AMLOMYL 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Amlomyl, 5 mg, Tablets
3. Amlomyl, 10 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. CONTENTS OF THE PACKAGE LEAFLET:
4. What is Amlomyl and what is it used for
5. Important information before taking Amlomyl
   1. When not to take Amlomyl
   2. Warnings and precautions
   3. Children and adolescents
   4. Amlomyl with other medicines
   5. Amlomyl with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Amlomyl
   1. Use in children and adolescents
   2. Taking too much Amlomyl
   3. Missing a dose of Amlomyl
   4. Stopping treatment with Amlomyl
7. Possible side effects
   1. If you experience any of the following side effects, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital.
   2. Reporting side effects
8. How to store Amlomyl
9. Contents of the pack and other information
   1. What Amlomyl contains
   2. What Amlomyl looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Mylan Healthcare Sp. z o.o.
   7. Date of last revision of the leaflet: 07/2022

Package Leaflet: Information for the Patient

Amlomyl, 5 mg, Tablets

Amlomyl, 10 mg, Tablets

Amlodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

CONTENTS OF THE PACKAGE 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 used to treat high blood pressure (hypertension) or chest pain (angina pectoris) and its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine works by relaxing blood vessels, so that blood can pass through them more easily.
In patients with angina, Amlomyl improves blood supply to the heart, reducing the amount of oxygen it needs, and thus preventing chest pain. The medicine does not provide immediate relief from chest pain due to angina.
If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Amlomyl

When not to take Amlomyl

Warnings and precautions

Before taking Amlomyl, talk to your doctor or pharmacist if you have or have had:

• heart failure
• a recent heart attack
• severe increase in blood pressure (hypertensive crisis)
• liver disease

During treatment
Tell your doctor if:

• you are elderly and your dose needs to be increased, as extra caution is needed when increasing the dose in the elderly

Children and adolescents

Amlomyl has not been studied in children under 6 years old. Amlomyl can be used in children and adolescents from 6 to 17 years old (see section 3).
For more information, consult your doctor.

Amlomyl with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
Amlomyl may affect other medicines or other medicines may affect Amlomyl:

• antifungal medicines (e.g. ketoconazole, itraconazole)
• certain HIV medicines (e.g. ritonavir, indinavir, nelfinavir)
• antibiotics (e.g. rifampicin, erythromycin, clarithromycin)
• St. John's Wort
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion used to treat severe disturbances of body temperature)
• simvastatin (a medicine used to lower cholesterol)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that alter the immune system's response). 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 levels of this medicine in the blood

Amlomyl may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure.

Amlomyl with food and drink

Patients taking Amlomyl should not eat grapefruit or drink grapefruit juice, as it may increase the levels of the active substance amlodipine in the blood, resulting in an unpredictable increase in the blood pressure-lowering effect of Amlomyl.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of amlodipine in pregnant women has not been established.
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, tell your doctor before taking Amlomyl. Your doctor will decide whether you can take Amlomyl during breastfeeding, if the benefits are greater than the risks for the baby.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Amlomyl may affect your ability to drive or use machines.
If you experience dizziness, headache, fatigue, or nausea, do not drive or use machines. These side effects are more likely to occur at the start of treatment.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Amlomyl

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Amlomyl is 5 mg once daily. The dose may be increased to 10 mg once daily.
The medicine can be taken with or without food and drink. It is recommended to take the medicine at the same time each day, with a glass of water.
Patients with liver problems
Your doctor may prescribe a lower dose and monitor you more closely if you have liver disease.

Use in children and adolescents

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

Taking too much Amlomyl

Taking too many tablets may cause a severe drop in blood pressure. This can lead to dizziness, lightheadedness, fainting, weakness, or a rapid heartbeat. If the blood pressure drop is too severe, it can cause shock. The skin may become cool and clammy, and fainting may occur. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid in the lungs (pulmonary edema) may occur. If you have taken too many amlodipine tablets, seek medical help immediately.

Missing a dose of Amlomyl

Stay calm. If you forget to take a tablet, skip it. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Amlomyl

Your doctor will tell you how long to take the medicine. If you stop taking the medicine before your doctor tells you to, your condition may get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital.

• Swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and skin rash, or other allergic reactions
• Heart attack, irregular heartbeat, or rapid heartbeat
• Pancreatitis, which may cause severe abdominal and back pain with very severe illness
• Yellowing of the skin or eyes, pale stools, dark urine, or abdominal pain (these may be signs of liver problems, such as hepatitis or jaundice)
• Difficulty speaking and swallowing, balance disorders, stiffness of facial muscles (mask-like face), dragging of the feet when 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)

• swelling caused by fluid retention

Common(may affect up to 1 in 10 people)

• headache, dizziness, sleepiness (especially at the start 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
• vision disturbances, including double vision
• shortness of breath, muscle cramps

Uncommon(may affect up to 1 in 100 people)

• mood changes (including anxiety, depression), insomnia
• trembling, taste disturbances, fainting
• numbness or tingling of the limbs, decreased sensitivity
• ringing in the ears
• slow heartbeat
• low blood pressure
• runny or stuffy nose (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, feeling unwell
• joint or muscle pain, back pain
• weight gain or loss

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

• confusion

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

• increased risk of infection and fever, sore throat, mouth ulcers (due to a decrease in white blood cells), unusual bruising or bleeding (due to a decrease in platelets)
• high blood sugar (hyperglycemia)
• nerve disorders that may cause weakness, numbness, or tingling
• gum overgrowth
• bleeding gums
• stomach upset (gastritis)
• increased liver enzymes, which may indicate abnormal liver function, e.g. due to bile duct obstruction
• a skin rash that looks like measles, which may be accompanied by high fever and joint pain (erythema multiforme)
• peeling of the skin on large areas of the body
• inflammation of blood vessels, often with skin rash
• sensitivity to light
• disorders that include stiffness, trembling, and (or) movement problems

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlomyl

Keep the medicine out of the 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 that month.
Store in the original package to protect from light.
Do not use this medicine if the tablets change color.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 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 side. 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 side. 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
For more information on this medicine and its authorized names in 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