Leaflet: Information for the User

Ranolazine Krka 375 mg prolonged-release tablets EFG

Ranolazine Krka 500 mg prolonged-release tablets EFG

Ranolazine Krka 750 mg prolonged-release tablets EFG

Read 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor even if they do not appear in this leaflet. See section 4.

Ranolazina 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.

Consult a doctor if it does not improve or worsens.

Do not take Ranolazina Krka:

• if you are allergic to ranolazine or 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 (acquired immune deficiency syndrome, AIDS) (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide or sotalol).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ranolazina Krka:

• 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 medicine or take other precautions.

Other medicines and Ranolazina Krka

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

Do not use any of the following medicines while taking ranolazine:

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

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

• certain medicines to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ transplant rejection (ciclosporin), or if you are taking heart tablets such as diltiazem or verapamil. These medicines may cause an increase in the number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of ranolazine treatment (see section 4). Your doctor may decide to give you a lower dose.
• medicines 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, as these medicines may make ranolazine less effective.
• heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine while you are taking ranolazine.
• certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• certain medicines to treat 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 you are taking ranolazine.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus), as your doctor may decide to change the dose of this medicine while you are taking ranolazine.

Taking Ranolazina Krka with food and drink

Ranolazine can be taken with or without food. While you are being treated with ranolazine, do not drink grapefruit juice.

Pregnancy and breastfeeding

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

Pregnancy

Do not take ranolazine if you are pregnant unless your doctor has told you that you can.

Breastfeeding

Do not take ranolazine if you are breastfeeding. Consult your doctor if you are breastfeeding.

Driving and operating machines

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

Ranolazine 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 machines. If you notice any of these symptoms, do not drive or operate machines until they have completely resolved.

Ranolazina Krka contains sodium

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

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

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

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

Use in children and adolescents

Children and adolescents under 18 years old should not take ranolazine.

If you take more Ranolazine Krka than you should

If you accidentally take too many ranolazine tablets or 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 (aluminum sheet containing the tablets) and the packaging, so that hospital staff can easily identify what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ranolazine Krka

If you forget to take a dose, take it as soon as you remember, except if it is almost time (less than 6 hours) for the next dose.

Do not take a double dose to compensate for the missed doses.

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

Stop taking ranolazine and consult your doctor immediately if you experience the following angioedema symptoms, which is a rare but potentially 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 your dose or advise you to stop taking ranolazine.

Other side effects you may experience:

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

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

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disturbances
• Alterations in sensation (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing
• 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, urea in the blood, increased platelet or white blood cell counts, electrocardiogram (ECG) alteration
• Joint swelling, limb pain
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Tinnitus in the ears and/or sensation of head spinning
• Abdominal pain or discomfort, indigestion, dry mouth, gas

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

• Inability to urinate
• Liver function test abnormalities
• 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
• 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
• Throat tightness
• Low sodium levels in the blood (hyponatremia) that may cause fatigue and confusion, muscle contractions, cramps, and coma

Side effects with unknown frequency (cannot be estimated from available data) are:

• Mioclonus

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 through 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 out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ranolazine Krka

• The active ingredient is ranolazine. Each prolonged-release tablet contains 375 mg, 500 mg, or 750 mg of ranolazine.
• The other components (excipients) are:

Ranolazine Krka 375 mg prolonged-release tablets : microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), hypromellose (5 mPa s), sodium hydroxide, and magnesium stearate (E470b) in the core of the tablet, and poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), and talc in the pellicular coating.

Ranolazine Krka 500 mg prolonged-release tablets : microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), hypromellose (5 mPa s), sodium hydroxide, and magnesium stearate (E470b) in the core of the tablet, and poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, and yellow iron oxide (E172) in the pellicular coating.

Ranolazine Krka 750 mg prolonged-release tablets : microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), hypromellose (5 mPa s), sodium hydroxide, and magnesium stearate (E470b) in the core of the tablet, and poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, and red iron oxide (E172) in the pellicular coating.

See section 2 “Ranolazine Krka contains sodium”.

Appearance of the product and contents of the package

Ranolazine Krka 375 mg prolonged-release tablets : The prolonged-release tablets are white, oval, biconvex, film-coated, and engraved with 375 on one side of the tablet. Dimensions of the tablet: approximately 15 x 7 mm.

Ranolazine Krka 500 mg prolonged-release tablets : The prolonged-release tablets are pale yellowish-brown, oval, biconvex, film-coated, and engraved with 500 on one side of the tablet. Dimensions of the tablet: approximately 17 x 8 mm.

Ranolazine Krka 750 mg prolonged-release tablets : The prolonged-release tablets are pink, oval, biconvex, film-coated, and engraved with 750 on one side of the tablet. Dimensions of the tablet: approximately 19 x 9 mm.

Ranolazine Krka is supplied in boxes containing 30, 60, or 100 prolonged-release tablets in blisters.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: December 2022

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