Ranolazine Wockhardt 750mg Prolonged-Release – patient leaflet, side effects, dosage

1. What Ranolazine Wockhardt is and what it is used for

What Ranolazine Wockhardt is

Ranolazine Wockhardt 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 Wockhardt

Do not take Ranolazine Wockhardt:

• 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).

Warnings and precautions

Talk to your doctor before taking Ranolazine Wockhardt:

• 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 Wockhardt

Do not use the following medicines if you take Ranolazine Wockhardt:

• 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 Wockhardt 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 Wockhardt (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 Wockhardt 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 Wockhardt
  • 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 Wockhardt

  • 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 Wockhardt.

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Ranolazine Wockhardt with food and drink

Ranolazine Wockhardt can be taken with or without food. While being treated with Ranolazine Wockhardt, you should not drink grapefruit juice.

Pregnancy

You should not take Ranolazine Wockhardt if you are pregnant unless your doctor has advised you to do so.

Breast-feeding

You should not take Ranolazine Wockhardt if you are breastfeeding. 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 Wockhardt on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.

Ranolazine Wockhardt 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 Wockhardt 750mg prolonged-release tablets contain the azo colouring agent E102. This colouring agent may cause allergic reactions.

Ranolazine Wockhardt 750mg 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 1mmol sodium (23mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.

3. How to take Ranolazine Wockhardt

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 375mg tablet twice a day. After 2−4 weeks, your doctor may increase the dose to get the right effect. The maximum dose of Ranolazine Wockhardt is 750mg 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 Wockhardt.

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Use in children and adolescents

Children and adolescents under 18 years old should not take Ranolazine Wockhardt.

If you take more Ranolazine Wockhardt than you should

If you accidentally take too many Ranolazine Wockhardt 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 Wockhardt

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 Wockhardt 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 Wockhardt.

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:

• 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 extremities
• 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 side effects (occur in 1 to 10 users in 10,000) are:

• 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 side effects (frequency cannot be estimated from the available data) are:

• myoclonus (involuntary contractions of muscles).

  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:

  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 Wockhardt

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 blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ranolazine Wockhardt contains

The active substance in Ranolazine Wockhardt is ranolazine. Each tablet contains 375mg, 500mg, or 750mg ranolazine. The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer and microcrystalline cellulose.

Depending on the tablet strength, the tablet coatings also contain:

375mg tablet: titanium dioxide, macrogol, polysorbate 80 and Blue #2/Indigo Carmine Aluminium Lake (E132).

500mg tablet: polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow (E172) and iron oxide red (E172).

750mg tablet: titanium dioxide, glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102).

What Ranolazine Wockhardt looks like and contents of the pack

Ranolazine Wockhardt prolonged-release tablets are oval shaped tablets.

The 375mg tablets are pale blue, oval shaped biconvex tablet debossed with ‘R3’ on one side and plain on other side.

The 500mg tablets are pale yellow, oval shaped biconvex tablet debossed with ‘R5’ on one side and plain on other side.

The 750mg tablets are pale green, oval shaped biconvex tablet debossed with ‘R7’ on one side and plain on other side.

Tablets are supplied in blister packs consisting of PVC/PVDC/Aluminium blisters which are further packed into a carton. Each carton contains 30, 60 or 100 tablets. Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Manufacturer

CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, UK

Other Formats

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0800 198 5000 (UK only).

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 02/2026.

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