Amlomil

Leaflet accompanying the packaging: patient information

Amlomyl, 5 mg, tablets

Amlomyl, 10 mg, tablets

Amlodipine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

TABLE OF CONTENTS OF THE LEAFLET:

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

1. What is Amlomyl and what is it used for

Amlomyl contains amlodipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists).
Amlomyl is indicated for the treatment of high blood pressure (hypertension) or chest pain called angina pectoris and its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine widens the blood vessels so that blood can flow more easily.
In patients with coronary heart disease, Amlomyl makes it easier for blood to reach the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
The medicine does not provide immediate relief from chest pain caused by coronary heart disease.
Consult a doctor if the patient does not feel better or feels worse.

2. Important information before taking Amlomyl

When not to take Amlomyl

• if the patient is allergic to amlodipine or any of the other ingredients of this medicine listed in section 6 or to any other calcium channel blocker
• if the patient has very low blood pressure (hypotension)
• if the patient has obstruction of the outflow of blood from the left ventricle of the heart (e.g. the patient has aortic stenosis)
• if the patient has heart failure after a heart attack
• in case of cardiogenic shock (a condition in which the heart is unable to deliver enough blood to the body)

Warnings and precautions

Before starting treatment with Amlomyl, discuss it with your doctor or pharmacist if the patient has or has had:

• Heart failure
• Sudden increase in blood pressure (hypertensive crisis)
• Liver disease

During treatment
Consult a doctor

• if the patient is elderly and the dose of the medicine needs to be increased, as special precautions are required when increasing the dose in elderly patients

Children and adolescents

No studies have been conducted on the use of Amlomyl in children under 6 years of age. Amlomyl should be used in hypertension in children and adolescents from 6 to 17 years of age (see section 3).
For further information, consult a doctor.

Amlomyl and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Amlomyl may interact with other medicines or other medicines may interact with Amlomyl:

• antifungal medicines (e.g. ketoconazole, itraconazole)
• so-called protease inhibitors used in the treatment of HIV (e.g. ritonavir, indinavir, nelfinavir)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used in heart diseases)
• dantrolene (infusion used in severe body temperature disorders)
• simvastatin (a medicine used to lower cholesterol levels)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that affect the immune system). Amlodipine may increase the levels of these medicines in the blood
• cyclosporin (in patients who have had a kidney transplant and are taking this medicine), as amlodipine may affect the level of this medicine in the blood

Amlomyl may enhance the blood pressure-lowering effect of other antihypertensive medicines.

Amlomyl with food and drink

Patients taking Amlomyl should not consume grapefruit juice or grapefruits, as they may increase the levels of active amlodipine ingredients in the blood, which may result in an unexpected increase in the blood pressure-lowering effect of Amlomyl.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
The safety of amlodipine in pregnant women has not been established.
Amlodipine has been shown to pass into human milk in small amounts. If the patient is breastfeeding or plans to start breastfeeding, she should inform her doctor before starting treatment with this medicine. The doctor will recommend taking amlodipine only if the benefits of treatment outweigh the risks to the baby.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Amlomyl may affect the ability to drive and use machines.
If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or operate machinery. These side effects may occur especially at the beginning of treatment.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Amlomyl

Take this medicine always as directed by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist
The recommended initial dose of Amlomyl is 5 mg once a day. The dose may be increased to 10 mg once a day.
The medicine can be taken with or without food and drinks. It is recommended to take the medicine at the same time every day, with a glass of water.
Patient with liver function disorders
The doctor may prescribe a lower dose and perform frequent checks if the patient has liver disease.

Use in children and adolescents

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

Taking a higher dose of Amlomyl than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. Dizziness, lightheadedness, fainting, weakness, or rapid heartbeat may occur. If the blood pressure drop is too sharp, shock may occur. The skin may become cool and moist, and fainting may also occur. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur. If too many amlodipine tablets have been taken, seek medical help immediately.

Missing a dose of Amlomyl

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

Stopping treatment with Amlomyl

The doctor will inform the patient about the duration of treatment with Amlomyl. If the patient stops taking the medicine before the doctor recommends it, the disease may recur.
In case of any further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlomyl can cause side effects, although not everybody gets them.

If any of the following side effects occur after taking the medicine, stop taking the medicine and contact a doctor or go to the emergency department of the nearest hospital.

• Swelling of the eyelids, lips, tongue, or throat, causing difficulty breathing or swallowing
• Severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blisters, peeling, and skin swelling, inflammation of the mucous membrane (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular or abnormal heartbeat, rapid heartbeat
• Pancreatitis, which can cause severe abdominal and back pain with very poor general condition
• Yellowing of the skin or eyes, pale stools, dark urine, or abdominal pain (These may be symptoms of liver function disorders, such as hepatitis or jaundice)
• Difficulty speaking and swallowing, balance disorders, stiffness of facial muscles (so-called mask-like face), dragging of the feet while walking, stiffness of the arms and legs, trembling of the hands and fingers (extrapyramidal syndrome)

Other possible side effects:
Very common(may affect more than 1 in 10 people)

• Edema caused by fluid retention

Common(may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Rapid heartbeat (awareness of heartbeat), flushing
• Abdominal pain, nausea, changes in bowel movements, including diarrhea, constipation, indigestion
• Swelling of the ankles, fatigue, unusual weakness
• Visual disturbances, including double vision
• Shortness of breath, muscle cramps

Uncommon(may affect up to 1 in 100 people)

• Mood changes (including anxiety, depression), insomnia
• Tremors, taste disorders, fainting
• Numbness or tingling of the limbs, decreased sensation
• Ringing in the ears
• Slow heartbeat
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis), cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration, rash, and hives
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort, or enlargement of the breasts in men
• Pain, chest pain, poor general condition
• Joint or muscle pain, back pain
• Weight gain or loss

Rare(may affect up to 1 in 1,000 people)

• Disorientation

Very rare(may affect less than 1 in 10,000 people)

• Increased incidence of infections and fever, sore throat, mouth ulcers (due to a decrease in the number of white blood cells), unusual bruising, and bleeding (due to a decrease in the number of platelets)
• High blood sugar levels (hyperglycemia)
• Nerve disorders that can cause weakness, numbness, or tingling
• Gingival swelling
• Gingival bleeding
• Abdominal bloating (gastritis)
• Increased liver enzyme levels associated with abnormal liver function, e.g. bile duct obstruction
• A skin rash resembling measles, which may be associated with high fever and joint pain (erythema multiforme)
• Peeling of the skin on large areas of the body
• Vasculitis, often with skin rash
• Skin sensitivity to light
• Disorders including stiffness, tremors, and/or movement problems

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell a doctor or pharmacist. Side 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
Phone: +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 will help gather more information on the safety of the medicine.

5. How to store Amlomyl

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or bottle after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Do not use this medicine if the tablets have changed color.
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. Contents of the pack and other information

What Amlomyl contains

• The active substance is amlodipine.
• One tablet contains 5 mg or 10 mg of amlodipine (in the form of amlodipine besylate).
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate.

What Amlomyl looks like and contents of the pack

Amlomyl, 5 mg, tablets are white, round, biconvex tablets with "5" engraved on one side and a score line on the other. The tablets can be divided into two equal halves.
Amlomyl, 10 mg, tablets are white, round, biconvex tablets with "10" engraved on one side and a score line on the other. The tablets can be divided into two equal halves.
Amlomyl, tablets are packaged in blisters containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 180 tablets per pack.
Amlomyl, tablets are packaged in bottles containing 28, 30, 56, 100, 180, 500 tablets per pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary
Mylan BV
Dieselweg 25
3752 LB Bunschoten
Netherlands
Mylan UK Healthcare Limited
Building 20
Station Close
Potters Bar, EN6 1TL
United Kingdom
To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: 07/2022