Apoamlo

Package Leaflet: Information for the User

ApoAmlo, 5 mg, tablets

ApoAmlo, 10 mg, tablets

Amlodipine
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is ApoAmlo and what is it 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 is ApoAmlo and what is it used for

ApoAmlo contains the active substance amlodipine, which belongs to a group of medicines called
calcium antagonists.
ApoAmlo is indicated for the treatment of high blood pressure (hypertension) or chest pain (angina pectoris),
including a rare form of angina pectoris called Prinzmetal's angina.
In patients with high blood pressure, this medicine widens the blood vessels, making it easier for blood to flow.
In patients with angina pectoris, ApoAmlo improves blood flow to the heart muscle, increasing the supply of oxygen,
which helps to prevent chest pain. This medicine does not provide immediate relief from angina attacks.

2. Important information before taking ApoAmlo

When not to take ApoAmlo

• If you are allergic (hypersensitive) to amlodipine or 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 breathing;
• If you have very low blood pressure (hypotension);
• If you have narrowing of the aortic valve or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body);
• If you have heart failure after a heart attack.

Warnings and precautions

Before starting to take ApoAmlo, you should discuss it with your doctor or pharmacist if you have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• Significant increase in blood pressure (hypertensive crisis).
• Liver disease.
• Necessity to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of ApoAmlo in children under 6 years of age.
ApoAmlo can only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3).
For further information, you should consult your doctor.

ApoAmlo and other medicines

You should tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
ApoAmlo may interact with other medicines or other medicines may interact with ApoAmlo. Such medicines include:

• Ketoconazole, itraconazole (antifungal medicines);
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV);
• Rifampicin, erythromycin, clarithromycin (used to treat bacterial infections or antibiotics);
• St. John's Wort;
• Verapamil, diltiazem (medicines used to treat heart conditions);
• Dantrolene (used 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);
• Cyclosporin (an immunosuppressive medicine).

ApoAmlo may lower blood pressure more than other blood pressure medicines.

ApoAmlo with food and drink

Patients taking ApoAmlo should not drink grapefruit juice or eat grapefruits, as they may increase the levels of the active substance, amlodipine, in the blood, which may lead to unpredictable increases in the blood pressure-lowering effect of ApoAmlo.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine in pregnant women has not been established. If you are pregnant, think you may be pregnant, or plan to become pregnant, you should consult your doctor before taking this medicine.

Breastfeeding

It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking this medicine.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

ApoAmlo may affect your ability to drive or operate machines. If the tablets cause dizziness, drowsiness, fatigue, or headache, you should not drive or operate machines; you should contact your doctor immediately.

ApoAmlo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take ApoAmlo

You should always take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, you should ask 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.
You can take this medicine before or after meals and drinks. You should take this medicine at the same time every day, with a glass of water. You should not take ApoAmlo with grapefruit juice.

Use in children and adolescents

In children and adolescents (aged 6-17 years), the recommended initial dose is usually 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
ApoAmlo 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained from ApoAmlo 5 mg tablets, as these tablets are not designed to be split in half.
It is important to take the tablets continuously. You should not wait until you have used up all the tablets before visiting your doctor.

Taking more than the recommended dose of ApoAmlo

Taking too many tablets may cause a decrease in blood pressure, which can be dangerous.
You may experience dizziness, lightheadedness, fainting, or weakness. In case of a significant decrease in blood pressure, you may experience shock. Your skin may become cool and moist, and you may lose consciousness.
If you have taken too many ApoAmlo tablets, you should contact your doctor or go to the emergency department of your nearest hospital immediately.
Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema).

Missing a dose of ApoAmlo

You should stay calm. If you forget to take a tablet, you should skip it.
You should take the next dose at the right time. You should not take a double dose to make up for the missed dose.

Stopping treatment with ApoAmlo

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

4. Possible side effects

Like all medicines, ApoAmlo can cause side effects, although not everybody gets them.
If you experience any of the following side effects after taking ApoAmlo, 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 difficulty breathing
• Severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very severe malaise

The following very common side effects have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Very common side effects: occurring in at least 1 in 10 patients

• Swelling (fluid retention)

The following common side effects have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Common side effects: occurring in less than 1 in 10 patients but more than 1 in 100 patients

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Pounding heart (awareness of heartbeat), sudden reddening, especially of the face
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Uncommon side effects: occurring in less than 1 in 100 patients but more than 1 in 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Dizziness, taste disturbances, fainting
• Tingling or numbness of the hands and feet
• Ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by inflammation of the nasal mucous membrane (non-allergic rhinitis)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, changes in skin color
• Disorders of urination, increased need to urinate at night, increased frequency of urination
• Disorders of erection, discomfort or enlargement of the breasts in men
• Pain, malaise
• Pain in the joints or muscles, back pain
• Weight gain or loss

Rare side effects: occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients

• Disorientation

Very rare side effects: occurring in less than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising or bleeding
• Increased blood sugar levels (hyperglycemia)
• Nerve disorders, which may cause muscle weakness, tingling, or numbness
• Diarrhea
• Abdominal bloating (not related to the stomach)
• Liver disorders, liver inflammation, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some test results
• Increased muscle tension
• Vasculitis, often with skin rash
• Sensitivity to light
• A syndrome involving stiffness, tremor, and (or) difficulty moving

Frequency not known (frequency cannot be estimated from the available data):
tremor, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions of Medicinal Products, 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
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 ApoAmlo

You should keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer required.
These measures will help protect the environment.

6. Contents of the pack and other information

What ApoAmlo contains

• The active substance of ApoAmlo is amlodipine in the form of amlodipine besylate.
  Each tablet contains amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine.
• The other ingredients are: 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 tablets with beveled edges, in a barrel-shaped form, with the inscription "C" on one side and "58" on the other.
Tablet size: 7.9 mm x 5.6 mm.
ApoAmlo, 10 mg, tablets:
White or almost white, flat, round tablets (with a diameter of 9.5 mm), with beveled edges, with the inscription "C" on one side and "59" on the other.
ApoAmlo tablets are available in blisters of PVC/PVDC/Aluminum, in a cardboard box.
Pack sizes:
Blisters containing:
20, 28, 30, 56, 60, 98, and 100 tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z.o.o
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Amlodipine AB 5 mg/10 mg tablets
Czech Republic:
Amlodipine Aurovitas 5 mg/10 mg tablets
Poland:
ApoAmlo
Portugal:
Amlodipine Aurovitas
Spain:
Amlodipino Aurovitas 5 mg/10 mg tablets EFG

Date of last revision of the leaflet: 01/2023