Amlodipine Vitabalans

Package Leaflet: Information for the User

Amlodipine Vitabalans, 5 mg, tablets

Amlodipine Vitabalans, 10 mg, tablets

Amlodipine

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

• Keep this package 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 Package Leaflet

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

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

Amlodipine Vitabalans contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine Vitabalans is used to treat high blood pressure (hypertension) or chest pain (angina pectoris), which is a rare form of angina called Prinzmetal's angina or variant angina.
In patients with high blood pressure, the medicine widens the blood vessels, making it easier for the blood to flow. In patients with angina, Amlodipine Vitabalans improves blood flow to the heart muscle, increasing the supply of oxygen, which helps to prevent chest pain. The medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Amlodipine Vitabalans

When not to take Amlodipine Vitabalans

• If you are allergic to amlodipine or any other ingredient 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 is unable to supply enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions
Before starting to take Amlodipine Vitabalans, discuss it with your doctor.
Tell your doctor if you have or have had:

• recently had a heart attack
• heart failure
• sudden increase in blood pressure (hypertensive crisis)
• liver disease
• need to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of Amlodipine Vitabalans in children under 6 years of age. Amlodipine Vitabalans should be used in hypertension in children and adolescents from 6 to 17 years of age (see section 3). For further information, consult your doctor.

Amlodipine Vitabalans and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Amlodipine Vitabalans may affect other medicines or other medicines may affect Amlodipine Vitabalans:

• 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 (infusion used to treat severe body temperature disorders)
• tacrolimus (medicine used to change the way the immune system works)
• simvastatin (medicine used to lower cholesterol levels)
• cyclosporin (immunosuppressive medicine)

Amlodipine Vitabalans may increase the lowering of blood pressure to a greater extent if you are taking other anti-hypertensive medicines.

Amlodipine Vitabalans with food and drink

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

Pregnancy and breastfeeding and fertility

The safety of amlodipine in pregnancy has not been established. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Amlodipine Vitabalans.

Driving and using machines

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

3. How to take Amlodipine Vitabalans

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The tablet can be divided into equal doses.
The usual initial dose of Amlodipine Vitabalans is 5 mg once a day. The dose may be increased to 10 mg of Amlodipine Vitabalans once a day.
The medicine can be taken with or without food and drinks. It is recommended to take the medicine at the same time every day, with a glass of water. Do not take Amlodipine Vitabalans with grapefruit juice.

Use in children and adolescents

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

Taking too much Amlodipine Vitabalans

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, feeling of emptiness in the head, fainting, or weakness. If the blood pressure drops too low, it may cause shock. The skin may become cool and moist, and fainting may occur.
Up to 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).
If you have taken too many Amlodipine Vitabalans tablets, seek medical attention immediately.

Missing a dose of Amlodipine Vitabalans

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 Amlodipine Vitabalans

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following very rare, serious side effects after taking the medicine, contact your 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 severe rash, hives, redness of the skin, 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, irregular heartbeat
• pancreatitis, which may cause severe abdominal and back pain with very poor general health

The following side effects have 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.
Common (may affect up to 1 in 10 people)

• headache, dizziness, drowsiness (especially at the start of treatment)
• palpitations (awareness of heartbeat), flushing
• abdominal pain, nausea
• swelling of the ankles, fatigue

Other side effects that have been reported are listed below. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Uncommon (may affect up to 1 in 100 people)

• mood changes, anxiety, depression, insomnia
• trembling, taste disturbances, fainting, weakness
• numbness or tingling of the limbs, lack of pain sensation
• visual disturbances, double vision, ringing in the ears
• low blood pressure
• sneezing and (or) runny nose caused by inflammation of the nasal mucous membrane (rhinitis)
• change in bowel movements, diarrhea, constipation, indigestion, dry mouth, vomiting
• hair loss, increased sweating, itching, red spots on the skin, change in skin color
• urinary disorders, increased need to urinate at night, increased frequency of urination
• erectile dysfunction, discomfort or enlargement of the breasts in men
• weakness, pain, poor general health
• joint or muscle pain, muscle cramps, back pain
• weight gain or loss

Rare (may affect up to 1 in 1,000 people)

• confusion

Very rare (may affect up to 1 in 10,000 people)

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and bleeding (red blood cell damage)
• high blood sugar levels (hyperglycemia)
• nerve disorders, which may cause weakness, numbness, or tingling
• cough, gum 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
• inflammation of blood vessels, often with skin rash
• sensitivity to light
• disorders including stiffness, trembling, and (or) movement problems

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to
Department for the Surveillance of Adverse Reaction to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Vitabalans

Keep the 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 month stated.
Store in the original packaging 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 Amlodipine Vitabalans contains

The active substance of the medicine is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine in the form of amlodipine besylate.
The other ingredients of the medicine are microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, and sodium carboxymethylcellulose (type A).

What Amlodipine Vitabalans looks like and contents of the pack

What Amlodipine Vitabalans tablets look like:
Amlodipine Vitabalans 5 mg: white, round, biconvex tablets with a dividing line on one side and a logo "3" on the other, with a diameter of 9 mm.
Amlodipine Vitabalans 10 mg: white, round, biconvex tablets with a dividing 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.

Marketing Authorisation Holder and Manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Phone: +358 (3) 615600
Fax: +358 (3) 6183130

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Amlodipine Vitabalans (Germany, Denmark, Estonia, Finland, Lithuania, Latvia, Norway, Poland, Sweden)
Amlodipin Vitabalans (Czech Republic, Hungary, Slovenia, Slovakia)

Date of last revision of the package leaflet: 2022-12-12