Patient leaflet - Anzipro 375 mg prolonged-release tablets
1. What Anzipro is and what it is used for
Anzipro 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 Anzipro
Do not take Anzipro
- 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).
Warning and precautions
Talk to your doctor before taking Anzipro:
- 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 Anzipro
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Do not use the following medicines if you take Anzipro:
- 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 Anzipro 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 Anzipro (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 Anzipro 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 Anzipro.
- 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 Anzipro.
- 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 Anzipro.
Anzipro with food and drink
Anzipro can be taken with or without food. While being treated with Anzipro, you should not drink grapefruit juice.
Pregnancy
You should not take Anzipro if you are pregnant unless your doctor has advised you to do so.
Breast-feeding
You should not take Anzipro if you are breast-feeding. Ask your doctor for advice if you are breastfeeding.
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 Anzipro on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.
Anzipro 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.
Anzipro contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Anzipro
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 Anzipro 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 Anzipro.
Use in children and adolescents
Children and adolescents under 18 years old should not take Anzipro.
If you take more Anzipro than you should
If you accidentally take too many Anzipro 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 Anzipro
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Anzipro 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 Anzipro. Other side effects you may experience include the following:
Common side effects (may affect up to 1 in 10 people) are:
Constipation
Dizziness
Headache
Feeling sick, vomiting
Feeling weak
Uncommon side effects (may affect up to 1 in 100 people) 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 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 side effects (may affect up to 1 in 1000) 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
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 Anzipro
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 package 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 throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Anzipro contains
The active substance in Anzipro is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
The other ingredients are:
Tablet core: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide, hypromellose and magnesium stearate.
Tablet-coating: hypromellose, hydroxypropylcellulose, macrogol and titanium dioxide.
What Anzipro looks like and contents of the pack
The 375 mg tablets are white, oblong, convex, film-coated tablets of dimensions 15 mm x 7.2 mm, with “375“ embossed on one side.
The 500 mg tablets are white, oblong, convex, film-coated tablets of dimensions 16.5 mm x 8.0 mm, with “500“ embossed on one side.
The 750 mg tablets are white, oblong, convex, film-coated tablets of dimensions 19 mm x 9.2 mm, with “750“ embossed on one side.
Anzipro is supplied in cardboard boxes containing 30, 60 or 100 tablets in PVC/PVDC/Aluminium blisters.
Not all pack-sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Ridge Pharma Limited
Merlin House, Brunel Road, Theale
Reading, RG7 4AB
United Kingdom
Manufacturer:
Adamed Pharma S.A.,
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland