Norvasc

Warning!
Keep the leaflet. Information on the immediate packaging 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 for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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. 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 a rare form of angina 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 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 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:

• a recent heart attack,
• heart failure,
• significantly elevated 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 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 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, which in turn may 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 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 breast milk. If the patient is breastfeeding or plans 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 or 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. the medicine 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 strengths.
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 and drinks. It is recommended to take this medicine
at the same time every day, with water. Norvasc must 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 seeing your doctor.
Taking more Norvasc than prescribed
Taking too many tablets may cause a reduction or even dangerous lowering of 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 a doctor immediately or go to the nearest hospital emergency department.
Breathing difficulties due to fluid accumulation in the lungs (pulmonary edema) may occur even up to 24–48 hours after taking the medicine.
Missing a dose of Norvasc
Stay calm. If a patient forgets to take a tablet, the missed dose should be skipped.
The next dose should be taken 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 take this medicine. If you stop taking this medicine before your doctor advises,
your condition may return.
If you have any further doubts 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 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 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, heart 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 reactions have been reported. If any of these adverse reactions are troublesome for the patient or last longer than one week, you should 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 last longer than one week, you should 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 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 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.
• Increased or decreased 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 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.
• Inflammation of blood vessels, 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 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 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. These 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: 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, polygonal tablets marked with "AML-10" on one side and "Pfizer" on the other side of the tablet.
Norvasc is available in blister packs containing 30 tablets.
For further information, please contact the marketing authorization holder or parallel importer.

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

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

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

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

Marketing authorization number in Romania, country of export: 5655/2013/01
Parallel import authorization number: 336/18

This medicinal product is authorized for sale in the European Economic Area countries 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 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 10 mg comprimidos
United Kingdom: Amlodipine