Ranolazine Normon 750 mg prolonged-release tablets EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ranolazina Normon is a medicine used in combination with other medications for the treatment of angina pectoris, a condition that causes chest pain or discomfort felt anywhere from the neck to the upper abdomen in the upper half of the body, often occurring during physical exertion or particularly intense activity.

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

2. What you need to know before starting to 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 to treat 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

Talk to 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 abnormal electrocardiogram (ECG).

• If you are elderly.

• If you are underweight (60 kg or less).

• If you have heart failure.

If any of these apply to you, your doctor may decide to prescribe a lower dose of the medicine or take other precautions.

Other medicines and Ranolazine Normon

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

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

• Certain medicines used to treat 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 taking:

• Certain medicines to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (cyclosporine), or heart medications such as diltiazem or verapamil. These medicines may increase the risk of adverse effects such as dizziness, nausea, or vomiting, which are possible side effects of ranolazine treatment (see section 4). If you are taking these medicines, your doctor may decide to prescribe a lower dose of ranolazine.
• Medicines for epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin for an infection (e.g. tuberculosis); or if you are taking the herbal remedy St. John’s wort (Hypericum perforatum), as these medicines may reduce the effectiveness of ranolazine.
• Heart medicines containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking ranolazine.
• Certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, amitriptyline), as these medicines may affect your electrocardiogram (ECG).
• Certain medicines used to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medicines used to treat high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of these medicines while you are taking ranolazine.
• Certain medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may decide to adjust the dose of these medicines while you are taking ranolazine.

Taking Ranolazine Normon with food and drinks

Ranolazine may be taken with or without food. While taking ranolazine, you must not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

You must not take ranolazine during pregnancy unless your doctor has specifically instructed you to do so.

You must not take ranolazine while breastfeeding. Consult your doctor 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 whether you can drive or use machines.

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

Ranolazine Normon contains sodium

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

3. How to take Ranolazina Normon

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Always swallow the tablets whole with water. Do not chew, suck, crush the tablets, or split them in half, as this may affect how the medicine is released in your body.

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

It is important that you inform your doctor if you experience adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or, if this is not sufficient, may instruct you to stop treatment with ranolazine.

Use in children and adolescents

Children and adolescents under 18 years of age must not take ranolazine.

If you take more Ranolazina Normon than you should

If you accidentally take more ranolazine 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 center. Take any leftover tablets with you, together with the blister pack (aluminum sheet containing the tablets) and the outer carton, so that hospital staff can easily identify what you have taken.

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

If you forget to take Ranolazina 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 away). Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You must stop taking ranolazine and contact your doctor immediately if you experience the following symptoms of angioedema, a rare but potentially serious condition:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives or difficulty breathing

Inform your doctor if you experience frequent adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or instruct you to stop taking ranolazine.

The following is a list of other possible adverse effects you may experience:

Frequent adverse effects (occur in 1 to 10 out of every 100 users):

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

Uncommon adverse effects (occur in 1 to 10 out of every 1,000 users):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Sensory disturbances (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, faintness or dizziness upon standing
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nosebleeds
• Double vision
• Excessive sweating, itching
• Feeling of swelling or puffiness
• Hot flushes, low blood pressure
• Increased levels of a substance called creatinine, increased blood urea, increased platelet or white blood cell counts, changes in electrocardiogram (ECG)
• Joint swelling, limb pain
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or sensation of spinning (vertigo)
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare adverse effects (occur in 1 to 10 out of every 10,000 users):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Changes in sense of smell, numbness of mouth or lips, hearing loss
• Cold sweats, rash
• Coordination problems
• Drop in blood pressure upon standing
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Feeling of coldness in hands and legs
• Hives, skin allergic reactions
• Impotence
• Inability to walk due to balance problems
• Inflammation of the pancreas or intestine
• Memory loss
• Throat tightness
• Low sodium levels in blood (hyponatremia), which may cause fatigue and confusion
• Muscle twitching, cramps, and coma

Adverse effects with frequency not known (cannot be estimated from available data): Myoclonus

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 stated on the packaging and on each blister, following "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines you no longer need. 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 components are:

Tablet core: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide, hypromellose and magnesium stearate.

Tablet coating: 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, printed with "375", "500" or "750" on one side.

Ranolazine Normon is available in cardboard boxes containing 60 tablets in blister packs.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent review of this leaflet: November 2022

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