Patient Information Leaflet: Information for the User

Amlodipine Vitabalans, 5 mg, tablets
Amlodipine Vitabalans, 10 mg, tablets
Amlodipinum
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
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. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Amlodipine Vitabalans is and what it is used for
What you need to know before taking Amlodipine Vitabalans
How to take Amlodipine Vitabalans
Possible side effects
How to store Amlodipine Vitabalans
Contents of the pack and other information

1. What Amlodipine Vitabalans is and what it is used for

Amlodipine Vitabalans contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlodipine Vitabalans is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina pectoris, including the less common forms such as Prinzmetal's angina or variant angina.
In patients with high blood pressure, the medicine relaxes blood vessels, making it easier for blood to flow. In patients with angina, Amlodipine Vitabalans improves blood flow to the heart muscle, increasing the oxygen supply, thereby helping to prevent chest pain. The medicine does not provide immediate relief of angina-related chest pain.

2. Important information before using Amlodipine Vitabalans

When not to use Amlodipine Vitabalans

If the patient is allergic 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, skin redness 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 is unable to deliver sufficient blood to the body).
If the patient has heart failure following a previous heart attack.

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

a recent heart attack
heart failure
acute high blood pressure (hypertensive crisis)
liver disease
need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Amlodipine Vitabalans in children under 6 years of age have not been conducted. Amlodipine Vitabalans may be used for arterial hypertension in children and adolescents aged 6 to 17 years (see section 3). For further information, please consult your doctor.
Amlodipine Vitabalans 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 use.
Amlodipine Vitabalans may affect the action of other medicines or other medicines may affect the action of Amlodipine Vitabalans:

ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV treatment)
rifampicin, erythromycin, clarithromycin (antibiotics)
St. John's wort
verapamil, diltiazem (medicines used for heart conditions)
dantrolene (an infusion used in severe disturbances of body temperature)
tacrolimus (a medicine used to alter the way the immune system works)
simvastatin (a medicine that lowers cholesterol levels)
cyclosporine (an immunosuppressive medicine)

Amlodipine Vitabalans may enhance the blood pressure-lowering effect if the patient is taking other antihypertensive medicines.
Amlodipine Vitabalans with food and drink
Patients taking Amlodipine Vitabalans should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active ingredient amlodipine, which could lead to an unexpected intensification of the blood pressure-lowering effect of Amlodipine Vitabalans.
Pregnancy, breastfeeding and fertility
The safety of using amlodipine during pregnancy has not been established. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
It has been shown that small amounts of amlodipine pass into human breast milk. If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before using Amlodipine Vitabalans.
Driving and operating machinery
Amlodipine 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. Contact your doctor immediately.

3. How to use Amlodipine Vitabalans

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
The tablet may be divided into equal doses.
The usual starting dose of Amlodipine Vitabalans is 5 mg once daily. The dose may be increased to 10 mg of Amlodipine Vitabalans once daily.
Amlodipine Vitabalans may be taken regardless of meals or drinks. It is recommended to take the medicine at the same time each day, with water. Do not take Amlodipine Vitabalans 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 once daily. The maximum recommended dose is 5 mg once daily.
It is important to take the tablets continuously. Do not wait until all tablets are used up before visiting your doctor.

Taking more Amlodipine Vitabalans 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. If the drop in blood pressure is too severe, shock may develop. The skin may become cold and clammy, and fainting may also occur.
Breathing difficulties due to excess fluid accumulating in the lungs (pulmonary edema) may occur even 24–48 hours after taking the medicine.
If too many tablets of Amlodipine Vitabalans have been taken, seek immediate medical help.

If you miss a dose of Amlodipine Vitabalans
Stay calm. If you forget to take a tablet, skip that dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Amlodipine Vitabalans
Your doctor will advise you on how long to take this medicine. If you stop taking Amlodipine Vitabalans before your doctor recommends, your 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 everyone experiences them.
If any of the following very rare, serious adverse reactions occur after taking the medicine, contact a doctor immediately:

sudden wheezing, chest pain, shortness of breath, or difficulty breathing
swelling of the eyelids, face, and lips
swelling of the tongue and throat causing severe breathing difficulties
severe skin reactions, including intense rash, hives, redness of the entire body's skin, severe 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 severe abdominal and back pain accompanied by a very poor general condition

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or persist for more than one week, contact a doctor.
Common (may occur in less than 1 in 10 people)

Headache, dizziness, drowsiness (especially at the beginning of treatment)
Palpitations (awareness of heartbeat), flushing
Abdominal pain, nausea
Ankle swelling, fatigue

Other reported adverse reactions are listed below. If any of these adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon (may occur in less than 1 in 100 people)

Mood changes, anxiety, depression, insomnia
Tremor, taste disturbances, fainting, weakness
Numbness or tingling of limbs, loss of pain sensation
Visual disturbances, double vision, tinnitus
Low blood pressure
Sneezing and/or nasal discharge due to inflammation of the nasal mucosa (nasal catarrh)
Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting
Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
Urination disorders, increased need to urinate at night, increased frequency of urination
Erectile dysfunction, discomfort or enlargement of breasts in men
Weakness, pain, malaise
Joint or muscle pain, muscle cramps, back pain
Increase or decrease in body weight

Rare (may occur in less than 1 in 1,000 people)

Confusion

Very rare (may occur in less than 1 in 10,000 people)

Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and easier bleeding (damage to red blood cells)
Excess glucose in the blood (hyperglycemia)
Nerve disorders which may cause weakness, tingling, or numbness
Cough, gum swelling
Abdominal bloating (gastric catarrh)
Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity which may affect certain test results
Increased muscle tone
Vasculitis, often with skin rash
Light sensitivity
Movement disorders involving stiffness, tremors, and/or movement difficulties

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Amlodipine Vitabalans

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Store 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 Amlodipine Vitabalans contains
The active substance is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine
in the form of amlodipine besylate.
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, magnesium
stearate and sodium carboxymethyl starch (type A).
What Amlodipine Vitabalans looks like and contents of the pack
What the Amlodipine Vitabalans tablets look like:
Amlodipine Vitabalans 5 mg: white, round, convex tablets with a division line on one side and the logo
“3” on the other, with a diameter of 9 mm.
Amlodipine Vitabalans 10 mg: white, round, convex tablets with a division line on one side, with a
diameter of 9 mm.
The tablet can be divided into equal doses.
Pack sizes:
30, 60, 90 and 100 tablets
Not all pack sizes may be marketed.
Responsible entity and manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Tel: +358 (3) 615600
Fax: +358 (3) 6183130
This medicinal product is authorized in the European Economic Area countries under the following names:
Amlodipine Vitabalans (Germany, Denmark, Estonia, Finland, Lithuania, Latvia, Norway, Poland,
Sweden)
Amlodipin Vitabalans (Czech Republic, Hungary, Slovenia, Slovakia)