Lercanidipine Mylan Italia

Patient Information Leaflet

Lercanidipine Mylan Italia 10 mg film-coated tablets, 20 mg film-coated tablets

Lercanidipine hydrochloride
Generic Medicine
Read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lercanidipine Mylan Italia is and what it is used for
2. What you need to know before taking Lercanidipine Mylan Italia
3. How to take Lercanidipine Mylan Italia
4. Possible side effects
5. How to store Lercanidipine Mylan Italia
6. Contents of the pack and other information

1. What Lercanidipine Mylan Italia is and what it is used for

Lercanidipine Mylan Italia belongs to a group of medicines called calcium channel blockers, which block the entry of calcium into the muscle cells of the heart and blood vessels that carry blood away from the heart (arteries). It is the entry of calcium into these cells that causes heart contractions and narrowing of the arteries. By blocking calcium entry, calcium channel blockers reduce heart contraction and dilate (widen) the arteries, thereby lowering blood pressure. It is not recommended for children under 18 years of age.
Lercanidipine Mylan Italia has been prescribed for you to treat high blood pressure, also known as hypertension.

2. What you need to know before taking Lercanidipine Mylan Italia

Do not take Lercanidipine Mylan Italia

• if you are allergic to lercanidipine hydrochloride or to any of the excipients of this medicine (listed in section 6)
• if you have had allergic reactions to medicines closely related to Lercanidipine Mylan Italia (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
• if you suffer from certain heart conditions
• uncontrolled heart failure
• obstruction to blood flow from the heart
• unstable angina (angina at rest or worsening progressively)
• if you have had a heart attack less than one month ago
• if you have severe kidney or liver problems
• if you are taking CYP3A4 isoenzyme inhibitor medicines:
• antifungal drugs (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin or troleandomycin)
• antiviral drugs (such as ritonavir)
• concurrently with another medicine called cyclosporine
• with grapefruit or grapefruit juice
• if you are pregnant, planning to become pregnant, or if you are of childbearing age and not using any contraceptive method
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipine Mylan Italia:

• if you suffer from certain heart problems, or if you have a pacemaker.
• if you have angina pectoris, Lercanidipine Mylan Italia may very rarely cause an increase in the frequency of attacks, which may last longer and become more severe. Myocardial infarction has been reported in isolated cases.
• if you have liver or kidney problems, or if you are on dialysis.

Other medicines and Lercanidipine Mylan Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Lercanidipine Mylan Italia with other medicines may alter the effect of these medicines or of Lercanidipine Mylan Italia. It is particularly important that your doctor knows if you are already being treated with any of the following medicines:

• phenytoin or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• midazolam (a medicine that helps you sleep)
• cimetidine, at doses higher than 800 mg (a medicine for ulcer, indigestion or heartburn)
• digoxin (a medicine for treating heart disease)
• terfenadine or astemizole (medicines for allergies)
• amiodarone or quinidine (medicines for treating rapid heartbeat)
• medicines known as beta-blockers, for example metoprolol (medicines for treating high blood pressure).

Lercanidipine Mylan Italia with food, beverages and alcohol
Do not consume alcohol during treatment with Lercanidipine Mylan Italia, as it may increase the effect of Lercanidipine Mylan Italia.
Do not eat grapefruit or drink grapefruit juice, as it may increase the effect of Lercanidipine Mylan Italia.
Pregnancy and breastfeeding
Ask your doctor for advice before taking any medicine.
If you are taking Lercanidipine Mylan Italia and are considering planning a pregnancy, consult your doctor.
Lercanidipine Mylan Italia must not be used during pregnancy or if you are planning to become pregnant, or if you are of childbearing age and not using any contraceptive method.
Lercanidipine Mylan Italia must not be used during breastfeeding.
Driving and using machines
Lercanidipine Mylan Italia has a negligible effect on the ability to drive or use machinery. However, side effects such as dizziness, weakness, fatigue and, rarely, drowsiness may occur. You should be cautious until you know how you react to Lercanidipine Mylan Italia.
Lercanidipine Mylan Italia contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Lercanidipine Mylan Italia

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one film-coated tablet of Lercanidipine Mylan Italia 10 mg once daily, at
the same time each day, preferably in the morning, at least 15 minutes before breakfast, because a
high-fat meal significantly increases the levels of the medicine in the blood.
If necessary, your doctor may advise increasing your dose to one film-coated tablet of Lercanidipine
Mylan Italia 20 mg daily.
The tablets should preferably be swallowed whole with half a glass of water. The score line is only
intended to facilitate breaking the tablet for easier swallowing and not for dividing it into equal
doses.
Elderly
No adjustment of the daily dose is required. However, particular caution is recommended at the
start of treatment.
Patients with liver or kidney problems
Particular care is necessary when starting treatment. Your doctor may decide to adjust the dose.
Use in children and adolescents
The use of Lercanidipine Mylan Italia is not recommended in children and adolescents under 18
years of age.
If you take more Lercanidipine Mylan Italia than you should
Contact your doctor, the nearest hospital emergency department, or the Poison Information Centre
immediately for advice.
Taking more than the prescribed dose may cause excessive lowering of blood pressure and irregular
or rapid heartbeat. It may also cause loss of consciousness.
If you forget to take Lercanidipine Mylan Italia
If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your
next dose. Then continue as before. Do not take a double dose to make up for the forgotten dose.
If you stop taking Lercanidipine Mylan Italia
If you stop treatment with Lercanidipine Mylan Italia, your blood pressure may rise again. Consult
your doctor before stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects can be serious. If you experience any of the following side effects, contact your doctor immediately or go to the nearest hospital emergency department:
Rare (may affect up to 1 in 1,000 people)

• Chest pain that may spread to the arms or neck, and sometimes to the shoulders and back, due to inadequate blood flow to the heart (angina pectoris). If you suffer from angina pectoris, Lercanidipine Mylan Italia may very rarely cause an increase in the frequency of attacks, which may last longer and become more severe.

Very rare (may affect up to 1 in 10,000 people)

• Allergic reactions including shortness of breath, laboured breathing or breathing difficulties; swelling of the face, lips, tongue or other parts of the body; skin rash, itching or hives
• Heart attack.

Other side effects:
Uncommon (may affect up to 1 in 100 people)

• Headache, dizziness
• Rapid heartbeat, awareness of heartbeat
• Flushing (transient, episodic redness of the face, neck or upper chest)
• Swelling of the ankles.

Rare (may affect up to 1 in 1,000 people)

• Drowsiness, weakness, fatigue
• Nausea, vomiting, diarrhoea, abdominal pain, indigestion
• Skin rash
• Muscle pain
• Passage of large amounts of urine.

Very rare (may affect up to 1 in 10,000 people)

• Drop in blood pressure that may cause dizziness, lightheadedness or fainting
• Increased liver enzyme levels in the blood
• Need to urinate more frequently
• Swelling of the gums.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercanidipine Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use Lercanidipine Mylan Italia after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lercanidipine Mylan Italia contains

• The active substance is lercanidipine hydrochloride. Each 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Each 20 mg film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other components are: magnesium stearate, povidone, sodium starch glycolate (type A), monohydrate lactose (see section "Lercanidipine Mylan Italia contains lactose"), microcrystalline cellulose. The film coating of the 10 mg tablets also contains macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172). The film coating of the 20 mg tablets also contains macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Lercanidipine Mylan Italia and contents of the pack
Lercanidipine Mylan Italia 10 mg tablets are yellow, round, biconvex, film-coated, with a diameter of 6.5 mm, with a break line on one side and marked with "L" on the other side.
Lercanidipine Mylan Italia 20 mg tablets are pink, round, biconvex, film-coated, with a diameter of 8.5 mm, with a break line on one side and marked with "L" on the other side.
The score line is only intended to facilitate breaking and swallowing and is not intended to divide the tablet into equal doses.
Lercanidipine Mylan Italia 10 mg film-coated tablets are available in blister packs containing 14, 20, 28, 30, 50, 56, 98, or 100 tablets.
Lercanidipine Mylan Italia 20 mg film-coated tablets are available in blister packs containing 28, 30, 50, 56, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Actavis Hf., Reykjavikurvegur 78, IS 220 Hafnarfjörður, Iceland
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza 2600, Bulgaria

This medicinal product is authorised in the European Economic Area Member States under the following names: