Amlonor

Package Leaflet: Information for the Patient

Amlonor, 5 mg, tablets

Amlonor, 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Amlonor and what is it used for

Amlonor contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlonor 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, Amlonor makes it easier for blood to reach the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
This medicine does not provide immediate relief of chest pain caused by angina.

2. Important information before taking Amlonor

When not to take Amlonor:

Warnings and precautions

Before taking Amlonor, 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 Amlonor in children under 6 years of age.
Amlonor should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain further information, you should contact your doctor.

Amlonor and other medicines

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

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (infusion used in severe body temperature disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporin (an immunosuppressive medicine).

Amlonor may lower blood pressure more, if you are taking other anti-hypertensive medicines.

Amlonor with food and drink

Patients taking Amlonor should not consume grapefruit juice or grapefruits, as they may cause an increase in the level of the active substance - amlodipine in the blood, which may result in an unforeseen increase in the effect of Amlonor in lowering blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor 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 child, ask your doctor for advice 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, tell your doctor before taking Amlonor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Amlonor 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.

Amlonor contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Amlonor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual initial dose of Amlonor 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 this medicine every day at the same time, with a glass of water. Do not take Amlonor with grapefruit juice.

Use in children and adolescents

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

Taking a higher dose of Amlonor than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may then experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. If the blood pressure drop is very large, shock may occur. The skin may become cool and moist, and you may lose consciousness. If you have taken too many Amlonor tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Up to 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).

Missing a dose of Amlonor

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 the missed dose.

Stopping treatment with Amlonor

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

4. Possible side effects

Like all medicines, Amlonor 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 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 severe difficulty breathing
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and skin swelling, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, arrhythmias
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition.

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

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

• Swelling (fluid retention)

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

Common side effects: occurring in less than 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• 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 reported include the following. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon side effects: occurring in less than 1 in 100 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 and (or) runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the mucous membrane in the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Sexual dysfunction, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Joint or muscle pain, back pain
• Weight gain or loss

Rare side effects: occurring in less than 1 in 1,000 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 and easier bleeding
• High blood sugar levels (hyperglycemia)
• Nerve disorders that can cause muscle weakness, tingling, or numbness
• Gingival swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some test results
• Increased muscle tension
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremors, and (or) difficulty moving

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49 21 301
fax: 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 Amlonor

Keep this medicine out of the sight and reach of children.
Store the medicine in its original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Amlonor contains

• The active substance of Amlonor is amlodipine in the form of amlodipine besylate. Each tablet contains 5 mg or 10 mg of amlodipine in the form of amlodipine besylate.
• The other ingredients are: microcrystalline cellulose (12), povidone (90), sodium carboxymethylcellulose (type A), magnesium stearate.

What Amlonor looks like and contents of the pack

White or almost white, round, single-sided, convex tablets with a dividing line.
The pack contains 30 tablets in PVC/PVDC 90 g/m /Al blisters or an orange glass bottle in a cardboard box.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: