Package Leaflet: Information for the User

Ranolazine Normon 375 mg prolonged-release tablets EFG

Ranolazine Normon 500 mg prolonged-release tablets EFG

Ranolazine Normon 750 mg prolonged-release tablets EFG

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

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

Ranolazina Normon is a medication used in combination with others for the treatment of angina pectoris, 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 abdomen, often after physical exercise or particularly intense activity.

Consult a doctor if it worsens or does not improve.

Do not take Ranolazina Normon

• If you are allergic to ranolazine or to 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 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 disturbances (e.g. quinidine, dofetilide or sotalol).

Warnings and precautions

Consult your doctor before starting to take ranolazine:

• 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 underweight (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 Ranolazina Normon

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

Do not use any of the following medications while taking ranolazine:

• Certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (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 medication such as diltiazem or verapamil. These medications may cause a higher number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of ranolazine treatment (see section 4). If you are taking these medications, your doctor may decide to give you a lower dose of ranolazine.
• Medications to treat 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, inform your doctor because these medications may make ranolazine less effective.
• Heart medications containing digoxin or metoprolol, as your doctor may decide to change your dose while taking ranolazine.
• Certain medications to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disturbances (e.g. disopyramide, procainamide) and medications to treat 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), as your doctor may decide to change the dose of this medication while you are taking ranolazine.

Taking Ranolazina Normon with food and drinks

Ranolazine can be taken with or without food. While you are taking ranolazine, do not drink grapefruit juice.

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

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

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 operate machinery. If you notice any of these symptoms, do not drive or operate machinery until they have passed.

Ranolazina Normon contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Swallow the whole tablets 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 taken 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 taken twice a day.

It is essential to 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 sufficient, instruct you to stop taking ranolazine treatment.

Use in children and adolescents

Children and adolescents under 18 years old should not take ranolazine.

If you take more Ranolazina Normon than you should

If you accidentally take more ranolazine tablets than you should take or take tablets of a higher dose than recommended by your doctor, it is essential to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency department. Bring with you the remaining tablets, along with the blister (aluminum sheet containing the tablets) and the packaging, so that hospital staff can easily identify what you have taken.

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

If you forgot to take Ranolazina Normon

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next dose (less than 6 hours). Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking ranolazine and consult your doctor immediately if you experience the following angioedema symptoms, which is a rare but serious condition:

• 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 your dose or advise you to stop taking ranolazine.

Below, other side effects that you may experience are listed:

Frequent side effects (occurring in between 1 and 10 in every 100 users):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Weakness (Astenia)

Rare side effects (occurring in between 1 and 10 in every 1,000 users):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disturbances
• Alterations in senses (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nasal bleeding
• Diplopia
• Excessive sweating, itching
• Sensation of swelling or heaviness
• Hot flashes, low blood pressure
• Increased levels of a substance called creatinine, urea in the blood, platelet or white blood cell counts, alteration of the electrocardiogram (ECG)
• Swelling of the joints, pain in the limbs
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Tinnitus in the ears and/or sensation of the head spinning
• Abdominal pain or discomfort, indigestion, dry mouth, gas

Rare side effects (occurring in between 1 and 10 in every 10,000 users):

• Inability to urinate
• Lab test alterations of the liver
• Acute renal failure
• Alterations in the sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweat, hives
• Coordination problems
• Low blood pressure when standing up
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Sensation of cold in hands and legs
• Hives, skin allergic reactions
• Impotence
• Inability to walk due to balance problems
• Pancreatitis or intestinal inflammation
• Memory loss
• Stridor in the throat
• Low sodium levels in blood (hyponatremia) that may cause fatigue and confusion,
• Muscle contractions, cramps, and coma.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use https://www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on each blister, after “CAD”. The expiration date is the last day of the month indicated

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ranolazina Normon

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

The other components are:

Tablet core: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1), sodium hydroxide, hypromellose and magnesium stearate.

Tablet coating: Hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide E-171.

Appearance of the product and content of the container

Ranolazina Normon prolonged-release tablets are white, elongated and convex, printed with “375”, “500” or “750” on one side.

Ranolazina Normon is presented in cardboard boxes with 60 tablets in blisters

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Lodzkie,

Poland

Last review date of this leaflet: November 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/