Ranexa 375 mg prolonged-release tablets
Ranexa 500 mg prolonged-release tablets
Ranexa 750 mg prolonged-release tablets
Ranolazine
Read all of this leaflet carefully before you start taking this medicine.
In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.
- Keep this leaflet and the Patient Alert Card. You may need to read it again.
- Always show the Patient Alert Card to any doctor involved in your treatment, including physicians treating conditions other than angina pectoris.
- Please make sure you have a list of all your other medicines with you at any visit to a health care professional.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Ranexa is and what it is used for
2. Before you take Ranexa
3. How to take Ranexa
4. Possible side effects
5. How to store Ranexa
6. Further information
What Ranexa Is And What It Is Used For
Ranexa is a medicine used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.
Before You Take Ranexa
Do not take Ranexa
- if you are allergic (hypersensitive) to ranolazine or any of the other ingredients of Ranexa listed in section 6 of this leaflet.
- if you have severe kidney problems.
- if you have moderate or severe liver problems.
- if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Take special care with Ranexa
Speak to your doctor before taking Ranexa:
- 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 low weight (60 kg or less).
- if you have heart failure.
Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
Using other medicines
Do not use the following medicines if you take Ranexa:
- certain medicines 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 you take Ranexa if you use:
- certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil. These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranexa (see section 4). Your doctor may decide to give you a lower dose.
- medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for an infection (e.g. tuberculosis); or are taking the herbal remedy St. John's Wort, as these medicines may cause Ranexa to be less effective.
- heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine whilst you are taking Ranexa.
- certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
- certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Taking Ranexa with food and drink
Ranexa can be taken with or without food. While being treated with Ranexa, you should not drink grapefruit juice.
Pregnancy
You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
Breast-feeding
You should not take Ranexa if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.
Ask your doctor for advice before using any medicine.
Driving and using machines
No studies on the effects of Ranexa on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.
Ranexa may cause side effects such as dizziness (common) and blurred vision (uncommon) that may affect your ability to drive or use machinery. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Important information about some of the ingredients of Ranexa
The 750 mg prolonged-release tablets contain the azo colouring agent E102. This colouring agent may cause allergic reactions.
The 750 mg prolonged-release tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Ranexa
Always take Ranexa exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
Always swallow the tablets whole with water. Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
The starting dose for adults is one 375 mg tablet twice a day. After 2-4 weeks, your doctor may increase the dose to get the right effect. The maximum dose of Ranexa is 750 mg twice a day.
It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick. Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.
Children and adolescents under 18 years old should not take Ranexa.
If you take more Ranexa than you should
If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once. If you cannot contact your doctor, go to the nearest accident and emergency department. Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
If you forget to take Ranexa
If you forget to take a dose, take it as soon as you remember unless it is nearly time to take your next dose. Do not take a double dose to make up for a forgotten dose.
Possible Side Effects
Like all medicines, Ranexa can cause side effects, although not everybody gets them. These are usually mild or moderate.
You should stop taking Ranexa and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe:
- swollen face, tongue, or throat
- difficulty swallowing
- hives or difficulty breathing
Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting. Your doctor may lower your dose or stop treatment with Ranexa.
Other side effects you may experience include the following:
Common side effects (occur in 1 to 10 users in 100) are:
Constipation
Dizziness
Headache
Feeling sick, vomiting
Feeling weak
Uncommon side effects (occur in 1 to 10 users in 1,000) are:
Anxiety, difficulty sleeping
Blurred vision, visual disturbance
Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness, faint or fainting, dizziness upon standing
Dark urine, blood in urine, difficulty urinating
Dehydration
Difficulty breathing, cough, nose bleed
Excessive sweating, itching
Feeling swollen or bloated
Hot flushes, low blood pressure
Increases in a substance called creatinine or increases in urea in your blood, increase in blood platelets or white blood cells, changes in ECG heart tracing
Joint swelling, pain in extremity
Loss of appetite and/or weight loss
Muscle cramp
Ringing in the ears and/or feeling a spinning sensation
Stomach pain or discomfort, indigestion, dry mouth, or wind
Rare side effects (occur in 1 to 10 users in 10,000) are:
Abnormal laboratory values for liver
Change in sense of smell, numbness in mouth or lips, impaired hearing
Cold sweat, rash
Decrease in blood pressure upon standing
Decreased or loss of consciousness
Disorientation
Feeling of coldness in hands and legs
Hives, allergic skin reaction
Impotence
Inflammation of pancreas or intestine
Loss of memory
Throat tightness
In some isolated cases, acute kidney failure has been reported with the use of Ranexa.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Ranexa
Keep out of the reach and sight of children.
Do not use Ranexa after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Ranexa contains
The active substance in Ranexa is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132)
500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
What Ranexa looks like and contents of the pack
Ranexa prolonged-release tablets are oval shaped tablets.
The 375 mg tablets are pale blue and are engraved with CVT375 or 375 on one side.
The 500 mg tablets are light orange and are engraved with CVT500 or 500 on one side.
The 750 mg tablets are pale green and are engraved with CVT750 or 750 on one side.
Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles. Not all pack-sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
or
or
or
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in 07/2010.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Ranexa Patient Alert Card
(Carry this card with you at all times)
Information to the patient
This card contains important safety information you should know before you are given Ranexa and during treatment with Ranexa.
- Show this card to any doctor involved in your treatment.
Prior to Ranexa treatment
Before taking Ranexa speak to your doctor if you:
- Have problems with your kidneys
- Have liver problems
- Have ever had an abnormal electrocardiogram (ECG)
- Are taking medications to treat epilepsy, bacterial or fungal infections, HIV infection, depression or heart rhythm disorders
- Are taking the herbal remedy St John’s Wort
- Are taking allergy medicines
During Ranexa treatment
- Do not drink Grapefruit Juice whilst taking Ranexa.
- Call your doctor if you feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
Dates of Ranexa treatment:
Start………………………
- See the Ranexa package leaflet for more information.
- Please make sure you have a list of all your other medicines with you at any visit to the health care professional.
Patient’s name…………………………..
Doctor’s name…………………………..
Doctor’s phone………………………….
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