Ranozek

Leaflet attached to the packaging: patient information

Ranozek, 375 mg, prolonged-release tablets

Ranozek, 500 mg, prolonged-release tablets

Ranozek, 750 mg, prolonged-release tablets

Ranolazine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ranozek and what is it used for
• 2. Important information 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 is Ranozek and what is it used for

Ranozek is a medicine used in combination with other medicines to treat angina pectoris, characterized by chest pain or discomfort in the upper body between the neck and abdomen, often caused by physical exertion or excessive physical activity.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Ranozek

When not to take 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 kidney function disorders.
• if the patient has moderate or severe liver function disorders.
• 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 heart rhythm disorders (e.g. quinidine, dofetilide or sotalol).

Warnings and precautions

Before starting to take Ranozek, the patient should discuss this with their doctor:

• if the patient has kidney disease of mild or moderate severity.
• if the patient has liver disease of mild severity.
• 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 situations apply to the patient, the doctor may decide to use a lower dose or take other precautions.

Ranozek and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The following medicines must not be taken 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 heart rhythm disorders (e.g. quinidine, dofetilide or sotalol).

The patient should tell their doctor or pharmacist before taking Ranozek if they are taking:

• certain medicines used to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporin) or if the patient is taking certain heart medicines, 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). The doctor may decide to reduce the dose of Ranozek.
• medicines used to treat epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine or phenobarbital); rifampicin used to treat infection (e.g. tuberculosis) or herbal medicines containing St. John's Wort, as these medicines may reduce the effectiveness of Ranozek.
• heart medicines containing digoxin or metoprolol, as the doctor may decide to change the dose of these medicines during treatment with Ranozek.
• certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and depression (e.g. imipramine, doxepin, amitriptyline), as they may affect the patient's ECG.
• certain medicines used to treat depression (bupropion), mental disorders, HIV infection (efavirenz) or cancer (cyclophosphamide).
• certain medicines used to lower high cholesterol levels in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and damage. The doctor may decide to change the dose of these medicines during treatment with Ranozek.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporin, sirolimus, everolimus), as the doctor may decide to change the dose of these medicines during treatment with Ranozek.

Ranozek with food and drink

Ranozek can be taken with or after a meal. The patient must not drink grapefruit juice while taking Ranozek.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should ask their doctor for advice before taking this medicine.
Pregnancy
If the doctor has not prescribed Ranozek, the patient must not take it during pregnancy.
Breastfeeding
Ranozek must not be taken during breastfeeding. If the patient is breastfeeding, they should ask their doctor for advice.

Driving and using machines

No studies have been conducted on the effects of Ranozek on the ability to drive and use machines. The patient should ask their doctor for advice on driving and using machines.
Ranozek may cause side effects such as dizziness (frequent), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), coordination problems (rare), which may affect the ability to drive or use machines. If the patient experiences these symptoms, they must not drive or use machines until the symptoms have completely disappeared.
Ranozek contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Ranozek

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should ask their doctor or pharmacist.
The tablets should always be swallowed whole with water. The patient must not crush, suck, chew the tablets or divide them in half, as this may alter the special release properties of the tablets in the body.
The initial dose for adults is: one 375 mg tablet twice a day. After 2-4 weeks, the doctor may increase the dose to achieve the desired effect of the medicine. The maximum dose of Ranozek is 750 mg twice a day.
It is essential to inform the doctor if the patient experiences side effects such as dizziness, nausea or vomiting. The doctor may reduce the dose or stop Ranozek.

Use in children and adolescents

Children and adolescents under 18 years of age must not take Ranozek.

Overdose of Ranozek

If the patient has accidentally taken more Ranozek tablets or a higher dose than prescribed, they should immediately inform their doctor. If it is not possible to inform the doctor, the patient should go to the nearest hospital emergency department. The patient should take all remaining tablets, including the packaging, so that the hospital staff can easily identify the medicine that has been taken.

Missed dose of Ranozek

If the patient misses a dose, they should take it as soon as possible, unless it is almost time (less than 6 hours) for the next dose. The patient must not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ranozek can cause side effects, although not everybody gets them.
The patient should stop taking Ranozek and immediately contact their doctor if they experience the following symptoms of angioedema, which is rare but can be severe:

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

The patient should tell their doctor if they experience frequent side effects such as dizziness, nausea or vomiting. The doctor may reduce the dose or stop Ranozek.
Other side effects that may occur include:

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

Constipation
Dizziness
Headache
Nausea, vomiting
Feeling weak

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

Change in sensation
Anxiety, difficulty sleeping, confusion, hallucinations
Blurred vision, vision disturbances
Changes in sensation (touch or taste), tremors, feeling tired or slow, drowsiness or somnolence (increased, uncontrollable tendency to fall asleep), feeling faint or fainting, dizziness when standing up
Dark urine, blood in urine, difficulty urinating
Dehydration
Breathing difficulties, cough, nosebleeds
Double vision
Excessive sweating, itching
Feeling bloated or swollen
Sudden flushing of the face, low blood pressure
Increased creatinine or urea levels in the blood, increased platelet or white blood cell count, changes in ECG
Joint swelling, pain in limbs
Loss of appetite and/or weight loss
Muscle cramps, muscle weakness
Ringing in the ears and/or feeling dizzy
Stomach pain or discomfort, indigestion, dry mouth or gas

Rare side effects (may affect up to 1 in 1000 people):

Difficulty urinating
Abnormal liver function test results
Acute kidney failure
Change in sense of smell, numbness in the mouth or lips, hearing impairment
Cold sweats, rash
Coordination problems
Low blood pressure when standing up
Loss of consciousness or decreased consciousness
Disorientation
Feeling cold in hands and feet
Hives, skin allergic reactions
Impotence
Walking difficulties due to balance disorders
Pancreatitis or intestinal inflammation
Memory loss
Throat constriction
Low sodium levels in the blood (hyponatremia), which may cause fatigue and confusion, muscle tremors, cramps and coma.
Side effects with unknown frequency(frequency cannot be estimated from available data):
Clonic muscle seizures.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ranozek

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

The active substance of Ranozek is ranolazine. One tablet contains 375 mg, 500 mg or 750 mg of ranolazine.
The other ingredients are:
Core:Microcrystalline cellulose, type 101, Methacrylic acid and ethyl acrylate copolymer (1:1), Sodium hydroxide, Hypromellose E50, Magnesium stearate.
AquaPolish P white 014.58C coating:Hypromellose E5, Hypromellose E15, Hydroxypropylcellulose, Macrogol 8000, Titanium dioxide (E171)

What Ranozek looks like and contents of the pack

White, elongated, biconvex, film-coated tablet, 15 mm x 7.2 mm in size, with "375" engraved on one side.
White, elongated, biconvex, film-coated tablet, 16.5 mm x 8.0 mm in size, with "500" engraved on one side.
White, elongated, biconvex, film-coated tablet, 19 mm x 9.2 mm in size, with "750" engraved 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 authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A,
05-152 Czosnów
Phone: +48 22 732 77 00

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Ranozek
Netherlands:
Ranozek 375 mg prolonged-release tablets
Ranozek 500 mg prolonged-release tablets
Ranozek 750 mg prolonged-release tablets
Germany:
Ranozek 375 mg retard tablets
Ranozek 500 mg retard tablets
Ranozek 750 mg retard tablets
Latvia:
Ranozek 375 mg prolonged-release tablets
Ranozek 500 mg prolonged-release tablets
Ranozek 750 mg prolonged-release tablets
Italy:
Ranozek
Spain:
Ranozek 375 mg prolonged-release tablets EFG
Ranozek 500 mg prolonged-release tablets EFG
Ranozek 750 mg prolonged-release tablets EFG

Date of last revision of the leaflet: