Amlozek

Leaflet included in the packaging: patient information

Amlozek, 5 mg, tablets

Amlozek, 10 mg, tablets

Amlodipine
Read the leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leafletto be able to read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Amlozek and what is it used for
• 2. Important information before taking Amlozek
• 3. How to take Amlozek
• 4. Possible side effects
• 5. How to store Amlozek
• 6. Package contents and other information

1. What is Amlozek and what is it used for

Amlozek contains the active substance amlodipine, which belongs to a group of medicines called
calcium antagonists.
Amlozek is indicated for the treatment of high blood pressure (hypertension) or chest pain, known as angina pectoris, whose rare form is Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine dilates blood vessels, making it easier for blood to flow through them. In patients with coronary heart disease, Amlozek facilitates blood flow to the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not provide immediate relief from chest pain caused by angina pectoris.

2. Important information before taking Amlozek

When not to take Amlozek:

• if the patient is allergic to amlodipine or any other component of this medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include: itching, skin redness, or difficulty breathing,
• if the patient has very low blood pressure (hypotension),
• if the patient has a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body),
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Amlozek, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

• recent heart attack,
• heart failure,
• significant increase in blood pressure (hypertensive crisis),
• liver disease,
• need to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of Amlozek in children under 6 years of age.
Amlozek can only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain additional information, consult a doctor.

Amlozek and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Amlozek may interact with other medicines, and other medicines may interact with Amlozek. These include:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort,
• verapamil, diltiazem (medicines used to treat heart conditions),
• dantrolene (used in severe body temperature disorders),
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels),
• cyclosporin (an immunosuppressive medicine).

Amlozek may lower blood pressure more than other antihypertensive medicines.

Amlozek with food and drink

Patient taking Amlozek should not consume grapefruit juice or grapefruits while taking Amlozek, as they may cause an increase in the level of the active substance - amlodipine - in the blood, which may result in an unexpected increase in the effect of Amlozek, lowering blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor before taking this medicine.
Pregnancy
There is no data on the safety of amlodipine during pregnancy.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before starting to take Amlozek.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Amlozek may affect the ability to drive or operate machines. If the tablets cause dizziness, drowsiness, fatigue, or headache, do not drive or operate machines; consult a doctor immediately.

Amlozek contains sodium

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

3. How to take Amlozek

This medicine should always be taken as directed by a doctor. In case of doubts, consult a doctor.
Usually, the initial dose of Amlozek is 5 mg once a day. The dose may be increased to 10 mg once a day.
This medicine can be taken with or without food and drinks. It is recommended to take this medicine every day at the same time, with a glass of water. Do not take Amlozek with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years old), the usual initial dose is 2.5 mg once a day. The maximum recommended dose is 5 mg once a day. Amlozek 5 mg tablets can be divided into halves to obtain a 2.5 mg dose.
It is essential to take the tablets continuously. Do not wait until all the tablets have been used before visiting a doctor.

Taking more than the recommended dose of Amlozek

Taking too many tablets may cause a decrease in blood pressure, which can be dangerous. Dizziness, lightheadedness, fainting, or weakness may occur. If the decrease in blood pressure is significant, shock may occur. The skin may become cold and sweaty, and the patient may lose consciousness. If too many Amlozek tablets have been taken, consult a doctor or go to the emergency department of the nearest hospital immediately.

Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Amlozek

Stay calm. If a patient forgets to take a tablet, they should skip it. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Amlozek treatment

The doctor will inform the patient how long to take this medicine. If the patient stops taking this medicine before the doctor recommends, the disease may recur.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlozek can cause side effects, although not everybody gets them.
Immediatelyconsult a doctor if any of the following side effects occur after taking the medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, causing severe difficulty breathing.
• Severe skin reactions, including intense rash, hives, redness of the skin, intense itching, blisters, and peeling of the skin, as well as Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions.
• Heart attack, arrhythmias.
• Pancreatitis, which may cause severe abdominal pain radiating to the back, accompanied by a very poor general condition.

The following very common side effectshave been reported. If any of these side effects are troublesome for the patient or last for more than a week, they should consult a doctor.

Very common side effects: occurring in at least 1 in 10 patients

• Edema (fluid retention)

The following common side effectshave been reported. If any of these side effects are troublesome for the patient or last for more than a week, they should consult a doctor.

Common side effects: occurring in less than 1 in 10 patients but more than 1 in 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing of the face
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Edema of the ankles

Other reported side effects are listed below. If any of the side effects worsen or if any side effects not listed in the leaflet occur, consult a doctor or pharmacist.

Uncommon side effects: occurring in less than 1 in 100 patients but more than 1 in 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Dizziness, taste disturbances, fainting,
• Tingling or numbness of the extremities, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing and (or) runny nose caused by inflammation of the nasal mucosa (not a cold)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or enlargement of the breasts in men
• Pain, malaise
• Pain in the joints or muscles, back pain
• Weight gain or loss

Rare side effects: occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients

• Disorientation

Very rare side effects: occurring in less than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to the occurrence of atypical bruising and easier bleeding
• High blood sugar levels (hyperglycemia)
• Nerve disorders that can cause muscle weakness, tingling, or numbness
• Diarrhea
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, jaundice, increased liver enzyme activity, which can be detected in the results of some tests
• Increased muscle tone
• Vasculitis, often with a skin rash
• Photosensitivity
• A disorder involving stiffness, tremors, and (or) difficulty moving

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, consult a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Amlozek

Keep the medicine out of sight and reach of children.
Store in a dry place.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Amlozek contains

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

What Amlozek looks like and what the package contains

Amlozek, 5 mg, tablets: white tablets with the number "5" embossed on one side and a score line on the other side.
Amlozek, 10 mg, tablets: white tablets with the number "10" embossed on one side and a score line on the other side.
The package contains 30 or 60 tablets in PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of the last update of the leaflet: