Aldan

Package Leaflet: Information for the User

ALDAN, 5 mg, tablets

ALDAN, 10 mg, tablets

Amlodipine

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

1. What is Aldan and what is it used for

Aldan belongs to a group of medicines called calcium channel blockers, dihydropyridine derivatives.
It is used to treat high blood pressure, stable angina pectoris, and vasospastic angina pectoris (Prinzmetal's angina).

2. Important information before taking Aldan

When not to take Aldan:

• if you are allergic to amlodipine, other dihydropyridine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure;
• if you have clinically significant aortic stenosis;
• if you have cardiogenic shock;
• if you have unstable angina pectoris, except for vasospastic angina (Prinzmetal's angina).

Warnings and precautions

Before taking Aldan, consult your doctor or pharmacist.
Be particularly cautious when taking Aldan:

• if you have aortic stenosis and are taking other blood pressure-lowering medicines: the medicine may cause an excessive drop in blood pressure;
• if you have liver function disorders: your doctor may recommend a dose reduction;
• in elderly patients: your doctor may recommend a lower dose, which can then be gradually increased;
• if you have severe circulatory failure.

Consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Other medicines and Aldan

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Aldan with food and drink

Do not take the medicine with grapefruit juice, as it increases the concentration in the blood.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
The medicine should not be taken during pregnancy, unless absolutely necessary.
Breastfeeding should be discontinued during treatment with Aldan.
It is not known whether amlodipine passes into breast milk.

Driving and using machines

Aldan may cause drowsiness and dizziness, especially at the beginning of treatment. When starting to take the medicine, consult your doctor about the possibility of driving, operating machines, and using hazardous tools.

Aldan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered 'sodium-free'.

3. How to take Aldan

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
Hypertension
The usual dose is 5 mg once daily. The maximum daily dose is 10 mg.
Stable angina pectoris, Prinzmetal's angina
The recommended dose is 5 to 10 mg once daily.
Swallow the tablet with a sufficient amount of liquid, e.g., a glass of water.
Aldan should be taken regularly, every day at the same time.
If you feel that the effect of Aldan is too strong or too weak, consult your doctor.
Taking Aldan in patients with liver function disorders
In patients with liver failure, a dose reduction is recommended.

Use in children

The medicine is intended for use in adults over 18 years of age.

Overdose of Aldan

A significant drop in blood pressure with an increase in heart rate may occur.
Overdose of the medicine may also be asymptomatic. If you have taken more than the recommended dose, consult your doctor or pharmacist immediately.

Missed dose of Aldan

If you miss a dose one day, do not take a double dose the next day.

4. Possible side effects

Like all medicines, Aldan can cause side effects, although not everybody gets them.
The medicine is usually well-tolerated in doses up to 10 mg per day, and side effects may be mild or moderate.
The side effects listed below have been classified by system organ class and frequency.
Very common (≥1/10); common (≥1/100 to <1>Common:
edema (10.8%), headache (7.3%), fatigue (4.5%), palpitations (4.5%), dizziness (3.4%), nausea (2.9%), flushing (2.6%), abdominal pain (1.6%), somnolence (1.4%). Side effects were the reason for discontinuation of the medicine in 1.5% of patients.
Uncommon:
tachycardia, bradycardia, atrial fibrillation (very rapid contractions), chest pain, hypotension, paresthesia, seizures, peripheral neuropathy, constipation, dyspepsia, diarrhea, vomiting, gingival hyperplasia, pancreatitis, arthralgia, muscle spasms, myalgia, libido disorder, depression, nervousness, sleep disorders, involuntary urination, tremors, general weakness, back pain, hot flushes, malaise.
Very rare:
skin rash, jaundice, increased liver enzyme activity.
No effect of amlodipine on laboratory test results (potassium, glucose, triglycerides, total cholesterol, HDL cholesterol, uric acid, creatinine) has been found.
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.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 the medicine.

5. How to store Aldan

Keep the medicine out of the sight and reach of children.
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 that month.
Store in a temperature below 25°C.
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 Aldan contains

• The active substance is amlodipine in the form of amlodipine besylate. One tablet contains 5 mg or 10 mg of amlodipine in the form of amlodipine besylate.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose, magnesium stearate.

What Aldan looks like and contents of the pack

The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Phone: (24) 357 44 44

Date of last revision of the leaflet: