Agen 10

Package Leaflet: Information for the Patient

Agen 5, 5 mg, tablets

Agen 10, 10 mg, tablets

Amlodipine

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

• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Agen and what is it used for

Agen contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Agen is used to treat high blood pressure (hypertension) or chest pain (angina pectoris) and its rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine widens the blood vessels so that blood can flow more easily.
In patients with coronary heart disease, Agen improves blood supply to the heart muscle, increasing the amount of oxygen delivered, which in turn prevents the occurrence of chest pain.
This medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Agen

When not to take Agen:

• 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 may 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 (aortic stenosis) or cardiogenic shock (a condition where the heart cannot deliver enough blood to the body),
• if you have heart failure after a heart attack.

Warnings and precautions

Before taking Agen, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had:

• Recently had a 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 Agen in children under 6 years of age.
Agen can only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To get more information, consult your doctor.

Agen and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Agen may interact with other medicines or other medicines may interact with Agen.
These include:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (used in severe body temperature disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that affect the immune system, used to prevent organ rejection and to treat certain cancers)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporin (a medicine that suppresses the immune system)

Agen may lower blood pressure more when you take other blood pressure-lowering medicines.

Taking Agen with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no data on the safety of amlodipine in pregnancy. If you think you may be pregnant or plan to have a baby, tell your doctor before taking Agen.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, tell your doctor before taking Agen.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Agen may affect your ability to drive or use machines. If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or use machines; contact your doctor immediately.

Agen contains sodium

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

3. How to take Agen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Agen is 5 mg once a day. The dose may be increased to 10 mg once a day.
This medicine can be taken with or without food and drinks. It is recommended to take it every day at the same time, with a glass of water. Do not take Agen with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6-17 years), the usual recommended initial dose is 2.5 mg once a day.
The maximum recommended dose is 5 mg once a day. Agen 5 mg tablets can be divided into halves to achieve a 2.5 mg dose.
It is important to take the tablets continuously. Do not wait until you have used all the tablets before visiting your doctor.

Taking a higher dose of Agen than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In the event of a significant drop in blood pressure, shock may occur. The skin becomes cool and moist, and you may lose consciousness.
Even up to 24-48 hours after taking the medicine, shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema) may occur.
If you have taken too many Agen tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Agen

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

Stopping treatment with Agen

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

4. Possible side effects

Like all medicines, Agen can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you experience any of the following side effects after taking Agen:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• Swelling of the eyelids, face, or lips;
• Swelling of the tongue and throat, causing severe difficulty breathing;
• Severe skin reactions, including strong rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• Heart attack, arrhythmias;
• Pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition.

The following very common side effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.
Very common side effects(occurring in more than 1 in 10 patients):

• Swelling of the ankles (edema).

The following common side effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.
Common side effects(occurring in less than 1 in 10 patients but more than 1 in 100 patients):

• Headache, dizziness, drowsiness (especially at the beginning of treatment);
• Palpitations (awareness of heartbeat), sudden flushing of the face;
• Abdominal pain, nausea;
• Changes in bowel movements, diarrhea, constipation, indigestion;
• Fatigue, weakness;
• Visual disturbances, double vision;
• Muscle cramps.

Other reported side effects are listed below. If any of the side effects get worse or if you experience any side effects not listed in this leaflet, 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;
• Tremors, taste disturbances, fainting;
• Numbness or tingling of limbs, lack of pain sensation;
• Ringing in the ears;
• Low blood pressure;
• Sneezing or runny nose caused by inflammation of the nasal mucosa (rhinitis);
• Cough;
• Dryness of the mucous membranes of the mouth, vomiting;
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration;
• Urinary disorders, increased need to urinate at night, increased frequency of urination;
• Sexual disorders, discomfort or enlargement of the breasts in men;
• Pain, poor general condition;
• Pain in the joints or muscles, back pain;
• Weight gain or weight 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 can lead to unusual bruising and easier bleeding;
• High blood sugar levels (hyperglycemia);
• Nerve disorders that can cause weakness, numbness, or tingling;
• Gum swelling;
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity found in blood tests;
• Increased muscle tone;
• Vasculitis, often with skin rash;
• Sensitivity to light.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Tremors, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring 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
You can also report side effects to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after 'EXP'. The expiry date refers to the last day of that month.
Store in a temperature below 25°C in the original package to protect from light.
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 Agen contains

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

What Agen looks like and contents of the pack

Agen 5: white or almost white, oval tablets, with a score line on one side and engraved with "A" and "5" on either side of the score line.
Agen 10: white or almost white, oval tablets, with a score line on one side and engraved with "A" and "10" on either side of the score line.
The tablets can be divided into equal doses.
Agen 5 and Agen 10 are available in PVC/PVDC/Aluminum (white) or PVC/Aluminum (white) blisters.
Pack sizes: 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., Dolni Mecholupy, U kabelovny 130, 102 37 Prague 10, Czech Republic.

For more information, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 375 92 00

Date of last revision of the leaflet: