Package Insert: Information for the Patient

Ranozek 375 mg Extended-Release Tablets EFG

Ranozek 500 mg Extended-Release Tablets EFG

Ranozek 750 mg Extended-Release Tablets EFG

ranolazine

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.See section 4.

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

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

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 leaflet.
• if you have severe kidney problems.
• if you have moderate or severe liver problems.
• if you are taking certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (acquired immunodeficiency syndrome, 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 abnormal electrocardiogram (ECG).
• 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 cases, your doctor may decide to give you a lower dose of the medication or take other precautions.

Other medications and Ranozek

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

Do not use any of the following medications while taking Ranozek:

-certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (acquired immunodeficiency syndrome, AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Inform your doctor or pharmacist before taking this medication if you are using:

• certain medications to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medication used to prevent organ transplant rejection (cyclosporine), or if you are taking heart tablets such as diltiazem or verapamil. These medications may cause a greater number of 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 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 medicine called St. John's Wort, 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 your dose while taking this medication.
• certain medications to treat allergies (e.g. terfenadine, astemizole, or mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and medications to treat depression (e.g. imipramine, doxepin, or amitriptyline), as these medications may alter your electrocardiogram (ECG).
• certain medications to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• certain medications to treat high cholesterol levels in the blood (e.g. simvastatin, lovastatin, or atorvastatin). These medications may cause muscle pain and damage. Your doctor may decide to change the dose of this medication while taking this medication.
• certain medications used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, or everolimus), so your doctor may decide to change the dose of this medication while 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, do not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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.

Breastfeeding

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

Driving and operating machinery

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

This medication may cause side effects such as dizziness (frequent), blurred vision (infrequent), confusion (infrequent), hallucinations (infrequent), double vision (infrequent), coordination problems (rare), which may affect your ability to drive or operate machinery. If you notice any of these symptoms, do not drive or operate machinery 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".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Swallow the tablets whole with water. Do not chew, suck, or crush the tablets, or divide them in half, as this can affect how the medication is released in your body.

The initial dose for adults is one 375 mg tablet taken 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 medication is 750 mg taken twice a day.

It is essential to inform your doctor if you experience side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or, if that is not sufficient, instruct you to stop taking this medication.

Use in children and adolescents

Children and adolescents under 18 years old 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 take or take tablets of a higher dose than recommended by your doctor, it is essential to inform your doctor immediately. If you cannot reach your doctor, go to the nearest emergency department. Bring with you the remaining tablets, along with the blister pack and packaging, so that hospital staff can easily identify 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 forgot to take Ranozek

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next dose (less than 6 hours). Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Inform 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 the following:

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

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (Asthenia)

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

Altered sensitivity

Anxiety, difficulty sleeping, confusion, hallucinations

Blurred vision, vision disturbances

Alterations in senses (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up

Dark urine, blood in urine, difficulty urinating

Dehydration

Difficulty breathing, cough, nasal bleeding

Diplopia

Excessive sweating, pruritus

Sensation of swelling or heaviness

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, alteration of the electrocardiogram (ECG)

Swelling of the joints, pain in the limbs

Loss of appetite and/or weight loss

Muscle cramps, muscle weakness

Tinnitus in the ears and/or sensation of the head spinning

Abdominal pain or discomfort, indigestion, dry mouth, gas

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

Inability to urinate

Abnormal liver function test results

Acute renal failure

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

Cold sweat, urticaria

Coordination problems

Low blood pressure when standing up

Decreased level of consciousness or loss of consciousness

Disorientation

Sensation of cold in hands and feet

Hives, skin allergic reactions

Impotence

Inability to walk due to balance problems

Pancreatitis or intestinal inflammation

Memory loss

Stridor in the throat

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

Unknown frequency(frequency cannot be estimated from available data):

Myoclonus

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. 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 through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Ranozek

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

The other components are:

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

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

Appearance of the product and contents of the package

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

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

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

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized inthe member states of the European Economic Area with the following names:

Last review date of this leaflet: May 2022

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