RANOZEK 750 MG PROLONGED-RELEASE TABLETS EFG

2. What you need to know before you take Ranozek

Do not take Ranozek

• 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 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 taking this medicine:

• 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 Ranozek

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 Ranozek:

• 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).

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

• certain medicines for bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ rejection after transplantation (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medicines may cause more 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 give you a lower dose of this medicine.
• medicines for epilepsy or other neurological disorders (e.g., phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin for tuberculosis; or if you are taking a herbal medicine called St. John's Wort, you should inform your doctor because these medicines may make this medicine less effective.
• heart medicines that contain digoxin or metoprolol, as your doctor may decide to change your dose while taking this medicine.
• certain medicines for allergies (e.g., terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g., disopyramide, procainamide), and medicines for depression (e.g., imipramine, doxepin, amitriptiline), as these medicines may alter your electrocardiogram (ECG).
• certain medicines for depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• certain medicines for 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 taking this medicine.
• certain medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while taking this medicine.

Taking Ranozek with food and drinks

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

Pregnancy

Do not take this medicine if you are pregnant unless your doctor has told you to.

Breastfeeding

Do not take this medicine if you are breastfeeding. Ask your doctor for advice 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 if you can drive or use machines.

This medicine 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 experience any of these symptoms, do not drive or use machines until they have passed.

Ranozek contains sodium

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

3. How to take Ranozek

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 this medicine 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 the treatment with this medicine.

Use in children and adolescents

Children and adolescents under 18 years should 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 that you inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency center. Take the remaining tablets, along with the blister and packaging, so that the 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 Toxicology Information Service, phone 91 562 04 20, indicating 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). Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

You should stop taking this medicine 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 this medicine.

Other side effects you may experience include:

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

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (asthenia)

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

Altered sensitivity

Anxiety, difficulty sleeping, confusion, hallucinations

Blurred vision, vision disorders

Sensory disturbances (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

Breathing difficulties, cough, nosebleeds

Double vision

Excessive sweating, itching

Feeling of swelling or bloating

Hot flashes, low blood pressure

Increased levels of a substance called creatinine or increased urea in the blood, increased 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(may affect up to 1 in 1,000 people):

Urination problems

Abnormal liver laboratory values

Acute kidney failure

Disturbances in the sense of smell, numbness of the mouth or lips, hearing loss

Cold sweat, 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

Throat tightness

Low sodium levels in the blood (hyponatremia) that can cause fatigue and confusion, muscle contractions, cramps, and coma.

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

Myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 Ranozek

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

The other ingredients are:

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

White AquaPolish coating: hypromellose (E464), hydroxypropylcellulose (E463), macrogol 8000 (E1521), and titanium dioxide (E171).

Appearance of the product and pack contents

The 375 mg tablets are white, oval, convex, and have dimensions of 15 mm x 7.2 mm, and are engraved with "375" on one side.

The 500 mg tablets are white, oval, convex, and have dimensions of 16.5 mm x 8.0 mm, and are engraved with "500" on one side.

The 750 mg tablets are white, oval, convex, and have dimensions of 19 mm x 9.2 mm, and are engraved with "750" on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the European Economic Area member states under the following names:

Date of last revision of this leaflet: May 2022

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