Ranozek 375 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ranozek 375 mg prolonged-release tablets EFG

Ranozek 500 mg prolonged-release tablets EFG

Ranozek 750 mg prolonged-release tablets EFG

ranolazine

Read the entire 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Ranozek is and what it is used for
2. What you need to know before taking Ranozek
3. How to take Ranozek
4. Possible side effects
5. How to store Ranozek
6. Contents of the pack and other information

1. What Ranozek is and what it is used for

Ranozek is a medicine used in combination with other treatments for angina pectoris, a condition that causes chest pain or discomfort felt anywhere in the upper half of the body between the neck and the upper abdomen, often occurring after 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 taking Ranozek

Do not take Ranozek

• if you are allergic to ranolazine or to 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 taking 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).

Warnings and precautions

Talk to your doctor before taking this medicine:

• 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 Ranozek

Tell 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 Ranozek:

• 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 this medicine if you are using:

• certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or if you are taking heart tablets such as diltiazem or verapamil. These medicines may increase the likelihood of side effects such as dizziness, nausea, or vomiting, which are possible side effects of treatment with this medicine (see section 4). If you are taking these medicines, your doctor may decide to prescribe a lower dose of this medicine.
• medicines used to treat 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 remedy called St. John’s wort (Hypericum perforatum), you must inform your doctor, as these medicines may make this medicine less effective.
• heart medicines containing digoxin or metoprolol, as your doctor may decide to adjust your dose while you are taking this medicine.
• certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or medicines used to treat 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 (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of this medicine while you are taking them.
• certain medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), in which case your doctor may decide to adjust the dose of this medicine while you are taking them.

Taking Ranozek with food and drink

This medicine may be taken with or without food. While being treated with this medicine, 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 using this medicine.

Pregnancy

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

Breastfeeding

You must not take this medicine while breastfeeding. Seek advice from your doctor if you are breastfeeding.

Driving and using machines

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

This medicine may cause side effects such as dizziness (common), 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 experience any of these symptoms, do not drive or operate machinery until they have resolved.

Ranozek contains sodium

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

3. How to take Ranozek

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Always swallow the tablets whole with water. Do not chew, suck, crush, or split the tablets, 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 this medicine is 750 mg twice daily.

It is important to inform your doctor if you experience adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or, if necessary, instruct you to stop taking this medicine.

Use in children and adolescents

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

If you take more Ranozek than you should

If you accidentally take more tablets of this medicine than you should, or take tablets of a higher dose than recommended by your doctor, it is important to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency center. Take any remaining tablets with you, along with the blister pack and container, 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, stating the medicine and the amount ingested.

If you forget to take Ranozek

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 missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

You must stop taking this medicine and consult your doctor immediately if you experience the following symptoms of angioedema, which is a rare disorder but may be serious:

• 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 this medicine.

Other adverse effects you may experience include the following:

Frequent adverse effects (may affect up to 1 in 10 people):

Constipation
Dizziness
Headache
Nausea, vomiting
Weakness (asthenia)

Uncommon adverse effects (may affect up to 1 in 100 people):

Altered sensitivity
Anxiety, difficulty sleeping, confusion, hallucinations
Blurred vision, visual disturbances
Sensory disturbances (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness upon standing
Dark urine, blood in urine, difficulty urinating
Dehydration
Breathing difficulty, cough, nosebleeds
Double vision
Excessive sweating, itching
Sensation of swelling or puffiness
Hot flushes, low blood pressure

Increased levels of a substance called creatinine or increased blood urea, increased platelet or white blood cell counts, electrocardiogram (ECG) abnormalities
Joint swelling, limb pain
Loss of appetite and/or weight loss
Muscle cramps, muscle weakness
Ringing in the ears and/or sensation of dizziness
Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare adverse effects (may affect up to 1 in 1,000 people):

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
Tightness in the throat
Low sodium levels in blood (hyponatremia), which may cause fatigue and confusion, muscle twitching, cramps, and coma.

Frequency not known (frequency cannot be estimated from available data):

Myoclonus

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranozek

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

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ranozek

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

The other components are:

Tablet core: microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide (E524), hypromellose (E464), and magnesium stearate (E470b).

Film coating AquaPolish P white: hypromellose (E464), hydroxypropylcellulose (E463), polyethylene glycol 8000 (E1521), and titanium dioxide (E171).

Appearance of the product and contents of the container

The 375 mg tablets are white, film-coated, oval-shaped, convex tablets, 15 mm x 7.2 mm in size, with "375" engraved on one side.

The 500 mg tablets are white, film-coated, oval-shaped, convex tablets, 16.5 mm x 8.0 mm in size, with "500" engraved on one side.

The 750 mg tablets are white, film-coated, oval-shaped, convex tablets, 19 mm x 9.2 mm in size, with "750" engraved on one side.

Ranozek is available in packs containing 30, 60, or 100 tablets in PVC/PVDC-Aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
c/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid
Spain

Manufacturer

Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5
95-200 Pabianice
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Atika Pharma S.L.
Calle Viera y Clavijo, 30, 2nd floor
35002 Las Palmas de Gran Canaria
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: May 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es.