Ranolazine PR Tablets 750mg (NEFAZOR)(NEFAZOR-XR)

Ranolazine Prolonged-Release Tablets 500mg (NEFAZOR)(NEFAZOR-XR)
Ranolazine Prolonged-Release Tablets 750mg (NEFAZOR)(NEFAZOR-XR)
Ranolazine Prolonged-Release Tablets 1000mg (NEFAZOR)(NEFAZOR-XR)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects to talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What NEFAZOR XR is and what it is used for
2. What you need to know before you take NEFAZOR XR
3. How to take NEFAZOR XR
4. Possible side effects
5. How to store NEFAZOR XR
6. Contents of the pack and other information

1. What NEFAZOR XR is and what it is used for

NEFAZOR XR is a medicine used in combination with other medicines to treat angina pectoris, which is chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take NEFAZOR XR

Do not take NEFAZOR XR

if you are allergic to ranolazine or any of the other ingredients of this medicine listed in section 6 of this leaflet.
if you have severe kidney problems.
if you have moderate or severe liver problems.
if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, oxiconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Warning and precautions

Talk to your doctor before taking NEFAZOR XR:

if you have mild or moderate kidney problems.
if you have mild liver problems.
if you have ever had an abnormal electrocardiogram (ECG).
if you are elderly.
if you have low weight (60 kg or less).
if you have heart failure.

Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.

Using other medicines and NEFAZOR XR

Do not use the following medicines if you take NEFAZOR XR:

certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before you take NEFAZOR XR if you use:

certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil. These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of NEFAZOR XR (see section 4). Your doctor may decide to give you a lower dose.
medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for infection (e.g. tuberculosis), or are taking the herbal remedy St. John’s Wort, as these medicines may cause NEFAZOR XR to be less effective.
heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine whilst you are taking NEFAZOR XR.
certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
certain medicines to treat high levels of cholesterol in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle injury. Your doctor may decide to change the dose of this medicine while you are taking NEFAZOR XR.
certain medicines used to prevent transplanted organ rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while you are taking NEFAZOR XR.

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

NEFAZOR XR with food and drink

NEFAZOR XR can be taken with or without food. While being treated with NEFAZOR XR, you should not drink grapefruit juice.

Pregnancy

You should not take NEFAZOR XR if you are pregnant unless your doctor has advised you to do so.

Breast-feeding

You should not take NEFAZOR XR if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

No studies on the effects of NEFAZOR XR on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.

NEFAZOR XR may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems (rare), that may affect your ability to drive or use machines. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.

NEFAZOR XR 750mg prolonged-release tablets contain the azo colouring agent E102. This colouring agent may cause allergic reactions.

NEFAZOR XR 750mg prolonged-release tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ?sodium-free?.

3. How to take NEFAZOR XR

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

Always swallow the tablets whole with water. Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.

The starting dose for adults is one 375mg tablet twice a day. After 2?4 weeks, your doctor may increase the dose to get the right effect. The maximum dose of NEFAZOR XR is 750mg twice a day.

It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick. Your doctor may lower your dose or, if this is not sufficient, stop treatment with NEFAZOR XR.

Use in children and adolescents

Children and adolescents under 18 years old should not take NEFAZOR XR.

If you take more NEFAZOR XR than you should

If you accidentally take too many NEFAZOR XR tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once. If you cannot contact your doctor, go to the nearest accident and emergency department. Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.

If you forget to take NEFAZOR XR

If you forget to take a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking NEFAZOR XR and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe:

swollen face, tongue, or throat
difficulty swallowing
hives or difficulty breathing

Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting. Your doctor may lower your dose or stop treatment with NEFAZOR XR.

Other side effects you may experience include the following:

Common side effects (occur in 1 to 10 users in 100) are:

Constipation

Dizziness

Headache

Feeling sick, vomiting

Feeling weak

Uncommon side effects (occur in 1 to 10 users in 1,000) are:

Altered sensation

Anxiety, difficulty sleeping, confusional state, hallucination

Blurred vision, visual disturbance

Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness, faint or fainting, dizziness upon standing

Dark urine, blood in urine, difficulty urinating

Dehydration

Difficulty breathing, cough, nose bleed

Double vision

Excessive sweating, itching

Feeling swollen or bloated

Hot flushes, low blood pressure

Increases in a substance called creatinine or increases in urea in your blood, increase in blood platelets or white blood cells, changes in ECG heart tracing

Joint swelling, pain in extremity

Loss of appetite and/or weight loss

Muscle cramp

Ringing in the ears and/or feeling a spinning sensation

Stomach pain or discomfort, indigestion, dry mouth, or wind

Rare side effects (occur in 1 to 10 users in 10,000) are:

A lack of ability to urinate

Abnormal laboratory values for liver

Acute kidney failure

Change in sense of smell, numbness in mouth or lips, impaired hearing

Cold sweat, rash

Coordination problems

A decrease in blood pressure upon standing

Decreased or loss of consciousness

Disorientation

Feeling of coldness in hands and legs

Hives, allergic skin reaction

Impotence

Inability to walk due to imbalance

Inflammation of pancreas or intestine

Loss of memory

Throat tightness

Low level of sodium in the blood (hyponatremia) which can cause tiredness and confusion, muscle twitching, cramps, and coma.

The following has also been reported:

Muscle weakness.

5. How to store NEFAZOR XR

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What NEFAZOR XR contains

The active substance in NEFAZOR XR is ranolazine. Each tablet contains 375 mg, 500 mg, or 750mg ranolazine.

The other ingredients are hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.

Depending on the tablet strength, the tablet coatings also contain:

375mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132)

500mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)

750mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)

What NEFAZOR XR looks like and contents of the pack

NEFAZOR XR prolonged-release tablets are oval-shaped tablets.

NEFAZOR XR is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles. Not all pack sizes may be marketed.

7.? Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll-Free Phone: (1800-222-434 / 1800-222-825)Ranolazine Prolonged-Release Tablets 500mg (NEFAZOR)(NEFAZOR-XR)