Norvasc

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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 in the form of amlodipine besylate, 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 a rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine relaxes 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 a known allergy (hypersensitivity) 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 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 recent 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
• 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, consult your doctor.

Norvasc and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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
• 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 grapefruit, as they 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 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 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 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 directed by your doctor or pharmacist. If in doubt,
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 regardless of meals or 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 once daily.
The maximum recommended dose is 5 mg once daily.
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 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 too many Norvasc tablets have been taken, contact your doctor immediately or
go to the emergency department of the nearest hospital.
Breathlessness caused by excess fluid accumulating in the lungs (pulmonary oedema) may occur
even up to 24–48 hours after taking the medicine.
If you miss a dose of Norvasc
Stay calm. If you forget 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
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following adverse reactions 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, hives, redness of the entire skin surface, intense itching, blisters, skin peeling, and skin swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, heart rhythm disorders
• Pancreatitis, which may cause acute pain in the upper abdomen radiating to the back, accompanied by severe malaise

The following very common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or if they last longer than one week, you should 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 troublesome for the patient or if they last longer than one week, you should 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, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

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 in 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 disorders, 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
• 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 determined from available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions 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 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Norvasc contains
The active substance is amlodipine (in the form of amlodipine besilate).
Each tablet contains 10 mg of amlodipine.
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, polygonal tablets marked with "AML-10" on one side and "VLE" on the other side of the tablet.
Norvasc 10 mg tablets are available in PVC-PVDC/Al blisters in a cardboard carton containing 30 tablets.

For more detailed information, please contact the responsible party or the parallel importer.

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

Manufacturer:
Medis International a.s.
Prumyslova 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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorization number in Romania, 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

This medicinal product is authorized for marketing 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 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 10 mg comprimidos
United Kingdom: Amlodipine

Other sources of information
Detailed information about 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/