This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Ranexa 375 mg prolonged-release tablets
Ranexa 500 mg prolonged-release tablets
Ranexa 750 mg prolonged-release tablets
Ranolazine
In addition to this leaflet, you will find a Patient Alert Card within the box, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.
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
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.
Speak to your doctor before taking Ranexa:
Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
Do not use the following medicines if you take Ranexa:
Tell your doctor or pharmacist before you take Ranexa if you use:
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Ranexa can be taken with or without food. While being treated with Ranexa, you should not drink grapefruit juice.
You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
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.
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), blurred vision (uncommon), confusional state (uncommon) and hallucination (uncommon) that may affect your ability to drive or use machines. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
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.
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 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 a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose. Do not take a double dose to make up for a forgotten dose.
Like all medicines, Ranexa can cause side effects, although not everybody gets them.
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:
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, confusional state, hallucination
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
Acute kidney failure
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
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.
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 after EXP.
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.
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)
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.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 03/2012.
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
(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.
Prior to Ranexa treatment
Before taking Ranexa speak to your doctor if you:
During Ranexa treatment
Dates of Ranexa treatment:
Start………………………
Patient’s name………………………….
Doctor’s name………………………….
Doctor’s phone………………………….
Link to this document from your website:http://www.medicines.ie/medicine/14285/XPIL/Ranexa++prolonged-release+tablets/