Zanidip Novum 8mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Zanidip Novum 8 mg film-coated tablets Zanidip Novum 16 mg film-coated tablets
lercanidipine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE:
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Zanidip Novum is and what it is used for
2. Before you take Zanidip Novum
3. How to take Zanidip Novum
4. Possible side effects
5. How to store Zanidip Novum
6. Further information
1. WHAT ZANIDIP NOVUM IS AND WHAT IT IS USED FOR
Zanidip Novum belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Zanidip Novum is used to treat high blood pressure also known as hypertension .
2. BEFORE YOU TAKE ZANIDIP NOVUM
DO NOT TAKE ZANIDIP NOVUM AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip Novum tablets
• You have had allergic reactions to drugs closely related to Zanidip Novum tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
• You are suffering from certain heart diseases: o Untreated heart failure
o Obstruction to flow of blood from the heart o Unstable angina (angina at rest or progressively increasing) o Within one month of heart attack
• You have severe liver or kidney problems
• You are taking drugs that are inhibitors of CYP3A4 isoenzyme: o Antifungal medicines (such as ketoconazole or itraconazole) o Macrolide antibiotics (such as erythromycin or troleandomycin) o Antivirals (such as ritonavir)
• You are taking another drug called ciclosporin or cyclosporin (used after transplants to prevent organ rejection)
• With grapefruit or grapefruit juice
Do not use if you are pregnant or breastfeeding (see section
Pregnancy and Breastfeeding for more information).
TAKE SPECIAL CARE WITH ZANIDIP NOVUM AND TELL YOUR DOCTOR IF:
• You have certain other heart conditions or you have a pacemaker or have pre-existing angina
• You have problems with your liver or kidneys or you are on dialysis
USING OTHER MEDICINES
Please tell your doctor or pharmacist if:
• You are taking or have recently taken any other medicines, including medicines obtained without a prescription
• You are taking beta-blockers e.g. metoprolol, diuretics (water tablets) or ACE-inhibitors (medicines to treat high blood pressure)
• You are taking cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn)
• You are taking digoxin (a medicine to treat a heart problem)
• You are taking midazolam (a medicine that helps you sleep)
• You are taking rifampicin (a medicine to treat tubercolosis)
• You are taking astemizole or terfenadine (medicines for allergies)
• You are taking amiodarone or quinidine (medicines to treat a fast heart beat)
• You are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual.
TAKING ZANIDIP NOVUM WITH FOOD AND DRINK
• Patients should not consume alcohol during treatment with Zanidip Novum tablets since it may increase the effect of Zanidip Novum tablets.
• Patients should not take grapefruit or grapefruit juice.
PREGNANCY AND BREAST FEEDING
Do not use Zanidip Novum if you are pregnant or breast-feeding, or you wish to become pregnant or if you are not using any contraceptive method.
If you are taking Zanidip Novum and think that you may be pregnant, consult your doctor.
DRIVING AND USING MACHINES
Caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how Zanidip Novum affects you.
INFORMATION ABOUT SOME INGREDIENTS OF ZANIDIP NOVUM
If you have been told by your doctor that you have an intolerance to some sugars, e.g. intolerance to lactose, galactosaemia or glucose/galactose malabsorption syndrome, contact your doctor before taking this medicinal product, as the tablets contain lactose.
3. HOWTO TAKE ZANIDIP NOVUM
Zanidip Novum 8 mg film-coated tablets are equivalent to Zanidip 10 mg film-coated tablets.
Zanidip Novum 16 mg film-coated tablets are equivalent to Zanidip 20 mg film-coated tablets.
Always take Zanidip Novum exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults: The usual dose is one tablet of Zanidip Novum 8mg film-coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast, because a high fat meal significantly increases blood levels of the drug. Your doctor may advise you to increase the dose to one tablet of Zanidip Novum 16 mg film-coated tablet daily, if needed. The tablets should preferably be swallowed whole with some water.
Elderly: No adjustment of the daily dose is required. However, special care should be exercised in starting treatment.
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Patients with liver or kidney problems: Special care is needed in starting treatment in these patients and an increase in daily dose to 16 mg should be approached with caution.
Children: This medicine should not be used in children under 18 years of age.
If you have any further questions on the use of this product ask your doctor.
IF YOU TAKE MORE ZANIDIP NOVUM THAN YOU SHOULD
Do not exceed the prescribed dose
If you take more than the prescribed dose or in the event of overdose, seek medical advice immediately and, if possible, take your tablets and/or the container with you.
Exceeding the correct dosage may cause blood pressure to become too low, and the heart to beat irregularly or faster. It may also lead to unconsciousness.
IF YOU FORGET TO TAKE ZANIDIP NOVUM
If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose to make up for a forgotten tablet.
IF YOU STOP TAKING ZANIDIP NOVUM
If you stop taking Zanidip Novum your blood pressure may increase again. Please consult your doctor before stopping the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanidip Novum can cause side effects, although not everybody gets them.
Some side effects can be serious.
If you experience any of these side effects tell your doctor straight away.
Rare (affects 1 to 10 users in 10,000): angina pectoris (chest pain due to lack of blood to your heart).
Very rare (affects less than 1 user in 10,000): chest pain, fall in blood pressure, fainting and allergic reactions (symptoms include itching, rash, hives).
If you suffer from pre existing angina pectoris, with the group of medicines to which Zanidip Novum belongs, you may experience increased frequency, duration or severity of these attacks. Isolated cases of heart attack may be observed.
Other possible side effects:
Uncommon (affects 1 to 10 users in 1,000): headache, dizziness, faster heart beats, palpitations (heart pounding or racing), sudden reddening of the face, neck or upper chest, ankle swelling.
Rare (affects 1 to 10 users in 10,000): sleepiness, feeling sick, vomiting, heartburn, stomach pain, diarrhoea, skin rash, muscle pain, passage of large amounts of urine, tiredness.
Very rare (affects less than 1 user in 10,000): swelling of gums, changes in liver function (detected by blood tests), increase in the usual number of times one urinates.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
5. HOWTO STORE ZANIDIP NOVUM
Keep out of the reach and sight of children
Do not use Zanidip Novum after the expiry date, which is stated on the label, carton and on blister. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture. The original package should be kept in a dry place.
Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
6. FURTHER INFORMATION
WHAT ZANIDIP NOVUM CONTAINS
- Each tablet of Zanidip Novum 8 mg contains as active ingredient 7.55 mg of lercanidipine (present as lercanidipine hydrochloride 8 mg) and is equivalent (i.e. gives the same concentrations of active substance in blood) to a tablet of Zanidip 10 mg.
- Each tablet of Zanidip Novum 16 mg contains as active ingredient 15.10 mg of lercanidipine (present as lercanidipine hydrochloride 16 mg) and is equivalent (i.e. gives the same concentrations of active substance in blood) to a tablet of Zanidip 20 mg.
The other ingredients are:
Core tablet: Lactose monohydrate, Microcrystalline cellulose,
Povidone, Sodium starch glycolate, Silica colloidal anhydrous,
Poloxamer 407, Magnesium stearate.
Film coating: Hypromellose, Talc, Titanium Dioxide (E171),
Macrogol 6000, Iron oxide (E172)
WHAT ZANIDIP NOVUM LOOKS LIKE AND CONTENTS OF THE PACK
Zanidip Novum 8 mg: yellow, circular, biconvex, film-coated tablet. Zanidip Novum 16 mg: pink, circular, biconvex, film-coated tablet. Zanidip Novum is available in blister packs of 7, 14, 28, 35, 50, 56, 98, 100 tablets. Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy
Manufacturer
Pharmathen SA, 6 Dervenakion str., 153 51 Pallni Attiki, Greece
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy ’
This medicinal product is authorised in the following Member States of the EEA:
Austria
Belgium
Germany
Denmark
Greece
Spain
Finland
Italy
Luxemburg
Netherlands
Portugal
Sweden
United Kingdom
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Date of last revision of the text: 02/2010 records
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