RANOZEK 375 MG PROLONGED-RELEASE TABLETS

2. What you need to know before taking Ranozek

Do not take Ranozek

• if you are allergic to ranolazine or any of the other components of this medication listed in section 6 of this package leaflet.
• if you have severe kidney problems.
• if you have moderate or severe liver problems.
• if you are taking certain medications 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 medication:

• 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 underweight (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 medication or take other precautions.

Other medications and Ranozek

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not use any of the following medications if you are taking Ranozek:

• certain medications 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 medication if you are using:

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

Taking Ranozek with food and drinks

This medication can be taken with or without food. While you are being treated with this medication, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take this medication if you are pregnant unless your doctor has told you to do so.

Breastfeeding

Do not take this medication if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.

Driving and using machines

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

This medication 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.

Ranozek contains sodium

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

3. How to take Ranozek

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Always 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 medication is released in your body.

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

It is essential 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 this medication.

Use in children and adolescents

Children and adolescents under 18 years of age should not take this medication.

If you take more Ranozek than you should

If you accidentally take more tablets of this medication than you should, or take tablets of a higher dose than recommended by your doctor, it is essential 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 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

You should stop taking this medication and consult your doctor immediately if you experience the following symptoms of angioedema, which is a rare but potentially 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 medication.

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 urea in the blood, increased platelet or white blood cell counts, altered electrocardiogram (ECG)

Swollen 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):

Urinary retention

Abnormal liver laboratory values

Acute kidney failure

Disturbances in the 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

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 available data):

Myoclonus

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through 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 medication.

5. Storage of Ranozek

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ranozek

The active ingredient 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, film-coated tablets, 15 mm x 7.2 mm in size, and have "375" engraved on one side.

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

The 750 mg tablets are white, oval, convex, film-coated tablets, 19 mm x 9.2 mm in size, and have "750" engraved 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 medication is authorized inthe Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet: May 2022

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