Norvasc

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Norvasc (NORVASC), 5 mg, tablets

Amlodipine
Norvasc and НОРВАСК are different trade names for the same medicine, written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 indicated for the treatment of high blood pressure (hypertension) or chest pain, known as angina pectoris, and its rare form known as 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 facilitates blood flow to the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Norvasc

When not to take Norvasc

• if the patient has been diagnosed with 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, skin redness, or difficulty breathing,
• if the patient has very low blood pressure (hypotension),
• if the patient has a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body),
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Norvasc, the patient should discuss it with their doctor or pharmacist. The patient should inform their doctor if they 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, the patient should consult their doctor.

Norvasc and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking now or have taken recently, as well as any medicines they plan to take.
Norvasc may interact with other medicines or other medicines may interact with Norvasc:

• 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 (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) Norvasc may lower blood pressure more, if the patient is taking other anti-hypertensive medicines.

Norvasc with food and drink

Patient taking Norvasc 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 unexpected increase in the effect of Norvasc, lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
There is no data on the safety of amlodipine during pregnancy. If the patient suspects pregnancy or plans to become pregnant, they should inform their doctor before taking Norvasc.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should inform their doctor before taking Norvasc.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Norvasc may affect the patient's ability to drive and use machines. If the tablets cause nausea, dizziness, or fatigue, or headache, the patient should not drive or operate machinery; they should contact their doctor immediately.

Norvasc contains sodium

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

3. How to take Norvasc

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their 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. Norvasc should not be taken with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years old), the usual recommended initial dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day. Norvasc 5 mg tablets can be divided into two halves to obtain a 2.5 mg dose.
It is essential to take the tablets continuously. The patient should not wait until all the tablets have been used before visiting their doctor.

Taking a higher dose of Norvasc than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In case of a significant decrease in blood pressure, shock may occur. The skin becomes cold and moist, and the patient may lose consciousness. If the patient has taken too many Norvasc tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.
Even 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

The patient should remain calm. If they forget to take a tablet, they should skip it.
The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Norvasc

The doctor will inform the patient how long they should take this medicine. If the patient stops taking this medicine before their doctor advises, their illness may recur.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Norvasc can cause side effects, although not everybody gets them.
The patient should immediatelycontact their doctor if they 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 increased rash, hives, redness of the skin all over the body, intense 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 can cause severe abdominal pain, radiating to the back, with very poor general condition

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

• Swelling (fluid retention) If any of the side effects get serious, or if the patient notices any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

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

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Heart palpitations (awareness of heart rhythm), facial redness
• 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 the patient notices any side effects not listed in this leaflet, they should tell their 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
• Tinnitus
• Low blood pressure
• Sneezing/rhinitis caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the mucous membrane of the mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, 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

• 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, gum bleeding
• Abdominal distension (gastritis)
• Abnormal liver function, hepatitis, jaundice, increased liver enzyme activity, found in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremors, and (or) difficulty walking

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C; 02-222 Warsaw, tel: (+48 22) 49 21 301, fax: (+48 22) 49 21 309, website: http://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Norvasc

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Norvasc contains

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

What Norvasc looks like and contents of the pack

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 or without marking on the other side of the tablet.
Norvasc 5 mg, tablets are available in blisters containing 30 tablets.
To obtain more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

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

Manufacturer:

MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Bulgaria, the country of export:20000435

Parallel import authorization number: 119/25

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
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos
United Kingdom: Amlodipine

Date of approval of the leaflet: 27.03.2025 [Information on the trademark]