RANOLAZINE NORMON 750 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Ranolazine Normon 375 mg prolonged-release tablets EFG

Ranolazine Normon 500 mg prolonged-release tablets EFG

Ranolazine Normon 750 mg prolonged-release tablets EFG

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, pharmacist, or nurse.
• 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ranolazine Normon and what is it used for

Ranolazine Normon is a medicine that is used in combination with other medicines for the treatment of angina pectoris, which is a disease that causes pain in the chest or discomfort that is felt in any part of the upper half of the body between the neck and the upper part of the abdomen, often after physical exercise or a particularly intense activity.

You should consult a doctor if it worsens or does not improve.

2. What you need to know before you take Ranolazine Normon

Do not take Ranolazine Normon

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

Warnings and precautions

Consult your doctor before starting to take ranolazine:

• If you have mild or moderate kidney problems.
• If you have mild liver problems.
• If you have ever had an electrocardiogram (ECG) abnormality
• If you are an elderly person.
• If you are a person of low weight (60 kg or less).

• If you have heart failure.

If you are in any of these situations, your doctor may decide to give you a lower dose of the medicine or take other precautions.

Other medicines and Ranolazine Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use any of the following medicines if you are taking ranolazine:

• Certain medicines for the treatment of bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g., quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before taking ranolazine if you are using:

• Certain medicines for treating bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ rejection after transplantation (cyclosporine), or if you are taking heart tablets such as diltiazem or verapamil. These medicines may cause a greater number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of treatment with ranolazine (see section 4). If you are taking these medicines, your doctor may decide to give you a lower dose of ranolazine.
• Medicines for the treatment of epilepsy or other neurological disorders (e.g., phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin to treat an infection (e.g., tuberculosis); or if you are taking a herbal medicine called St. John's Wort, you should inform your doctor because these medicines may make ranolazine less effective.
• Heart medicines that contain digoxin or metoprolol, as your doctor may decide to change the dose while you are taking ranolazine.
• Certain medicines for treating allergies (e.g., terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g., disopyramide, procainamide), and medicines for treating depression (e.g., imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• Certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medicines for treating high cholesterol levels in the blood (e.g., simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and damage. Your doctor may decide to change the dose of this medicine while you are taking ranolazine.
• Certain medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may decide to change the dose of this medicine while you are taking ranolazine.

Taking Ranolazine Normon with food and drinks

Ranolazine can be taken with or without food. While you are being treated with ranolazine, you should not drink grapefruit juice.

Pregnancy and breastfeeding

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

You should not take ranolazine if you are pregnant unless your doctor has told you that you can.

You should not take ranolazine if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.

Driving and using machines

No studies on the effects of ranolazine on the ability to drive and use machines have been performed. Ask your doctor if you can drive or use machines.

Ranolazine may cause side effects such as dizziness (frequent), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), coordination problems (rare), which may affect your ability to drive or use machines. If you notice any of these symptoms, do not drive or use machines until they have passed.

Ranolazine Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ranolazine Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water. Do not chew, suck, or crush the tablets, or divide them in half, as this may affect the way the medicine is released into your body.

The initial dose for adults is one 375 mg tablet twice a day. After a period of time between 2 and 4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of ranolazine is 750 mg twice a day.

It is important that you inform your doctor if you experience side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or tell you to stop taking ranolazine.

Use in children and adolescents

Children and adolescents under 18 years should not take ranolazine.

If you take more Ranolazine Normon than you should

If you accidentally take more tablets than you should, or take tablets of a higher dose than recommended by your doctor, it is important that you inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency department. Take the remaining tablets, along with the blister pack and packaging, so that hospital staff can easily see what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ranolazine Normon

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

4. Possible side effects

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

You should stop taking ranolazine and consult your doctor immediately if you experience the following symptoms of angioedema, which is a rare but serious disorder:

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives or difficulty breathing

Tell your doctor if you experience frequent side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or tell you to stop taking ranolazine.

The following are other side effects that you may experience:

Frequent side effects (occurring in between 1 and 10 of every 100 users):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Weakness (asthenia)

Uncommon side effects (occurring in between 1 and 10 of every 1,000 users):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disorders
• Altered senses (touch or taste), tremors, fatigue or weakness, somnolence or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in the urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nosebleed
• Double vision
• Excessive sweating, itching
• Feeling of swelling or bloating
• Hot flashes, low blood pressure
• Increased levels of a substance called creatinine, urea in the blood, platelet or white blood cell counts in the blood, altered electrocardiogram (ECG)
• Swelling of the joints, pain in the limbs
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or feeling of spinning
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare side effects (occurring in between 1 and 10 of every 10,000 users):

• Urination problems
• Altered liver laboratory values
• Acute kidney failure
• Altered sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweats, rash
• Coordination problems
• Low blood pressure when standing up
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Feeling of cold in hands and feet
• Hives, allergic skin reactions
• Impotence
• Inability to walk due to balance problems
• Pancreatitis or intestinal inflammation
• Memory loss
• Tightness in the throat
• Low sodium levels in the blood (hyponatremia) that can cause fatigue and confusion,
• Muscle contractions, cramps, and coma.

Side effects with unknown frequency (cannot be estimated from the available data): Myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranolazine Normon

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

Do not use this medicine after the expiry date which is stated on the packaging and on each blister, after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ranolazine Normon

The active substance is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg of ranolazine.

The other ingredients are:

Core of the tablet: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), sodium hydroxide, hypromellose, and magnesium stearate.

Coating of the tablet: Hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide E-171.

Appearance of the product and contents of the pack

Ranolazine Normon prolonged-release tablets are white, elongated, and convex, with "375", "500", or "750" engraved on one side.

Ranolazine Normon is available in cardboard boxes containing 60 tablets in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Lodzkie,

Poland

Date of last revision of this leaflet: November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/