Aldan
Poland
Table of Contents
Package leaflet: Information for the user
ALDAN, 5 mg, tablets
ALDAN, 10 mg, tablets
Amlodipine
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual. Do not share it with others.
- This medicine may harm another person, even if their symptoms are the same.
- If any of the side effects worsen or if any new side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Table of contents:
- What Aldan is and what it is used for
- Important information before taking Aldan
- How to take Aldan
- Possible side effects
- How to store Aldan
- Contents of the pack and other information
1. What Aldan is and what it is used for
Aldan belongs to a group of medicines called calcium channel blockers, specifically dihydropyridine derivatives.
It is used to treat essential hypertension, stable angina pectoris, and vasospastic angina (Prinzmetal's angina).
2. Important information before using Aldan
When not to use Aldan:
- if the patient is allergic to amlodipine, other dihydropyridine derivatives, or any of the other ingredients of this medicine (listed in section 6);
- if the patient has hypotension;
- if the patient has clinically significant aortic valve stenosis;
- if the patient has cardiogenic shock;
- if the patient has unstable angina, except for vasospastic angina (Prinzmetal's variant).
Warnings and precautions
Before starting treatment with Aldan, consult a doctor or pharmacist.
Exercise special caution when using Aldan:
- if aortic stenosis is present and the patient is taking other antihypertensive medicines: administration of the medicine may lead to excessive reduction in arterial blood pressure;
- in patients with impaired liver function: the doctor may recommend a reduced dose;
- in elderly patients: the doctor may recommend a lower starting dose, which may then be gradually increased;
- in patients with severe circulatory failure.
Consult a doctor, even if the above warnings refer to conditions that occurred in the past.
Other medicines and Aldan
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
Aldan with food and drink
Do not take Aldan with grapefruit juice, as it increases plasma concentrations.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Aldan must not be used during pregnancy unless absolutely necessary.
Breastfeeding is recommended to be discontinued during treatment with Aldan.
It is unknown whether amlodipine is excreted in human milk.
Driving and operating machinery
Aldan may cause drowsiness and dizziness, especially at the beginning of treatment. When starting treatment, consult a doctor regarding the ability to drive, operate machinery, or use dangerous tools.
Aldan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free."
3. How to use Aldan
This medicine should always be used exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist.
Arterial hypertension
The usual recommended 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 an adequate 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.
Use of Aldan in patients with impaired liver function
In patients with hepatic insufficiency, a reduced dose is recommended.
Use in children
This medicine is intended for use in individuals over 18 years of age.
Taking more Aldan than recommended
A significant drop in blood pressure with an increased heart rate may occur.
Overdose may also be asymptomatic. If you have taken more than the recommended dose, seek immediate medical advice from your doctor or pharmacist.
Missing a dose of Aldan
If you miss a dose on any given day, do not take a double dose the next day.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The medicine, when used at a dose up to 10 mg per day, is usually well tolerated, and adverse effects
may be mild or moderate.
The adverse effects listed below have been classified according to system organ classes and frequency of occurrence.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000, including single cases).
Common:
oedema (10.8%), headache (7.3%), feeling of fatigue (4.5%), palpitations (4.5%), dizziness (3.4%), nausea (2.9%), facial flushing (2.6%), abdominal pain (1.6%), somnolence (1.4%). Adverse effects were the reason for discontinuation of the medicine in 1.5% of patients.
Uncommon:
tachycardia, bradycardia, atrial fibrillation/flutter (very rapid contractions), chest pain, hypotension, paraesthesia, convulsions, peripheral neuropathy, constipation, dyspepsia, diarrhoea, vomiting, gingival hyperplasia, pancreatitis, joint pain, muscle cramps, muscle pain, libido disorder, depression, nervousness, sleep disorders, urinary incontinence, lip tremor, general weakness, back pain, hot flushes, malaise.
Very rare:
skin rashes, jaundice, increased liver enzyme activity.
No influence of amlodipine on laboratory test results (potassium, glucose, triglycerides, total cholesterol, HDL cholesterol, uric acid, creatinine) has been observed.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Aldan
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the specified month.
Store below 25 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the package and other information
What Aldan contains
- The active substance is amlodipine in the form of amlodipine besilate. One tablet contains 5 mg or 10 mg of amlodipine as amlodipine besilate.
- Other components are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch, magnesium stearate.
What Aldan looks like and contents of the pack
Pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: (24) 357 44 44