Patient leaflet - ZANIDIP 20 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zanidip® 20 mg film-coated tablets
(lercanidipine hydrochloride)
Zanidip tablets are available in the following strengths: 10mg and 20mg.
The name of your medicine is Zanidip 20 mg film-coated tablets but will be referred to as Zanidip throughout this leaflet. Please note that Zanidip 10 mg will also be referred to in this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
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1. What Zanidip is and what it is used for
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2. What you need to know before you take Zanidip
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3. How to take Zanidip
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4. Possible side effects
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5. How to store Zanidip
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6. Contents of the pack and other information
1. what zanidip is and what it is used for
Zanidip, lercanidipine hydrochloride, belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives) that lower blood pressure.
Zanidip is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old).
2. what you need to know before you take zanidip
Do not take Zanidip:
- If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip tablets.
- If you are suffering from certain heart diseases: o Obstruction to flow of blood from the heart o Untreated heart failure
o Unstable angina (chest discomfort occurring at rest or progressively increasing)
o Within one month of heart attack
- If you have severe liver problems.
- If you have severe kidney problems or you are undergoing dialysis.
- If you are taking medicines that are inhibitors of hepatic metabolism, such as:
o antifungal medicines (such as ketoconazole or itraconazole)
o macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
o antivirals (such as ritonavir)
- If you are taking another medicine called ciclosporin or cyclosporin (used after transplants to prevent organ rejection).
- With grapefruit or grapefruit juice.
Warning and precautions
Talk to your doctor or pharmacist before taking Zanidip:
- If you have a heart problem
- If you have liver or kidney problems
You must tell your doctor if you think you are (or might become) pregnant or breast-feeding (see pregnancy, breast-feeding and fertility section).
Children and adolescents
The safety and efficacy of Zanidip in children aged up to 18 years have not been established.
Other medicines and Zanidip
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when Zanidip is taken with other medicines the effect of Zanidip or of the other medicine may be changed or certain side effects may occur more frequently (see also section 2 “Do not take Zanidip”).
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
- rifampicin (a medicine to treat tubercolosis)
- astemizole or terfenadine (medicines for allergies)
- amiodarone, quinidine or sotalol (medicines to treat a fast heart beat)
- midazolam (a medicine that helps you sleep)
- digoxin (a medicine to treat a heart problem)
- beta-blockers e.g. metoprolol (a medicine to treat high
blood pressure, heart failure and abnormal heart rhythms)
- cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn)
- simvastatin (a medicine to lower cholesterol in your blood)
- other medicines to treat high blood pressure
Zanidip with food, drink and alcohol
- A high fat meal significantly increases blood levels of the medicine (see section 3).
- Alcohol can increase the effect of Zanidip. Do not consume alcohol during treatment with Zanidip.
- Zanidip must not be taken with grapefruit or grapefruit juice (they can increase its hypotensive effect). See section 2 – Do not take Zanidip.
Pregnancy, breast-feeding and fertility
Zanidip is not recommended if you are pregnant, it should not be used during breast-feeding. There are no data from the use of Zanidip in pregnant women and in nursing mothers. If you are pregnant or breast-feeding, if you are not using any contraceptive method, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
If you develop dizziness, weakness or drowsiness with this medicine, do not drive a vehicle or operate machines.
Zanidip contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
L-01-1639-02
3. how to take zanidip
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: The recommended dose is 10 mg once daily, at the same time each day, preferably in the morning at least 15 minutes before breakfast. Your doctor may advise you to increase the dose to one Zanidip 20 mg daily, if needed (see section 2 “Zanidip with food, drink and alcohol”).
The tablets should preferably be swallowed whole with some water.
Use in children: This medicine should not be used in children under 18 years of age.
Elderly patients: No adjustment of the daily dose is required. However, special care should be exercised in starting treatment.
Patients with liver or kidney problems: special care is needed in starting treatment in these patients and an increase in daily dose to 20 mg should be approached with caution.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
If you take more Zanidip than you should
Do not exceed the prescribed dose. If you take more than the prescribed dose, talk to your doctor or go to the hospital straight away. Take the medicine pack with you. Taking more than the correct dose can cause an excessive drop in blood pressure and your heart can beat irregularly or faster.
If you forget to take Zanidip
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 dose.
If you stop taking Zanidip
If you stop taking Zanidip 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 medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Some side effects can be serious.
Rare (may affect up to 1 in 1,000 people ): angina pectoris (e.g. chest tightness due to lack of blood to your heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.
Patients with pre existing angina pectoris may experience increased frequency, duration or severity of these attacks with the group of medicines to which Zanidip belongs. Isolated cases of heart attack may be observed.
Other possible side effects:
Common
Uncommon (may affect up to 1 in 100 people ): dizziness, fall in blood pressure, heartburn, feeling sick, stomach pain, skin rash, itching, muscle pain, passage of large amounts of urine, feeling weak or feeling tired.
Rare (may affect up to 1 in 1,000 people ): sleepiness, vomiting, diarrhoea, hives, increase in the usual number of times one urinates, chest pain.
Not known (frequency cannot be estimated from the available data ): swelling of gums, changes in liver function (detected by blood tests), cloudy fluid (when performing dialysis through a tube into your abdomen), swelling of your face, lip, tongue or throat which may cause difficulty in breathing or swallowing.
Reporting of suspected adverse reactions
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 Yellow Card Scheme at r 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 zanidip
Keep out of the sight and reach of children.
Store in the original package in order to protect from light. Do not take these tablets after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.
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 protect the environment.
If the tablets show any signs of discolouration or deterioration consult your pharmacist for advice.
6. contents of the pack and other information
Each film-coated tablet contains 20 mg lercanidipine hydrochloride (equivalent to 18.8mg lercanidipine).
Tablet core contains: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and povidone K30.
Tablet coating contains: magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000, and iron oxide (E172).
Zanidip tablets are pink, circular, biconvex tablets, scored on one side and plain on the other.
Zanidip tablets are available in blister packs of 28 tablets.
PL 20774/1639 Zanidip 20mg film-coated Tablets
Zanidip tablets are manufactured by Recordati Industria Chimica e Farmaceutica S.p.A., I-20148 Milan, Italy. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock Bolton BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.
Leaflet revision date: 21st February 2019
Zanidip is a registered trademark.
POM
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