RANOLAZINE KRKA 375 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Ranolazine Krka

Do not take Ranolazine 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 for bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (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 Ranolazine Krka:

• 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 Ranolazine Krka

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 ranolazine:

• certain medicines for the treatment of bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide or sotalol).

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

• certain medicines for treating bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ rejection after transplantation (cyclosporin), 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 treatment with ranolazine (see section 4). Your doctor may decide to give you a lower dose.
• medicines for the treatment of 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, as these medicines may make ranolazine less effective.
• medicines for the heart that contain digoxin or metoprolol, as your doctor may want to change the dose of this medicine while you are taking ranolazine.
• certain medicines for treating 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 for treating depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• certain medicines for treating high blood cholesterol levels (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 rejection after transplantation (e.g. tacrolimus, cyclosporin, sirolimus, everolimus), as your doctor may decide to change the dose of this medicine while you are taking ranolazine.

Taking Ranolazine Krka with food and drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breast-feeding

You should not take ranolazine if you are breast-feeding. Consult your doctor if you are breast-feeding.

Driving and using machines

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

Ranolazine 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 completely resolved.

Ranolazine Krka contains sodium

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

3. How to take Ranolazine Krka

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 crush, chew or break the tablets, 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 2-4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of ranolazine 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 ranolazine.

Use in children and adolescents

Children and adolescents under 18 years 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 important that you inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency department. 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 or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ranolazine Krka

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

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

You should stop taking ranolazine 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 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)

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disorders
• Altered senses (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, urea in the blood, increased platelet or white blood cell counts in the blood, 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) are:

• Urination problems
• Abnormal liver laboratory values
• Acute kidney failure
• Altered 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

Side effects with frequency not known (cannot be estimated from the available data) are:

• 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 Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranolazine Krka

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Store below 25°C.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Ranolazine Krka

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

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

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

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

See section 2 “Ranolazine Krka contains sodium”.

Appearance of the product and pack contents

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

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

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

Ranolazine Krka is available in packs of 30, 60 or 100 prolonged-release tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

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

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:December 2022

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