Ranolazine Doc Generici

Package leaflet: Information for the patient

Ranolazine Doc Generici 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 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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

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

1. What Ranolazina Doc Generici is and what it is used for

Ranolazina Doc Generici 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.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ranolazina Doc Generici

Do not take Ranolazina Doc Generici

• 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 Generici:

• 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 prescribe a lower dose or take other precautions.
Other medicines and Ranolazina Doc Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use the following medicines if you are taking Ranolazina Doc Generici:

• 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 Generici if you are using:

• certain medicines to treat bacterial infection (erythromycin) or fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (cyclosporine), or if you are taking heart medications such as diltiazem or verapamil. These medicines may increase the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranolazina Doc Generici (see section 4). Your doctor may decide to prescribe you a lower dose;
• medicines for 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, because these medicines may reduce the effectiveness of Ranolazina Doc Generici;
• heart medicines containing digoxin or metoprolol, because your doctor may decide to adjust the dose of these medicines while you are taking Ranolazina Doc Generici;
• certain medicines for treating 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 the ECG;
• certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide);
• certain medicines for treating 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 Generici;
• certain medicines used to prevent rejection after organ transplantation (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to adjust the dose of these medicines while you are taking Ranolazina Doc Generici.

Ranolazina Doc Generici with food and drinks
Ranolazina Doc Generici may be taken with or without food. During treatment with Ranolazina Doc Generici, you must not drink grapefruit juice.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Do not take Ranolazina Doc Generici during pregnancy unless advised by your doctor.
Breastfeeding
If you are breastfeeding, you must not take Ranolazina Doc Generici. Consult your doctor if you are breastfeeding.
Driving and using machines
No studies on the effects of Ranolazina Doc Generici on the ability to drive and use machines have been performed. Ask your doctor for advice regarding driving and using machines.
Ranolazina Doc Generici 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 Generici contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ranolazine Doc Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablets should 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 Ranolazine Doc Generici 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 Ranolazine Doc Generici.
Use in children and adolescents
Children and adolescents under 18 years of age must not take Ranolazine Doc Generici.
If you take more Ranolazine Doc Generici than you should
If you accidentally take too many Ranolazine Doc Generici tablets or 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 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 Ranolazine Doc Generici
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose (within 6 hours). Do not take a double dose to make up for a forgotten 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 everybody gets them.

You must stop taking Ranolazina Doc Generici and contact your doctor immediately if you experience the following symptoms of angioedema, a rare but sometimes serious condition:

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

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 Generici.

Other possible side effects 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
• disturbances in senses (touch or taste), tremor, feeling of fatigue or sluggishness, numbness or drowsiness, feeling faint 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 trace
• joint swelling, limb pain
• loss of appetite and/or weight loss
• muscle cramps, muscle weakness
• sensation of ringing 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
• altered sense of smell, numbness of mouth or lips, hearing impairment
• cold sweating, rash
• coordination problems
• drop in blood pressure upon standing
• reduction or loss of consciousness
• disorientation
• feeling of coldness in hands and feet
• hives, allergic skin reaction
• impotence
• difficulty walking due to loss of balance
• inflammation of the pancreas or intestine
• memory loss
• sensation of tightness in the throat
• low levels of sodium in the blood (hyponatraemia) which may cause tiredness 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 Doc Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 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 Doc Generici contains
The active substance in Ranolazina Doc Generici is ranolazine. Each tablet contains 375 mg, 500 mg or
750 mg of ranolazine.
The other components are:
Tablet core: microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1),
sodium hydroxide (E524), hypromellose (E464), magnesium stearate (E470b).
White AquaPolish P film coating system: hypromellose (E464), hydroxypropylcellulose (E463), macrogol
8000 (E1521), titanium dioxide (E171).

Description of the appearance of Ranolazina Doc Generici and package contents
The 375 mg tablets are white, oval-shaped, convex, film-coated tablets, 15 mm x 7.2 mm in size, with "375" printed on one side.
The 500 mg tablets are white, oval-shaped, convex, film-coated tablets, 16.5 mm x 8.0 mm in size, with "500" printed on one side.
The 750 mg tablets are white, oval-shaped, convex, film-coated tablets, 19 mm x 9.2 mm in size, with "750" printed on one side.
Ranolazina Doc Generici is available in packages containing 30, 60 or 100 tablets in PVC/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

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

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland

This medicinal product is authorized in the following European Economic Area (EEA) Member States under the following names:
Netherlands: Ranolazine ELC 375 mg tabletten met verlengde afgifte
Ranolazine ELC 500 mg tabletten met verlengde afgifte
Ranolazine ELC 750 mg tabletten met verlengde afgifte

Austria: Ranolazin Genericon 375 mg Retardtabletten
Ranolazin Genericon 500 mg Retardtabletten
Ranolazin Genericon 750 mg Retardtabletten

Bulgaria: Ranolazine ELC 375 mg Таблетка с удължен освобождаване
Ranolazine ELC 500 mg Таблетка с удължено освобождаване
Ranolazine ELC 750 mg Таблетка с удължено освобождаване

Cyprus: Ranolazine ELC 375 mg Δισκία παρατεταμένης αποδέσμευσης
Ranolazine ELC 500 mg Δισκία παρατεταμένης αποδέσμευσης
Ranolazine ELC 750 mg Δισκία παρατεταμένης αποδέσμευσης

Estonia: Ranolazine ELC

Croatia: Ranolazin ELC 375 mg tablete s produljenim oslobađanjem
Ranolazin ELC 500 mg tablete s produljenim oslobađanjem
Ranolazin ELC 750 mg tablete s produljenim oslobađanjem

Ireland: Ranolazine 375 mg Prolonged-release tablet
Ranolazine 500 mg Prolonged-release tablet
Ranolazine 750 mg Prolonged-release tablet

Italy: Ranolazina Doc Generici

Lithuania: Ranolazine ELC 375 mg pailginto atpalaidavimo tabletės
Ranolazine ELC 500 mg pailginto atpalaidavimo tabletės
Ranolazine ELC 750 mg pailginto atpalaidavimo tabletės

Portugal: Ranolazina ELC

Romania: Ranolazină Atb 375 mg comprimate cu eliberare prelungită
Ranolazină Atb 500 mg comprimate cu eliberare prelungită
Ranolazină Atb 750 mg comprimate cu eliberare prelungită

Slovenia: Ranolazin ELC 375 mg tablete s podaljšanim sproščanjem
Ranolazin ELC 500 mg tablete s podaljšanim sproščanjem
Ranolazin ELC 750 mg tablete s podaljšanim sproščanjem

Spain: Ranolazina Cinfa 375 mg Comprimido de liberación prolongada EFG
Ranolazina Cinfa 500 mg Comprimido de liberación prolongada EFG
Ranolazina Cinfa 750 mg Comprimido de liberación prolongada EFG

Greece: RANOLAZINE/GENEPHARM