Amlodipine

Package leaflet: Information for the patient

Amlomyl, 5 mg, tablets
Amlomyl, 10 mg, tablets
Amlodipine
Please read all of this leaflet carefully before taking this medicine because it
contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

CONTENTS OF THE LEAFLET:

1. What Amlomyl is and what it is used for
2. What you need to know 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 Amlomyl is and what it is 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 known as angina pectoris, including its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine dilates blood vessels, allowing blood to flow more easily. In patients with ischaemic heart disease, Amlomyl improves blood flow to the heart muscle by increasing oxygen supply, thereby helping to prevent chest pain. Amlomyl does not provide immediate relief from angina pain caused by ischaemic heart disease.
Consult your doctor if you do not feel better or if you feel worse.

2. Important information before using Amlomyl

When not to use Amlomyl

• if the patient has a known allergy to amlodipine or any of the other ingredients of this medicine listed in section 6, or to any other calcium antagonist
• if the patient has very low blood pressure (hypotension)
• if the patient has impaired blood outflow from the left ventricle of the heart (e.g. aortic valve stenosis)
• if the patient has heart failure following a previous heart attack
• in case of cardiogenic shock (a condition in which the heart cannot supply sufficient blood to the body)

Warnings and precautions
Before starting treatment with Amlomyl, consult your doctor or pharmacist if the patient:

• has heart failure
• has acute high blood pressure (hypertensive crisis)
• has liver disease

During treatment
Consult your doctor:

• if the patient is elderly and a dose increase is required, as special precautions should be taken when increasing the dose in elderly patients

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

Amlomyl with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to use.
Amlomyl may affect the action of other medicines, or other medicines may affect the action of Amlomyl:

• antifungal medicines (e.g. ketoconazole, itraconazole)
• protease inhibitors used in HIV treatment (e.g. ritonavir, indinavir, nelfinavir)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's wort (Hypericum perforatum)
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (an infusion used in severe disturbances of body temperature)
• simvastatin (a medicine used to lower cholesterol levels)
• tacrolimus, sirolimus, temsirolimus and everolimus (immunosuppressive medicines). Amlodipine may increase blood levels of these medicines
• cyclosporine (in patients who have undergone kidney transplantation and are taking this medicine), because amlodipine may affect blood levels of cyclosporine

Amlomyl may cause an enhanced reduction in blood pressure if the patient is taking other antihypertensive medicines.

Amlomyl with food and drink
Patients taking Amlomyl should not consume grapefruit juice or grapefruit, as these may increase blood concentrations of amlodipine, potentially leading to an unexpected increase in the blood pressure-lowering effect of Amlomyl.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The safety of amlodipine use during pregnancy has not been established.
It has been shown that amlodipine passes into human milk in small amounts. If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting treatment with this medicine. The doctor will decide whether amlodipine should be used only if the benefits outweigh the risks to the infant.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Amlomyl may affect the ability to drive and use machinery.
If tablets cause nausea, dizziness, fatigue or headache, the patient should not drive or operate machinery. These adverse effects may occur especially at the beginning of treatment.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to use Amlomyl

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended initial dose of Amlomyl is 5 mg once daily. The dose may be
increased to 10 mg once daily.
Amlomyl may be taken regardless of meals and drinks. It is recommended to take the medicine at the
same time each day, with water.

Patients with impaired liver function
The doctor may prescribe a lower dose and perform frequent monitoring if the patient suffers from
liver disease.

Use in children and adolescents
In children and adolescents (6–17 years of age), the usual recommended starting dose is 2.5 mg
once daily. The maximum recommended dose is 5 mg once daily.
Tablets may be divided into equal doses.
It is important to take the tablets continuously. Do not wait until all tablets are used up before visiting
the doctor.

Taking more Amlomyl than recommended
Taking too many tablets may cause a reduction or even dangerous lowering of blood pressure.
Dizziness, a feeling of emptiness in the head, fainting, weakness, or sudden palpitations may occur.
If blood pressure drops too sharply, shock may develop. The skin may become cold and clammy, and fainting may also occur.
Up to 24–48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).
In case of overdose with amlodipine tablets, seek immediate medical help.

Missing a dose of Amlomyl
Stay calm. If a dose is missed, skip that dose and take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping Amlomyl treatment
The doctor will inform the patient about the duration of treatment with this medicine.
If the patient stops taking the medicine before advised by the doctor, the condition may recur.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur after taking the medicine, stop using the medicine immediately and contact your doctor or go to the emergency department of the nearest hospital.

• Swelling of the eyelids, lips, tongue or throat causing severe breathing or swallowing difficulties
• Severe skin reactions including intense rash, hives, generalized redness of the skin, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular or abnormal heartbeat, rapid heartbeat
• Pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition
• Yellowing of the skin or eyes, pale stools, dark urine or abdominal pain (these may be symptoms of liver dysfunction such as hepatitis or jaundice)
• Difficulty speaking and swallowing, balance disturbances, facial muscle stiffness (so-called mask-like face), shuffling gait, stiffness of arms and legs, hand and finger tremors (extrapyramidal syndrome)

Other possible adverse reactions:
Very common (may occur in more than 1 in 10 people)

• Swelling due to fluid retention

Common (may occur in 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, nausea, changes in bowel habits including diarrhoea, constipation, indigestion
• Ankle swelling, fatigue, unusual weakness
• Visual disturbances, including double vision
• Shortness of breath, muscle cramps

Uncommon (may occur in 1 in 100 people)

• Mood changes (including anxiety, depressed mood), insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, reduced sensation
• Tinnitus
• Slowed heart rate
• Low blood pressure
• Sneezing/runny nose due to nasal mucosal inflammation (rhinitis), cough
• Dry mouth, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration, rash and hives, purple spots on the skin
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or breast enlargement in men
• Pain, chest pain, malaise
• Joint or muscle pain, back pain
• Increase or decrease in body weight

Rare (may occur in 1 in 1,000 people)

• Disorientation

Very rare (may occur in fewer than 1 in 10,000 people)

• Increased incidence of infections and fever, sore throat, oral ulcers (due to decreased white blood cell count), unusual bruising and easier bleeding (due to decreased platelet count)
• High blood glucose levels (hyperglycaemia)
• Nerve disorders which may cause weakness, tingling or numbness
• Gum swelling
• Bleeding gums
• Abdominal bloating (gastritis)
• Increased liver enzyme levels associated with impaired function, e.g. bile duct obstruction
• Measles-like skin rash, possibly associated with high fever and joint pain (erythema multiforme)
• Skin peeling over large areas of the body
• Inflammation of blood vessels, often with skin rash
• Skin photosensitivity
• Disorders involving stiffness, tremors and/or movement difficulties

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Amlomyl

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or
blister pack after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Do not use this medicine if there is any change in the colour of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Amlomyl contains

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

What Amlomyl looks like and contents of the pack
Amlomyl 5 mg tablets are white, round, biconvex tablets with "5" embossed on one side and a score line on the other. The tablets may be divided into two equal parts.
Amlomyl 10 mg tablets are white, round, biconvex tablets with "10" embossed on one side and a score line on the other. The tablets may be divided into two equal parts.
Amlomyl tablets are packed in blisters containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 180 tablets per pack.
Amlomyl tablets are also packed in bottles containing 28, 30, 56, 100, 180, 500 tablets per pack.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product and its brand names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00