RANOLAZINA 375 mg Tabletka O Przedłużonym Uwalnianiu

Treść ulotki

1. Ranolazina DOC 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets
   1. What is Ranolazina DOC and what is it used for
   2. What you need to know before you take Ranolazina DOC
   3. How to take Ranolazina DOC
   4. Possible side effects
   5. How to store Ranolazina DOC
   6. Package Contents and Other Information

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

Generic medicine

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

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

Ranolazina DOC 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 know before you take Ranolazina DOC

Do not take Ranolazina DOC

• 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 DOC:

• 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 DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not use the following medicines if you are taking Ranolazina DOC:

• 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 DOC 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 DOC (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 DOC;
• heart medicines based on digoxin or metoprolol, because your doctor may decide to change the dose of these medicines while you are taking Ranolazina DOC;
• 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 DOC;
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to change the dose of these medicines while you are taking Ranolazina DOC.

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

Ranolazina DOC with food and drink
Ranolazina DOC can be taken with or without food. During treatment with Ranolazina DOC you should not
drink grapefruit juice.
Pregnancy
Do not take Ranolazina DOC during pregnancy unless your doctor advises you to do so.
Breastfeeding
Do not take Ranolazina DOC 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, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.

Driving and using machines
No studies have been performed on the effects of Ranolazina DOC on the ability to drive and operate
machines. Ask your doctor about driving and using machines.
Ranolazina DOC 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 operate
machines. If you experience these symptoms, do not drive or operate machinery until they have completely resolved.

Ranolazina DOC 750 mg prolonged-release tablets contains the azo dye E102.
This coloring agent may induce allergic reactions.
Ranolazina DOC 750 mg prolonged-release tablets contains lactose monohydrate. If your doctor has
told you that you have an intolerance to any type of sugar, contact him before taking this
medicine.
Ranolazina DOC contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ranolazina DOC

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 DOC
is 750 mg twice daily.
It is important that you inform your doctor if undesirable effects such as dizziness, nausea or vomiting appear. Your
doctor may reduce the dosage or, if that is not enough, discontinue treatment with Ranolazina DOC.

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

If you take more Ranolazina DOC than you should
If you accidentally take too many tablets of Ranolazina DOC 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 DOC
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 a missed dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should stop taking Ranolazina DOC 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
• hives 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 DOC.
Other side effects that you may experience include:
Common side effects (may affect up to 1 in 10 people) are:

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

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbance
• 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, nosebleeds
• Double vision
• Excessive sweating, itching
• Feeling of bloating 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 cardiac 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(may affect up to 1 in 1000 people) 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 sweats, 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
• Hives, allergic skin reaction
• Impotence
• Difficulty walking due to lack of balance
• Inflammation of the pancreas or intestine
• Memory loss
• Feeling 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 on the basis of available
data) are:

• myoclonus

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 DOC

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 box and on the
bottle after the words “Exp.”
The expiry date refers to the last day of that month.
This medicine does not require any particular 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 DOC contains
The active ingredient of Ranolazina DOC is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg of
ranolazine.
The other ingredients 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/ brilliant blue FCF aluminium lake (E133).

Description of the appearance of Ranolazina DOC and package contents
Ranolazina extended-release tablets are oval-shaped tablets.
375 mg tablets are light blue with the inscription 375 imprinted on one side.
500 mg tablets are light orange with the inscription 500 imprinted on one side.
750 mg tablets are light green with the inscription 750 imprinted on one side.
Ranolazina DOC is supplied in blister packs of 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati, 40
20121 Milan

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