RANOLAZINE STADA 500 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Ranolazina Stada 375 mg prolonged-release tablets EFG

Ranolazina Stada 500 mg prolonged-release tablets EFG

Ranolazina Stada 750 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness 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 pack

1. What is Ranolazina Stada and what is it used for
2. What you need to know before you take Ranolazina Stada
3. How to take Ranolazina Stada
4. Possible side effects
5. Storage of Ranolazina Stada
6. Contents of the pack and other information

1. What is Ranolazina Stada and what is it used for

Ranolazina is a medicine that is used in combination with others for the treatment of angina pectoris, which is a disease that produces pain in the chest or discomfort that is felt in any part of the upper half of the body between the neck and the upper part of the abdomen, often after physical exercise or a particularly intense activity.

You should consult a doctor if it worsens or does not improve.

2. What you need to know before you take Ranolazina Stada

Do not take Ranolazina Stada

• if you are allergic to ranolazina or any of the other components of this medicine included in section 6 of this leaflet.
• if you have severe kidney problems.
• if you have moderate or severe liver problems.
• if you are taking certain medicines for 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

Consult your doctor before taking Ranolazina Stada:

• if you have mild or moderate kidney problems.
• if you have mild liver problems.
• if you have ever had an electrocardiogram (ECG) alteration.
• if you are an elderly person.
• if you are a person of low weight (60 kg or less).
• if you have heart failure.

If you are in any of these cases, your doctor may decide to give you a lower dose of the medicine or take other precautions.

Other medicines and Ranolazina Stada

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not use any of the following medicines if you are taking ranolazina:

• certain medicines for the treatment of 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 ranolazina if you are using:

• certain medicines for treating a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent organ rejection after a transplant (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medicines may cause a greater number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of treatment with ranolazina (see section 4). If you are taking these medicines, your doctor may decide to give you a lower dose of ranolazina.
• medicines for the treatment of epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine or phenobarbital); if you are taking rifampicin to treat an infection (e.g. tuberculosis); or if you are taking a herbal medicine called St. John's Wort, because these medicines may make ranolazina less effective.

(e.g. tuberculosis); or if you are taking a herbal medicine called St. John's Wort, because these medicines may make ranolazina less effective.

• medicines for the heart that contain digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change the dose while taking ranolazina.
• certain medicines for treating allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and medicines for the treatment of depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• certain medicines for treating 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 this medicine while taking ranolazina.
• certain medicines used to prevent organ rejection after a transplant (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while taking ranolazina.

Using Ranolazina Stada with food and drinks

Ranolazina can be taken with or without food. While being treated with ranolazina, you should not drink grapefruit juice.

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

You should not take ranolazina if you are pregnant unless your doctor has told you that you can.

Breastfeeding

You should not take ranolazina if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.

Driving and using machines

No studies on the effects of ranolazina on the ability to drive and use machines have been performed. Ask your doctor if you can drive or use machines.

Ranolazina 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 notice any of these symptoms, do not drive or use machines until they have passed.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Ranolazina Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water. Do not chew, suck or crush the tablets, or divide them in half, as this may affect the way the medicine is released into your body.

The initial dose for adults is one 375 mg tablet twice a day. After a period of time between 2 and 4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of ranolazina is 750 mg twice a day.

It is important that you inform your doctor if you experience side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or tell you to stop taking ranolazina.

Use in children and adolescents

Children and adolescents under 18 years should not take ranolazina.

If you take more Ranolazina Stada than you should

If you accidentally take more tablets of ranolazina than you should, or take tablets of a higher dose than recommended by your doctor, it is important that you inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency center. Take the remaining tablets, along with the packaging and box, so that the hospital staff can easily see what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ranolazina Stada

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose (less than 6 hours). Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must stop taking ranolazina and consult your doctor immediately if you experience the following symptoms of angioedema, which is a rare but serious disorder:

• 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 tell you to stop taking ranolazina.

The following are other side effects that you may experience:

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

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (asthenia)

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

Altered sensitivity

Anxiety, difficulty sleeping, confusion, hallucinations

Blurred vision, vision disorders

Sensory disturbances (touch or taste), tremors, fatigue or weakness, somnolence or lethargy, weakness or fainting, dizziness when standing up

Dark urine, blood in the urine, difficulty urinating

Dehydration

Breathing difficulties, cough, nasal bleeding

Double vision

Excessive sweating, itching

Feeling of swelling or bloating

Hot flashes, low blood pressure

Increased levels of a substance called creatinine, urea in the blood, platelet or white blood cell counts in the blood, alteration of the electrocardiogram (ECG)

Swelling of the joints, pain in the limbs

Lack of appetite and/or weight loss

Muscle cramps, muscle weakness

Ringing in the ears and/or sensation of the head spinning

Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare side effects(may affect up to 1 in 1,000 people) are:

Urination problems

Abnormal liver laboratory values

Acute kidney failure

Disturbances in the sense of smell, numbness of the mouth or lips, hearing loss

Coordination problems

Low blood pressure when standing up

Decreased level of consciousness or loss of consciousness

Disorientation

Feeling of cold in hands and feet

Hives, allergic skin reactions

Impotence

Inability to walk due to balance problems

Pancreatitis or intestinal inflammation

Memory loss

Throat tightness

Low sodium levels in the blood (hyponatremia) that can cause fatigue and confusion, muscle contractions, cramps, and coma.

Side effects with unknown frequency(cannot be estimated from the available data) are:

Myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranolazina Stada

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ranolazina Stada

The active substance of this medicine is ranolazina. Each tablet contains 375 mg, 500 mg or 750 mg of ranolazina.

The other ingredients are:

Core of the tablet:microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide (E524), hypromellose (E464), magnesium stearate (E470b).

Coating of the tablet, AquaPolish P white:hypromellose (E464),hydroxypropylcellulose (E463), macrogol 8000 (E1521), titanium dioxide (E171).

Appearance of the product and contents of the pack

The 375 mg tablets are white, oblong, convex, 15 mm x 7.2 mm in size, and have "375" engraved on one side.

The 500 mg tablets are white, oblong, convex, 16.5 mm x 8.0 mm in size, and have "500" engraved on one side.

The 750 mg tablets are white, oblong, convex, 19 mm x 9.2 mm in size, and have "750" engraved on one side.

Ranolazina Stada is available in cardboard boxes containing 30, 60 or 100 tablets in PVC/PVDC/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Jósefa Pilsudskiego 5,

95-200 Pabianice

Poland

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

Date of last revision of this leaflet:May 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/