Ralik

Leaflet accompanying the packaging: patient information

Ralik, 375 mg, prolonged-release tablets

Ralik, 500 mg, prolonged-release tablets

Ralik, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ralik and what is it used for

Ralik 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 Ralik

When not to take Ralik

• 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 problems.
• if the patient has moderate or severe liver problems.
• 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 Ralik, the patient should discuss the following with their doctor:

• if the patient has mild or moderate kidney problems.
• if the patient has mild liver problems.
• 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.

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

Ralik and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The following medicines must not be taken during treatment with Ralik:

• 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 Ralik 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 Ralik (see section 4). The doctor may decide to reduce the dose of Ralik.
• 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 Ralik.
• heart medicines containing digoxin or metoprolol, as the doctor may need to adjust the dose of these medicines while taking Ralik.
• 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 need to adjust the dose of these medicines while taking Ralik.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporin, sirolimus, everolimus), as the doctor may need to adjust the dose of these medicines while taking Ralik.

Ralik with food and drink

Ralik can be taken with or after a meal. Grapefruit juice must not be drunk while taking Ralik.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor before taking this medicine.
Pregnancy
Ralik must not be taken during pregnancy unless the doctor has advised it.
Breastfeeding
Ralik must not be taken while breastfeeding. If the patient is breastfeeding, they should consult their doctor.
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Driving and using machines

No studies have been conducted on the effects of Ralik on the ability to drive and use machines. The patient should consult their doctor about driving and using machines.
Ralik may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), coordination problems (rare), which may affect the ability to drive or use machines. If such symptoms occur, the patient should not drive or use machines until the symptoms have completely resolved.

Ralik 750 mg prolonged-release tablets contain the dye tartrazine (E 102). This dye may cause allergic reactions.

Ralik contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Ralik

This medicine should always be taken exactly as advised by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Tablets should always be swallowed whole, with a glass of water. The tablets must not be crushed, sucked, chewed or divided into halves, 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 Ralik is 750 mg twice a day.
It is important to inform the doctor if the patient experiences side effects such as dizziness, nausea or vomiting. The doctor may reduce the dose or stop Ralik.

Use in children and adolescents

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

Overdose of Ralik

In case of accidental ingestion of a larger number of Ralik tablets or a higher dose than recommended, the patient 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 container and packaging, so that hospital staff can easily identify the medicine taken.

Missed dose of Ralik

If a dose is missed, the patient should take it as soon as possible, unless it is almost time (less than 6 hours) for the next dose. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Ralik can cause side effects, although not everybody gets them.
The patient should stop taking Ralik and contact their doctor immediatelyif they experience any of the following symptoms of angioedema, which is rare but can be severe:
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• swelling of the face, tongue or throat
• difficulty swallowing
• hives or difficulty breathing

The patient should tell their doctor if they experience common side effects such as dizziness, nausea or vomiting. The doctor may reduce the dose or stop Ralik.

Other side effects that may occur

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, 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, limb pain
• 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 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
• Disorientation
• Feeling cold in hands and feet
• Hives, skin allergic reactions
• Impotence
• Walking problems 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):

• Short, shock-like muscle jerks or muscle group jerks (clonic muscle seizures).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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
Al. Jerozolimskie 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 Ralik

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
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

What Ralik contains

The active substance of Ralik is ranolazine. One tablet contains 375 mg, 500 mg or 750 mg of ranolazine.
The other ingredients are:
Tablet core:Microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, hypromellose, sodium hydroxide, magnesium stearate.
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132), iron oxide red (E 172), carnauba wax
500 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (E 172), carnauba wax
750 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, brilliant blue FCF (E 133), tartrazine (E 102), carnauba wax

What Ralik looks like and contents of the pack

Ralik prolonged-release tablets are oval-shaped.
The 375 mg tablets are light blue, oval, biconvex, film-coated tablets with "375" engraved on one side and smooth on the other.
The 500 mg tablets are light pink, oval, biconvex, film-coated tablets with "500" engraved on one side and smooth on the other.
The 750 mg tablets are light green, oval, biconvex, film-coated tablets with "750" engraved on one side and smooth on the other.
Ralik is available in cardboard boxes.
375 mg: PVC/PVDC/Aluminium blisters containing 10 or 15 tablets per blister. Each cardboard box contains 2, 3, 4, 6 or 10 blisters (30, 60 or 100 tablets)
500 mg and 750 mg: PVC/PVDC/Aluminium blisters containing 10 tablets per blister. Each cardboard box contains 3, 6 or 10 blisters (30, 60 or 100 tablets).
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw
phone: +48 22 822 93 06
e-mail: [email protected]

Importer

Farmak International Sp. z o.o.
Chełmżyńska 249 Street
04-458 Warsaw

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

Estonia: Ralik
Poland: Ralik
Date of last revision of the leaflet:May 2025
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