LACYDYNA 6 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lacydyna, 4 mg, Film-Coated Tablets
3. Lacydyna, 6 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
4. What is Lacydyna and What is it Used For
5. Important Information Before Taking Lacydyna
   1. When Not to Take Lacydyna:
   2. Warnings and Precautions
   3. Lacydyna and Other Medicines
   4. Taking Lacydyna with Food, Drink, and Alcohol
   5. Pregnancy, Breast-Feeding, and Fertility
   6. Driving and Using Machines
6. How to Take Lacydyna
   1. Taking More Lacydyna Than Prescribed
   2. Missing a Dose of Lacydyna
7. Possible Side Effects
   1. Stop Taking Lacydyna and Tell Your Doctor Immediately if You Experience Any of the Following Side Effects:
   2. Reporting Side Effects
8. How to Store Lacydyna
9. Contents of the Pack and Other Information
   1. What Lacydyna Contains
   2. What Lacydyna Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Importer
   4. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Lacydyna, 4 mg, Film-Coated Tablets

Lacydyna, 6 mg, Film-Coated Tablets

Lacydypine

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lacydyna and What is it 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 is Lacydyna and What is it Used For

Lacydyna contains the active substance lacydypine, which belongs to a group of medicines called calcium antagonists. Lacydyna helps to relax blood vessels, which causes them to widen. This makes it easier for blood to flow and as a result, lowers blood pressure. Regular intake of Lacydyna tablets, as recommended by your doctor, helps to lower blood pressure (in the treatment of high blood pressure).

2. Important Information Before Taking Lacydyna

When Not to Take Lacydyna:

• If you are allergic (hypersensitive) to lacydypine, other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6).
• If you have a heart disease called aortic stenosis. This is a narrowing of the valve in the heart, which makes it difficult for blood to flow out.
• If you have had a heart attack within the last month and in cases of severe heart failure.
• You should stop taking lacydypine if you experience chest pain (angina pectoris) or rapid and weak pulse, rapid and shallow breathing, low blood pressure, cold and sweaty skin, cyanosis of the lips or dizziness, fainting, weakness, or nausea.

If any of the above conditions apply to you, do not take Lacydyna. In case of doubt, consult your doctor or pharmacist before taking Lacydyna.

Warnings and Precautions

Before taking Lacydyna, discuss with your doctor or pharmacist:

• If you have heart rhythm disorders or any other heart diseases.
• If you have or have had liver disorders.

Lacydyna and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription, as well as 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 you are taking any of the following medicines:

• Medicines for high blood pressure
• Medicines for fungal infections
• Medicines for heart rhythm disorders (called anti-arrhythmic medicines)
• Medicines for depression, called tricyclic antidepressants
• Antibiotics (e.g., rifampicin)
• Medicines for epilepsy (seizures)
• Cimetidine - used for stomach disorders
• Cyclosporin (an immunosuppressant used in organ transplant recipients)
• Steroids or tetracosactide (used for inflammatory conditions, such as asthma, ulcerative colitis, or arthritis).

If you are going to have blood tests, inform the person performing the test that you are taking this medicine, as it may affect the results of liver function tests.

Taking Lacydyna with Food, Drink, and Alcohol

The medicine can be taken on an empty stomach or during meals. Consult your doctor about the possibility of consuming alcohol while taking this medicine, as alcohol may enhance the effect of Lacydyna. Do not take this medicine with grapefruit juice.

Pregnancy, Breast-Feeding, and Fertility

Do not take Lacydyna if you are pregnant, think you may be pregnant, or are breast-feeding. If you plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine may impair fertility in men.

Driving and Using Machines

This medicine may cause dizziness. If you experience this, do not perform tasks that require attention - do not drive or operate machinery. Lacydyna contains lactose monohydrate. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Lacydyna

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. It is important to take the correct number of tablets every day at the same time.

• The recommended initial 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.
• Swallow the tablets whole with water.
• Do not take the tablets with grapefruit juice.

Taking More Lacydyna Than Prescribed

If you take more Lacydyna than you should, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you, even if it is empty. Treatment may be necessary. Overdose symptoms may include irregular heart rhythm, rapid and shallow breathing, low blood pressure, cold and sweaty skin, or 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 forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Stop Taking Lacydyna and Tell Your Doctor Immediately if You Experience Any of the Following Side Effects:

• Chest pain (angina pectoris), including worsening chest pain.
• Severe deterioration in your condition with rapid heart rate, sweating, shortness of breath, and fainting.

Common(may affect up to 1 in 10 people)

• Headache
• Dizziness
• Sudden reddening, especially of the face
• Rapid or irregular heart rate (palpitations)
• Upset stomach or nausea
• Rash, skin redness, itching
• Increased urine production
• Feeling of weakness
• Swelling, especially in the ankles
• Changes in liver function test results

Uncommon(may affect up to 1 in 100 people)

• Chest pain (angina pectoris), including worsening chest pain
• Low blood pressure causing dizziness, fainting
• Gum swelling

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

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

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

• Tremors
• Depression

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. 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 Lacydyna

Keep this medicine out of the sight and reach of children. Store in the original package 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 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 Lacydyna Contains

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

What Lacydyna Looks Like and Contents of the Pack

Lacydyna 4 mg
White, oval, biconvex film-coated tablets with a score line on both sides and engraved with “4” on one side. The tablet can be divided into equal doses.
The medicine is available in aluminum/aluminum blisters in packs containing 14, 28, 30, 90 film-coated tablets.
Lacydyna 6 mg
White, oval, biconvex film-coated tablets engraved with “6” on one side.
The medicine is available in aluminum/aluminum blisters in packs containing 14, 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Importer

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

Date of Last Revision of the Leaflet: