LERCANIDIPINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Lercanidipine Hydrochloride 10 mg and 20 mg Film-coated Tablets

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking 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.

What is in this leaflet:

1. What Lercanidipine Hydrochloride is and what it is used for

2. What you need to know 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. Contents of the pack and other information

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H What Lercanidipine Hydrochloride is and what it is used for

Lercanidipine Hydrochloride belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives). Lercanidipine is used to treat mild to moderate high blood pressure also known as hypertension.

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■ What you need to know before you take Lercanidipine Hydrochloride Film-Coated Tablets

Do not take Lercanidipine:

• If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions to medicinal products closely related to Lercanidipine (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 heart attack

• if you have severe liver or kidney problems
• if you are taking medicinal products that are inhibitors of CYP3A4 isoenzyme:

• – antifungal medicines (such as ketoconazole or itraconazole)

• – macrolide antibiotics (such as erythromycin or troleandomycin)

• – antivirals (such as ritonavir)

• if you are taking another drug called ciclosporin or cyclosporin (used after transplants to prevent organ rejection)
• if you are taking grapefruit or grapefruit juice. Do not use if you are pregnant or breast-feeding (see section Pregnancy and breast-feeding for more information).

Warnings and precautions

Talk to your doctor or pharmacist before taking Lercanidipine Hydrochloride Film-Coated Tablets if:

• You have certain other heart conditions and do not have a pacemaker, or you have pre-existing angina
• You have problems with your liver or kidneys or you are on dialysis.

Children and adolescents

Lercanidipine should not be used for children and adolescents under 18 years.

Other medicines and Lercanidipine Hydrochloride Film-Coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Please tell your doctor or pharmacist if :

• 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 antifungal medicines (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin or troleandomycin) or antivirals (such as ritonavir). The effect of Lercanidipine may be increased. Therefore the co-administration should be avoided (see “Do not take Lercanidipine”).
• You are taking ciclosporin (a medicine which lowers the body’s resistance to disease). The effect of Lercanidipine as well as of ciclosporin may be increased. Therefore the co-administration should be avoided (see “Do not take Lercanidipine”).
• You are taking simvastatin (a medicine which lowers cholesterol level). Lercanidipine should be taken in the morning and simvastatin in the evening.

Lercanidipine with food and drink and alcohol

• Patients should not consume alcohol during treatment with Lercanidipine since it may increase the effect of Lercanidipine.
• Patients should not take grapefruit or grapefruit juice.

How to take Lercanidipine Hydrochloride Film-Coated Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

[10 mg]

Adults : The recommended dose is 10 mg lercanidipine hydrochloride daily at the same time each day, preferably in the morning at least 15 minutes before breakfast , because a high fat meal significantly increases blood levels of the active substance. Your doctor may advise you to increase the dose to two 10 mg tablets or one 20 mg tablets Lercanidipine (corresponding to 20 mg lercanidipine hydrochloride) daily, if needed.

The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water).

[20 mg]

Adults: The recommended dose is 10 mg lercanidipine hydrochloride daily at the same time each day, preferably in the morning at least 15 minutes before breakfast , because a high fat meal significantly increases blood levels

of the active substance. The dose of 10 mg is not possible with the tablets in this leaflet. Your doctor may advise you to increase the dose to one tablet Lercanidipine (corresponding to 20 mg lercanidipine hydrochloride) daily, if needed.

The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water).

Older people: 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.

Use in children and adolescents: This medicine should not be used in children and adolescents under 18 years of age.

If you have any further questions on the use of this product ask your doctor.

If you take more Lercanidipine 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

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

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.

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Possible side effects

Like all medicines, this medicine 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 (may affect up to 1 in 1,000 people): angina pectoris (chest pain due to lack of blood to your heart).

Very rare (may affect up to 1 in 10,000 people): 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 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 (may affect up to 1 in 100 people): headache, dizziness, faster heart beats, palpitations (heart pounding or racing), sudden reddening of the face, neck or upper chest, ankle swelling.

Rare (may affect up to 1 in 1,000 people): sleepiness, feeling sick, vomiting, heartburn, stomach pain, diarrhoea; skin rash, muscle pain, passage of large amounts of urine, tiredness.

Very rare (may affect up to 1 in 10,000 people): swelling of gums, changes in liver function (detected by blood tests), increase in the usual number of times one urinates.

Reporting of side effects

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 the Yellow Card Scheme at: or 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.

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■ How to store Lercanidipine Hydrochloride Film-Coated Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on each blister strip and on the outer carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C. Store in the original package in order to protect from light.

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 to protect the environment.

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Contents of the pack and other information

What Lercanidipine Hydrochloride Film-Coated Tablets contain

The active substance is lercanidipine hydrochloride.

One 10 mg Lercanidipine Hydrochloride Film-Coated Tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4 mg lercanidipine.

The other ingredients are:

Core: Maize starch, sodium starch glycolate (type A), silica, colloidal anhydrous, cellulose, microcrystalline, poloxamer 188, sodium stearyl fumarate, macrogol 6000.

Film-coating: Hypromellose (E464), macrogol 6000, iron oxide yellow (E 172), titanium dioxide (E 171).

One 20 mg Lercanidipine Hydrochloride Film-Coated Tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine.

The other ingredients are:

Core: Cellulose, microcrystalline, maize starch, sodium starch glycolate (type A), silica, colloidal anhydrous, povidone K 30, sodium stearyl fumarate.

Film-coating: Hypromellose (E464), macrogol 6000, iron oxide red (E 172), titanium dioxide (E 171).

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

10 mg: Lercanidipine Hydrochloride 10 mg Film-Coated Tablets are yellow, round shaped biconvex, film-coated tablet of 6.5 mm diameter, with score line on one side and plain on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

20 mg: Lercanidipine Hydrochloride 20 mg Film-Coated Tablets are pink, round shaped biconvex, film-coated tablet of 8.5 mm diameter, with score line on one side and plain on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Available in pack sizes of: 14, 28, 30, 50 x1, 56, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany

This leaflet was last revised October 2020

PL 00289/1283–4

EAS4381c