Amlozek

Leaflet included in the packaging: patient information

Amlozek, 5 mg, tablets

Amlozek, 10 mg, tablets

Amlodipine
You should carefully 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific person. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform 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 undesirable 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:

Warnings and precautions

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

• recently experienced a 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, you should contact your doctor.

Amlozek and other medicines

You should 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 temperature regulation 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

Patients 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 their 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 their 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 inform their doctor before starting to take Amlozek.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and operating machinery

Amlozek may affect your ability to drive or operate machinery. If the tablets cause dizziness, drowsiness, fatigue, or headache, you should not drive or operate machinery; you should contact your 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 according to the doctor's instructions. In case of doubts, you should consult your doctor.
The usual starting 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. You should not take Amlozek with grapefruit juice.

Use in children and adolescents

In children and adolescents (aged 6-17), the usual starting 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. You should not wait until all the tablets have been used before visiting your doctor.

Taking a higher dose of Amlozek than recommended

Taking too many tablets may cause a decrease in blood pressure, and even a dangerous decrease in blood pressure. Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. If the decrease in blood pressure is very significant, cardiogenic shock may occur. The skin may become cold and wet, and the patient may lose consciousness. If you have taken too many Amlozek tablets, you should contact your 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

You should stay calm. If you forget to take a tablet, you should skip it. You should take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping Amlozek treatment

Your doctor will inform you how long you should take this medicine. If you stop taking this medicine before your doctor recommends it, your condition may worsen.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following undesirable effects 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 strong rash, hives, skin redness, severe itching, blistering, and peeling of the skin, as well as Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions.
• Heart attack, arrhythmias.
• Pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition.

The following very common undesirable effects have been reported.If any of the undesirable effects are troublesome for the patient or last for more than a week, they should contact their doctor.

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

• Edema (fluid retention)

The following common undesirable effects have been reported.If any of the undesirable effects are troublesome for the patient or last for more than a week, they should contact their doctor.

Common undesirable 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), facial flushing
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Edema of the ankles

Other reported undesirable effects are listed below.If any of the undesirable effects worsen or if any undesirable effects not mentioned in the leaflet occur, you should inform your doctor or pharmacist.

Uncommon undesirable 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, lack of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing and (or) runny nose caused by inflammation of the nasal mucosa (non-allergic rhinitis)
• 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
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or breast enlargement in men
• Pain, malaise
• Joint or muscle pain, back pain
• Weight gain or loss

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

• Disorientation

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

• Decreased white blood cell count, decreased platelet count, which can lead to the occurrence of unusual 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 skin rash
• Sensitivity to light
• A disorder involving stiffness, tremors, and (or) difficulty moving

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, you should inform your doctor, pharmacist, or nurse.Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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.Undesirable effects can also be reported to the marketing authorization holder.Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Amlozek

The medicine should be stored 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. You should ask your 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 Amlozek is amlodipine in the form of amlodipine besylate. Each tablet contains 5 mg or 10 mg of amlodipine in the form of amlodipine besylate.
• The 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 dividing line on the other side.
Amlozek, 10 mg, tablets: white tablets with the number "10" embossed on one side and a dividing 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 marketed.

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 last revision of the leaflet: