Patient leaflet - Ranolazine Torrent 375 mg prolonged-release tablets
1. What Ranolazine is and what it is used for
Ranolazine 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
Do not take Ranolazine if:
- 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, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Warning and precautions
Talk to your doctor before taking Ranolazine:
- 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 and Ranolazine
Do not use the following medicines if you take Ranolazine:
- 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 Ranolazine 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 (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 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.
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.
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. Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. Ranolazine with food and drink
Ranolazine can be taken with or without food. While being treated with Ranolazine, you should not drink grapefruit juice.
Pregnancy
You should not take Ranolazine if you are pregnant unless your doctor has advised you to do so. Breast-feeding
You should not take Ranolazine 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 Ranolazine on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.
Ranolazine 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 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.
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say it is essentially ‘sodium-free’.
3. How to take Ranolazine
Always take this medicine exactly as your doctor has told you to. 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 Ranolazine 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 Ranolazine.
Use in children and adolescents
Children and adolescents under 18 years old should not take Ranolazine.
If you take more Ranolazine than you should
If you accidentally take too many Ranolazine 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 Ranolazine
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 Ranolazine 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 Ranolazine.
Other side effects 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 1000 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)
- 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
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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton after EXP.
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 contains
The active substance is ranolazine. Each prolonged-release tablet contains 375 mg, 500 mg or 750 mg of ranolazine Tablet core: methacrylic acid – ethyl acrylate copolymer (1:1) (type A), cellulose microcrystalline 101, hypromellose 2910 (E464), sodium hydroxide, magnesium stearate
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000, polysorbate 80 (E433), FD&C Blue#2/Indigotine Aluminum Lake (E132)
500 mg tablet: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), macrogol 8000 (E1521), talc (E553b), yellow iron oxide (E172iii), red iron oxide (E172ii)
750 mg tablet: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518), Iron Oxide Yellow (E172), FD&C Blue#1/FCF Fast Blue Aluminum Lake (E133)
What Ranolazine looks like and contents of the pack
375 mg tablet: Pale blue oval-shaped tablet engraved with “375” on one side and with dimensions 15.1 x 7.6 mm. 500 mg tablet: Light orange oval-shaped tablet engraved with “500” on one side and with dimensions 16.7 x 8.2 mm. 750 mg tablet: Pale green oval-shaped tablet engraved with “750” on one side and with dimensions 19.0 x 8.9 mm. PVC/PVDC//Aluminum blister or PVC/PCTFE(Aclar)//Aluminum blister.
Pack sizes: 30, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building,
4 Gatwick Road,
Crawley, West Sussex,
RH10 9BG,
United Kingdom
Manufacturer
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95, Pikermi Attiki, 19009,
Greece
This leaflet was last revised in 06/2025
8091267-7803