Agen 10

Patient Information Leaflet

Agen 5, 5 mg, tablets
Agen 10, 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. 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 you personally. 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 inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Agen is and what it is used for
2. What you need to know 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 Agen is and what it is used for

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

2. Important information before using Agen

When not to use Agen:

• 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 may 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 cannot supply enough blood to the body),
• if the patient has heart failure following a recent heart attack.

Warnings and precautions
Before starting treatment with Agen, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has previously had:

• A recent heart attack;
• Heart failure;
• Severe high blood pressure (hypertensive crisis);
• Liver disease;
• Need for dose adjustment in elderly patients.

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

Agen and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Agen may affect the action of other medicines, or other medicines may affect the action of Agen. These include:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John’s wort (herbal remedy)
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (used in infusion for severe disturbances of body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (immunosuppressive medicines used to prevent organ transplant rejection and in the treatment of certain cancers)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporine (an immunosuppressive medicine)

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

Taking Agen with food and drink
Patients taking Agen should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active substance – amlodipine – which could result in an unexpected intensification of the blood pressure-lowering effect of Agen.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data on the safety of amlodipine use during pregnancy. If the patient suspects she may be pregnant or is planning to become pregnant, she should inform her doctor before using Agen.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting treatment with Agen.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Agen 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 their doctor immediately.

Agen contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; this means the medicine is considered "sodium-free".

3. How to use Agen

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
The recommended starting dose of Agen is 5 mg once daily. The dose may be increased to 10 mg
once daily.
This medicine can be taken regardless of meals and drinks. It is recommended to take it at the same
time each day, with water. Do not take Agen with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day. Agen 5 mg tablets may be divided in half to achieve
a 2.5 mg dose.
It is important to take the tablets continuously. Do not wait until all tablets are used before visiting
the doctor.
Taking more Agen than recommended
Taking too many tablets may cause a reduction, or even a dangerous drop, in blood pressure.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. In cases of severe
hypotension, shock may develop. The skin then becomes cold and clammy, and the patient may
lose consciousness.
Even up to 24–48 hours after taking the medicine, shortness of breath may occur due to fluid
accumulating in the lungs (pulmonary oedema).
If too many Agen tablets have been taken, contact a doctor immediately or go to the nearest
hospital emergency department.
Missing a dose of Agen
Stay calm. If a dose is missed, skip that dose and take the next dose at the usual time. Do not take
a double dose to make up for a missed dose.
Stopping Agen treatment
Your doctor will advise how long this medicine should be taken. If treatment is stopped before
the doctor advises, the condition may return.
If you have any further questions 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 everybody will experience them.
Immediately contact a doctor if any of the following adverse reactions occur after using the medicine:

• 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 severe rash, urticaria, redness of the skin over the entire body, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• Heart attack, heart rhythm disorders;
• Pancreatitis, which may cause sudden 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 to the patient or persist for more than one week, contact a doctor.
Very common adverse reactions (occurring in more than 1 in 10 patients):

• Swelling of the ankles (oedema).

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or persist for more than one week, contact a doctor.
Common adverse reactions (occurring in fewer than 1 in 10 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 habits, diarrhoea, constipation, indigestion;
• Fatigue, weakness;
• Visual disturbances, double vision;
• Muscle cramps.

Other reported adverse reactions are listed below. If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse reactions (occurring in fewer than 1 in 100 patients):

• Mood changes, anxiety, depression, insomnia;
• Tremor, taste disturbances, fainting;
• Numbness or tingling of limbs, loss of pain sensation;
• Tinnitus;
• Low blood pressure;
• Sneezing or nasal discharge due to 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 breasts in men;
• Pain, malaise;
• Joint or muscle pain, back pain;
• Increase or decrease in body weight.

Rare adverse reactions (occurring in fewer than 1 in 1,000 patients):

• Disorientation.

Very rare adverse reactions (occurring in fewer than 1 in 10,000 patients):

• Decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising and easier bleeding;
• High blood glucose levels (hyperglycaemia);
• Nerve disorders which may cause weakness, tingling or numbness;
• Swelling of the gums;
• Abdominal bloating (gastritis);
• Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests;
• Increased muscle tone;
• Vasculitis, often with skin rash;
• Photosensitivity.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Tremor, muscle rigidity, facial masking, slowed movements, shuffling gait, unsteady walking.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Agen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
blister after: "Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures 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 carboxymethyl starch, magnesium stearate.

What Agen looks like and contents of the pack
Agen 5: white or almost white, oval tablets, with a division line on one side and embossed marking "A" and "5" to the left and right of the division line.
Agen 10: white or almost white, oval tablets, with a division line on one side and embossed marking "A" and "10" to the left and right of the division line.
The tablets can be divided into equal doses.
Agen 5 and Agen 10 are available in blisters made of PVC/PVDC/Aluminium (white) or PVC/Aluminium (white).
Pack sizes: 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva k.s., Dolni Mecholupy, U kabelovny 130, 102 37 Prague 10, Czech Republic.

For further information, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00