Ralik

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Ralik is and what it is 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 Ralik is and what it is used for

Ralik is a medicine used in combination with other medicines for the treatment of chronic angina pectoris,
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 Ralik

When not to use 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 renal function impairment.
• if the patient has moderate or severe hepatic function 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 Ralik, discuss the following with your 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 insufficiency.

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

Ralik and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Do not take the following medicines 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 cardiac arrhythmias (e.g. quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before taking Ralik 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 Ralik (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 products containing St. John's wort, as these medicines may reduce the effectiveness of Ralik.
• heart medications containing digoxin or metoprolol, as the doctor may decide to adjust the dose of these medicines during treatment with Ralik.
• certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), cardiac arrhythmias (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, amitriptyline), as they may affect the patient's ECG pattern.
• certain medicines used to treat depression (bupropion), psychiatric disorders, HIV infection (efavirenz), or cancer (cyclophosphamide).
• certain medicines used to lower high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle damage. The doctor may decide to adjust the dose of these medicines during treatment with Ralik.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as the doctor may decide to adjust the dose of these medicines during treatment with Ralik.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
Ralik must not be used during pregnancy unless otherwise advised by a doctor.

Breastfeeding
Ralik must not be used during breastfeeding. If breastfeeding, consult your doctor.

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

Ralik may cause side 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 these symptoms have completely resolved.

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

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

3. How to use Ralik

This medicine should always be taken as directed by the doctor. If in doubt, consult the 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 Ralik is 750 mg twice daily.
It is important to inform the doctor if adverse effects such as dizziness, nausea, or vomiting occur. The doctor may reduce the dose, and if this proves insufficient, discontinue Ralik.
Use in children and adolescents
Children and adolescents under 18 years of age should not take Ralik.
Taking more than the recommended dose of Ralik
If an excessive number of Ralik tablets or a dose higher than recommended is taken by accident, contact the doctor immediately. If contacting the doctor is not possible, go to the nearest hospital emergency department. Bring all remaining tablets, including the container and packaging, to assist hospital staff in identifying the medicine taken.
Missed dose of Ralik
If a dose is missed, take it as soon as possible, unless the next dose is due within less than 6 hours. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

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

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Urticaria 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 Ralik.
Other adverse reactions that may occur in patients 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 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 blood creatinine or urea levels, increased platelet or white blood cell count, changes in ECG recording
• Joint swelling, limb pain
• Loss of appetite and (or) weight loss
• Muscle cramps, decreased muscle strength
• Ringing in the ears 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 urinating
• Abnormal laboratory test results indicating impaired liver function
• Acute kidney failure
• Altered sense of smell, numbness of the oral cavity or lips, hearing impairment
• Cold sweats, rash
• Coordination problems
• Decreased blood pressure upon standing
• Reduced or loss of consciousness
• Disorientation
• Cold sensation in hands and feet
• Urticaria, skin allergic reactions
• Impotence
• Walking difficulties due to balance disorders
• Pancreatitis or intestinal inflammation
• Memory loss 4
• Throat tightness
• Low sodium concentration 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):

• Brief, shock-like jerks of a muscle or group of muscles (clonic muscle jerks).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Ralik

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must 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

What Ralik contains
The active substance in Ralik is ranolazine. One tablet contains 375 mg, 500 mg or 750 mg of ranolazine.
The other ingredients are:
Tablet core: Microcrystalline cellulose type 101, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, hypromellose, sodium hydroxide, magnesium stearate.
Depending on the strength, the tablet coatings also contain:
375 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, lac (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 tablets.
375 mg tablets are light blue, oval, biconvex coated tablets with "375" embossed on one side and smooth on the other.
500 mg tablets are light pink, oval, biconvex coated tablets with "500" embossed on one side and smooth on the other.
750 mg tablets are light green, elongated, biconvex coated tablets with "750" embossed 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 Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Ralik
Poland: Ralik