Zanidip 10 mg film-coated tablets
Zanidip 20 mg film-coated tablets
lercanidipine hydrochloride
Please read this leaflet before taking your medicine and keep it in a safe place just in case you require it again. This leaflet contains only the most essential information on your medicine. If you have any other questions about your medicine or if you are unsure about anything, ask your doctor or your pharmacist.
Zanidip
10 mg: 1 tablet contains 10 mg of lercandipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine.
Zanidip
20 mg: 1 tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine.
The following inactive ingredients are also included in Zanidip tablets, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
Zanidip
is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets*.
Lercanidipine belongs to a group of medicines called calcium channel blockers (of the dihydropyridine group) which are used to treat high blood pressure.
Marketing Authorisation Holder and Manufacturer of the product: Manufactured for
Recordati PharmaceuticalsIsis House
43 Station Rd
Henley on Thames
OXON
RG9 1AT
Tel: 01491 576336
by the Marketing Authorisation holder
Why has Zanidip been prescribed for me ?
Zanidip
has been prescribed by your doctor to treat your high blood pressure, also known as hypertension.
Who can take Zanidip tablets?
Adults over 18 years old can take the tablets. They are not recommended for children under 18 years old.
When should I NOT take Zanidip?
Do not take Zanidip tablets if:
- You are sensitive or allergic to lercanidipine
- You are allergic to any of the ingredients in Zanidip tablets
- You have had allergic reactions to drugs closely related to Zanidip tablets ( such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
- You are pregnant or breast-feeding, or you wish to become pregnant or do not use any contraceptive method
- If you are taking Zanidip and think that you may be pregnant, consult your doctor
- You are suffering from certain heart diseases:
- Uncontrolled cardiac failure
- Obstruction to flow of blood from the heart
- Unstable angina (angina at rest or progressively increasing)
- Within one month of heart attack
- You have severe liver or kidney problems
What other cautions should be observed when taking Zanidip?
Also tell your doctor or pharmacist if you have any condition in the list below:
- Certain other heart conditions, or if you have a pacemaker
- Problems with your liver or kidney, or you are on dialysis
- You have an intolerance to lactose, galactosaemia or glucose/galactose malabsorption syndrome, as the Zanidip 20 mg tablet contains 60 mg of lactose and the Zanidip 10 mg tablet contains 30 mg of lactose.
What if I am taking other drugs?
If you take Zandip tablets with some other medicines, the effect of Zanidip tablets or the other medicine may be increased. Tell your doctor or pharmacist if:
- You are taking drugs that are inhibitors of CYP3A4 isoenzyme (medicines that will increase the absorption of lercanidipine):
- Antifungal medicines (such as ketoconazole or itraconazole)
- Macrolide antibiotics (such as erythromycin or troleandomycin)
- Antivirals ( such as ritonavir)
- You are taking beta-blockers, diuretics or ACE-inhibitors (medicines to treat high blood pressure), although these may be safely taken with Zanidip
- 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 (a medicine for allergies)
- You are taking terfenadine (a medicine for allergies)
- You are taking amiodarone or quinidine (medicines to treat a fast heart beat)
- You are taking phenytoin or carbamazepine (medicines for epilepsy)
- You are taking medicines which lower the body’s resistance to disease (such as ciclosporin/cyclosporin
- You are taking grapefruit or grapefruit juice
Drinking alcohol during your treatment with Zanidip tablets may increase the effect of Zanidip tablets, you are therefore advised to stop or strictly limit your consumption of alcoholic drinks.
When and how do I take Zanidip ?
Take Zanidip as prescribed by your doctor. Usually this will be one Zanidip 10 mg 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 Zanidip 20 mg film-coated tablet daily, if needed.
The tablets should preferably be swallowed whole with some water.
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.
What should I do if I forget to take my Zanidip ?
Take your normal dose immediately and continue as prescribed the next day.
If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose.
Driving and using machines
Zanidip should not affect your ability to drive or use machines but caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how Zanidip affects you.
What undesirable effects may occur ?
Like all medicines, Zanidip can cause side effects. The most commonly reported side effects in the clinical trials were:
Headache, dizziness, ankle swelling, faster heart beats, awareness of the beating of the heart, and transient episodic redness of the face and neck.
Uncommon
(affecting less than 1 out 100 patients): headache, dizziness, faster heart beats, awareness of the beating of the heart, transient episodic redness of the face and neck, ankle swelling.
Rare
(affecting less than 1 out 1, 000 of patients): sleepiness, chest pain, nausea, vomiting, rash, muscle pain, passage of large amounts of urine, tiredness.
Very rare
(affecting less than 1 out 10, 000 of patients): fainting, allergic reaction, swelling of gums, increase in blood test values which show changes in the way the liver is working, fall in blood pressure which can cause dizziness, light-headedness or fainting, increase in the usual number of times one urinates, and chest pain.
If you experience any of these problems with Zanidip, please tell your doctor immediately.
If you experience any other side effects, tell your doctor immediately.
When reporting any undesirable effects, remember to mention any other drugs you may be taking, even those for occasional use.
How should I store my Zanidip tablets ?
It is best if you keep your Zanidip tablets in the original container supplied. The package should be kept in a dry place. Do not store above 25° C
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use tablets after the expiry date, which is marked on both the outer carton and on each blister strip of tablets.
Remember: this medicine has been prescribed for you. Do not give it to anyone else under any circumstances.
PL 04595/0005 (Zanidip 10 mg film-coated tablets).
PL 04595/0010 (Zanidip 20 mg film-coated tablets).
Date of review of this leaflet: May 2006
For any further information about this product, please ring: 0044 (0) 1784 898300
*The printed leaflet will refer to the marketed pack size of 28 tablets only.
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