Norvasc

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Norvasc (Zorem), 5 mg, tablets
Amlodipine
Norvasc and Zorem are different trade names for the same medicine.
Please read the 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 another person, 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:

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 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 (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot 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:

• Recent heart attack
• Heart failure
• Marked increase in 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, 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 (so-called protease inhibitors used in the treatment of HIV)
• 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 could result in 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 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 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 their 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 take Norvasc

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Norvasc is available in tablets of 5 mg and 10 mg strength.
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 independently of food 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 per day.
The maximum recommended dose is 5 mg per day. Norvasc 5 mg tablets may be divided into halves
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 visiting
your doctor.

Taking more Norvasc than recommended
Taking too many tablets may cause a decrease, or even a dangerous reduction, in blood pressure.
Symptoms may include dizziness, a "hollow" feeling in the head, fainting, or weakness. In cases of
severe hypotension, shock may occur. The skin then becomes cold and moist, 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 due to excess fluid accumulating in the lungs (pulmonary oedema) may occur up to
24–48 hours after taking the medicine.

If you miss a dose of Norvasc
Stay calm. If a patient forgets to take a tablet, simply 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 advise you on 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 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, 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 acute 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, 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 last longer than one week, contact your doctor.
Common adverse reactions: affecting up to 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, dyspepsia
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling

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 of 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 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: 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
• Movement 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 those 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 181 C, 02-222 Warsaw, tel.: +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 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.
Store below 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 packaging 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
5 mg tablets: White or almost white, octagonal tablets, embossed with "AML 5" and a division line on one side and the Pfizer logo on the other side.
The tablet can be divided into equal doses.
5 mg tablets: White or almost white, octagonal tablets, embossed with "AML 5" and a division line on one side, without marking on the other side.
The tablet can be divided into equal doses.
Norvasc 5 mg tablets are available in blisters containing 30 tablets per cardboard box.

For further information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in the Czech Republic, 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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 83/374/01-C
Parallel import authorisation number: 28/19

This medicinal product is authorised 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 5 mg tablets, Amlodipine Upjohn 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos, Norvas 10 mg comprimidos
United Kingdom: Amlodipine