Norvasc

Warning! The package leaflet must be retained. Information on the immediate packaging is in a foreign language.
Norvasc (Istin), 10 mg, tablets
Amlodipine
Norvasc and Istin are different brand names for the same medicine.
Please read this leaflet carefully before using the 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 give it to 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.

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, 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.

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 recent 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,
• 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
Inform 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 (herbal remedy),
• verapamil, diltiazem (medicines used for heart conditions),
• dantrolene (used intravenously in severe disturbances of body temperature),
• tacrolimus, sirolimus, temsirolimus, and everolimus (immunosuppressive medicines),
• 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 is insufficient 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 Norvasc.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
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 used 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 tablets.
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. 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. 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 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 then 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 oedema) may occur even up to
24–48 hours after taking the medicine.
If you miss a dose of Norvasc
Remain calm. If a dose is missed, skip it. 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 advise you on how long to continue taking 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 experiences 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 or throat causing significant breathing difficulties.
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blisters, peeling and swelling of the skin, 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 bothersome to the patient or if they 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 bothersome to the patient or if they 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, indigestion.
• Fatigue, weakness.
• Vision disturbances, double vision.
• Muscle cramps.
• Swelling of 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 the limbs, loss of pain sensation.
• Tinnitus.
• Low blood pressure.
• Sneezing/runny nose 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 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 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, 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 this medicine can be collected.

5. How to store Norvasc

Keep the 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. This will help protect the environment.

6. Contents of the pack 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, octagonal tablets marked with "AML-10" on one side and "VLE" on the other side of the tablet.
Norvasc is available in blisters containing 28 tablets.

Translation of some abbreviations appearing on the blister:
MON - Monday
TUE - Tuesday
WED - Wednesday
THU - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday

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

Responsible party in Ireland, 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

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

Irish (country of export) licence number: PA 23055/012/002
Parallel import licence number: 113/21

This medicine is authorised 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