Package leaflet: Information for the patient

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 adverse reaction, including those not listed in this leaflet, talk to your doctor. See section 4.

Contents of this leaflet

What Ranolazine DOC is and what it is used for
What you need to know before taking Ranolazine DOC
How to take Ranolazine DOC
Possible side effects
How to store Ranolazine DOC
Contents of the pack and other information

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

Ranolazina DOC 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, which may occur anywhere in the upper part of the trunk between the neck and the upper abdomen, often triggered by physical exertion or excessive activity.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ranolazina DOC

Do not take Ranolazina DOC

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 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 are of low body weight (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 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 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 for bacterial infection (erythromycin) or fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or if you are taking heart medications 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 DOC (see section 4). Your doctor may decide to prescribe a reduced 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 product St John’s wort, because these medicines may reduce the effectiveness of Ranolazina DOC;
heart medications containing digoxin or metoprolol, because your doctor may need to adjust the dose of these medicines while you are taking Ranolazina DOC;
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 affect your ECG;
certain medicines for depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide);
certain medicines for 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 DOC;
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 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 may be taken with or without food. During treatment with Ranolazina DOC, you must not drink grapefruit juice.
Pregnancy
Do not take Ranolazina DOC during pregnancy unless advised by your doctor.
Breast-feeding
Do not take Ranolazina DOC if you are breast-feeding. Consult your doctor if you are breast-feeding.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor before taking this medicine.
Driving and using machines
No studies on the effects of Ranolazina DOC on the ability to drive or use machines have been performed. Consult your doctor regarding driving and using machines.
Ranolazina DOC may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), 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 DOC 750 mg prolonged-release tablets contain the azo dye E102.
This dye may cause allergic reactions.
Ranolazina DOC 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor 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 exactly as directed 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, as this could affect how 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 DOC 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 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 Ranolazina DOC tablets or take a higher dose than recommended by your doctor, it is important to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency room. 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 DOC
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 away). Do not take a double dose to make up for a missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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 your dose or stop treatment with Ranolazina DOC.

Other possible side effects you may experience include:

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

Constipation
Dizziness
Headache
Nausea, vomiting
Feeling of weakness

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

Altered sensitivity
Anxiety, difficulty sleeping, confusion, hallucinations
Blurred vision, visual disturbance
Sensory disturbances (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
Breathing difficulties, 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 ECG heart tracing
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 (may affect up to 1 in 1,000 people):

Difficulty urinating normally
Abnormal liver laboratory values
Acute kidney failure
Changes in 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 (hyponatremia), 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 Ranolazina DOC

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 box, and the bottle after the word “Exp.”
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 DOC contains
The active substance in Ranolazina DOC is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg of
ranolazine.
The other components 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 /
indigo carmine 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 contents of the pack
Ranolazina prolonged-release tablets are oval-shaped.
The 375 mg tablets are light blue, with "375" printed on one side.
The 500 mg tablets are light orange, with "500" printed on one side.
The 750 mg tablets are light green, with "750" printed on one side.
Ranolazina DOC is supplied in packs of 60 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121 Milano
Italy

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