Lercanidipine HCl 10 mg Teva, filmomhulde tabletten

1. WHAT IS AND WHAT IT IS USED FOR

<Lercanidipine hydrochloride> belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives).

<Lercanidipine hydrochloride> 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. BEFORE YOU TAKE

Do NOT take <Lercanidipine hydrochloride>

• If you are allergic (hypersensitive) to lercanidipine or to any of the ingredients in <Lercanidipine hydrochloride>
• If you have had allergic reactions to medicines that are closely related to <Lercanidipine hydrochloride> (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
• If you are suffering from certain heart diseases:
  • untreated heart failure
  • obstruction to flow of blood from the heart
  • unstable angina (angina at rest or progressively increasing)
  • within one month of a heart attack
• If you have severe liver or kidney problems
• If you are taking medicines that are inhibitors of the CYP3A4 isoenzyme: antifungal medicines (such as ketoconazole or itraconazole)
• If you are taking another medicine called ciclosporin or cyclosporin (a medicine used after organ transplant)
• With grapefruit or grapefruit juice
• If you are pregnant, or if you wish to become pregnant or if you are a woman of child-bearing age and do not use any contraceptive method
• If you are breast-feeding

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Take special care with <Lercanidipine hydrochloride>

You should consult your doctor before taking <Lercanidipine hydrochloride> tablets:

• If you have certain other heart conditions with dysfunction of the left heart ventricle, or an abnormal heart rhythm such as sick sinus syndrome and you do not have a pacemaker
• If you have angina pectoris, lercanidipine may in very rare cases cause increased frequency of attacks that may last longer and become more severe. Myocardial infarction has been reported in isolated cases.
• If you have mild or moderate problems with your liver or kidneys

Taking other medicines

Please tell your doctor 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 per day, 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 tuberculosis)
• 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.
• You are taking simvastatin (a medicine which lowers cholesterol). <Lercanidipine hydrochloride> should be taken in the morning and simvastatin in the evening.
• You are taking antifungal medicines (such as ketoconazole or itraconazole). The effect of <Lercanidipine hydrochloride> may be increased, and these medicines should not be taken together (see “Do not take <Lercanidipine hydrochloride>”).
• You are taking ciclosporin (a medicine used after organ transplant). The effect of both <Lercanidipine hydrochloride> and ciclosporin may be increased, so these medicines should not be taken together (see “Do not take <Lercanidipine hydrochloride>”).

Taking <Lercanidipine hydrochloride> with food and d rink

You should not consume alcohol, eat grapefruit or drink grapefruit juice as this may increase the effect of <Lercanidipine hydrochloride>.

Pregnancy and breast-feeding

Do not take <Lercanidipine hydrochloride> 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 <Lercanidipine hydrochloride> and think that you may be pregnant, consult your doctor.

Ask your doctor for advice before taking any medicine.

Driving and using machines

<Lercanidipine hydrochloride> has a negligible influence on the ability to drive or use machines. However, caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how <Lercanidipine hydrochloride> affects you..

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Important information about some of the ingredients of <Lercanidipine hydrochloride>

<Lercanidipine hydrochloride> 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.

10 mg strength: <Lercanidipine hydrochloride> contains tartrazine aluminium lake (E102) and may cause allergic reactions.

20 mg strength: <Lercanidipine hydrochloride> contains allura red AC aluminium lake (E129) and may cause allergic reactions.

3. HOW TO TAKE

Always take <Lercanidipine hydrochloride> exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one <Lercanidipine hydrochloride> 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 your blood levels of the medicine.

Your doctor may decide to increase your dose to one <Lercanidipine hydrochloride> 20 mg film-coated tablet daily, if needed.

The tablets should preferably be swallowed whole with half a glass of water.

Elderly: although no adjustment of the daily dosage is necessary, special care is needed when starting lercanidipine treatment in the elderly.

Patients with mild to moderate 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.

<Lercanidipine hydrochloride> is not recommended for use in children and adolescents below 18 years of age.

If you take more <Lercanidipine hydrochloride> 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 vomiting or unconsciousness.

If you forget to take <Lercanidipine hydrochloride>

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 <Lercanidipine hydrochloride>

If you stop taking <Lercanidipine hydrochloride> 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.

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Like all medicines, <Lercanidipine hydrochloride> 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 (affect 1 to 10 users in 10,000):

• Angina pectoris (chest pain due to lack of blood to your heart)

Very rare (affect 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 <Lercanidipine hydrochloride> 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 side effects (affect 1 to 10 users in 1,000):

• Headache, dizziness
• Faster heartbeats, palpitations (heart pounding or racing), ankle swelling
• Sudden reddening of the face, neck or upper chest

Rare side effects (affect 1 to 10 users in 10,000):

• Sleepiness
• Angina pectoris (chest pain)
• Heartburn, feeling sick, diarrhoea, stomach pain, vomiting
• Skin rash
• Muscle pain
• Passage of large amounts of urine
• Tiredness

Very rare side effects (affect less than 1 user in 10,000):

• Swelling of gums
• Increase in the usual number of times one urinates
• Changes in liver function (detected by blood tests)

Other side effecs the frequency of which is not known (frequency cannot be estimated from the available data):

• Disorders combining stiffness, trembling and/or movement disturbances

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. HOW TO STORE

Keep out of the reach and sight of children.

Do not use <Lercanidipine hydrochloride> after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.

Blisters

Store in the original package in order to protect from light.

Bottles

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Store in the original package in order to protect from light.

Bottles (after first opening container)

Store in the original package in order to protect from light. Discard 30 days after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What <Lercanidipine hydrochloride> contains

• The active substance is lercanidipine hydrochloride. 10 mg strength: One film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4 mg lercanidipine. 20 mg strength: One film-coated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine.
• The other ingredients are lactose monohydrate, sodium starch glycolate (potato), microcrystalline cellulose, povidone and magnesium stearate in the tablet core, and a film-coat of 10 mg strength: Opadry 03F32418 yellow containing hypromellose (E464), titanium dioxide (E171), tartrazine aluminium lake (E102), macrogol 6000, talc and iron oxide yellow (E172). 20 mg strength: Opadry 03F34650 pink containing hypromellose (E464), titanium dioxide (E171), allura red AC aluminium lake (E129), macrogol 6000, talc, indigo carmine aluminium lake (E132).

What <Lercanidipine hydrochloride> looks like and contents of the pack

• 10 mg strength: Yellow to dark yellow, round convex film-coated tablet debossed with the number "10" on one side and scored on the other. 20 mg strength: Light pink to pink, round convex film-coated tablet debossed with the number "20" on one side and scored on the other. The tablet can be divided into equal halves.
• 10 mg strength:<Lercanidipine hydrochloride> is available in blister packs of 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 tablets, hospital pack of 50x1 tablet and calendar packs of 28 tablets and in

bottles of 30 tablets. Not all pack sizes may be marketed.

20 mg strength:<Lercanidipine hydrochloride> is available in blister packs of 15, 28, 30, 50, 56, 60, 90, 98, 100 tablets, hospital pack of 50x1 tablet and calendar packs of 28 tablets and in bottles of 30 tablets. Not all pack sizes may be marketed.

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Marketing Authorisation Holder and manufacturer MAH

Teva Nederland B.V. Swensweg 5

2031 GA Haarlem Nederland

Fabrikanten

Teva UK Ltd

Brampton Road

Hamden Park, Eastbourne

East Sussex, BN22 9AG

Engeland

Pharmachemie B.V.

Swensweg 5

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2031 GA Haarlem

Nederland

Teva Sante

Rue Bellocier

89100 Sens

Frankrijk

Teva Pharmaceutical Works Private Limited Company Pallagi út 13

4042 Debrecen Hongarije

Teva Czech Industries s.r.o. Ostravská 29, č.p. 305

747 70 Opava-Komárov Tsjechië

Teva Pharma S.L.U.

C/C, nº 4, Poligono Industrial Malpica

50016 Zaragoza

Spanje

In het register ingeschreven onder

RVG 107822 (Lercanidipine HCl 10 mg Teva, filmomhulde tabletten)

RVG 107825 (Lercanidipine HCl 20 mg Teva, filmomhulde tabletten)

This medicinal product is authorised in the Member States of the EEA under the following names:

<To be completed nationally>

This leaflet was last approved in July 2011.

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