Ranozek

Package Leaflet: Information for the Patient

Ranozek, 375 mg, prolonged-release tablets

Ranozek, 500 mg, prolonged-release tablets

Ranozek, 750 mg, prolonged-release tablets

Ranolazine

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

• You should 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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package 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, which is characterized by chest pain or discomfort in the upper body between the neck and the abdomen, often caused by physical exertion or excessive physical activity.
If there is no improvement or if you feel worse, you should consult your doctor.

2. Important information before taking Ranozek

When not to take Ranozek

• if you are allergic to ranolazine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you have moderate or severe liver problems.
• if you are 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, you should discuss this with your doctor:

• 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 your body weight is low (60 kg or less).
• if you have heart failure.

If any of the above situations apply to you, your doctor may decide to use a lower dose or take other precautions.

Ranozek and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take the following medicines while taking 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).

Tell your doctor or pharmacist before taking Ranozek if you 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 you are 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). Your 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 your doctor may decide to change the dose of these medicines while taking 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 change in the ECG recording in you.
• 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. Your doctor may decide to change the dose of these medicines while taking Ranozek.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporin, sirolimus, everolimus), as your doctor may decide to change the dose of these medicines while taking Ranozek.

Ranozek with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
If your doctor has not prescribed Ranozek, do not take it during pregnancy.
Breastfeeding
Do not take Ranozek while breastfeeding. If you are breastfeeding, ask your doctor for advice.

Driving and using machines

Ranozek has not been studied for its effect on the ability to drive or use machines. Ask your 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 your ability to drive or use machines. If you experience these symptoms, do not drive or use machines until they have completely resolved.
Ranozek contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is essentially 'sodium-free'.

3. How to take Ranozek

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with water. Do not crush, suck, chew or divide the tablets, as this may change the special release properties of the tablets in your body.
The initial dose for adults is: one 375 mg tablet twice a day. After 2-4 weeks, your 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 important to inform your doctor if you experience side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop Ranozek.

Use in children and adolescents

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

Overdose of Ranozek

If you accidentally take more Ranozek tablets or a higher dose than recommended, tell your doctor immediately. If it is not possible to contact your doctor, go to the nearest hospital emergency department. Take all remaining tablets, including the package and packaging, so that hospital staff can easily determine which medicine has been taken.

Missed dose of Ranozek

If you miss a dose, take it as soon as you remember, unless it is almost time (less than 6 hours) for your next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ranozek can cause side effects, although not everybody gets them.
Stop taking Ranozek and contact your doctor immediately if you 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.

Tell your doctor if you experience frequent side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop Ranozek.
Other side effects that may occur include:

Common 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 of fainting or fainting
Dark urine, blood in urine, difficulty urinating
Dehydration
Breathing difficulties, cough, nosebleeds
Double vision
Excessive sweating, itching
Feeling of swelling or bloating
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 recording
Joint swelling, pain in limbs
Loss of appetite and/or weight loss
Muscle cramps, muscle weakness
Ringing in the ears and/or feeling of spinning
Stomach pain or discomfort, indigestion, dry mouth or gas

Rare side effects (may affect up to 1 in 1,000 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
Decreased blood pressure when standing up
Loss of consciousness or decreased consciousness
Disorientation
Feeling cold in hands and feet
Hives, allergic skin 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 the available data):
Clonic muscle spasms.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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.
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 which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
Coating AquaPolish P white 014.58C:Hypromellose E5, Hypromellose E15, Hydroxypropylcellulose, Macrogol 8000, Titanium dioxide (E171)

What Ranozek looks like and contents of the pack

White, oblong, biconvex, film-coated tablet, 15 mm x 7.2 mm in size, with "375" engraved on one side.
White, oblong, biconvex, film-coated tablet, 16.5 mm x 8.0 mm in size, with "500" engraved on one side.
White, oblong, 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 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

Date of last revision of the leaflet: