Norvasc

Patient Information Leaflet: User Information

Norvasc, 5 mg, tablets

Norvasc, 10 mg, tablets

Amlodipine

Read the 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Norvasc and what is it used for

Norvasc contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Norvasc 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, Norvasc improves blood flow to the heart muscle, increasing the supply of oxygen, which prevents chest pain. This medicine does not immediately relieve chest pain caused by angina.

2. Important information before taking Norvasc

When not to take Norvasc

• if you have been told that you have an allergy (hypersensitivity) to amlodipine or 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 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 taking Norvasc, 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 Norvasc in children under 6 years of age. Norvasc can 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, consult your doctor.

Norvasc and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Norvasc may affect other medicines or other medicines may affect Norvasc:

• Ketoconazole, 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 (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)
• Cyclosporin (an immunosuppressive medicine)

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

Norvasc with food and drink

Patients taking Norvasc should not drink grapefruit juice or eat grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may lead to an unpredictable increase in the effect of Norvasc, lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
There is no data on the safety of amlodipine in pregnancy. If you are pregnant or plan to become pregnant, tell your doctor before taking Norvasc.
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 Norvasc.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

Norvasc contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Norvasc

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Norvasc 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 Norvasc with grapefruit juice.

Use in children and adolescents

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

Taking more than the recommended dose of Norvasc

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may feel dizzy, feel faint, or faint, or feel weak. In case of a significant drop in blood pressure, shock may occur. The skin becomes cool and moist, and you may lose consciousness. If you have taken too many Norvasc tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Norvasc

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

Stopping Norvasc treatment

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 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.
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 great difficulty in breathing
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense 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 pain radiating to the back, with very poor general condition

The following very common side effectshave been reported. If any of these side effects bother you or last more than a week, you should contact your doctor.

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 these side effects bother you or last more than a week, you should contact your doctor.

Common side effects: occurring in less than 1 in 10 patients but more than 1 in 100 patients

• Headache, dizziness, drowsiness (especially at the start 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 are listed below. If any of the side effects get 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 but more than 1 in 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of the limbs, lack of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/rhinitis (inflammation of the nasal mucosa)
• Cough
• Dryness of the mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Joint or muscle pain, back pain
• Weight increase or decrease

Rare side effects: occurring in less than 1 in 1,000 patients but more than 1 in 10,000 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 bleeding
• High blood sugar (hyperglycaemia)
• Nerve disorders, which may cause muscle weakness, tingling, or numbness
• Gum swelling, gum bleeding
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, found in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremor, and/or difficulty in movement

Frequency not known: cannot be estimated from the available data

• Tremor, stiff posture, mask-like face, slow movements, and a shuffling, unbalanced gait

Reporting side effects

If you experience any side effects, including any 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.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Norvasc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Norvasc contains

The active substance is amlodipine.
Each tablet contains 5 mg or 10 mg of amlodipine (as amlodipine besylate).
The other ingredients are: calcium hydrogen phosphate anhydrous, magnesium stearate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A).

What Norvasc looks like and contents of the pack

5 mg tablets: White or almost white, octagonal tablets with "AML 5" and a score line on one side and "VLE" on the other side of the tablet. The tablet can be divided into equal doses.
10 mg tablets: White or almost white, octagonal tablets with "AML-10" on one side and "VLE" on the other side of the tablet.
Norvasc 5 mg, tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets, calendar packs containing 28 and 98 tablets, and single-dose blisters containing 50 x 1 and 500 x 1 tablets.
Norvasc 10 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, 500 tablets, calendar packs containing 28 and 98 tablets, and single-dose blisters containing 50 x 1 and 500 x 1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

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

Tablets:

Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Iceland, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sweden: Norvasc
Czech Republic: Zorem
Ireland, Malta, United Kingdom: Istin
Ireland: Amlodipine Upjohn 5 mg tablets, Amlodipine Upjohn 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos, Norvas 10 mg comprimidos;
United Kingdom: Amlodipine
Date of last revision of the leaflet:01/2025

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
http://www.urpl.gov.pl/