Ranolazine Stada 500 mg prolonged-release tablets EFG

Package Leaflet: Information for the User

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours. It may harm them.
• If you experience any adverse effects, talk to your doctor, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ranolazina is a medicine used in combination with other medications for the treatment of angina pectoris, a condition that causes chest pain or discomfort felt anywhere in the upper half of the body between the neck and the upper abdomen, often occurring during physical exertion or particularly intense activity.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before starting to take Ranolazine Stada

Do not take Ranolazina Stada

• if you are allergic to ranolazine or to 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 (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g., quinidine, dofetilide, or sotalol).

Warnings and precautions

Talk to 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 elderly.
• if you are of low body weight (60 kg or less).
• if you have heart failure.

If any of these apply to you, your doctor may decide to prescribe 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 need to use any other medicines.

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

• certain medicines used 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).

Tell 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 rejection of a transplanted organ (cyclosporine), or heart medicines such as diltiazem or verapamil. These medicines may increase the likelihood 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 prescribe a lower dose of ranolazine.

• medicines used to treat epilepsy or other neurological disorders (e.g., phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin for an infection (e.g., tuberculosis); or if you are taking the herbal remedy St. John’s wort (hypericum), because these medicines may make ranolazine less effective.

• heart medicines containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking ranolazine.

• certain medicines used to treat allergies (e.g., terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g., disopyramide, procainamide), or depression (e.g., imipramine, doxepine, amitriptyline), as these medicines may affect your electrocardiogram (ECG).

• certain medicines used to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).

• certain medicines used to treat high cholesterol levels in the blood (e.g., simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of this medicine while you are taking ranolazine.

• certain medicines used to prevent rejection of a transplanted organ (e.g., tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to adjust the dose of this medicine while you are taking ranolazine.

Use of Ranolazina Stada with food and drink

Ranolazine may be taken with or without food. While taking ranolazine, you must not drink grapefruit juice.

Pregnancy and breastfeeding

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

Pregnancy

You must not take ranolazine during pregnancy unless your doctor has told you that you may do so.

Breastfeeding

You must not take ranolazine while breastfeeding. Consult your doctor if you are breastfeeding.

Driving and using machines

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

Ranolazine may cause side effects such as dizziness (common), 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 experience 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, i.e., essentially “sodium-free”.

3. How to take Ranolazina Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Always swallow the tablets whole with water. Do not chew, suck or crush the tablets, and do not split them in half, as this may affect how the medicine is released in your body.

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

It is important that you inform your doctor if you experience adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or, if necessary, instruct you to stop treatment with ranolazine.

Use in children and adolescents

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

If you take more Ranolazina Stada 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 important to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency center. Take any remaining tablets with you, together with the packaging and carton, so that hospital staff can easily identify what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You must stop taking ranolazine and consult your doctor immediately if you experience the following symptoms of angioedema, a rare but potentially serious condition:

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives or difficulty breathing

Inform your doctor if you experience frequent adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or instruct you to stop taking ranolazine.

The following is a list of other possible adverse effects you may experience:

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

Constipation
Dizziness
Headache
Nausea, vomiting
Weakness (asthenia)

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

Altered sensation
Anxiety, difficulty sleeping, confusion, hallucinations
Blurred vision, visual disturbances
Sensory disturbances (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness upon standing
Dark urine, blood in urine, difficulty urinating
Dehydration
Breathing difficulty, cough, nosebleeds
Double vision
Excessive sweating, itching
Sensation of swelling or puffiness
Hot flushes, low blood pressure
Increased levels of a substance called creatinine, increased blood urea, increased platelet or white blood cell counts, electrocardiogram (ECG) abnormalities
Joint swelling, limb pain
Loss of appetite and/or weight loss
Muscle cramps, muscle weakness
Ringing in the ears and/or sensation of dizziness

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

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

Inability to urinate
Abnormal liver laboratory values
Acute kidney failure
Changes in the sense of smell, numbness of the mouth or lips, hearing loss
Cold sweats, rash
Coordination problems
Drop in blood pressure upon standing
Reduced level of consciousness or loss of consciousness
Disorientation
Sensation of coldness in hands and legs
Hives, skin allergic reactions
Impotence
Inability to walk due to balance problems
Inflammation of the pancreas or intestine
Memory loss
Tightness in the throat
Low sodium levels in the blood (hyponatremia), which may cause fatigue and confusion, muscle twitching, cramps, and coma.

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

Myoclonus

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranolazine Stada

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ranolazina Stada

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

The other components are:

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

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

Appearance of the product and contents of the container

The 375 mg tablets are white, film-coated, oblong, convex, measuring 15 mm x 7.2 mm, with the inscription “375” engraved on one side.

The 500 mg tablets are white, film-coated, oblong, convex, measuring 16.5 mm x 8.0 mm, with the inscription “500” engraved on one side.

The 750 mg tablets are white, film-coated, oblong, convex, measuring 19 mm x 9.2 mm, with the inscription “750” engraved on one side.

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

Only certain 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 European Economic Area Member States under the following names:

Date of the most recent review of this leaflet: May 2022

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