Amlozek

Package leaflet: Information for the patient

Amlozek, 5 mg, tablets
Amlozek, 10 mg, tablets
Amlodipine
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Amlozek is and what it is used for

Amlozek contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlozek is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina pectoris, including the rare form called 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 ischemic heart disease, Amlozek improves blood flow to the heart muscle by increasing the amount of oxygen delivered, thereby preventing chest pain. This medicine does not provide immediate relief of angina-induced chest pain.

2. Information before using Amlozek

When Amlozek must not be used:

• if the patient is allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include: itching, redness of the skin or difficulty in breathing,
• if the patient has very low blood pressure (hypotension),
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body),
• if the patient has heart failure following a myocardial infarction.

Warnings and precautions
Before starting treatment with Amlozek, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has ever had any of the following conditions:

• recent myocardial infarction,
• heart failure,
• severe increase in blood pressure (hypertensive crisis),
• liver disease,
• need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Amlozek in children under 6 years of age have not been conducted.
Amlozek may only be used for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
For additional information, please consult your doctor.

Amlozek and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Amlozek may interact with other medicines, and other medicines may interact with Amlozek. These include:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV infection),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St John's wort (Hypericum perforatum),
• verapamil, diltiazem (medicines used for heart conditions),
• dantrolene (used intravenously in cases of severe disturbances in body temperature),
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines that suppress the patient's immune system),
• simvastatin (a medicine that lowers cholesterol levels),
• cyclosporine (an immunosuppressive medicine).

Amlozek may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.

Amlozek with food and drink
Patients taking Amlozek should not consume grapefruit juice or grapefruits during treatment with Amlozek, as they may increase the blood concentration of the active substance – amlodipine – which could lead to an unexpected intensification of the blood pressure-lowering effect of Amlozek.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Pregnancy
There are no data available on the safety of amlodipine use during pregnancy.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting treatment with Amlozek.

Before using any medicine, consult your doctor or pharmacist.

Driving and using machines
Amlozek may affect the ability to drive or operate machinery. If the tablets cause nausea, dizziness, fatigue or headache, the patient should not drive or operate machinery and should contact the doctor immediately.

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

3. How to use Amlozek

This medicine should always be taken as directed by your doctor. If in doubt, consult your
doctor.
The usual starting dose of Amlozek is 5 mg once daily. The dose may be increased to
10 mg once daily.
This medicine may be taken regardless of meals and drinks. It is recommended to take this medicine at the same time every day, with water. Do not take Amlozek with grapefruit juice.
Use in children and adolescents
In children and adolescents (aged 6–17 years), the usual starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day. Amlozek 5 mg tablets may be divided in half
to achieve a 2.5 mg dose.
It is important to take the tablets continuously. Do not wait until all tablets are used up before
visiting your doctor.
Taking more than the recommended dose of Amlozek
Taking too many tablets may cause a drop in blood pressure, even to dangerously low levels.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. If the drop in blood
pressure is very severe, shock may develop. The skin may become cold and moist, and the patient
may lose consciousness. If an overdose of Amlozek has been taken, contact your doctor immediately
or go to the emergency department of the nearest hospital.
Shortness of breath due to fluid accumulation in the lungs (pulmonary edema) may occur even up to 24–48 hours after taking the medicine.
Missed dose of Amlozek
Stay calm. If a patient forgets to take a tablet, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping the use of Amlozek
Your doctor will inform you how long you should take this medicine. If you stop taking this medicine before your doctor advises, your condition may recur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.
You should contact your doctor immediately if any of the following adverse reactions 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 significant breathing difficulties.
• Severe skin reactions, including severe rash, hives, redness of the entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, heart rhythm disorders.
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

The following very common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or last longer than one week, you should contact your doctor.
Very common adverse reactions: occurring in at least 1 out of 10 patients

• Fluid retention (oedema)

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or last longer than one week, you should contact your doctor.
Common adverse reactions: occurring in less than 1 out of 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), facial flushing
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

Other reported adverse reactions are listed below. If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse reactions: occurring in less than 1 out of 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Tingling or numbness in the limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing and/or nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, 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
• Joint or muscle pain, back pain
• Increase or decrease in body weight

Rare adverse reactions: occurring in less than 1 out of 1,000 patients

• Disorientation

Very rare adverse reactions: occurring in less than 1 out of 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and easier bleeding
• High blood glucose levels (hyperglycaemia)
• Nerve-related disorders which may cause muscle weakness, tingling or numbness
• Gum swelling
• Abdominal bloating (gastritis)
• Liver dysfunction, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detectable in certain blood tests
• Increased muscle tension
• Vasculitis, often with skin rash
• Photosensitivity
• A condition involving stiffness, tremors and/or difficulty moving

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Amlozek

Keep this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Amlozek contains

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

What Amlozek looks like and contents of the pack
Amlozek 5 mg tablets: white tablets with the number "5" embossed on one side and a division line on the other side.
Amlozek 10 mg tablets: white tablets with the number "10" embossed on one side and a division line on the other side.
Packaging contains 30 or 60 tablets in PVC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńsków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
Pieńsków, ul. M. Adamkiewicza 6A
05-152 Czosnów