Patient leaflet - Ranolazine Celix 750 mg prolonged-release tablets
1. What Ranolazine Celix is and what it is used for
Ranolazine Celix 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.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Ranolazine Celix
Do not take Ranolazine Celix
if you are allergic to ranolazine or 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 using 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).
Warnings and precautions
Talk to your doctor before taking Ranolazine Celix:
- 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.
Other medicines and Ranolazine Celix
Do not use the following medicines if you take this medicine:
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 this medicine 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 Ranolazine Celix (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 Ranolazine Celix 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 Ranolazine Celix.
- 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).
- certain medicines to treat high levels of cholesterol in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle injury. Your doctor may decide to change the dose of this medicine while you are taking Ranolazine Celix.
- certain medicines used to prevent transplanted organ rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while you are taking Ranolazine Celix.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Ranolazine Celix with food and drink
This medicine can be taken with or without food. While being treated with this medicine, you should not drink grapefruit juice.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant unless your doctor has advised you to do so.
You should not take this medicine if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
No studies on the effects of this medicine on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.
This medicine may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems (rare), 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.
Ranolazine Celix contains lactose and sodium.
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg)
per prolonged-release tablet, that is to say essentially ‘sodium-free’.
3. How to take Ranolazine Celix
Always take this medicine exactly as your doctor has told you. 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 this medicine 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 this medicine.
Use in children and adolescents
Children and adolescents under 18 years old should not take this medicine.
If you take more Ranolazine Celix than you should
If you accidentally take too many tablets of this medicine 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 Ranolazine Celix
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking this medicine 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 this medicine.
Other side affects you may experience include the following:
Common (may affect up to 1 in 10 people):
- Constipation
- Dizziness
- Headache
- Feeling sick, vomiting
- Feeling weak
Uncommon (may affect up to 1 in 100 people):
- Altered sensation
- 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
- Double vision
- 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, muscle weakness
- Ringing in the ears and/or feeling a spinning sensation
Stomach pain or discomfort, indigestion, dry mouth,
or wind
Rare (may affect up to 1 in 1,000 people):
- A lack of ability to urinate
- Abnormal laboratory values for liver
- Acute kidney failure
Change in sense of smell, numbness in mouth or lips,
impaired hearing
- Cold sweat, rash
- Coordination problems
- Decrease in blood pressure upon standing
- Decreased or loss of consciousness
- Disorientation
- Feeling of coldness in hands and legs
- Hives, allergic skin reaction
- Impotence
- Inability to walk due to imbalance
- Inflammation of pancreas or intestine
- Loss of memory
- Throat tightness
Low level of sodium in the blood (hyponatremia) which
can cause tiredness and confusion, muscle twitching, cramps, and coma.
Not known (frequency cannot be estimated from the available data):
Sudden, brief involuntary twitching or jerking of
a muscle or group of muscles (myoclonus)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ranolazine Celix
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ranolazine Celix contains
The active substance is ranolazine. Each tablet contains 375 mg, 500 mg and 750 mg ranolazine.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, methacrylic acid-ethyl acrylate copolymer, sodium hydroxide, hypromellose, magnesium stearate.
Depending on the tablet strength, the tablet coating also contains:
- 375mg tablet: titanium dioxide, macrogol, triacetin, indigo carmine aluminium lake (E132)
- 500 mg tablet: titanium dioxide, macrogol, triacetin, iron oxide yellow (E172)
- 750 mg tablet: titanium dioxide, macrogol, triacetin, brilliant blue FCF aluminium lake (E133)
What Ranolazine Celix tablets look like and contents of the pack
Ranolazine Celix prolonged-release tablets are oblong shaped tablets.
The 375 mg tablets are pale blue approximately
15.00mm x 7.20mm and are debossed with RAN375 on one side.
The 500 mg tablets are yellow approximately
16.50mm x 8.00mm and are debossed with RAN500 on one side.
The 750 mg tablets are light blue approximately
19.00mm x 9.20mm and are debossed with RAN750 on one side.
The blisters consist of a PVC/PE/PVDC White Opaque base foil and Aluminum Lidding foil.
Ranolazine Celix tablets are supplied in cartons containing 28, 30, 56, 60 or 100 tablets in blister strip.
Not all pack-sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Celix Pharma Ltd
12 Constance Street, London
E16 2DQ, United Kingdom
Manufacturer:
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park,
Paola, Malta. PLA 3000
or
GMP Manufacturing Ltd,
Marfleet House,
Valletta Street,
Hull HU9 5NP,
United Kingdom
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact medinfo@celixpharma.com. This leaflet was last revised in April 2024
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