Labigat

PACKAGE LEAFLET

Package leaflet: Information for the patient

LABIGAT 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets

ranolazine
equivalent medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

1. What LABIGAT is and what it is used for
2. What you need to know before taking LABIGAT
3. How to take LABIGAT
4. Possible side effects
5. How to store LABIGAT
6. Package contents and other information

1. What LABIGAT is and what it is used for

LABIGAT is a medicine used in combination with other medicines for the treatment of angina pectoris, a condition characterized by pain or discomfort in the chest, located anywhere in the upper part of the trunk between the neck and the upper abdomen, often triggered by physical exertion or excessive activity.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LABIGAT

Do not take LABIGAT

• if you are allergic to ranolazine or to any of the other ingredients of this medicine listed in section 6.
• 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 (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Warnings and precautions
Talk to 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 abnormal electrocardiogram (ECG).
• if you are elderly.
• if you are underweight (60 kg or less).
• if you have heart failure.

In these cases, your doctor may decide to prescribe a lower dose or take other precautions.
Other medicines and LABIGAT
Do not take the following medicines if you are taking LABIGAT:

• certain medicines for bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (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 bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or if you are taking heart medications such as diltiazem or verapamil. These medicines may increase the risk of side effects such as dizziness, nausea, or vomiting, which are possible side effects of LABIGAT (see section 4). Your doctor may decide to prescribe a lower dose.
• medicines for epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin for an infection (e.g. tuberculosis) or the herbal product St. John’s wort, as these medicines may reduce the effectiveness of LABIGAT.
• heart medications containing digoxin or metoprolol, because your doctor may need to adjust the dose of these medicines while you are taking LABIGAT.
• certain medicines for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, or amitriptyline), as these medicines may alter your ECG.
• certain medicines for depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide). Certain medicines for high cholesterol levels in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines can cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of these medicines while you are taking LABIGAT. Certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to adjust the dose of these medicines while you are taking LABIGAT.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LABIGAT with food and drinks
LABIGAT can be taken with or without food. During treatment with LABIGAT, you must not drink grapefruit juice.
Pregnancy
Do not take LABIGAT during pregnancy unless advised by your doctor.
Breast-feeding
Do not take LABIGAT if you are breast-feeding. Consult your doctor if you are breast-feeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breast-feeding, consult your doctor before taking this medicine.
Driving and using machines
No studies on the effects of LABIGAT on the ability to drive or operate machinery have been conducted. Consult your doctor regarding driving and using machinery.
LABIGAT may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), abnormal coordination (rare), which could affect your ability to drive or use machinery. If you experience these symptoms, do not drive or use machinery until they have completely resolved.
LABIGAT contains tartrazine
LABIGAT 750 mg prolonged-release tablets contain the azo dye E102. This dye may cause allergic reactions.
LABIGAT contains lactose monohydrate
LABIGAT 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
LABIGAT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. essentially ‘sodium-free’.

3. How to take LABIGAT

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Always swallow the tablets whole with water. Do not crush, suck, chew or split the tablets, as this could affect how the medicine is released into your body.
The initial dose for adults is one 375 mg tablet twice daily. After 2–4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of LABIGAT is 750 mg twice daily.
It is important that you inform your doctor if you experience any adverse effects such as dizziness, or a feeling or state of malaise. Your doctor may reduce the dose or, if necessary, discontinue treatment with LABIGAT.

Use in children and adolescents
Children and adolescents under 18 years of age must not take LABIGAT.

If you take more LABIGAT than you should
If you accidentally take too many LABIGAT tablets or take 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 room. Take any remaining tablets with you, including the container and packaging, so that hospital staff can easily identify what you have taken.

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 for your next dose (less than 6 hours away). Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You must stop taking LABIGAT and go to a doctor immediately if you experience the following symptoms of angioedema, which is a rare but sometimes serious condition:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives or difficulty breathing.

Inform your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop treatment with LABIGAT.
Other possible side effects you may experience are:
Common (may affect up to 1 in 10 people):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Feeling of weakness.

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Changes in sensation (touch or taste), tremor, feeling of fatigue or sluggishness, numbness or drowsiness, feeling faint or fainting, dizziness when standing up
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Breathing difficulties, cough, nosebleeds
• Double vision
• Excessive sweating, itching
• Feeling of bloating or fullness
• Hot flushes, low blood pressure
• Increase in a substance called creatinine or increased blood urea levels, increased platelet or white blood cell count in blood, changes in ECG heart tracing
• Joint swelling, pain in extremities
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Sensation of ringing in the ears and/or dizziness
• Stomach pain or discomfort, indigestion, dry mouth or intestinal gas

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

• Difficulty urinating normally
• Abnormal liver laboratory values
• Acute kidney failure
• Impaired sense of smell, numbness of mouth or lips, hearing impairment
• Cold sweating, skin rash
• Coordination problems
• Drop in blood pressure when standing up
• Reduced or loss of consciousness
• Disorientation
• Feeling of coldness in hands and feet
• Hives, allergic skin reaction
• Impotence
• Difficulty walking due to loss of balance
• Inflammation of the pancreas or intestine
• Memory loss
• Sensation of throat tightness
• Low sodium levels in blood (hyponatremia) which may cause fatigue and confusion, muscle twitching, cramps and coma.

Not known (frequency cannot be estimated from available data):

• Myoclonus

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LABIGAT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on each tablet blister and
on the outer carton and bottle after the word “Exp.”.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LABIGAT contains
The active substance of LABIGAT is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg of ranolazine.
The excipients are: hypromellose, methacrylic acid-ethyl acrylate copolymer 1:1, sodium hydroxide, microcrystalline cellulose, magnesium stearate.
Depending on the tablet strength, the coating also contains:
375 mg tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol/PEG (E 1521), FD&C Blue #2/Indigo Carmine Aluminum Lake (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, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake (E 133), FD&C Yellow #5 / Tartrazine Aluminum Lake (E 102)

Description of the appearance of LABIGAT and package contents
LABIGAT prolonged-release tablets are oval-shaped tablets.
The 375 mg tablets are light blue oval tablets, with dimensions: length: 15.0 ± 0.2 mm, width: 7.2 ± 0.2 mm, thickness: 6.7 ± 0.5 mm, marked with "375" on one side.
The 500 mg tablets are light orange oval tablets, with dimensions: length: 16.6 ± 0.2 mm, width: 8.1 ± 0.2 mm, thickness: 7.2 ± 0.5 mm, marked with "500" on one side.
The 750 mg tablets are light green oval tablets, with dimensions: length: 18.9 ± 0.2 mm, width: 9.2 ± 0.2 mm, thickness: 8.2 ± 0.5 mm, marked with "750" on one side.
LABIGAT is supplied in cardboard boxes containing 30, 60 or 100 tablets in blisters or 60 tablets in plastic bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmathen S.A.
Dervenakion 6,
15351 Pallini Attiki,
Greece

Manufacturers
Pharmathen International S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece

Pharmathen S.A.
Dervenakion 6,
15351 Pallini Attiki,
Greece

This medicinal product is authorized in the European Economic Area member states under the following names: