Norvasc

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Norvasc, 5 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 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 individual. Do not give it to others. This medicine may harm someone else, even if their symptoms of illness are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell 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 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 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 myocardial infarction.

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

• Recent myocardial infarction
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• Requirement 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 with other medicines
Tell your doctor or pharmacist about any 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 more strongly 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 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 plans 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 exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg tablets.
The recommended initial 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 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 a dangerous drop, in blood pressure.
Symptoms may include dizziness, a sensation of "emptiness" in the head, fainting, or weakness. In
cases of severe hypotension, shock may occur. The skin becomes cold and clammy, and the patient
may lose consciousness. If an overdose of Norvasc is taken, contact a doctor immediately or go to
the emergency department of the nearest hospital.
Breathlessness due to fluid accumulation 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 continue taking this medicine. If you stop taking
this medicine before your doctor advises, your condition may recur.
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, urticaria, redness of the entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, cardiac 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 troublesome for the patient or if they last longer than one week, contact your doctor.
Very common adverse reactions: occurring in at least 1 out of 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, contact your doctor.
Common adverse reactions: 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
• 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: occurring in less than 1 out of 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 disturbances, 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 reactions: occurring in less than 1 out of 1,000 patients

• Disorientation

Very rare adverse reactions: occurring in less than 1 out of 10,000 patients

• Decreased number of white blood cells, decreased number of platelets, which may lead to occurrence of 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 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 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 the 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 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. Such measures will help 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 marked with "AML 5" and a division line on one side and "VLE"
on the other side of the tablet. The tablet can be divided into equal doses.
Norvasc 5 mg tablets are available in blister packs containing 30 tablets, packed in a cardboard box.

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

Marketing Authorisation Holder in Romania, the 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
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice, Czech Republic

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 Romania, the country of export: 5654/2013/01
Parallel Import Licence Number: 55/18

This medicinal product is authorised in the European Economic Area member states under the following names:
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 5 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos
United Kingdom: Amlodipine