RANOLAZINA TSENTIVA 375 mg Extended-release tablet

Зміст інструкції

1. Ranolazina Zentiva 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets
   1. What is Ranolazina Zentiva and what is it used for
   2. What you need to do before you take Ranolazina Zentiva
   3. How to take Ranolazina Zentiva
   4. Possible side effects
   5. How to store Ranolazina Zentiva
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

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

Ranolazina Zentiva is a medicine used in association with other medicines for the treatment
of angina pectoris, a condition that manifests with 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 exercise or
excessive activity.
See your doctor if you do not feel better or if you feel worse.

2. What you need to do before you take Ranolazina Zentiva

Do not take Ranolazina Zentiva

• if you are allergic to ranolazine or 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 using 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).

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 weigh little (60 kg or less).
• if you have heart failure. In these cases, your doctor may decide to give you 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 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 Ranolazina Zentiva if you are using:

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

Ranolazina Zentiva with food and drink
You can take Ranolazina Zentiva with or without food. During treatment with Ranolazina Zentiva you should not
drink grapefruit juice.

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

Breastfeeding
Do not take Ranolazina Zentiva if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor
for advice before taking this medicine.

Driving and using machines
Studies have not been performed on the effects of Ranolazina Zentiva on the ability to drive
and use machines. Ask your doctor for advice about driving and using machines.
Ranolazina Zentiva may cause side effects such as dizziness (common), blurred vision (not
common), confusion (not common), hallucinations (not common), double vision (not common),
abnormal coordination (rare), which may 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 contains the azo dye
E102. This dye may cause allergic reactions.
Ranolazina Zentiva 750 mg prolonged-release tablets contains lactose monohydrate. If
your doctor has told you that you have an intolerance to some types of sugar, contact him or her before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, which is
essentially ‘sodium-free’.

3. How to take Ranolazina Zentiva

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

Use in children and adolescents
Children and adolescents under 18 years of age must not take Ranolazina Zentiva.

If you take more Ranolazina Zentiva than you should
If you accidentally take too many Ranolazina Zentiva tablets or take a higher dose than
recommended by your doctor, it is important that you inform him/her immediately. If you cannot contact
your doctor, go to the nearest emergency room. Bring with you any remaining tablets,
including the container and the box so that hospital staff can easily understand what
you are taking.

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 to
take the next dose (if less than 6 hours remain). Do not take a double dose to make up for
forgetting the dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Ranolazina Zentiva and see your doctor immediately 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
• urticaria or difficulty breathing

Tell your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may
reduce the dosage or stop treatment with Ranolazina Zentiva.
Other side effects that you may experience include:
Common side effects (occur in 1–10 people out of 100) are:

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

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confused state, hallucinations
• Blurred vision, visual disturbances
• Changes in the senses (of touch or taste), tremor, feeling tired or sluggish, numbness or drowsiness, feeling faint or fainting, dizziness when standing up
• Dark urine, blood in the urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nosebleed
• Double vision
• Excessive sweating, itching
• Feeling of swelling or fullness
• Hot flushes, low blood pressure
• Increases in a substance called creatinine or increases in urea in the blood, increased number of platelets or white blood cells in the blood, changes in the heart tracing on an ECG
• Joint swelling, pain in the extremities
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Feeling of sounds in the ears and/or dizziness
• Stomach pain or discomfort, indigestion, dry mouth or flatulence

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

• Difficulty urinating normally
• Altered laboratory values for the liver
• Acute renal failure
• Alteration of the sense of smell, numbness of the mouth or lips, impaired hearing
• Cold sweat, rash
• Problems with coordination
• Lowering of blood pressure when standing up
• Reduced or loss of consciousness
• Disorientation
• Feeling of coldness in the hands and feet
• Urticaria, allergic skin reaction
• Impotence
• Difficulty walking due to lack of balance
• Inflammation of the pancreas or intestine
• Memory loss
• Sensation of constriction in the throat
• Low levels of sodium in the blood (hyponatremia) which can cause fatigue and confusion, muscle contractions, cramps and coma. Side effects with unknown frequency (frequency cannot be estimated based on available data) are:
• Myoclonus

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Ranolazina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on each blister and on the pack and
on the bottle after the words “Exp.”.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 ingredient of 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 dosage, the coating also contains:
375 mg tablet: hypromellose 2910, titanium dioxide, macrogol 8000, polysorbate 80 and FD&C Blue No.2/
indigotine aluminium lake (E132)
500 mg tablet: polyvinyl alcohol, titanium dioxide, macrogol 3350, macrogol 8000, 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/ FCF brilliant blue aluminium lake (E133)

Description of the appearance of Ranolazina Zentiva and contents of the pack
The prolonged-release tablets of Ranolazina Zentiva are oval-shaped tablets.
The 375 mg tablets are light blue in colour with the inscription 375 imprinted on one side. The
500 mg tablets are light orange in colour with the inscription 500 imprinted on one side. The
750 mg tablets are light green in colour with the inscription 750 imprinted on one side.
Ranolazina Zentiva is supplied in boxes of 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

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