Amlodipine

Package leaflet: Information for the patient

Amlonor, 5 mg, tablets
Amlonor, 10 mg, tablets
Amlodipine
Please read all of this leaflet carefully before taking this medicine, because
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 the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Amlonor is and what it is 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 Amlonor is and what it is used for

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

2. Important information before using Amlonor

When not to use Amlonor:

• if the patient is allergic (hypersensitive) to amlodipine or to any of the other ingredients of the medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include itching, redness of the skin, or difficulty 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 deliver sufficient blood to the body),
• if the patient has heart failure following a previous heart attack.

Warnings and precautions
Before starting treatment with Amlonor, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has 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 Amlonor in children under 6 years of age have not been conducted.
Amlonor should be used only for the treatment of arterial hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Amlonor with 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.
Amlonor may interact with other medicines, or other medicines may interact with Amlonor:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV treatment),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's wort (Hypericum perforatum),
• verapamil, diltiazem (medicines used for heart conditions),
• dantrolene (an infusion 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),
• cyclosporine (an immunosuppressive medicine).

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

Amlonor with food and drink
Patients taking Amlonor 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 Amlonor's blood pressure-lowering effect.

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 before using this medicine.

Pregnancy
There is insufficient data on the safety of amlodipine during pregnancy. If the patient suspects she may be pregnant or is planning a pregnancy, she should consult her doctor before using this medicine.

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 Amlonor.

Before taking any medicine, consult your doctor or pharmacist.

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

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

3. How to use Amlonor

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The usual initial dose of Amlonor is 5 mg once daily. The dose may be increased to 10 mg once daily.
This medicine can be taken independently of meals and drinks. It is recommended to take this medicine
at the same time every day, with water. Amlonor must not be taken 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 per day.
The maximum recommended dose is 5 mg per day. Amlonor 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 up before visiting
the doctor.

Taking more Amlonor than recommended
Taking too many tablets may cause a reduction, or even dangerous lowering, of blood pressure.
This may lead to dizziness, a feeling of "emptiness" in the head, fainting, or weakness. If the drop in blood
pressure is very severe, shock may occur. The skin may become cold and clammy, and the patient may
lose consciousness. In case of overdose with Amlonor, contact a doctor immediately or go to the emergency
department of the nearest hospital.
Shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur even
24–48 hours after taking the medicine.

If you miss a dose of Amlonor
Stay calm. If the patient forgets to take a tablet, skip the missed dose. Take the next dose at the
scheduled time. Do not take a double dose to make up for the missed dose.

Stopping use of Amlonor
Your doctor will inform you 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 questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following adverse reactions occur after using this 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 entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Myocardial infarction, 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 if they last longer than one week, 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 to the patient or if they last longer than one week, contact your doctor.
Common adverse reactions: occurring in no more than 1 out of 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), facial flushing
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, dyspepsia
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

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 less than 1 out of 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 and/or nasal congestion 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, nocturia (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 less than 1 out of 1,000 patients

• Disorientation

Very rare adverse reactions: occurring in less than 1 out of 10,000 patients

• Decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and easier bleeding
• High blood glucose levels (hyperglycaemia)
• Nerve-related disorders which may cause muscle weakness, tingling or numbness
• Gum swelling
• Abdominal bloating (gastritis)
• Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain laboratory test results
• Increased muscle tone
• Vasculitis, often associated with skin rash
• Light sensitivity
• Disorders involving stiffness, tremor and/or movement difficulties

Reporting of adverse reactions
If any adverse reactions occur, including any 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Amlonor

Keep this medicine out of sight and reach of children.
Store the medicine in its original packaging, at a temperature not exceeding 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Amlonor contains

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

What Amlonor looks like and contents of the pack
White or almost white, round, convex on one side, scored tablets.
The pack contains 30 tablets in blisters made of PVC/PVDC 90 g/m\²/Al or in an amber glass bottle, all contained in a cardboard box.
Marketing Authorisation 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