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LERCANIDIPINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): LERCANIDIPINE HYDROCHLORIDE / LERCANIDIPINE HYDROCHLORIDE / LERCANIDIPINE HYDROCHLORIDE

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Lercanidipine hydrochloride 10 mg
Film-coated Tablets

2929
16.11.16[3]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

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)
Lercanidipine with food, drink and alcohol
You must not eat grapefruit or drink grapefruit juice as this may increase the
effect of Lercanidipine.

This medicine is available using the above name but will be referred to as
Lercanidipine hydrochloride tablets or Lercanidipine throughout the leaflet.
Also available in 20 mg strength.

If you use alcohol together with Lercanidipine you may experience
dizziness/fainting, tiredness or weakness. This is because the medicine may
lower your blood pressure considerably together with alcohol.

What is in this leaflet:
1. What Lercanidipine hydrochloride tablets are and what they are used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
If you are pregnant or breast‑feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. Do not use if you are pregnant, or if you wish to become pregnant
or if you are a woman in childbearing age and do not use any contraceptive
method.

1. WHAT LERCANIDIPINE HYDROCHLORIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Lercanidipine belongs to a group of medicines called calcium channel
blockers that block the entry of calcium into the muscle cells of the heart and
the blood vessels that carry blood away from the heart (the arteries). It is the
entry of calcium into these cells that causes the heart to contract and
arteries to narrow. By blocking the entry of calcium, calcium channel
blockers decrease contraction of the heart and dilate (widen) the arteries,
and the blood pressure is reduced.

Do not use if you are breast-feeding.

Lercanidipine has been prescribed to you to treat your high blood pressure,
also known as hypertension.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Do not take Lercanidipine if you:
- are allergic to lercanidipine or any of the other ingredients of this
medicine (listed in section 6).
- have had allergic reactions to medicines that are closely related to
Lercanidipine hydrochloride tablets (such as amlodipine, nicardipine,
felodipine, isradipine, nifedipine or lacidipine)
- are suffering from certain heart diseases:
- uncontrolled cardiac failure
- an obstruction to flow of blood from the heart
- unstable angina (angina at rest or progressively increasing)
- have had a heart attack less than one month ago
- have severe liver or kidney problems
- are taking drugs that are inhibitors of CYP3A4 isoenzyme:
- antifungal medicines (such as ketoconazole or intraconazole)
- macrolide antibiotics (such as erythromycin or troleandomycin)
- antivirals (such as ritonavir)
- at the same time as another drug called ciclosporin or cyclosporin
- with grapefruit or grapefruit juice
- are pregnant, or if you wish to become pregnant or if you are a woman in
child-bearing age and do not use any contraceptive method
- if you are breast-feeding
Warnings and precautions
Talk to your doctor before taking Lercanidipine hydrochloride tablets if you:
- have a heart condition known as sick sinus syndrome, and do not have
a pacemaker
- suffer from chest pain (angina pectoris), Lercandipine may in very rare
cases cause increased frequency of attacks that may last longer and
become more severe. Heart attacks have been reported in isolated cases.
- have problems with your liver or kidney, or you are on dialysis
Other medicines and Lercanidipine
Please tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including medicines obtained without a
prescription.
Taking Lercanidipine with certain other medicines (see below), may alter the
effect of these medicines or of Lercanidipine.

Driving and using machines
Lercanidipine has 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.
Lercanidipine contains lactose monohydrate
Lercanidipine tablets contains 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
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is one Lercanidipine hydrochloride 10mg filmcoated 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 20mg film-coated tablet daily, if needed.
The tablets should preferably be swallowed whole with 1/2 glass of water.
The score line is only there to help you break the tablet if you have difficulty
swallowing it whole.
Use in children and adolescents
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, the nearest hospital casualty department or
the centre for poison information for advice.
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 Lercanidipine
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 to make up for a forgotten dose.
If you stop taking Lercanidipine
If you stop taking Lercanidipine 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 frequencies of side effect have been listed below according to the
following definitions:
Very common:
may affect more than 1 in 10 people
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Very rare:
may affect up to 1 in 10,000 people
Not known:
frequency cannot be estimated from the available
data
Uncommon: Headache, dizziness, faster heartbeats, awareness of the
beating of the heart, flushing (transient episodic redness of the face and
neck), ankle swelling.
Rare: Sleepiness, weakness, tiredness, nausea, vomiting, diarrhoea,
abdominal pain, indigestion, rash, muscle pain, passage of large amounts of
urine, angina pectoris.
Very rare, not known: Decrease in blood pressure which may lead to
fainting, allergic reaction, swelling of gums, increase in liver enzyme blood
test values, fall in blood pressure which can cause dizziness, lightheadedness or fainting, increase in the usual number of times one urinates,
chest pain and heart attack.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not store above 25°C.
Store in the original package to protect from moisture.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lercanidipine hydrochloride tablets contains
The active substance is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg lercanidipine hydrochloride,
equivalent to 9.4 mg lercanidipine.
The other ingredients are:
Tablet core: Magnesium stearate, povidone, sodium starch glycolate (Type
A), lactose monohydrate, microcrystalline cellulose.
Film-coating: Macrogol, polyvinyl alcohol (partly hydrolysed), talc, titanium
dioxide (E 171), yellow iron oxide (E 172).
What Lercanidipine hydrochloride tablets looks like and contents of
the pack
Lercanidipine hydrochloride 10mg tablets are yellow, round, biconvex filmcoated 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: Blisters 28 tablets and 98 tablets
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Balkanpharma – Dupnitsa AD, 3 Samokovsko Schosse Str, Dupnitsa 2600,
Bulgaria.
Actavis Ltd., B16 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta.
Actavis hf., Reykjavikurvegur 78, Hafnarfjordur, IS-220, Iceland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2929

Leaflet revision and issue date (Ref) 16.11.16[3]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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