Norvasc

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Norvasc

10 mg, tablets

Amlodipine

You should carefully read the contents of the leaflet before using 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 package and other information

1. What is Norvasc and what is it used for

Norvasc contains the active substance amlodipine in the form of amlodipine besylate, 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 delivered, 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 narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot deliver enough blood to the body),
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Norvasc, you should discuss it with your doctor or pharmacist.
You should inform 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, you should consult a doctor.

Norvasc and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 temperature regulation 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 you are taking other antihypertensive medicines.

Norvasc with food and drink

Patients 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 you suspect you are pregnant or plan to become pregnant, you should 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, you should tell your doctor before taking Norvasc.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Norvasc may affect your ability to drive and use machines. If the tablets cause nausea, dizziness, or fatigue, or headache, you should not drive or operate machinery; you should contact your 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 exactly as advised by your doctor or pharmacist. If you are unsure, you should consult 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. You should not take Norvasc with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years), the usual recommended initial dose is 2.5 mg once a day.
The maximum recommended dose is 5 mg once a day.
It is essential to take the tablets continuously. You should not wait until you have used all the tablets before visiting your 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. You 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 cool and moist, and you may lose consciousness. If you have taken too many Norvasc tablets, you should 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 caused by excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Norvasc

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

Stopping Norvasc

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 worsen.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Norvasc 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 severe difficulty in breathing
• Severe skin reactions, including severe 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 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 the side effects are troublesome for you or if they last for 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 the side effects are troublesome for you or if they last for more than a week, you should contact your doctor.

Common side effects: occurring in no more than 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Pounding heart (awareness of heartbeat), 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 reported side effects are listed below. If any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should tell your 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, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the mucous membranes 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
• Pain in the joints or muscles, back pain
• Weight gain or loss

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 bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremors, and (or) difficulty in movement

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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Norvasc

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
You should not store it above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Norvasc contains

The active substance of Norvasc is amlodipine (in the form of amlodipine besylate).
Each tablet contains 10 mg of amlodipine.
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate.

What Norvasc looks like and contents of the package

White or almost white, octagonal tablets with "AML-10" on one side and "Pfizer" on the other side of the tablet.
Norvasc 10 mg tablets are available in PVC-PVDC/Al blisters in a cardboard box containing 30 tablets.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export

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

Manufacturer:

R-Pharm Germany GmbH
Heinrich-Mack-Strasse 35
89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in Romania, the country of export: 5655/2013/01
5655/2013/04
5655/2013/05
5655/2013/07
5655/2013/08
5655/2013/09
5655/2013/11
5655/2013/12
5655/2013/13

Parallel import authorization number: 36/23 Date of approval of the leaflet: Approved: 07.03.2023

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 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 10 mg comprimidos;
United Kingdom: Amlodipine

Other sources of information

Detailed information about 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/
[Information about the reserved trademark]