What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL17780/0521, PL17780/0522.

Lercanidipine Hydrochloride 10mg and 20mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lercanidipine Hydrochloride 10mg Film-coated Tablets

Lercanidipine Hydrochloride 20mg Film-coated Tablets

lercanidipine hydrochloride

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor 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 Lercanidipine Hydrochloride Film-coated Tablets are and what they are used for
2. Before you take Lercanidipine Hydrochloride Film-coated Tablets
3. How to take Lercanidipine Hydrochloride Film-coated Tablets
4. Possible side effects
5. How to store Lercanidipine Hydrochloride Film-coated Tablets
6. Further information

1. WHAT LERCANIDIPINE HYDROCHLORIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Lercanidipine belongs to a group of medicines called calcium channel blockers. They block the entry of calcium into the muscle cells of the heart and the blood vessels that carry blood away from the heart. It is the entry of calcium into these cells that causes the heart to contract and blood vessels to narrow.

By blocking the entry of calcium, calcium channel blockers decrease contraction of the heart and widen the blood vessels, and the blood pressure is reduced.

Lercanidipine has been prescribed to you for treatment of mild to moderate high blood pressure, also known as hypertension.

2. BEFORE YOU TAKE LERCANIDIPINE HYDROCHLORIDE FILM-COATED TABLETS

Do not take Lercanidipine Hydrochloride Film-coated Tablets if you:

  • are allergic (hypersensitive) to lercanidipine or to any of the ingredients in Lercanidipine Hydrochloride Film-coated Tablets
  • have had allergic reactions to medicines closely related to lercanidipine (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
  • are suffering from certain heart diseases:
    • uncontrolled heart failure
    • an obstruction to flow of blood from the heart
    • unstable angina (angina at rest or progressively increasing)
    • if you have had heart attack less than one month ago
  • have severe liver or kidney problems
  • are pregnant, if you wish to become pregnant or if you are a woman of child-bearing age and do not use any contraceptive method
  • are breast-feeding
  • are taking ciclosporin
  • are taking antifungal medicines (such as ketoconazole or itraconazole)
  • drink grapefruit juice
  • are taking macrolide antibiotics (such as erythromycin or troleandomycin)
  • are taking antivirals (such as ritonavir for HIV)

Take special care with Lercanidipine Hydrochloride Film-coated Tablets

You should consult your doctor before taking Lercanidipine Hydrochloride Film-coated Tablets if you:

  • suffer from angina, as taking lercanidipine may lead to chest pain or increased frequency of chest pain
  • have sick sinus syndrome and don’t have a pacemaker
  • have problems with your liver or kidney, 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.

Taking Lercanidipine Hydrochloride Film-coated Tablets with certain other medicines (see below), may alter the effect of these medicines or of lercanidipine.

It is especially important for your doctor to know if you are already being treated with any of the following medicines:

  • phenytoin or carbamazepine (medicines for epilepsy)
  • rifampicin (a medicine to treat tuberculosis)
  • midazolam (a medicine that helps you sleep)
  • cimetidine, more than 800mg (a medicine for ulcers, indigestion, or heartburn)
  • digoxin (a medicine to treat a heart problem)
  • terfenadine or astemizole (medicines for allergies)
  • amiodarone or quinidine (medicines to treat a fast heart beat)
  • metoprolol (a medicine to treat high blood pressure)
  • simvastatin (a medicine for high cholesterol value)

Taking Lercanidipine Hydrochloride Film-coated Tablets with food and drink

You must not eat grapefruit or drink grapefruit juice as this may increase the effect of lercanidipine.

Please do not drink alcohol during treatment with lercanidipine as it may increase the effectiveness of this medicine in reducing your blood pressure, which can cause dizziness/fainting, tiredness or weakness.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

If you are taking lercanidipine and think that you may be pregnant, consult your doctor.

Lercanidipine should not be used if you are pregnant, if you wish to become pregnant or if you are a woman of childbearing age and do not use any contraceptive method.

Lercanidipine Hydrochloride Film-coated Tablets should not be used if you are breast-feeding.

Driving and using machines

Lercanidipine Hydrochloride Film-coated Tablets have a negligible influence on the ability to drive or use machines. However, side effect such as dizziness, weakness, tiredness and rarely sleepiness may occur. You should be careful until you know how you react to Lercanidipine.

Important information about some of the ingredients of Lercanidipine Hydrochloride Film-coated Tablets

Lercanidipine Hydrochloride Film-coated Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE LERCANIDIPINE HYDROCHLORIDE FILM-COATED TABLETS

Always take Lercanidipine Hydrochloride Film-coated Tablets 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. This is 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 you to increase your dose to one Lercanidipine Hydrochloride 20 mg film-coated tablet daily, if needed.

The tablets should preferably be swallowed whole with 1/2 glass of water. The tablets can be divided into equal halves.

Lercanidipine is not recommended for use in children and adolescents below 18 years.

If you take more lercanidipine than you should

Immediately contact a doctor or the nearest hospital casualty department.

Exceeding the correct dosage may cause your blood pressure to become too low, and your heart to beat irregularly or faster. It may also lead to unconsciousness.

If you forget to take your Lercanidipine Hydrochloride Film-coated Tablets

If you forget to take a dose of Lercanidipine Hydrochloride Film-coated Tablets then take it as soon as you remember, unless it is nearly time for 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, lercanidipine can cause side effects, although not everybody gets them.

Uncommon (occur in less than 1 out of 100 users):

Headache, dizziness, faster heartbeats, awareness of the beating of the heart, flushing (temporary redness of the face and neck), ankle swelling.

Rare (occur in less than 1 out of 1000 users):

Sleepiness, weakness, tiredness, nausea, vomiting, diarrhoea, abdominal pain, indigestion, rash, muscle pain, passage of large amounts of urine, angina pectoris.

Very rare (occur in less than 1 out of 10,000 users):

Fainting, allergic reaction, swelling of gums, increase in liver enzyme values (seen in blood tests), fall in blood pressure which can cause dizziness, light-headedness or fainting, more frequent urination, chest pain and heart attack.

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 LERCANIDIPINE HYDROCHLORIDE FILM-COATED TABLETS

Keep out of the reach and sight of children.

Do not use Lercanidipine Hydrochloride Film-coated Tablets after the expiry date, which is stated on the, carton after EXP. The expiry date refers to the last day of that month.

Storage conditions:

Do not store above 25°C. Store in the original package in order to protect from moisture.

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.

6. FURTHER INFORMATION

What Lercanidipine Hydrochloride Film-coated Tablets contain

  • The active substance is lercanidipine hydrochloride.
    One 10mg film-coated tablet contains 10mg lercanidipine hydrochloride, equivalent to 9.4mg lercanidipine..
    One 20mg film-coated tablet contains 20mg lercanidipine hydrochloride, equivalent to 18.8mg lercanidipine.
    The other ingredients are:
    Tablet core: Magnesium stearate, povidone, sodium starch glycolate(Type A), lactose monohydrate, microcrystalline cellulose.
    Film-coating 10mg tablets: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
    Film-coating 20mg tablets: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

What Lercanidipine Hydrochloride Film-coated Tablets look like and contents of the pack

Lercanidipine Hydrochloride 10mg Film-coated Tablets are yellow, round, biconvex 6.5mm film-coated tablets, scored on one side, and marked 'L' on the other side.

Lercanidipine Hydrochloride 20mg Film-coated Tablets are pink, round, biconvex 8.5mm film-coated tablets, scored on one side, and marked 'L' on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pack sizes:

Blister packs containing:

Lercanidipine Hydrochloride 10mg Film-coated Tablets: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 tablets

Lercanidipine Hydrochloride 20mg Film-coated Tablets: 7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

Manufacturer

Actavis hf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland

Or

Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

Or

Balkanpharma – Dupnitsa AD
3 Samokovsko Str.
Dupnitsa 2600
Bulgaria

This leaflet was last revised in November 2012

‘Zentiva’ is a registered trademark © 2012 Zentiva