Norvasc

Caution!
Please retain the 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 for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
• 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. 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 angina-related chest pain.

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 deliver 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 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 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 other medicines, or other medicines may affect Norvasc:

• ketoconazole, itraconazole (antifungal medicines),
• 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 (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—leading 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 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.

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 exactly as directed by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg doses.
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 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 before visiting
the 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 caused by excess fluid accumulating in the lungs (pulmonary edema) may occur
even up to 24–48 hours after taking the medicine.
Missing a dose of Norvasc
Remain 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
The doctor will inform the patient how long this medicine should be taken. If the patient stops
taking this medicine before the doctor advises, the condition may recur.
If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediately contact your doctor 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 and throat causing significant difficulty in breathing.
• Severe skin reactions, including severe rash, urticaria, generalized redness of the skin, intense itching, blisters, skin peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, heart rhythm disturbances.
• Pancreatitis, which may cause acute abdominal pain 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 to the patient or last longer than one week , contact a 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 to the patient or last longer than one week , contact a 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 symptoms 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 of 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 spots on the skin, 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 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 bruises 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).
• Abnormal liver function, hepatitis, jaundice, increased liver enzyme activity detected in blood tests.
• Increased muscle tone.
• Vasculitis, often with skin rash.
• Photosensitivity.
• 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 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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. This will help protect the environment.

6. Contents of the package and other information

What Norvasc contains
The active substance is amlodipine.
Each tablet contains 5 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 5" and a division line on one side and "Pfizer"
on the other side of the tablet. The tablet can be divided into equal doses.
Norvasc is available in PVC-PVDC/Al blisters containing 30 tablets.
For further information, please contact the responsible party or parallel importer.

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

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

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation number in Romania, country of export: 5654/2013/01
Parallel import licence number: 71/23

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,
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