Norvasc

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Norvasc (NORVASK), 5 mg, tablets
amlodipine
Norvasc and NORVASK are different trade names of the same medicinal product, written in
Polish and Bulgarian languages.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any further questions, please 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 similar.
• 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. What you need to know 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 less common 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 helping to prevent 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, skin redness or difficulty 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 had:

• Recent heart attack
• Heart failure
• Severe 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 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, 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 (so-called 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 grapefruit, as these may increase the blood concentration of the active substance amlodipine, which could 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 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.

Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Norvasc may affect the ability to drive and use 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. essentially "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.
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 with or without food and drink. It is recommended to take this medicine
at the same time each 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 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 prescribed
Taking too many tablets may cause a decrease or even dangerous lowering of blood pressure.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. In cases of severe
hypotension, 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 oedema) may occur
up to 24–48 hours after taking the medicine.

If you forget to take Norvasc
Stay calm. If a dose is missed, skip that dose and 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 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 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
• Myocardial infarction, cardiac arrhythmias
• 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 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 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
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

Other reported adverse reactions are listed below. If any adverse reaction worsens 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/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
• 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 number of white blood cells, 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 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 rigidity, 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of 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: http://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorisation holder or parallel importer. 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 in use. 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 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 score line on one side and "VLE"
or no marking on the other side of the tablet.
Norvasc 5 mg tablets are available in blisters containing 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

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

Manufacturer:
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Number in Bulgaria, the country of export: 20000435
Parallel Import Marketing Authorisation Number: 119/25
This medicinal product is authorised in the European Economic Area under the following names:

Tablets:
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