Lapixen

Leaflet attached to the packaging: patient information

Lapixen, 2 mg, film-coated tablets

Lapixen, 4 mg, film-coated tablets

Lapixen, 6 mg, film-coated tablets

Lacidipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lapixen and what is it used for

Lapixen contains lacidipine, which belongs to a group of medicines called calcium antagonists.
Lapixen helps to relax blood vessels, which causes them to widen. This makes it easier for blood to flow and as a result, blood pressure is lowered.
Taking Lapixen tablets regularly, as recommended by your doctor, helps to lower blood pressure (treatment of high blood pressure).

2. Important information before taking Lapixen

When not to take Lapixen

• If the patient is allergic to lacidipine, other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a heart disease called aortic stenosis. This is a narrowing of the valve in the heart, which makes it difficult for blood to flow.
• If the patient has had a heart attack within the last month.
• Lacidipine should be stopped if chest pain (angina pectoris) or rapid and shallow breathing, low blood pressure, cold and sweaty skin, or dizziness, fainting, weakness, or nausea occur.

Do not take Lapixen if any of the above conditions apply to you.
In case of doubt, consult your doctor or pharmacist before taking Lapixen.

Warnings and precautions

Before taking Lapixen, discuss with your doctor or pharmacist:

• if you have heart rhythm disorders or any other heart disease,
• if you have or have had liver disorders.

Children and adolescents

Lapixen is not recommended for children and adolescents under 18 years of age due to a lack of experience with safety and efficacy in this patient group.

Lapixen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
This includes herbal preparations, as Lapixen may affect the action of some medicines, and some medicines may affect the action of Lapixen.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines for high blood pressure,
• medicines that control heart rhythm (called anti-arrhythmic medicines),
• medicines for depression, called tricyclic antidepressants,
• medicines for fungal infections (e.g., ketoconazole, itraconazole),
• antibiotics (e.g., erythromycin, rifampicin),
• sedatives and hypnotics,
• medicines for mental disorders,
• medicines for epilepsy (seizures),
• antihistamines - used for allergies (hypersensitivity),
• cimetidine (a medicine used for stomach disorders),
• cyclosporin (an immunosuppressive medicine used, e.g., in transplant patients),
• tetracosactide (a medicine used for diagnosis and treatment of adrenal gland disorders),
• corticosteroids (medicines used for inflammatory conditions, asthma, and some skin diseases).

Before blood tests, inform the person performing the test that you are taking Lapixen, as this medicine may affect liver test results.

Lapixen with food, drink, and alcohol

The medicine can be taken on an empty stomach or during a meal.
Do not drink grapefruit juice while taking Lapixen.
Alcohol may enhance the effect of the medicine. Be cautious while taking Lapixen and consuming alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Lapixen during pregnancy, when planning a pregnancy, or while breastfeeding.
This medicine may affect fertility in men.

Driving and using machines

While taking Lapixen, dizziness may occur. In this case, do not drive, use tools, or operate machinery.
Lapixen contains lactose(a sugar found in milk).
If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Lapixen

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
It is important to take the right number of tablets every day at the same time.

• The usual starting dose is 2 mg once a day, taken every morning.
• After 3-4 weeks, your doctor may increase the dose to 4 mg once a day, taken every morning.
• If necessary, your doctor may further increase the dose to 6 mg once a day, taken every morning, which is the maximum daily dose.

Take the tablets out of the blister pack just before taking.

• Swallow the tablets with water.
• Do not take the tablets with grapefruit juice.

Lapixen, 4 mg, film-coated tablets
The tablet can be divided into two equal doses.
If you need to take 2 mg of Lapixen, i.e., half a 4 mg tablet, leave the unused half in the blister pack and take it within 48 hours.

Taking more than the recommended dose of Lapixen

If you have taken more than the recommended dose, contact your doctor or go to the emergency department of your nearest hospital immediately.
Take the leaflet, any remaining tablets, and the packaging with you to the doctor or hospital so that they know what tablets you have taken.
Treatment may be necessary.
Overdose may cause irregular heartbeat, rapid and shallow breathing, low blood pressure, cold and sweaty skin, or dizziness, fainting, weakness, or nausea.

Missing a dose of Lapixen

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, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Lapixen

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lapixen can cause side effects, although not everybody gets them.

Stop taking Lapixen and contact your doctor immediately if you experience any of the following symptoms:

• Chest pain (angina pectoris), including worsening chest pain,
• Sudden swelling of the face, lips, and tongue, which may cause difficulty breathing (angioedema),
• Rapid and weak pulse (heart rate), rapid and shallow breathing, low blood pressure, cold and sweaty skin, or blue discoloration of the lips.

Side effects are divided into the following frequencies:

Very common:

occur in more than 1 in 10 patients,

Common:

occur in 1 to 10 in 100 patients,

Uncommon:

occur in 1 to 10 in 1,000 patients,

Rare:

occur in 1 to 10 in 10,000 patients,

Very rare:

occur in less than 1 in 10,000 patients,

Frequency not known:

cannot be estimated from the available data.
Common:

• headache,
• dizziness,
• sudden redness (especially of the face),
• rapid or irregular heartbeat (palpitations),
• swelling (edema), especially in the ankles. The above side effects usually disappear during continued treatment.
• rapid heartbeat,
• nausea or vomiting,
• skin rash, redness (local redness of the skin), and itching of the skin,
• increased urine production (polyuria),
• feeling of weakness,
• changes in liver blood test results.

Uncommon:

• chest pain (angina pectoris), including worsening chest pain,
• fainting, low blood pressure,
• gum swelling (gingival hyperplasia).

Rare:

• angioedema (an allergic reaction that causes swelling, e.g., of the face, tongue, and throat, which may cause difficulty breathing and swallowing),
• hives,
• depression,
• muscle cramps.

Very rare:

• tremors.

Frequency not known:

• involuntary muscle contractions or tics and changes in muscle tension and slowed movements.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
{current address, phone number, and fax of the Department}
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lapixen

Keep the medicine out of the 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.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Lapixen contains

The active substance is lacidipine.
Lapixen, 2 mg, film-coated tablets: each tablet contains 2 mg of lacidipine.
Lapixen, 4 mg, film-coated tablets: each tablet contains 4 mg of lacidipine.
Lapixen, 6 mg, film-coated tablets: each tablet contains 6 mg of lacidipine.
The other ingredients are:
tablet core:
anhydrous lactose, povidone K30, magnesium stearate;
tablet coating: AquaPolish P white 010.47 Cwith the composition - hypromellose, talc, propylene glycol, titanium dioxide (E171).

What Lapixen looks like and contents of the pack

Lapixen, 2 mg, film-coated tablets:
film-coated tablets, round, white, convex on both sides.
Lapixen, 4 mg, film-coated tablets:
film-coated tablets, oval, white, convex on both sides, with a dividing line on one side.
The tablet can be divided into two equal doses.
Lapixen, 6 mg, film-coated tablets:
film-coated tablets, oval, white, convex on both sides, with "6 mg" embossed on one side.
Lapixen film-coated tablets are packaged in OPA/Aluminium/PVC/Aluminium blisters, together with the patient leaflet, in a cardboard box.
The pack contains:
7, 14, 28, or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: + 48 61 66 51 500
faks: + 48 61 66 51 505
[email protected]

Date of last revision of the leaflet: