Ranva

PACKAGE LEAFLET

Package leaflet: information for the patient

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

ranolazine
Generic 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Ranva is and what it is used for
  2. What you need to know before taking Ranva
  3. How to take Ranva
  4. Possible side effects
  5. How to store Ranva
  6. Contents of the pack and other information

1. What Ranva is and what it is used for

Ranva 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 trunk between the neck and the upper abdomen, 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 Ranva

Do not take Ranva

• 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 Ranva:

• 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 have a low body weight (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 Ranva
Do not use the following medicines if you are taking Ranva:

• 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 Ranva 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 occurrence of side effects such as dizziness, nausea, or vomiting, which are possible side effects of Ranva (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); or 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 Ranva.
• heart medications containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking Ranva.
• 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 affect 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 Ranva.
• certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may need to adjust the dose of these medicines while you are taking Ranva.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ranva with food and drink
Ranva can be taken with or without food. During treatment with Ranva, you must not drink grapefruit juice.

Pregnancy and breastfeeding
Do not take Ranva during pregnancy unless advised by your doctor.
Do not take Ranva if you are breastfeeding. Ask your doctor for advice if you are breastfeeding.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
No studies on the effects of Ranva on the ability to drive and use machines have been conducted. Consult your doctor regarding driving and using machines.
Ranva may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), and abnormal coordination (rare), which could affect your ability to drive or use machines.
If you experience any of these symptoms, do not drive or use machines until they have completely resolved.

Ranva 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 Ranva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The tablets should always be swallowed 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 Ranva is 750 mg twice daily.
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 necessary, discontinue treatment with Ranva.
Use in children and adolescents
Children and adolescents under 18 years of age must not take Ranva.
If you take more Ranva than you should
If you accidentally take too many Ranva 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 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 Ranva
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 missed dose.

4. Possible side effects

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

• 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, feeling unwell or vomiting. Your doctor may reduce the dose or stop treatment with Ranva.
Other side effects you may experience include:
Common side effects (may affect up to 1 in 10 people):

• constipation
• dizziness
• headache
• feeling unwell, vomiting
• feeling of weakness.

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

• altered sensitivity
• anxiety, difficulty sleeping, confusion, hallucinations
• blurred vision, visual disturbances
• changes in sensations (touch or taste), tremor, feeling of tiredness or sluggishness, numbness or drowsiness, feeling faint or fainting, dizziness when standing up
• dark urine, blood in urine, difficulty urinating
• dehydration
• difficulty breathing, cough, nosebleed
• double vision
• excessive sweating, itching
• feeling of bloating 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 ECG pattern
• swelling of joints, pain in extremities
• 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 intestinal gas.

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

• difficulty urinating normally
• abnormal liver laboratory values
• acute kidney failure
• altered sense of smell, numbness of mouth or lips, hearing impairment
• cold sweating, rash
• coordination problems
• drop in blood pressure when standing up
• reduction or loss of consciousness
• disorientation
• feeling cold in hands and feet
• hives, allergic skin reaction
• impotence
• inability to walk due to lack of balance
• inflammation of the pancreas or intestine
• memory loss
• tightness in the throat
• low sodium levels in the blood (hyponatremia) which may cause tiredness and confusion, muscle twitching, cramps and coma.

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

• myoclonus

Reporting of side effects
If you get any side effects, including ones 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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ranva

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 packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Ranva contains
The active substance in Ranva is ranolazine.
Each tablet contains 375 mg of ranolazine.
Each tablet contains 500 mg of ranolazine.
Each tablet contains 750 mg of ranolazine.
The other components are: microcrystalline cellulose, hypromellose, ethyl acrylate-methacrylic acid copolymer, sodium hydroxide, magnesium stearate.
[375 mg]: The film coating contains: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132)
[500 mg]: The film coating contains: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (E 172)
[750 mg]: The film coating contains: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc

Description of the appearance of Ranva and contents of the pack
Ranva 375 mg prolonged-release tablets are light blue, oval-shaped, film-coated tablets, printed with "375" on one side and smooth on the other. The tablet measures approximately 14.9 mm x 7.1 mm.
Ranva 500 mg prolonged-release tablets are light orange, oval-shaped, film-coated tablets, printed with "500" on one side and smooth on the other. The tablet measures approximately 16.5 mm x 8.0 mm.
Ranva 750 mg prolonged-release tablets are white to almost white, oval-shaped, film-coated tablets, printed with "750" on one side and smooth on the other. The tablet measures approximately 18.8 mm x 9.1 mm.
Ranva is supplied in PVC/PVDC/Al and PVC/Aclar/PVC aluminium press-through blisters containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143 – 00156 Roma
Italy

Manufacturer
Pliva Hrvatska d.o.o.
Prilaz baruna Filipovica 25
Zagreb, 10000
Croatia

This medicinal product is authorised in the European Economic Area Member States under the following names:
IT: Ranva

Other sources of information
The most up-to-date approved information on this medicinal product is available by scanning the QR code included in the package leaflet with a smartphone or device. The same information is also available at the following URL: [URL to be included]