APONIL

Package leaflet: Information for the user

Aponil 4 mg film-coated tablets, 6 mg film-coated tablets

Lacidipine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leafleaflet. 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aponil is and what it is used for

Aponil is a medicine containing the active substance lacidipine and belongs to a class of medicines called "calcium antagonists".
Aponil is used in the treatment of hypertension and works by widening the blood vessels, allowing blood to flow more easily, thereby helping to lower blood pressure.

2. What you need to know before taking Aponil

Do not take Aponil

• if you are allergic to lacidipine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a heart condition called "aortic stenosis". This is a narrowing of the valve that allows blood to be pumped out of the heart, resulting in reduced blood flow;

Do not take Aponil if you are in any of the conditions listed above. If in doubt,
consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aponil:

• if you have heart problems;
• if you have liver problems.

Other medicines and Aponil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Some medicines may alter the activity of Aponil, either reducing or increasing it and causing unwanted effects.
In turn, Aponil may alter the activity of certain medicines, including:

• furosemide, propranolol, or captopril (used to treat high blood pressure);
• cimetidine (used to treat stomach ulcers);
• cyclosporine (used to prevent organ transplant rejection or to treat certain autoimmune diseases);
• corticosteroids (steroidal anti-inflammatory medicines) or tetracosactide (used to treat adrenal gland disorders). In these cases, the blood pressure-lowering effect (antihypertensive effect) may decrease.

Aponil with food and drink
You may take this medicine on an empty stomach or with food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will consider the risks and benefits of taking Aponil for you and your baby.
There is no information available on the safety of using Aponil during pregnancy.
The active substance and excipients in Aponil may pass into breast milk. Therefore, if you are breastfeeding,
consult your doctor before starting treatment with Aponil.
Driving and using machines
This medicine may cause dizziness. If you experience this or similar side effects,
do not drive or operate machinery requiring a certain level of attention.
Aponil contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Aponil

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended initial dose is 2 mg once daily, preferably taken in the morning at the same time each day.
After 3–4 weeks of treatment, your doctor may decide to increase the dose to 4 mg, up to a maximum of 6 mg daily, preferably taken in the morning at the same time each day.

Instructions for use:

• take the tablet with water;
• take this medicine with or without food;

If you take more Aponil than you should
If you accidentally take an excessive dose of Aponil, contact your doctor immediately or go to the nearest hospital. A significant drop in blood pressure, or an increased or decreased heart rate, is very likely.

If you forget to take Aponil
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Aponil
Take Aponil for the length of time recommended by your doctor and do not stop taking it without consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported:
Common (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations);
• rapid heartbeat (tachycardia);
• swelling (edema);
• dizziness;
• increased urine production;
• headache;
• skin redness and itching (cutaneous rash);
• hot flushes;
• stomach discomfort;
• nausea;
• fatigue;
• temporary increase in the level of a liver enzyme called “alkaline phosphatase (ALP)”, which may be detected in blood tests.

Uncommon (may affect up to 1 in 100 people)

• worsening of chest pain (worsening of pre-existing angina pectoris);
• pale appearance (pallor);
• low blood pressure (hypotension);
• fainting (syncope);
• bleeding;
• swollen and painful gums.

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

• severe allergic reactions with swelling of the face, tongue, or throat, which may cause difficulty in swallowing or breathing;
• itchy skin rash.

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

• restlessness or tremor of arms and legs;
• depression.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to 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 Aponil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store in the original container to protect from light and at a temperature not exceeding 30°C.
Remove the tablet from the blister pack only immediately before taking it.
Do not dispose of medicines 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 Aponil contains

• The active substance is lacidipine. Each tablet contains 4 mg or 6 mg of lacidipine.
• The other ingredients are: lactose, povidone, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol (PEG) 400, polysorbate 80.

Description of the appearance of Aponil and contents of the pack
Aponil is presented as round tablets with a score line.
It is available in the following pack sizes:
4 mg: 28 tablets.
6 mg: 14 tablets.
Marketing Authorization Holder
I.B.N. Savio S.r.l. - Via del Mare, 36 - Pomezia (RM).
Manufacturer
Istituto Biochimico Nazionale Savio S.r.l. - Via del Mare, 36 - Pomezia (RM).
Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR).