RANOLAZINE CINFA 375 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

ranolazine cinfa 375 mg prolonged-release tablets EFG

ranolazine cinfa 500 mg prolonged-release tablets EFG

ranolazine cinfa 750 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is ranolazine cinfa and what is it used for.
2. What you need to know before taking ranolazine cinfa.
3. How to take ranolazine cinfa.
4. Possible side effects.
5. Storage of ranolazine cinfa.
6. Package Contents and Additional Information.

1. What is ranolazine cinfa and what is it used for

Ranolazine is a medication used in combination with others for the treatment of angina pectoris, which is a disease that causes chest pain or discomfort 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 taking ranolazine cinfa

Do not take ranolazine cinfa

• If you are allergic to ranolazine or any of the other components of this medication (listed in section 6).
• If you have severe kidney problems.
• If you have moderate or severe liver problems.
• If you are taking certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g., quinidine, dofetilide, or sotalol).

Warnings and Precautions

Consult your doctor before starting to take ranolazine cinfa:

• If you have mild or moderate kidney problems.
• If you have mild liver problems.
• If you have ever had an electrocardiogram (ECG) abnormality.
• 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 situations, your doctor may decide to give you a lower dose of the medication or take other precautions.

Other Medications and Ranolazine Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not use any of the following medications if you are taking ranolazine:

• Certain medications for the treatment of bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g., quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before taking ranolazine if you are using:

• Certain medications to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medication used to prevent organ transplant rejection (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medications may cause a greater number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of treatment with ranolazine (see section 4). If you are taking these medications, your doctor may decide to give you a lower dose of ranolazine.
• Medications 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 remedy called St. John's Wort, you should inform your doctor because these medications may make ranolazine less effective.

(e.g., tuberculosis); or if you are taking a herbal remedy called St. John's Wort, you should inform your doctor because these medications may make ranolazine less effective.

• Medications for the heart that contain digoxin or metoprolol, as your doctor may decide to change the dose while you are taking ranolazine.
• Certain medications to treat allergies (e.g., terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g., disopyramide, procainamide), and medications for the treatment of depression (e.g., imipramine, doxepin, amitriptyline), as these medications may alter your electrocardiogram (ECG).
• Certain medications to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medications to treat high cholesterol levels in the blood (e.g., simvastatin, lovastatin, atorvastatin). These medications may cause muscle pain and damage. Your doctor may decide to change the dose of this medication while you are taking ranolazine.
• Certain medications used to prevent organ transplant rejection (e.g., tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medication while you are taking ranolazine.

Taking Ranolazine Cinfa with Food and Drinks

Ranolazine can be taken with or without food. While you are being treated with ranolazine, you should not drink grapefruit juice.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Do not take ranolazine if you are pregnant unless your doctor has told you that you can.

Breastfeeding

Do not take ranolazine if you are breastfeeding. Consult your doctor if you are breastfeeding.

Driving and Using Machines

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

Ranolazine may cause side effects such as dizziness (frequent), blurred vision (infrequent), confusion (infrequent), hallucinations (infrequent), double vision (infrequent), 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.

Ranolazine Cinfa Contains Sodium

Ranolazine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e., it is essentially "sodium-free".

3. How to Take Ranolazine Cinfa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Always swallow the tablets whole with water. Do not chew, suck, or crush the tablets, or divide them in half, as this may affect how the medication is released in 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 ranolazine is 750 mg twice a day.

It is essential 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 ranolazine.

Use in Children and Adolescents

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

If You Take More Ranolazine Cinfa Than You Should

If you accidentally take more ranolazine tablets than you should or take tablets of a higher dose than recommended by your doctor, it is essential 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 blister pack and packaging, so that 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 medication and the amount ingested.

If You Forget to Take Ranolazine Cinfa

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 missed doses.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

You should stop taking ranolazine 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 ranolazine.

The following are other side effects you may experience:

Frequent Side Effects(may affect up to 1 in 10 patients):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Weakness

Infrequent Side Effects(may affect up to 1 in 100 patients):

• 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
• Difficulty breathing, cough, nosebleeds
• 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, altered electrocardiogram (ECG)
• Swelling of the joints, pain in the limbs
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or a feeling of dizziness
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare Side Effects(may affect up to 1 in 1,000 patients):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Disturbances in the sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweats, rash
• 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 available data):

• Myoclonus

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ranolazine Cinfa

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Ranolazine Cinfa Composition

The active ingredient is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg of ranolazine.

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).

AquaPolish P-white coating:Hypromellose (E464), hydroxypropylcellulose (E463), macrogol 8000 (E1521), titanium dioxide (E171).

Appearance of the Product and Package Contents

The 375 mg tablets are white, oblong, convex, film-coated tablets with dimensions of 15 mm x 7.2 mm and with the inscription "375" engraved on one side.

The 500 mg tablets are white, oblong, convex, film-coated tablets with dimensions of 16.5 mm x 8.0 mm and with the inscription "500" engraved on one side.

The 750 mg tablets are white, oblong, convex, film-coated tablets with dimensions of 19 mm x 9.2 mm and with the inscription "750" engraved on one side.

Ranolazine Cinfa is packaged in PVC/PVDC/aluminum blister packs in cardboard boxes containing 30, 60, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Netherlands: Ranolazine ELC 375 mg / 500 mg / 750 mg prolonged-release tablets

Austria: Ranolazin ELC 375 mg / 500 mg / 750 mg prolonged-release tablets

Bulgaria: Ranolazine ELC 375 mg / 500 mg / 750 mg ???????? ? ???????? ?????????????

Cyprus: Ranolazine ELC 375 mg / 500 mg / 750 mg ?????? ?????????? ???????????

Estonia: Ranolazine ELC

Croatia: Ranolazin ELC 375 mg / 500 mg / 750 mg tablets with prolonged release

Ireland: Ranolazine 375 mg / 500 mg / 750 mg prolonged-release tablets

Lithuania: Ranolazine ELC 375 mg / 500 mg / 750 mg prolonged-release tablets

Portugal: Ranolazine ELC

Romania: Ranolazina ELC Group s.r.o. 375 mg / 500 mg / 750 mg prolonged-release tablets

Slovenia: Ranolazin ELC Group 375 mg / 500 mg / 750 mg tablets with prolonged release

Italy: Ranolazina ELC

Spain: Ranolazina Cinfa 375 mg / 500 mg / 750 mg prolonged-release tablets EFG

Greece: RANOLAZINE/GENEPHARM

Date of the Last Revision of this Package Leaflet:05/2022

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

Ranolazine Cinfa 375 mg prolonged-release tablets EFG

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88005/P_88005.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88005/P_88005.html

Ranolazine Cinfa 500 mg prolonged-release tablets EFG

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88006/P_88006.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88006/P_88006.html

Ranolazine Cinfa 750 mg prolonged-release tablets EFG

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88007/P_88007.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88007/P_88007.html