Ranozek

Patient Information Leaflet: Information for the patient

Ranozek 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets

Ranolazine
Generic medicine
Please read 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 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, contact your doctor. See section 4.

Contents of this leaflet

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

1. What Ranozek is and what it is used for

Ranozek 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.
You should contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Ranozek

Do not take Ranozek
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 Ranozek:

• 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 Ranozek
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 Ranozek:
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 Ranozek 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 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 Ranozek (see section 4). Your doctor may decide to prescribe 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, as these medicines may reduce the effectiveness of Ranozek.
heart medicines containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking Ranozek.
certain medicines for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine or amitriptyline), as 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 Ranozek.
certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may decide to adjust the dose of these medicines while you are taking Ranozek.

Ranozek with food and drink
Ranozek may be taken with or without food. During treatment with Ranozek, you must not drink grapefruit juice.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

Breastfeeding
Do not take Ranozek if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.

Driving and using machines
No studies have been conducted on the effects of Ranozek on the ability to drive or use machines.
Ask your doctor for advice regarding driving and using machines.
Ranozek 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 operate machinery until they have completely resolved.

This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. essentially 'sodium-free'.

3. How to take RANOZEK

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The tablets should always be swallowed whole with water. Do not crush, suck, chew or break the
tablets, nor split them in half, as this could affect how the medicine is released from the tablet 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 Ranozek is 750 mg twice daily.
It is important that you inform your doctor if you experience any adverse effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or, if necessary, discontinue treatment with Ranozek.
Use in children and adolescents
Children and adolescents under 18 years of age must not take Ranozek.
If you take more Ranozek than you should
If you accidentally take too many Ranozek 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 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 Ranozek
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 forgotten dose.
If you have any doubts about how to use 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 Ranozek and go to a 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 difficulty breathing.

Tell your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop treatment with Ranozek.

Other 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
• disturbances in senses (touch or taste), tremor, feeling of fatigue or lethargy
• numbness or drowsiness, feeling faint or fainting, dizziness when standing up
• 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
• increase in a substance called creatinine or increase in blood urea, increase in platelet or white blood cell count, changes in ECG heart tracing
• joint swelling, pain in extremities
• 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
• alteration of the sense of smell, numbness of mouth or lips, hearing impairment
• cold sweating, rash
• problems with coordination
• 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 levels of sodium in the blood (hyponatremia) which may cause tiredness and confusion
• muscle spasms, cramps and coma

Side effects with unknown frequency (frequency cannot be estimated from 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 RANOZEK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 Ranozek contains
The active substance in Ranozek 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-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 Ranozek and package contents
The 375 mg tablets are white, oblong, convex, film-coated tablets of size 15 mm x 7.2 mm,
with "375" engraved on one side.
The 500 mg tablets are white, oblong, convex, film-coated tablets of size 16.5 mm x 8.0 mm,
with "500" engraved on one side.
The 750 mg tablets are white, oblong, convex, film-coated tablets of size 19 mm x 9.2 mm,
with "750" engraved on one side.
Ranozek is supplied in cardboard boxes containing 30, 60 or 100 tablets in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed s.r.l.
Via G. Mazzini, 20
20123 Milano (Italy)

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Ranozek 375 mg tabletten met verlengde afgifte
Ranozek 500 mg tabletten met verlengde afgifte
Ranozek 750 mg tabletten met verlengde afgifte

Germany: Ranozek 375 mg Retardtabletten
Ranozek 500 mg Retardtabletten
Ranozek 750 mg Retardtabletten

Latvia: Ranozek 375 mg Ilgstošās darbības tablete
Ranozek 500 mg Ilgstošās darbības tablete
Ranozek 750 mg Ilgstošās darbības tablete

Poland: Ranozek

Italy: Ranozek

Spain: Ranozek 375 mg Comprimido de liberación prolongada EFG
Ranozek 500 mg Comprimido de liberación prolongada EFG
Ranozek 750 mg Comprimido de liberación prolongada EFG