Ranolazine Celix 750 mg Prolonged-release Tablets

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Active Ingredient:

ranolazine

Company:

Celix Pharma Ltd See contact details

ATC code:

C01EB18

About Medicine

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info

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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

Last updated on emc: 19 Jul 2023

View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53835/0039.

Print patient leaflet as text only

Ranolazine Celix Prolonged-release Tablets

Package leaflet: Information for the patient

Ranolazine Celix 375 mg Prolonged-release Tablets

Ranolazine Celix 500 mg Prolonged-release Tablets

Ranolazine Celix 750 mg Prolonged-release Tablets

ranolazine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ranolazine Celix is and what it is used for
2. What you need to know before you take Ranolazine Celix
3. How to take Ranolazine Celix
4. Possible side effects
5. How to store Ranolazine Celix
6. Contents of the pack and other information

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.

Store below 25°C.

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
PLA 3000
Malta

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 [email protected].

This leaflet was last revised in April 2023

Address

12 Constance Street, International House, London, E16 2DQ, UK

WWW

http://www.celixpharma.com/

Telephone

0800 669 6825

E-mail

[email protected]

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0800 669 6825

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+44 (0)203 105 6525

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