Lercanidipine Doc Generici
ItalyTable of Contents
Package leaflet: Information for the user
LERCANIDIPINE DOC Generici 10 mg film-coated tablets, 20 mg film-coated tablets
Generic Medicine
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What LERCANIDIPINE DOC Generici is and what it is used for
- What you need to know before taking LERCANIDIPINE DOC Generici
- How to take LERCANIDIPINE DOC Generici
- Possible side effects
- How to store LERCANIDIPINE DOC Generici
- Contents of the pack and other information
1. What LERCANIDIPINA DOC Generici is and what it is used for
LERCANIDIPINA DOC Generici belongs to a group of medicines called calcium channel blockers, which block the entry of calcium into the heart muscle cells and into the blood vessels that carry blood away from the heart (the arteries). The entry of calcium into these cells causes the heart to contract and the arteries to narrow. By blocking calcium entry, calcium channel blockers reduce the heart's contraction and dilate (widen) the arteries, thereby lowering blood pressure.
LERCANIDIPINA DOC Generici has been prescribed to you to treat high blood pressure, also known as hypertension.
2. What you need to know before taking LERCANIDIPINE DOC Generici
Do not take LERCANIDIPINE DOC Generici
- If you are allergic to lercanidipine or to any of the other ingredients of this medicine (listed in section 6)
- If you have had allergic reactions to medicines closely related to LERCANIDIPINE DOC Generici tablets (such as amlodipine, nicardipine, felodipina, isradipine, nifedipine or lacidipine)
- If you suffer from certain heart conditions:
- Uncontrolled heart failure
- Obstruction of blood flow from the heart
- Unstable angina (angina at rest or progressively worsening angina)
- If you have had a heart attack less than one month ago
- If you have severe liver or kidney problems
- If you are taking CYP3A4 enzyme inhibitors:
- 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 a woman 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 DOC Generici:
- If you have heart problems or have a pacemaker
- If you suffer from angina pectoris, lercanidipine may rarely cause an increase in the frequency of attacks, which may last longer and be more severe. In isolated cases, myocardial infarction has been reported
- If you have liver or kidney problems, or if you are on dialysis
Other medicines and LERCANIDIPINE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking LERCANIDIPINE DOC Generici with other medicines (listed below) may alter the effect of these medicines or of LERCANIDIPINE DOC Generici.
It is particularly important that your doctor knows if you are already taking any of the following medicines:
- phenytoin or carbamazepine (medicines for epilepsy)
- rifampicin (a medicine for tuberculosis)
- midazolam (a medicine that helps you sleep)
- cimetidine, more than 800 mg (a medicine for ulcers, indigestion, or heartburn)
- digoxin (a medicine for heart conditions)
- terfenadine or astemizole (medicines for allergies)
- amiodarone or quinidine (antiarrhythmic medicines)
- metoprolol (a medicine for treating high blood pressure)
- simvastatin (a medicine to treat high cholesterol levels)
LERCANIDIPINE DOC Generici with food, drinks and alcohol
Do not eat grapefruit or drink grapefruit juice, as this may increase the effects of LERCANIDIPINE DOC Generici.
If you drink alcohol while taking LERCANIDIPINE DOC Generici, you may experience dizziness/fainting, tiredness or weakness. Indeed, the medicine may considerably lower your blood pressure when taken together with alcohol.
Pregnancy and breastfeeding
Ask your doctor for advice before taking any medicine.
If you are taking LERCANIDIPINE DOC Generici and suspect you might be pregnant, consult your doctor.
Do not use LERCANIDIPINE DOC Generici if you are pregnant, planning to become pregnant, or if you are a woman of childbearing age and not using any contraceptive method.
Do not use LERCANIDIPINE DOC Generici if you are breastfeeding.
Driving and using machines
LERCANIDIPINE DOC Generici has a negligible effect on the ability to drive or use machinery. However, side effects such as dizziness, weakness, tiredness, and rarely somnolence may occur. You should be cautious until you know how you react to LERCANIDIPINE DOC Generici.
LERCANIDIPINE DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take LERCANIDIPINE DOC Generici
Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one film-coated tablet of LERCANIDIPINE DOC Generici 10 mg once daily,
always at the same time, preferably in the morning, at least 15 minutes before breakfast, as a high-fat
meal significantly increases plasma levels of the drug.
If necessary, your doctor may decide to increase the dose to one film-coated tablet of
LERCANIDIPINE DOC Generici 20 mg daily.
The tablets should preferably be swallowed whole with half a glass of water.
The break line is intended to facilitate tablet splitting if you have difficulty swallowing it whole.
Use in children and adolescents
LERCANIDIPINE DOC Generici is not recommended for use in children and adolescents under 18 years of age.
If you take more LERCANIDIPINE DOC Generici than you should
Contact a doctor, the nearest hospital, or a poison control center 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 DOC Generici
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 tablet.
If you stop taking LERCANIDIPINE DOC Generici
If you stop treatment with LERCANIDIPINE DOC Generici, your blood pressure may rise again.
Consult your doctor before stopping treatment.
If you have any questions about how to use 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 frequency of side effects is listed below according to the following categories:
| Very common: | affects more than 1 in 10 users |
| Common: | affects 1 to 10 in 100 users |
| Uncommon: | affects 1 to 10 in 1,000 users |
| Rare: | affects 1 to 10 in 10,000 users |
| Very rare, not known: | affects less than 1 in 10,000 users, frequency cannot be estimated from the available data |
Uncommon: headache, dizziness, increased heart rate, awareness of heartbeat,
flushing (transient and episodic redness of the face and neck), ankle swelling.
Rare: somnolence, weakness, fatigue, nausea, vomiting, diarrhoea, abdominal pain, indigestion,
rash, muscle pain, increased volume of urine, angina pectoris.
Very rare, not known: reduction in blood pressure leading to fainting, allergic reactions,
swelling of the gums, increased levels of liver enzymes in the blood, drop in blood pressure that
may cause dizziness, lightheadedness or fainting, increased need to urinate, chest pain and heart attack.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system
at http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store LERCANIDIPINE DOC Generics
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or the packaging after
Exp. The expiry date refers to the last day of that month.
Storage conditions:
Al/PVC blisters and Al/PVDC blisters: Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What LERCANIDIPINA DOC Generici contains
- The active substance is lercanidipine hydrochloride. One 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. One 20 mg film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
- Other components are:
Tablet core: magnesium stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose.
Film coating of 10 mg tablets: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172).
Film coating of 20 mg tablets: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of LERCANIDIPINA DOC Generici and contents of the pack
LERCANIDIPINA DOC Generici 10 mg tablets are yellow, round, biconvex, film-coated tablets with a diameter of 6.5 mm, with a break line on one side and the imprint 'L' on the other side.
LERCANIDIPINA DOC Generici 20 mg tablets are pink, round, biconvex, film-coated tablets with a diameter of 8.5 mm, with a break line on one side and the imprint 'L' on the other side.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
Pack sizes:
LERCANIDIPINA DOC Generici 10 mg film-coated tablets: 28 tablets
LERCANIDIPINA DOC Generici 20 mg film-coated tablets: 28 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy
Manufacturer
Actavis Hf.
Reykjavikurvegi 78,
P.O. Box 420,
IS-222 Hafnafjordur
Iceland
Actavis Ltd.
B16
Bulebel Industrial Estate
Zejtun ZTN 08
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Follereau, 25
24027 Nembro (Bergamo)
Italy
This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Denmark: Lercanidipinhydrochlorid DOC
Italy: LERCANIDIPINA DOC Generici