Aldan

Leaflet attached to the packaging: information for the user

ALDAN, 5 mg, tablets

ALDAN, 10 mg, tablets

Amlodipine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should 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, specifically 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, you should consult a doctor or pharmacist.
You should be particularly careful when taking Aldan:

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

You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Other medicines and Aldan

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

Aldan with food and drink

You should not drink grapefruit juice while taking this medicine, as it increases the concentration in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy unless clearly 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 this medicine, you should consult a doctor about the possibility of driving, operating machinery, and using hazardous tools.

Aldan contains sodium

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

3. How to take Aldan

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, 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.
The tablet should be swallowed 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, you should consult a doctor.
Taking Aldan in patients with liver function disorders
In patients with liver failure, a dose reduction is recommended.

Use in children

This 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, you should immediately consult a doctor or pharmacist.

Missing a 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, this medicine 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, decreased libido, 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, you should consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 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 this medicine.

5. How to store Aldan

The medicine should be stored out of 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Aldan contains

• The active substance of the medicine 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.
ul. Józefów 9
99-300 Kutno
Phone: (24) 357 44 44

Date of last revision of the leaflet: