Package leaflet: information for the patient

Ranolazine Accord 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets

ranolazine
Please read this entire 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 other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

What Ranolazine Accord is and what it is used for
What you need to know before taking Ranolazine Accord
How to take Ranolazine Accord
Possible side effects
How to store Ranolazine Accord
Contents of the pack and other information

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

Ranolazina Accord 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, which may occur anywhere in the upper body between the neck and the upper abdomen, and is often triggered by physical exertion or excessive activity.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ranolazina Accord

Do not take Ranolazina Accord

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 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 Ranolazina Accord:

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 Ranolazina Accord
Do not use the following medicines if you are taking Ranolazina Accord:

certain medicines used to treat 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 Ranolazina Accord if you are using:

certain medicines for bacterial infection (erythromycin) or fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (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 Ranolazina Accord (see section 4). Your doctor may decide to prescribe a lower dose.
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 the herbal product St John’s wort, as these medicines may reduce the effectiveness of Ranolazina Accord.
heart medicines containing digoxin or metoprolol, because your doctor may need to adjust the dose of these medicines while you are taking Ranolazina Accord.
certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, or amitriptyline), because these medicines may alter the 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 these medicines while you are taking Ranolazina Accord. Certain medicines used to prevent rejection after organ transplantation (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to adjust the dose of these medicines while you are taking Ranolazina Accord.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ranolazina Accord with food and drink
Ranolazina Accord can be taken with or without food. During treatment with Ranolazina Accord, you must not drink grapefruit juice.
Pregnancy
Do not take Ranolazina Accord during pregnancy unless advised by your doctor.
Breast-feeding
Do not take Ranolazina Accord if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Driving and using machines
No studies on the effects of Ranolazina Accord on the ability to drive or use machines have been performed. Consult your doctor regarding driving and using machines.
Ranolazina Accord 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 these symptoms, do not drive or use machines until the symptoms have completely resolved.
Ranolazina Accord 750 mg prolonged-release tablets contain the azo dye E102. It may cause allergic reactions.
Ranolazina Accord 500 mg and 750 mg prolonged-release tablets contain lactose monohydrate. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. it is essentially 'sodium-free'.

3. How to take Ranolazine Accord

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The tablets must always be swallowed whole with water. You must not crush, suck or chew the tablets, nor split them in half, as this could affect how the medicine is released from the tablet into your body.
The initial dose for adults is one 375 mg tablet twice daily. After 2–4 weeks, your doctor may increase the dosage to achieve the desired effect. The maximum dose of Ranolazine Accord is 750 mg twice daily.
It is important that you inform your doctor if you experience any side effects such as dizziness or feeling unwell. Your doctor may reduce the dose or, if this is not sufficient, discontinue treatment with Ranolazine Accord.
Use in children and adolescents
Children and adolescents under 18 years of age must not take Ranolazine Accord.
If you take more Ranolazine Accord than you should
If you accidentally take too many Ranolazine Accord tablets or take a higher dose than recommended by your doctor, it is important that you inform your doctor immediately. If you are unable to contact your doctor, go to the nearest emergency department. 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 Ranolazine Accord
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 a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Ranolazina Accord and go to your doctor immediately if you experience the following symptoms of angioedema, a rare but sometimes serious condition:

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

Tell your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop treatment with Ranolazina Accord.
Other possible side effects you may experience include:
Common side effects (occur in 1 to 10 people out of 100):
Constipation
Dizziness
Headache
Nausea, vomiting
Feeling weak.
Uncommon side effects (occur in 1 to 10 people out of 1,000):
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, nosebleed
Double vision
Excessive sweating, itching
Feeling of swelling or fullness
Hot flushes, low blood pressure
Increases in a substance called creatinine or increases in blood urea, increased platelet or white blood cell count, changes in the heart’s ECG pattern
Joint swelling, pain in the 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 side effects (occur in 1 to 10 people out of 10,000):
Difficulty urinating normally
Abnormal liver laboratory values
Acute kidney failure
Altered sense of smell, numbness of the mouth or lips, hearing impairment
Cold sweating, skin rash
Coordination problems
Decrease in blood pressure when standing up
Reduced or loss of consciousness
Disorientation
Feeling cold in hands and feet
Hives, allergic skin reaction
Impotence
Difficulty walking due to imbalance
Inflammation of the pancreas or intestine
Memory loss
Feeling of tightness in the throat
Low sodium levels in the blood (hyponatraemia) which may cause fatigue and confusion, muscle twitching, cramps and coma.
Side effects with unknown frequency (frequency cannot be determined from the 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 can also report side effects directly via the national reporting system at: 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 Ranolazine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging following the term "Exp.".
This medicine requires no 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. Contents of the Pack and Other Information

What Ranolazina Accord Contains
The active substance in Ranolazina Accord is ranolazine. Each tablet contains 375 mg, 500 mg,
or 750 mg of ranolazine.
The excipients are: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1),
hypromellose E5, sodium hydroxide, magnesium stearate.
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), Indigo Carmine
aluminium lake FD&C Blue #2 (E132), polysorbate 80.
500 mg tablet: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), macrogol
(E1521), triacetin, yellow iron oxide (E172), red iron oxide (E172).
750 mg tablet: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171),
triacetin, FD&C Blue No.1/Brilliant Blue FCF aluminium lake (E133) and FD&C Yellow No.5/Tartrazine aluminium lake (E102).

Description of the Appearance of Ranolazina Accord and Contents of the Pack
Ranolazina Accord prolonged-release tablets are oval-shaped tablets.
The 375 mg tablets are light blue, oval-shaped, approximately 15.0 × 7.5 mm, film-coated, with the inscription “HI3” engraved on one side and smooth on the other.
The 500 mg tablets are light orange, oval-shaped, approximately 16.5 × 8.1 mm, film-coated, with the inscription “HI1” engraved on one side and smooth on the other.
The 750 mg tablets are light green, oval-shaped, approximately 19.1 × 9.3 mm, film-coated, with the inscription “HI4” engraved on one side and smooth on the other.
Ranolazina Accord is packed in PVC/PVDC/Aluminium blisters containing 30, 60 or 100 tablets in a box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice,
Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta