Ranolazine Zentiva

PATIENT INFORMATION LEAFLET

Ranolazine Zentiva 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets

Equivalent medicinal product
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor. See section 4.

Contents of this leaflet

1. What Ranolazine Zentiva is and what it is used for
2. What you need to know before taking Ranolazine Zentiva
3. How to take Ranolazine Zentiva
4. Possible side effects
5. How to store Ranolazine Zentiva
6. Contents of the pack and other information

1. What Ranolazina Zentiva is and what it is used for

Ranolazina Zentiva is a medicine used in combination with other medicines for the treatment of
angina pectoris, a condition characterized by pain or discomfort in the chest, located anywhere in the
upper part of the trunk between the neck and the upper abdomen, often triggered by physical exertion or
excessive activity.
Contact your doctor if you do not feel better or if you feel worse.

2. What you must do before taking Ranolazina Zentiva

Do not take Ranolazina Zentiva

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

Warnings and precautions
Talk to your doctor before taking Ranolazina Zentiva:

• 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 elderly.
• if you are underweight (60 kg or less).
• if you have heart failure. In these cases, your doctor may decide to prescribe a lower dose or take other precautions.

Other medicines and Ranolazina Zentiva
Do not use the following medicines if you are taking Ranolazina Zentiva:

• certain medicines used to treat 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 Ranolazina Zentiva if you are taking:

• certain medicines for bacterial infection (erythromycin) or fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or heart medicines such as diltiazem or verapamil. These medicines may increase the risk of side effects such as dizziness, nausea, or vomiting, which are possible side effects of Ranolazina Zentiva (see section 4). Your doctor may decide to prescribe a lower dose.
• medicines for epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin for an infection (e.g. tuberculosis) or the herbal remedy St John’s wort, as these medicines may reduce the effectiveness of Ranolazina Zentiva.
• heart medicines containing digoxin or metoprolol, because your doctor may need to adjust the dose of these medicines while you are taking Ranolazina Zentiva.
• certain medicines for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, or amitriptyline), because these medicines may alter your ECG.
• certain medicines for depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
  certain medicines used to treat high cholesterol levels in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines can cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of these medicines while you are taking Ranolazina Zentiva.
  certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to adjust the dose of these medicines while you are taking Ranolazina Zentiva.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Ranolazina Zentiva with food and drink
Ranolazina Zentiva can be taken with or without food. During treatment with Ranolazina Zentiva, you must not drink grapefruit juice.

Pregnancy
Do not take Ranolazina Zentiva during pregnancy unless advised by your doctor.

Breast-feeding
Do not take Ranolazina Zentiva if you are breast-feeding. Consult your doctor if you are breast-feeding.

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

Driving and using machines
No studies on the effects of Ranolazina Zentiva on the ability to drive or use machines have been conducted. Consult your doctor regarding driving and using machines.
Ranolazina Zentiva may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), or abnormal coordination (rare), which could affect your ability to drive or use machines. If you experience these symptoms, do not drive or use machines until they have completely resolved.

Ranolazina Zentiva 750 mg prolonged-release tablets contain the azo dye E102. This colouring agent may cause allergic reactions.
Ranolazina Zentiva 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. essentially ‘sodium-free’.

3. How to take Ranolazina Zentiva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablets must always be swallowed whole with water. Do not crush, suck, chew, or split the tablets in half, as this could affect the way the medicine is released into your body.
The initial dose for adults is one 375 mg tablet twice daily. After 2–4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of Ranolazina Zentiva is 750 mg twice daily.
It is important that you inform your doctor if you experience any side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or, if necessary, discontinue treatment with Ranolazina Zentiva.

Use in children and adolescents
Ranolazina Zentiva must not be used in children and adolescents under 18 years of age.

If you take more Ranolazina Zentiva than you should
If you accidentally take too many Ranolazina Zentiva tablets or take a higher dose than prescribed by your doctor, it is important to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency department. Take any remaining tablets with you, including the container and packaging, so that hospital staff can easily identify what you have taken.

If you forget to take Ranolazina Zentiva
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 remaining). Do not take a double dose to make up for the missed dose.

4. Possible side effects

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

You must stop taking Ranolazina Zentiva and seek immediate medical attention if you experience the following symptoms of angioedema, which is a rare but sometimes serious condition:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives or difficulty breathing

Inform your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may reduce your dose or stop your treatment with Ranolazina Zentiva.

Other possible side effects you may experience include:

Common side effects (occur in 1–10 people out of 100):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Feeling of weakness

Uncommon side effects (occur in 1–10 people out of 1,000):

• Altered sensation
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Changes in sensation (touch or taste), tremor, feeling of fatigue or sluggishness, numbness or drowsiness, feeling of faintness or fainting, dizziness upon standing
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nosebleed
• Double vision
• Excessive sweating, itching
• Feeling of bloating or fullness
• Hot flushes, low blood pressure
• Increases in a substance called creatinine or increases in blood urea, increased platelet or white blood cell count, changes in the heart’s ECG pattern
• Joint swelling, pain in the extremities
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Sensation of sounds in the ears and/or dizziness
• Stomach pain or discomfort, indigestion, dry mouth or intestinal gas

Rare side effects (occur in 1–10 people out of 10,000):

• Difficulty urinating normally
• Abnormal liver function test results
• Acute kidney failure
• Altered sense of smell, numbness of mouth or lips, hearing impairment
• Cold sweating, rash
• Coordination problems
• Drop in blood pressure upon standing
• Reduced or loss of consciousness
• Disorientation
• Feeling of coldness in hands and feet
• Hives, allergic skin reaction
• Impotence
• Difficulty walking due to lack of balance
• Inflammation of the pancreas or intestine
• Memory loss
• Sensation of tightness in the throat
• Low sodium levels in the blood (hyponatraemia), which may cause fatigue and confusion, muscle twitching, cramps and coma

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

• Myoclonus

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ranolazine Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on each blister, the outer carton, and the bottle after the word "Exp.".
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ranolazina Zentiva contains
The active substance in Ranolazina Zentiva is ranolazine. Each tablet contains 375 mg, 500 mg, or
750 mg of ranolazine.
The excipients are: methacrylic acid-ethyl acrylate copolymer (1:1) (type A), microcrystalline
cellulose 101, hypromellose (2910), sodium hydroxide, and magnesium stearate.
Depending on the tablet strength, the coating also contains:
375 mg tablet: hypromellose 2910, titanium dioxide, macrogol 8,000, polysorbate 80, and FD&C Blue No.2/
indigo carmine aluminium lake (E132)
500 mg tablet: polyvinyl alcohol, titanium dioxide, macrogol 3,350, macrogol 8,000, talc, yellow iron oxide (E172), and red iron oxide (E172)
750 mg tablet: hypromellose 2910, lactose monohydrate, titanium dioxide, triacetin, FD&C Yellow No. 5/
tartrazine aluminium lake (E102), FD&C Blue No.1/ brilliant blue FCF aluminium lake (E133)

Description of the appearance of Ranolazina Zentiva and the contents of the pack
Ranolazina Zentiva prolonged-release tablets are oval-shaped tablets.
The 375 mg tablets are light blue in colour, with "375" printed on one side. The 500 mg tablets are light orange in colour, with "500" printed on one side. The 750 mg tablets are light green in colour, with "750" printed on one side.
Ranolazina Zentiva is supplied in boxes containing 30, 60, or 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
Elpen Pharmaceutical Co. Inc
95 Marathonos Ave., Pikermi, Attiki, 19009, Greece