RANOLAZINE ALTER 375 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Ranolazine Alter

Do not takeRanolazine Alter

• If you are allergic to ranolazine or any of the other components of this medication listed in section 6 of this package leaflet.
• If you have severe kidney problems.
• If you have moderate or severe liver problems.
• If you are using 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 taking ranolazine:

• 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 medication or take other precautions.

Other Medications and Ranolazine Alter

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).

Inform 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.
• Heart medications 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, amitriptiline), 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.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Ranolazine Alter 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

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

Breast-feeding

You should not take ranolazine if you are breast-feeding. Consult your doctor if you are breast-feeding.

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

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 (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.

Ranolazine Alter Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to Take Ranolazine Alter

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Always 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 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 important that you inform your doctor if you experience side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or, if that is not enough, indicate that you stop taking the treatment with ranolazine.

Use in Children and Adolescents

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

If You Take More Ranolazine Alter Than You Should

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 Alter

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 in the face, tongue, or throat
• Difficulty swallowing
• Hives or difficulty breathing

Inform your doctor if you experience frequent side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or indicate that you stop taking ranolazine.

The following are other side effects you may experience:

Frequent Side Effects (occurring in 1 to 10 out of 100 users):

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (Asthenia)

Uncommon Side Effects (occurring in 1 to 10 out of 1,000 users):

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, nosebleed

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 sensation of spinning

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

Rare Side Effects (occurring in 1 to 10 out of 10,000 users):

Urination problems

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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ranolazine Alter

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

Do not use this medication after the expiration date shown 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 through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Ranolazine Alter Composition

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

The other components are: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), sodium hydroxide, hypromellose, magnesium stearate, and coating [hypromellose, hydroxypropylcellulose, macrogol 8000, and titanium dioxide (E-171)].

Product Appearance and Package Contents

Ranolazine Alter prolonged-release tablets are film-coated, white, oblong, and convex.

The 375 mg tablets measure 15 x 7.2 mm and have 375 engraved on one side.

The 500 mg tablets measure 16.5 x 8.0 mm and have 500 engraved on one side.

The 750 mg tablets measure 19 x 9.2 mm and have 750 engraved on one side.

The tablets are available in PVC/PVDC-Al blister packs in packages of 60 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

Pabianice, 95-200

Poland

Date of Last Revision of this Package Leaflet: December 2022

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