Package leaflet: Information for the patient

Ranozek, 375 mg, prolonged-release tablets
Ranozek, 500 mg, prolonged-release tablets
Ranozek, 750 mg, prolonged-release tablets
Ranolazinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Ranozek is and what it is used for
Important information before taking Ranozek
How to take Ranozek
Possible side effects
How to store Ranozek
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 drugs for the treatment of chronic angina pectoris,
a condition characterized by chest pain or discomfort in the upper body between the neck and the upper abdomen,
often triggered by physical exertion or excessive physical activity.
If there is no improvement or if the patient feels worse, medical advice should be sought.

2. Important information before using Ranozek

When not to use Ranozek

if the patient is allergic to ranolazine or any of the other ingredients of this medicine (listed in section 6).
if the patient has severe renal impairment.
if the patient has moderate or severe hepatic impairment.
if the patient is taking certain medicines used to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or cardiac arrhythmias (e.g. quinidine, dofetilide, or sotalol).

Warnings and precautions
Before starting treatment with Ranozek, discuss the following with the doctor:

if the patient has mild or moderate kidney disease.
if the patient has mild liver disease.
if the patient has ever had an abnormal electrocardiogram (ECG).
if the patient is elderly.
if the patient's body weight is low (60 kg or less).
if the patient has circulatory failure.

If any of the above conditions apply, the doctor may decide to prescribe a lower dose or take other precautionary measures.

Ranozek with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take the following medicines during treatment with Ranozek:

certain medicines used to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or cardiac arrhythmias (e.g. quinidine, dofetilide, or sotalol).

Tell the doctor or pharmacist before taking Ranozek if the patient is taking:

certain medicines used to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or if the patient is taking certain heart medications such as diltiazem or verapamil. These medicines may increase the risk of adverse effects such as dizziness, nausea, or vomiting, which are possible side effects of Ranozek (see section 4). The doctor may decide to prescribe a lower dose.
medicines used to treat epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine, or phenobarbital), rifampicin used to treat infections (e.g. tuberculosis), or herbal medicines containing St. John's wort, as these may reduce the effectiveness of Ranozek.
heart medications containing digoxin or metoprolol, as the doctor may decide to adjust the dose of these medicines during treatment with Ranozek.
certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), cardiac arrhythmias (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepin, amitriptyline), as they may affect the patient's ECG.
certain medicines used to treat depression (bupropion), psychiatric disorders, HIV infection (efavirenz), or cancer (cyclophosphamide).
certain medicines that lower high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain or muscle damage. The doctor may decide to adjust the dose of these medicines during treatment with Ranozek.
certain medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as the doctor may decide to adjust the dose of these medicines during treatment with Ranozek.

Ranozek with food and drink
Ranozek may be taken with or after a meal. Grapefruit juice must not be consumed during treatment with Ranozek.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Pregnancy
Ranozek must not be used during pregnancy unless otherwise directed by the doctor.

Breastfeeding
Ranozek must not be used during breastfeeding. Consult the doctor if breastfeeding.

Driving and operating machinery
Studies on the effect of Ranozek on the ability to drive motor vehicles and operate mechanical equipment have not been conducted. Consult the doctor regarding driving and operating machinery.

Ranozek may cause adverse effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), and coordination problems (rare), which may affect the ability to drive or operate machinery. If such symptoms occur, the patient should not drive or operate machinery until the symptoms have completely resolved.

Ranozek contains less than 1 mmol sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Ranozek

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Tablets must always be swallowed whole with water. Do not crush, suck, chew, or split tablets, as this may alter the special release properties of the tablets in the patient's body.
The initial dose for adults is: one 375 mg tablet twice daily. After 2−4 weeks, the treating physician may increase the dose to achieve the desired therapeutic effect. The maximum dose of Ranozek is 750 mg twice daily.
It is important to inform the doctor if any adverse effects occur, such as dizziness, nausea, or vomiting. The doctor may reduce the dose, and if necessary, discontinue Ranozek treatment.
Use in children and adolescents
Children and adolescents under 18 years of age should not take Ranozek.
Taking more than the recommended dose of Ranozek
If an overdose of Ranozek tablets or a higher than recommended dose is accidentally taken, contact a doctor immediately. If contacting a doctor is not possible, go immediately to the nearest hospital emergency department. Bring all remaining tablets, including the container and packaging, so that hospital staff can easily identify the medicine taken.
Missed dose of Ranozek
If a dose of Ranozek is missed, take it as soon as possible, unless the next scheduled dose is due within less than 6 hours. Do not take a double dose to make up for the missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Ranozek should be discontinued and immediate medical advice sought if the patient develops any of the following symptoms of angioedema, which is rare but may be severe:

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

Inform the doctor if the patient experiences frequent adverse reactions such as dizziness, nausea or vomiting. The doctor may reduce the dose or discontinue treatment with Ranozek.
Other adverse reactions that may occur in the patient include:
Common adverse reactions (may occur in up to 1 in 10 people):
Constipation
Dizziness
Headache
Nausea, vomiting
Feeling of weakness
Uncommon adverse reactions (may occur in up to 1 in 100 people):
Altered sensation
Anxiety, difficulty sleeping, confusion, hallucinations
Blurred vision, visual disturbances
Changes in sensory perception (touch or taste), tremor, feeling of fatigue or sluggishness,
drowsiness or somnolence (increased, uncontrollable tendency to fall asleep), feeling faint or fainting, dizziness upon standing
Dark-coloured urine, blood in urine, difficulty passing urine
Dehydration
Breathing difficulties, cough, nosebleeds
Double vision
Excessive sweating, itching
Feeling of swelling or bloating
Sudden flushing of the face, low blood pressure
Increased blood creatinine or urea levels, increased platelet or white blood cell count, changes in ECG
Joint swelling, limb pain
Loss of appetite and (or) weight loss
Muscle cramps, decreased muscle strength
Tinnitus and (or) sensation of spinning
Stomach pain or discomfort, indigestion, dry mouth or flatulence
Rare adverse reactions (may occur in up to 1 in 1000 people):
Difficulty passing urine
Abnormal liver function test results
Acute kidney failure
Altered sense of smell, numbness of the mouth or lips, hearing impairment
Cold sweats, rash
Coordination problems
Decreased blood pressure upon standing
Reduced or loss of consciousness
Disorientation
Feeling of cold in hands and feet
Hives, skin allergic reactions
Impotence
Walking difficulties due to balance disorders
Pancreatitis or intestinal inflammation
Memory loss
Throat tightness
Low sodium levels in blood (hyponatremia), which may cause fatigue and confusion, muscle twitching, seizures and coma.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Clonic muscle seizures.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ranozek

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

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, type 101, Methacrylic acid and ethyl acrylate copolymer (1:1), Sodium hydroxide, Hypromellose E50, Magnesium stearate.
Coating AquaPolish P white 014.58C: Hypromellose E5, Hypromellose E15, Hydroxypropylcellulose, Polyethylene glycol 8000, Titanium dioxide (E171)
What Ranozek looks like and contents of the pack
White, elongated, convex film-coated tablet measuring 15 mm x 7.2 mm, with "375" embossed on one side.
White, elongated, convex film-coated tablet measuring 16.5 mm x 8.0 mm, with "500" embossed on one side.
White, elongated, convex film-coated tablet measuring 19 mm x 9.2 mm, with "750" embossed on one side.
Ranozek is available in cardboard boxes containing 30, 60 or 100 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A,
05–152 Czosnów
Tel.: + 48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Ranozek
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
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