LABIGAT 500 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Labigat 375 mg prolonged-release tablets EFG

Labigat 500 mg prolonged-release tablets EFG

Labigat 750 mg prolonged-release tablets EFG

ranolazine

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Labigat and what is it used for

Labigat is a medicine that is used in combination with other medicines for the treatment of angina pectoris, which is a disease that causes pain in the chest or discomfort that is 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 you take Labigat

Do not take Labigat

• If you are allergic to ranolazine or any of the other ingredients of this medicine included 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 for 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 Labigat:

• 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 medicine or take other precautions.

Other medicines and Labigat

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

• Certain medicines 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 Labigat if you are using:

• Certain medicines for treating a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent organ rejection after a transplant (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medicines may cause a greater number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of treatment with Labigat (see section 4). If you are taking these medicines, your doctor may decide to give you a lower dose of Labigat.
• Medicines 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 medicine called hypericum or St. John's wort, you should inform your doctor because these medicines may make Labigat less effective.
• Heart medicines that contain digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change the dose while you are taking Labigat.
• Certain medicines for treating allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and medicines for treating depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• Certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medicines for treating high blood cholesterol levels (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 LABIGAT.
• Certain medicines used to prevent organ rejection after a transplant (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while you are taking Labigat.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Labigat with food and drinks

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

Pregnancy

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

Breast-feeding

You should not take Labigat 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

Labigat 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.

Labigat contains tartrazine

Labigat 750 mg prolonged-release tablets contain the azo dye E102 (tartrazine). It may cause allergic reactions.

Labigat contains lactose

Labigat 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Labigat contains sodium

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

3. How to take Labigat

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 medicine is released in your body.

The recommended dose is:

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 Labigat 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, tell you to stop taking the treatment with Labigat.

Use in children and adolescents

Children and adolescents under 18 years should not take Labigat.

If you take more Labigat than you should

If you accidentally take more tablets of Labigat than you should or take tablets of a higher dose than recommended by your doctor, it is important 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 (aluminum sheet that contains the tablets) and the packaging, so that the 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 Toxicological Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Labigat

If you forget to take a dose, take it as soon as you remember unless it is almost time to take 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 medicines, this medicine can cause side effects, although not everybody gets them.

You must stop taking Labigat 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 Labigat.

The following are other side effects that you may experience:

Common: may affect up to 1 in 10 people

• constipation
• dizziness
• headache
• nausea, vomiting
• weakness

Uncommon: may affect up to 1 in 100 people

• altered sensitivity
• anxiety, difficulty sleeping, confusion, hallucinations
• blurred vision, vision disorders
• alterations of the senses (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, alteration of the 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 the head spinning
• stomach pain or discomfort, indigestion, dry mouth, or gas

Rare: may affect up to 1 in 1000 people

• inability to urinate
• altered liver laboratory values
• acute kidney failure
• alterations 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
• inflammation of the pancreas or intestine
• memory loss
• throat tightness
• low sodium levels in the blood (hyponatremia) that can cause fatigue and confusion, muscle contractions, cramps, and coma.

Frequency not known: frequency cannot be estimated from the available data

• myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.es/gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Labigat

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on each blister pack of tablets and on the outer packaging and bottle after EXP.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Labigat

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

The other ingredients are: hypromellose, methacrylic acid-ethyl acrylate copolymer 1:1, sodium hydroxide, microcrystalline cellulose, magnesium stearate.

Depending on the dose of the tablet, the tablet coating also contains:

375 mg tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol/PEG (E 1521), FD&C Blue No. 2/aluminum lake of carmine (E 132), polysorbate 80 (E 433).

500 mg tablet: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol/PEG (E 1521), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172).

750 mg tablet: hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin, aluminum lake FD&C Blue No. 1/brilliant blue FCF (E 133), aluminum lake FD&C Yellow No. 5/tartrazine (E 102).

Appearance of the product and pack contents

Labigat prolonged-release tablets are oval-shaped tablets.

The 375 mg tablets are light blue, oval-shaped, with dimensions of length: 15.0 ± 0.2 mm, width: 7.2 ± 0.2 mm, thickness: 6.7 ± 0.5 mm, engraved with "375" on one side.

The 500 mg tablets are light orange, oval-shaped, with dimensions of length: 16.6 ± 0.2 mm, width: 8.1 ± 0.2 mm, thickness: 7.2 ± 0.5 mm, engraved with "500" on one side.

The 750 mg tablets are pale green, oval-shaped, with dimensions of length: 18.9 ± 0.2 mm, width: 9.2 ± 0.2 mm, thickness: 8.2 ± 0.5 mm, engraved with "750" on one side.

Labigat is available in boxes containing 30, 60 or 100 tablets in blisters or 60 tablets in plastic bottles.

Not all pack sizes may be marketed.

Marketing authorisation holder

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

Manufacturer

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:March 2025

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