Lapixen

Package Leaflet: Information for the Patient

Lapixen, 2 mg, Film-Coated Tablets

Lapixen, 4 mg, Film-Coated Tablets

Lapixen, 6 mg, Film-Coated Tablets

Lacidipine

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 medications called calcium channel blockers.
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 a 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 channel blockers, or any of the other ingredients of this medication (listed in section 6).
• If the patient has a heart condition called aortic stenosis. This is a narrowing of the aortic valve in the heart, which makes it difficult for blood to flow out.
• If the patient has had a heart attack within the last month.
• Lacidipine should be discontinued 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 the patient. In case of doubts, consult a doctor or pharmacist before starting to take Lapixen.

Warnings and Precautions

Before starting to take Lapixen, discuss the following with a doctor or pharmacist:

• if the patient has heart rhythm disorders or any other heart conditions,
• if the patient has or has 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 Medications

Tell a doctor or pharmacist about all medications the patient is taking or has recently taken, as well as any medications planned to be taken.
This includes herbal preparations, as Lapixen may affect the action of some medications, and some medications may affect the action of Lapixen.
In particular, inform a doctor or pharmacist about taking any of the following medications:

• medications for high blood pressure,
• medications that control heart rhythm (called anti-arrhythmic medications),
• medications for depression, called tricyclic antidepressants,
• medications for fungal infections (e.g., ketoconazole, itraconazole),
• antibiotics (e.g., erythromycin, rifampicin),
• sedatives and sleeping pills,
• medications for mental disorders,
• medications for epilepsy (seizures),
• antihistamines - used to treat allergies,
• cimetidine (a medication used to treat stomach disorders),
• cyclosporin (an immunosuppressive medication used, e.g., in transplant patients),
• tetracosactide (a medication used to diagnose and treat adrenal cortex disorders),
• corticosteroids (medications used to treat inflammatory conditions, asthma, and certain skin diseases).

Before blood tests, inform the person performing the test about taking Lapixen, as this medication may affect liver test results.

Lapixen with Food, Drink, and Alcohol

The medication 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 medication. Be cautious when taking Lapixen and consuming alcohol.

Pregnancy, Breast-Feeding, and Fertility

If the patient is pregnant, breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
Do not take Lapixen during pregnancy, when planning a pregnancy, or during breast-feeding.
This medication may affect fertility in men.

Driving and Using Machines

While taking Lapixen, dizziness may occur. In such cases, do not drive vehicles, use tools, or operate machines.
Lapixen contains lactose(a sugar found in milk).
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication.

3. How to Take Lapixen

Always take this medication exactly as a doctor has told you. In case of doubts, consult a doctor or pharmacist.
It is important to take the correct 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, a doctor may increase the dose to 4 mg once a day, taken every morning.
• If necessary, a 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
A tablet can be divided into two equal doses.
If, according to the prescribed dosage, 2 mg of Lapixen should be taken, i.e., half a 4 mg tablet, the unused half should be left in the blister pack and taken within 48 hours.

Taking More Than the Recommended Dose of Lapixen

In case of taking more than the recommended dose, immediately contact a doctor or go to the emergency department of the nearest hospital. Take the package leaflet, any remaining tablets, and the packaging to the doctor or hospital so that it is clear what tablets were 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

In case of missing a dose, take it as soon as remembered on the same day.
However, if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.
Do not take a double dose to make up for a missed dose.

Stopping Lapixen Treatment

In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

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

Stop Taking Lapixen and Immediately Consult a Doctor if the Following Symptoms Occur:

• Chest pain (angina pectoris), including worsening chest pain,
• Sudden swelling of the face, lips, and tongue, which may lead to 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 according to their frequency of occurrence:

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 lead to 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 slowing of movements.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
{current address, phone number, and fax of the aforementioned Department}
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Lapixen

Keep the medication out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medication after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. 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/Aluminum/PVC/Aluminum 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
biofarm@biofarm.pl

Date of Last Revision of the Leaflet: