RANVA 375 mg Extended-Release Tablet

Зміст інструкції

1. Ranva 375 mg prolonged-release tablets, 500 mg prolonged-release tablets, 750 mg prolonged-release tablets
   1. What is Ranva and what is it used for
   2. What you need to know before you take Ranva
   3. How to take Ranva
   4. Possible side effects
   5. How to store Ranva
   6. Contents of the pack and other information

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

ranolazine
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ranva and what is it used for

Ranva is a medicine used in association with other medicines for the treatment of angina pectoris, a condition that manifests with 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 exercise or excessive activity.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Ranva

Do not take Ranva

• if you are allergic to ranolazine or 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 using certain medicines for the treatment of 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 weigh little (60 kg or less).
• if you suffer from heart failure

In these cases, your doctor may decide to give you 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 the treatment of 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 to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (cyclosporine), or if you are taking tablets for the heart such as diltiazem or verapamil. These medicines may increase the number of undesirable effects, such as dizziness, nausea or vomiting, which are the possible undesirable effects of Ranva (see section 4). Your doctor may decide to prescribe you a reduced dose.
• medicines to treat epilepsy or another neurological disorder (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 Ranva.
• medicines for the heart based on digoxin or metoprolol, because your doctor may decide to change the dose of these medicines while you are taking Ranva.
• certain medicines for the treatment of allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and depression (e.g. imipramine, doxepin or amitriptyline), as these medicines may alter the ECG.
• certain medicines for the treatment of depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• certain medicines for the treatment of high cholesterol levels in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines can cause pain and muscle damage. Your doctor may decide to change the dose of these medicines while you are taking Ranva.
• certain medicines used to prevent rejection from organ transplantation (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to change 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
You can take Ranva with or without food. During treatment with Ranva, you should 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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
Studies have not been conducted on the effects of Ranva on the ability to drive and use machines. Ask your doctor about driving and using machines.
Ranva may cause undesirable effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), abnormal coordination (rare), which may affect your ability to drive or use machines.
If you experience 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The tablets must always be swallowed whole with water. You must not break, suck or
chew the tablets or split them in half, as this could affect the way the medicine
is released from the tablet into your body.
The initial dosage in adults is one 375 mg tablet twice a day. After 2–4 weeks
your doctor may increase the dosage to achieve the desired effect. The maximum dosage of Ranva is
750 mg twice a day.
It is important that you inform your doctor if you experience undesirable effects such as dizziness, nausea or
vomiting. Your doctor may reduce the dosage or, if that is not enough, 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 dose higher than
recommended by your doctor, it is important that you inform him/her immediately. If you cannot contact your
doctor, go to the nearest emergency room. Bring with you any remaining tablets, including
the container and the box so that hospital staff can easily understand what you are
taking.

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 to
take the next dose (if less than 6 hours remain). Do not take a double dose to compensate
for the 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 see your 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
• urticaria or difficulty breathing.

Tell your doctor if you experience common side effects such as dizziness, feeling unwell or
vomiting. Your doctor may reduce the dosage or stop treatment with Ranva.
Other side effects that you may experience include:
Common side effects (may affect up to 1 in 10 people):

• constipation
• dizziness
• headache
• feeling unwell, vomiting
• feeling weak.

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

• altered sensitivity
• anxiety, difficulty sleeping, confusion, hallucinations
• blurred vision, visual disturbances
• alterations of the senses (of touch or taste), tremor, feeling tired or sluggish, numbness or drowsiness, feeling faint or fainting, dizziness when standing up
• dark urine, blood in the urine, difficulty urinating
• dehydration
• difficulty breathing, cough, nosebleed
• double vision
• excessive sweating, itching
• feeling of fullness or bloating
• hot flushes, low blood pressure
• increases in a substance called creatinine or increases in urea in the blood, increased number of platelets or white blood cells in the blood, changes in the cardiac tracing of the ECG
• swelling of the joints, pain in the extremities
• loss of appetite and/or weight loss
• muscle cramps, muscle weakness
• ringing in the ears and/or dizziness
• stomach pain or discomfort, indigestion, dry mouth or flatulence.

Rare side effects (may affect up to 1 in 1000 people):

• difficulty urinating normally
• altered laboratory values for the liver
• acute renal failure
• alteration of the sense of smell, numbness of the mouth or lips, impaired hearing
• cold sweats, rash
• problems with coordination
• lowering of blood pressure when standing up
• reduction or loss of consciousness
• disorientation
• feeling of coldness in the hands and feet
• urticaria, allergic skin reaction
• impotence
• Inability to walk due to lack of balance
• inflammation of the pancreas or intestine
• loss of memory
• sensation of constriction in the throat
• low levels of sodium in the blood (hyponatremia) which can cause fatigue and confusion, muscle contractions, cramps and coma.

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• myoclonus

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 Ranva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on each blister pack of tablets and
on the outside of the carton after Exp. The expiry date refers to the last day of that
month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 Ranva contains
The active ingredient of 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 ingredients are: microcrystalline cellulose, hypromellose, ethyl acrylate and
methacrylic acid copolymer, sodium hydroxide, magnesium stearate

[375 mg]:The film coating contains: partially hydrolyzed polyvinyl alcohol, titanium dioxide,
macrogol 3350, talc, aluminum indigotine lake (E132)

[500 mg]:The film coating contains: partially hydrolyzed polyvinyl alcohol, titanium dioxide,
macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)

[750 mg]:The film coating contains: partially hydrolyzed 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 imprinted with “375” on one side and smooth on the other side. 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 imprinted with “500” on one side and smooth on the other side. 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 imprinted with “750” on one side and smooth on the other side. The tablet measures
approximately 18.8 mm x 9.1 mm.
Ranva is supplied in PVC/PVDC/Al and PVC/Aclar/PVC blister packs containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Day Zero ehf.
Reykjavikurvegur 62
Hafnarfjördur 220
Iceland

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT: Ranva
IT: Ranva

Other sources of information
The most up-to-date information approved for this medicine is available by scanning the QR code
also at the following URL: [URL to be included] and on the website.