Apoamlo

Patient Information Leaflet

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

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

Table of contents

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

1. What ApoAmlo is and what it is used for

ApoAmlo contains the active substance amlodipine, which belongs to a group of medicines known as calcium channel blockers.
ApoAmlo is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina pectoris, including a less common form called vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, this medicine dilates blood vessels, thereby improving blood flow. In patients with angina, ApoAmlo improves blood flow to the heart muscle, increasing the oxygen supply, which helps prevent chest pain. This medicine does not provide immediate relief of angina pain.

2. Important information before taking ApoAmlo

When not to take ApoAmlo

• if the patient is allergic (hypersensitive) to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist – symptoms 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 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 heart attack.

Warnings and precautions
Before starting treatment with ApoAmlo, consult a doctor or pharmacist if the patient has or has had any of the following conditions:

• Recent heart attack.
• 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 ApoAmlo in children under 6 years of age have not been conducted.
ApoAmlo may only be used for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult a doctor.

ApoAmlo and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
ApoAmlo may affect the action of other medicines or other medicines may affect the action of ApoAmlo. Such medicines include:

• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV);
• rifampicin, erythromycin, clarithromycin (used in bacterial infections or antibiotics);
• St John's wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used for heart conditions);
• dantrolene (used intravenously in severe disturbances of 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).

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

ApoAmlo with food and drink
Patients taking ApoAmlo should not consume grapefruit juice or grapefruits, as they may increase the concentration of the active substance, amlodipine, in the blood, which could lead to unpredictable intensification of the blood pressure-lowering effect of ApoAmlo.

Pregnancy and breast-feeding
Pregnancy
The safety of amlodipine use in pregnant women has not been established. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Breast-feeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breast-feeding or planning to breast-feed, she should consult her doctor before using this medicine.
Before taking any medicine, consult a doctor or pharmacist.

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

ApoAmlo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take ApoAmlo

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended initial dose of ApoAmlo is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.
This medicine may be taken before or after meals and drinks. The medicine should be taken every day at the same time, with water. Do not take ApoAmlo with grapefruit juice.

Use in children and adolescents
In children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
ApoAmlo 2.5 mg tablets are currently not available, and a 2.5 mg dose cannot be obtained from ApoAmlo 5 mg tablets, because these tablets are not manufactured in a way that allows them to be split in half.

It is important to take the tablets regularly. Do not delay taking the tablets until your next doctor's appointment.

Taking more ApoAmlo than prescribed
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. In case of a significant drop in blood pressure, shock may develop. The skin then becomes cold and clammy, and the patient may lose consciousness. If too many ApoAmlo tablets have been taken, contact a doctor immediately or go to the emergency department of the nearest hospital.

Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary oedema) may occur up to 24–48 hours after taking the medicine.

If you miss a dose of ApoAmlo
Stay calm. If a dose is missed, skip that dose. Take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping ApoAmlo treatment
Your doctor will advise you on how long you should take this medicine. If you stop taking this medicine before your doctor advises, your condition may return.

If you have any further doubts about 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 experiences them.
If any of the following adverse reactions occur after taking the medicine,
you should contact your doctor immediately.

• 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 intense rash, urticaria, generalized redness of the skin, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, cardiac arrhythmias
• 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

• Swelling (fluid retention)

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), sudden flushing, particularly of the face
• Abdominal pain, nausea
• Changes in bowel rhythm, 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
reactions worsen or if any adverse reactions not listed in this leaflet occur,
you should 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/runny nose caused by 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 the appearance of unusual bruising or easy bleeding
• Increased blood glucose levels (hyperglycaemia)
• Nerve disorders, which may cause muscle weakness, tingling or numbness
• Gum swelling
• Abdominal bloating (gastritis)
• Liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain test results
• Increased muscle tension
• Vasculitis, often with skin rash
• Photosensitivity
• A disorder involving stiffness, tremor and/or difficulty moving

Frequency unknown (frequency cannot be estimated from available data): tremor,
rigid posture, mask-like face, slow movements and shuffling gait, unsteady gait.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse
reactions can be reported directly to the Department of Monitoring Adverse
Reactions of Medicinal Products at 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 responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store ApoAmlo

Keep this medicine out of the sight and reach of children.
There are no special requirements for the storage of this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ApoAmlo contains

• The active substance is amlodipine, in the form of amlodipine besilate. Each tablet contains amlodipine besilate equivalent to 5 mg or 10 mg of amlodipine.
• Other ingredients: microcrystalline cellulose (PH-112), microcrystalline cellulose (PH-101), calcium hydrogen phosphate, sodium carboxymethyl starch (Type A), magnesium stearate.

What ApoAmlo looks like and contents of the pack
ApoAmlo 5 mg tablets:
White or almost white, flat, bevel-edged, barrel-shaped tablets,
with the imprint "C" on one side and "58" on the other. Tablet size: 7.9 mm by 5.6 mm.
ApoAmlo 10 mg tablets:
White or almost white, flat, round tablets (9.5 mm in diameter) with bevelled edges,
with the imprint "C" on one side and "59" on the other.
ApoAmlo tablets are available in PVC/PVDC/Aluminium blisters, packed in cardboard cartons.
Pack sizes:
Blisters containing:
20, 28, 30, 56, 60, 98 and 100 tablets in blister packs within cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland

Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area under the following names:
Belgium: Amlodipin AB 5 mg/10 mg tabletten
Czech Republic: Amlodipin Aurovitas 5 mg/10 mg tablety
Poland: ApoAmlo
Portugal: Amlodipina Aurovitas
Spain: Amlodipino Aurovitas 5 mg/10 mg comprimidos EFG