizziness, fainting, extreme tiredness,
or visual disturbances.

!### Kidney

NIFEDINE should be taken with caution in patients undergoing kidney dialysis.
Consult your doctor before taking NIFEDINE.

!### Liver

NIFEDINE is not recommended for use in patients with liver disease and should be
used with caution when the liver is not working properly. Consult your doctor
before taking NIFEDINE.

!### Allergy

NIFEDINE is not recommended for use if you are allergic to Nifedipine.

!### Heart Disease

NIFEDINE is not recommended for use in patients who had a heart attack, unstable
angina, sudden angina attack, aortic stenosis (narrowing of the aortic valve)
and collapsed because of heart problems (cardiogenic shock). NIFEDINE should be
taken with caution in patients having poor cardiac reserve (the heart cannot
cope with increased strain). Consult with your doctor.

Others

NIFEDINE is not recommended for use if you have:

• inflammation of the bowel or intestines, such as Crohn’s disease
• obstruction or narrowing of intestines
• obstruction in the oesophagus (the tube connecting the throat to the stomach)
• Kock pouch (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut
• malignant hypertension (continuous rise in blood pressure despite management)

Before taking NIFEDINE, inform your doctor if you have:

• low blood pressure
• diabetic

Use in pediatrics:

NIFEDINE is not recommended for use in children and adolescents below 18 years
of age. Consult your doctor before taking NIFEDINE.

Interactions

A. Drug-Drug interactions:

• rifampicin (an antibiotic used to manage bacterial infections like tuberculosis)
• cimetidine (a medicine used to manage stomach ulcers)
• digoxin, diltiazem, quinidine, or beta-blockers like esmolol, and metoprolol (medicines used to manage heart conditions)
• quinupristin/dalfopristin (a combination antibiotic used to manage certain skin infections)
• phenytoin, carbamazepine or valproic acid (medicines used to manage epilepsy)
• cisapride (a medicine used to manage heartburn)
• magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure)
• erythromycin (a medicine used to manage or manage many infections)
• ketoconazole, itraconazole or fluconazole (medicines used to fungal infections)
• indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (medicines used to manage hiv)
• fluoxetine or nefazodone (medicines used to manage depression)
• tacrolimus (a medicine used to manage the rejection of transplanted organs)
• phenobarbital (a medicine usually used to manage insomnia or anxiety)

B.  Drug - Food interaction:

Do not drink grapefruit juice or eat grapefruit while taking NIFEDINE.

Overdosage:

If you or anyone else accidentally take too much of NIFEDINE, consult your
doctor immediately or visit the nearby hospital. The most common symptoms of
overdose are low blood pressure, heartbeats may be increased or slowed down,
increased blood sugar level, increased acidity in the blood, swelling in the
lungs, low blood oxygen levels and disturbances in consciousness leading to
unconsciousness.

Synopsis

Drug	:	Nifedipine
Pharmacological Category	:	Calcium Channel Blockers
Therapeutic Indication	:	High Blood Pressure, Angina
Dosage Forms	:	Tablet, Capsule

More Information

• Keep NIFEDINE out of reach from children
• Store at room temperature

FAQs About NIFEDINE

Can NIFEDINE be used to manage high blood pressure?

NIFEDINE can be used to manage high blood pressure by relaxing and expanding the
blood vessels for easy blood flow and also reducing the strain on the heart.

Can NIFEDINE be used in patients with liver and kidney disease?

NIFEDINE is not recommended for use in patients with liver disease and should be
used with caution when the liver is not working properly and the patient is
undergoing kidney dialysis. Consult your doctor before taking NIFEDINE.

Can NIFEDINE be given to children?

NIFEDINE should not be used by children or adolescents under the age of 18.
Consult your doctor before taking NIFEDINE.

Can NIFEDINE be taken with food?

NIFEDINE can be taken with or without food. But do not eat grapefruit or drink
grapefruit juice while taking NIFEDINE.

Does NIFEDINE cause constipation?

Constipation is one of the common side effects of NIFEDINE. Eat plenty of
fiber-rich foods, such as fresh fruits, vegetables, and cereals, and drink
plenty of water to manage constipation. Exercise more regularly.

Useful Diagnostic Tests

• Electrocardiogram (ECG)