Leaflet: Information for the User

Ranolazine Stada 375 mg prolonged-release tablets EFG

Ranolazine Stada 500 mg prolonged-release tablets EFG

Ranolazine Stada 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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, consult your doctor even if they are not listed in this leaflet. See section 4.

Ranolazina 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 Stada

• if you are allergic to ranolazine or any of the other ingredients of this medicine listed 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 to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (HIV/AIDS) (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 abnormal electrocardiogram (ECG).
• 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 medicine or take other precautions.

Other medicines and Ranolazina Stada

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

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

• certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (HIV/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 medicines to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (ciclosporin), or if you are taking heart tablets such as diltiazem or verapamil. These medicines 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 medicines, your doctor may decide to give you a lower dose of ranolazine.
• medicines 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, because these medicines may make ranolazine less effective.

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

Use of Ranolazina Stada 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 think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine.

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 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.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which 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 entire 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 Ranolazine Stada 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 the remaining tablets, along with the packaging and box, 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 Ranolazine Stada

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.

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

Like all medicines, this medicine 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 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.

The following are other side effects you may experience:

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

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (asthenia)

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

Altered sensitivity

Anxiety, difficulty sleeping, confusion, hallucinations

Blurred vision, vision disturbances

Alterations in sensation (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up

Dark urine, blood in the urine, difficulty urinating

Dehydration

Difficulty breathing, cough, nasal bleeding

Diplopia

Excessive sweating, pruritus

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, electrocardiogram (ECG) alteration

Joint swelling, limb pain

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

Inability to urinate

Liver function test abnormalities

Acute renal failure

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

Cold sweat, urticaria

Coordination problems

Low blood pressure when standing up

Decreased level of consciousness or loss of consciousness

Disorientation

Sensation of cold in hands and feet

Hives, skin allergic 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 may cause fatigue and confusion, muscle contractions, cramps, and coma.

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

Mioclonus

Reporting 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not dispose of the medicine through the drains or in the trash. Deposit the packaging and the medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Ranolazine Stada

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

The other components are:

Tablet core:microcrystalline cellulose (E460), acid methacrylic copolymer (1:1), sodium hydroxide (E524), hypromellose (E464), magnesium stearate (E470b).

Tablet coating system, AquaPolish P white:hypromellose (E464),hydroxypropyl cellulose (E463), macrogol 8000 (E1521), titanium dioxide (E171).

Appearance of the product and contents of the package

The 375 mg tablets are coated with a white film, oblong, convex, 15 mm x 7.2 mm in size, and have the inscription "375" engraved on one side.

The 500 mg tablets are coated with a white film, oblong, convex, 16.5 mm x 8.0 mm in size, and have the inscription "500" engraved on one side.

The 750 mg tablets are coated with a white film, oblong, convex, 19 mm x 9.2 mm in size, and have the inscription "750" engraved on one side.

Ranolazine Stada is supplied in carton boxes with 30, 60, or 100 tablets in PVC/PVDC/Aluminum blisters.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Jósefa Pilsudskiego 5,

95-200 Pabianice

Poland

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

Last review date of this leaflet:May 2022

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