Lacydyna

Package leaflet: Information for the patient

Lacydyna, 4 mg, coated tablets
Lacydyna, 6 mg, coated tablets
lacidipine
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

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

1. What Lacydyna is and what it is used for

Lacydyna contains the active substance lacidipine, which belongs to a group of medicines called
calcium channel antagonists. Lacydyna helps relax blood vessels, causing them to widen. This improves blood flow and consequently lowers blood pressure.
Regular, doctor-recommended use of Lacydyna tablets helps reduce arterial blood pressure (in the treatment of arterial hypertension).

2. Important information before using Lacydyna

When not to take Lacydyna:

• If the patient is allergic (hypersensitive) to lacidipine, other drugs in the calcium antagonist group, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a heart condition called aortic valve stenosis. This is a narrowing of a heart valve, causing impaired blood outflow.
• If the patient has recently suffered a myocardial infarction (heart attack) within the past month or has severe heart failure.
• The use of lacidipine should be discontinued if chest pain (angina pectoris), rapid and weak pulse, rapid and shallow breathing, low blood pressure, cold and clammy skin, cyanosis of the lips, dizziness, fainting, weakness, or nausea occur.

If any of the above conditions apply to the patient, Lacydyna should not be taken. In case of doubt, consult a doctor or pharmacist before starting treatment with Lacydyna.

Warnings and precautions

Before starting treatment with Lacydyna, discuss with your doctor or pharmacist:

• If the patient has any heart rhythm disorders or other heart conditions.
• If the patient currently has or has ever had any liver problems.

Lacydyna and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription. This also includes herbal preparations. This is because Lacydyna may affect the action of other medicines, and some medicines may affect the action of Lacydyna.

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• Medicines used to treat high blood pressure
• Medicines used to treat fungal infections
• Medicines used to treat heart rhythm disorders (called antiarrhythmics)
• Medicines used to treat depression, known as tricyclic antidepressants
• Antibiotics (e.g. rifampicin)
• Medicines used to treat epilepsy (seizures)
• Cimetidine – used to treat stomach disorders
• Cyclosporine (an immunosuppressive medicine used in organ transplant recipients)
• Steroids or tetracosactide (used to treat inflammatory conditions such as asthma, ulcerative colitis, or arthritis)

If blood tests are planned, inform the person performing the test that this medicine is being taken, as it may affect liver function test results.

Taking Lacydyna with food, drink, and alcohol

This medicine may be taken on an empty stomach or with food.

Consult your doctor regarding the consumption of alcohol while taking this medicine, as alcohol may enhance the effect of Lacydyna.

Do not take this medicine with grapefruit juice.

Pregnancy, breastfeeding, and effects on fertility

Do not take Lacydyna if the patient is pregnant, suspects she may be pregnant, or is breastfeeding. If the patient plans to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine may impair fertility in men.

Driving and operating machinery

This medicine may cause dizziness. If the patient experiences such symptoms, activities requiring alertness should be avoided – do not drive or operate machinery.

Lacydyna contains monohydrate lactose.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before starting treatment with this medicine.

3. How to take Lacydyna

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
It is important to take the correct number of tablets every day at the same time.

• The recommended starting dose is 2 mg, taken once daily in the morning.
• After 3-4 weeks, your doctor may increase the dose to 4 mg, taken once daily in the morning.
• If necessary, your doctor may further increase the dose to 6 mg, taken once daily in the morning, which is the maximum daily dose.
• Tablets should be swallowed whole with water.
• Do not take the tablets with grapefruit juice.

Taking more Lacydyna than recommended
If you take more tablets than recommended, contact your doctor immediately or go to the nearest hospital.
Take the medicine packaging with you, even if no tablets are left.
Treatment may be necessary. Symptoms of overdose may include irregular heartbeat, rapid and shallow breathing, low blood pressure, cold and clammy skin, dizziness, fainting, weakness, or nausea.

Missing a dose of Lacydyna
If you miss a dose, take it as soon as you remember, on the same day. However, if it is almost time for your next dose, take your usual dose in the morning. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, Lacydyna may cause adverse effects, although not everyone experiences them.
You should immediately tell your doctor if any of the following adverse effects occur:

• Chest pain (angina pectoris), including worsening chest pain.
• Marked deterioration in general condition with rapid heartbeat, sweating, shortness of breath, and fainting.

Common (may affect up to 1 in 10 patients)

• Headache
• Dizziness
• Sudden flushing, especially of the face
• Fast or irregular heartbeat (palpitations)
• Stomach upset or nausea
• Rash, skin redness, itching
• Increased frequency of urination
• Feeling of weakness
• Swelling, particularly around the ankles
• Changes in blood test results related to liver function

Uncommon (may affect up to 1 in 100 patients)

• Chest pain (angina piersiowa), including worsening chest pain
• Low blood pressure causing, for example, feeling faint or fainting
• Gum swelling

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

• Angioedema (an allergic reaction causing swelling of the face)
• Itchy skin rash (urticaria)
• Muscle cramps

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

• Tremor
• Depression

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lacydyna

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the
environment.

6. Contents of the pack and other information

What Lacydyna contains

• The active substance is lacidipine. Each coated tablet contains 4 mg or 6 mg of lacidipine.
• The other ingredients are: core – povidone K 30, lactose monohydrate, magnesium stearate; coating – Opadry white OY-S-7335 containing: titanium dioxide (E171), hypromellose.

What Lacydyna looks like and contents of the pack
Lacydyna 4 mg
White, oval, biconvex coated tablets with a dividing line on both sides and engraved "4" on one side. The tablet can be divided into equal doses.
The medicine is available in aluminium/aluminium blisters in pack sizes containing 14, 28, 30, or 90 coated tablets.
Lacydyna 6 mg
White, oval, biconvex coated tablets with engraved "6" on one side.
The medicine is available in aluminium/aluminium blisters in pack sizes containing 14 or 28 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
E-mail: [email protected]
Importer
Laboratories BTT
Z.I. de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany