NORVASC

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Norvasc (Zorem), 10 mg, tablets
amlodipine
Norvasc and Zorem are different trade names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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. What you need to know 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, increasing oxygen supply, thereby preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina pectoris.

2. Important information before using Norvasc

When not to use Norvasc

• if the patient has hypersensitivity (allergy) 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, skin redness, or difficulty 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 cannot deliver sufficient blood to the body),
• if the patient has heart failure following a previous heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Norvasc.
Inform your doctor if the patient has or has previously had:

• Recent heart attack
• Heart failure
• Severe increase in 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 interact with other medicines, or other medicines may affect Norvasc:

• ketoconazole, itraconazole (antifungal agents)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV treatment)
• 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 agents)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporine (an immunosuppressive medicine)

Norvasc may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.

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

Pregnancy and breastfeeding
Pregnancy
There are no data on the safety of amlodipine use during pregnancy. If the patient suspects she is pregnant or plans to become pregnant, she should 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 Norvasc.

Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines
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 their 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 instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg strengths.
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 independently of food and drinks. It is recommended to take this medicine
at the same time each 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 up before
visiting your doctor.
Taking more Norvasc than recommended
Taking too many tablets may cause a reduction, or even a dangerous reduction, in 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 too many Norvasc tablets have been taken, contact a 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 up to 24–48 hours after taking the medicine.
If you miss a dose of Norvasc
Stay calm. If a patient forgets to take a tablet, skip that 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 advise you on 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should contact your doctor immediately if any of the following adverse effects occur 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 significant difficulty in breathing
• Severe skin reactions, including severe rash, urticaria, redness of the entire body surface, intense itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Myocardial infarction, heart rhythm disorders
• Pancreatitis, which may cause sudden severe upper abdominal pain radiating to the back, accompanied by a very poor general condition

The following very common adverse effects have been reported. If any of these adverse effects are troublesome to the patient or last longer than one week, contact your doctor.
Very common adverse effects: occurring in at least 1 out of 10 patients

• Swelling (fluid retention)

The following common adverse effects have been reported. If any of these adverse effects are troublesome to the patient or last longer than one week, contact your doctor.
Common adverse effects: occurring in no more than 1 out of 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, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

Other reported adverse effects are listed below. If any of the adverse symptoms worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse effects: occurring in fewer than 1 out of 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
• Increase or decrease in body weight

Rare adverse effects: occurring in fewer than 1 out of 1,000 patients

• Disorientation

Very rare adverse effects: occurring in fewer than 1 out of 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 distension (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, slowed movements, and shuffling, unbalanced gait

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to 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 specified month.
Store below 25°C.
Medicines must 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. Package contents and other information

What Norvasc contains
The active substance is amlodipine.
Each tablet contains 10 mg of amlodipine (as amlodipine besylate).
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, marked with "AML 10" on one side and "Pfizer" on the other side of the tablet.
Norvasc 10 mg tablets are available in blister packs containing 30 tablets in a cardboard box.
The pack contains 3 blisters with 10 tablets each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den Ijssel
The Netherlands

Manufacturer:
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 83/375/01-C
Parallel import authorisation number: 116/23

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:

Tablets:
Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Iceland, Hungary, Italy, Latvia, Lithuania,
the 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