NORVASC

Warning! Keep the package leaflet, information on the immediate packaging in a foreign language!
Norvasc (Zorem)
5 mg, tablets
amlodipine
Norvasc and Zorem are different brand names of the same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 someone else, even if their symptoms are similar.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Norvasc is and what it is 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 Norvasc is and what it is used for

Norvasc contains the active substance amlodipine, which belongs to a group of medicines called
calcium channel blockers.
Norvasc is indicated for the treatment of high blood pressure (hypertension) or chest pain known as
angina pectoris, including its rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine dilates blood vessels, allowing blood to flow more easily. In patients with ischemic heart disease, Norvasc improves blood flow to the heart muscle by increasing oxygen supply, thereby preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. Important information before using Norvasc

When not to use Norvasc

• if the patient is allergic (hypersensitive) 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, redness of the skin or difficulty in 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 supply sufficient blood to the body),
• if the patient has heart failure following a heart attack.

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

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease
• Need for dose adjustment in elderly patients

Children and adolescents
Studies on the use of Norvasc in children under 6 years of age have not been conducted.
Norvasc may be used only for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Norvasc 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 take.
Norvasc may affect the action of other medicines, or other medicines may affect the action of Norvasc:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John's wort (Hypericum perforatum)
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (used intravenously in severe disturbances of body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (immunosuppressive medicines)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporine (an immunosuppressant medicine)

Norvasc may lower blood pressure more significantly if the patient is taking other antihypertensive medicines.

Norvasc with food and drink
Patients taking Norvasc should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active substance – amlodipine – which could result in an unexpected intensification of Norvasc's blood pressure-lowering effect.

Pregnancy and breastfeeding
Pregnancy
There are no adequate data on the safety of amlodipine during pregnancy. If the patient suspects she is pregnant or is planning a pregnancy, she must inform her doctor before taking Norvasc.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting treatment with Norvasc.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Norvasc 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 and should contact the doctor immediately.

Norvasc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Norvasc

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended starting dose of Norvasc is 5 mg once daily. The dose may be increased to 10
mg once daily.
This medicine can be taken with or without food and drink. It is recommended to take this medicine
at the same time every day, with water. Do not take Norvasc with grapefruit juice.
Use in children and adolescents
In children and adolescents (6–17 years of age), the usual recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day. Norvasc 5 mg tablets may be divided in half
to achieve a 2.5 mg dose.
It is important to take the tablets continuously. Do not wait until all tablets are used before visiting your doctor.
Taking more Norvasc than recommended
Taking too many tablets may cause a reduction, or even dangerous lowering, of blood pressure.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. In case of a severe drop in blood pressure, shock may develop. The skin then becomes cold and clammy, and the patient may lose consciousness. If an overdose of Norvasc is taken, contact your doctor immediately or go to the emergency department of the nearest hospital.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur even
24–48 hours after taking the medicine.
Missing a dose of Norvasc
Stay calm. If a patient forgets to take a tablet, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Norvasc treatment
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 return.
If you have any further doubts about using 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.
You should contact your doctor immediately if any of the following adverse reactions occur after taking this medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue or throat causing significant breathing difficulties
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blisters, skin peeling, and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, heart rhythm disturbances
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition

The following very common adverse reactions have been reported. If any of these adverse reactions are bothersome to the patient or if they last longer than one week, contact your doctor.
Very common adverse reactions: affecting at least 1 in 10 patients

• Swelling (fluid retention)

The following common adverse reactions have been reported. If any of these adverse reactions are bothersome to the patient or if they last longer than one week, contact your doctor.
Common adverse reactions: affecting no more than 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), facial flushing
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, dyspepsia
• Fatigue, weakness
• Vision disturbances, double vision
• Muscle cramps
• Ankle swelling

Other reported adverse reactions are listed below. If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse reactions: affecting less than 1 in 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or enlargement of breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increased or decreased body weight

Rare adverse reactions: affecting less than 1 in 1,000 patients

• Disorientation

Very rare adverse reactions: affecting 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 glucose levels (hyperglycaemia)
• Nerve disorders, which may cause muscle weakness, tingling, or numbness
• Gum swelling, bleeding gums
• Abdominal bloating (gastritis)
• Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Light sensitivity
• Disorders involving stiffness, tremor, and/or difficulty moving

Frequency not known: cannot be estimated from available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 this medicine.

5. How to store Norvasc

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

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

What Norvasc looks like and contents of the pack
White or almost white, octagonal tablets, embossed with the mark AML 5 and a division line on one side and the mark VLE on the other side. The tablet can be divided into equal doses.
White to almost white, octagonal tablets, embossed with the mark AML 5 and a division line on one side and no markings on the other side. The tablet can be divided into equal doses.
Norvasc 5 mg tablets are available in blister packs containing 30 tablets, packed in a cardboard carton.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The 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
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, the country of export:
83/374/01-C

Parallel Import Authorisation Number: 302/25

This medicinal product is authorised for sale in the European Economic Area countries 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

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