NORVASC

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Norvasc
10 mg, tablets
Amlodipine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if needed.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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 package 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, 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 deliver sufficient blood to the body),
• if the patient has heart failure following a heart attack.

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

• Recent heart attack
• Heart failure
• Marked 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 arterial 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 if the patient is currently taking, has recently taken or might take any other medicines.
Norvasc may affect the action of other medicines or other medicines may affect 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 (medicines that suppress the patient's immune system)
• 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 grapefruits, as they may increase the blood concentration of the active substance amlodipine, which could lead to an unexpected intensification of the blood pressure-lowering effect of Norvasc.

Pregnancy and breastfeeding
Pregnancy
There are no 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 your 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. this medicine is considered "sodium-free".

3. How to take Norvasc

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
you should 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 with or without food and drinks. It is recommended to take this medicine
at the same time each day, with water. Norvasc should not be taken 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
once daily. The maximum recommended dose is 5 mg once daily. Norvasc 5 mg tablets may be
split 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 decrease or even a dangerous drop in blood pressure.
Dizziness, a "hollow" feeling 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 your doctor immediately or
go to the nearest hospital emergency department.
Missed dose of Norvasc
Stay calm. If a dose is missed, 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
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 breathing difficulties
• Severe skin reactions, including severe rash, urticaria, generalized redness of the skin, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, cardiac rhythm disorders
• Pancreatitis, which may cause 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, dyspepsia
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling

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

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/nasal congestion 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 disturbances, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or breast enlargement in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increase or decrease in body weight

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

• Disorientation

Very rare adverse effects: occurring in less 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 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, 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 Drug Reactions of the Office for Registration 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
Reporting adverse effects helps to provide 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 stated on the carton after EXP. 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. Such measures will help protect the environment.

6. Contents of the packaging 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: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (type A), magnesium stearate.

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.

Norvasc 10 mg tablets are available in blisters containing 30 tablets.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen
Germany

Parallel importer:
Pharmapoint SA
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Poland
Prodlekpol Sp. z o.o.
Chełmżyńska 249
04-458 Warszawa
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warszawa
Poland

Marketing authorisation number in Romania, country of export: 5655/2013/01
Parallel import authorisation number: 189/18

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