Norvasc

Patient Information Leaflet: User Information

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.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Norvasc and what is it 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 is Norvasc and what is it used for

Norvasc contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Norvasc is indicated for the treatment of high blood pressure (hypertension) or chest pain, known as angina pectoris, and its rare form known as Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine widens the blood vessels so that blood can flow more easily. In patients with coronary heart disease, Norvasc facilitates blood flow to the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Norvasc

When not to take Norvasc

• if the patient has been diagnosed with an allergy (hypersensitivity) to amlodipine or 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 a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body),
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Norvasc, the doctor or pharmacist should be consulted.
The doctor should be informed if the patient has or has had:

• Recently had a heart attack
• Heart failure
• Significant increase in blood pressure (hypertensive crisis)
• Liver disease
• Necessity to increase the dose in elderly patients

Children and adolescents

No studies have been conducted on the use of Norvasc in children under 6 years of age. Norvasc can only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain further information, the doctor should be consulted.

Norvasc and other medicines

The doctor or pharmacist should be told about all medicines the patient is 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:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (used 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)
• cyclosporin (an immunosuppressive medicine)

Norvasc may lower blood pressure more, if the patient is taking other anti-hypertensive medicines.

Norvasc with food and drink

Patients taking Norvasc should not consume grapefruit juice or grapefruits, as they may cause an increase in the level of the active substance - amlodipine - in the blood, which may result in an unexpected increase in the effect of Norvasc, lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
There is no data on the safety of amlodipine during pregnancy. If the patient suspects pregnancy or plans to become pregnant, they should inform their doctor before taking Norvasc.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should inform their doctor before starting to take Norvasc.
Before taking any medicine, the doctor or pharmacist should be consulted.

Driving and using machines

Norvasc may affect the ability to drive and use machines. If the tablets cause nausea, dizziness, or fatigue, or headache, the patient should not drive or operate machinery; they should contact their doctor immediately.

Norvasc contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Norvasc

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Norvasc is available in tablets of 5 mg and 10 mg.
The recommended initial dose of Norvasc is 5 mg once a day. The dose may be increased to 10 mg once a day.
This medicine can be taken with or without food and drinks. It is recommended to take this medicine every day at the same time, with a glass of water. Norvasc should not be taken with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years), the usual recommended initial dose is 2.5 mg once a day.
The maximum recommended dose is 5 mg once a day. Norvasc 5 mg tablets can be divided into two equal doses of 2.5 mg.
It is essential to take the tablets continuously. The patient should not wait until all the tablets have been used before visiting the doctor.

Taking a higher dose of Norvasc than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In case of a significant decrease in blood pressure, shock may occur. The skin becomes cold and moist, and the patient may lose consciousness. If too many Norvasc tablets have been taken, the patient should contact their doctor or go to the emergency department of the nearest hospital immediately.
Even 24-48 hours after taking the medicine, shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Norvasc

The patient should remain calm. If they forget to take a tablet, they should skip it.
The next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping the use of Norvasc

The doctor will inform the patient how long they should take this medicine. If the patient stops taking this medicine before the doctor advises, the illness may recur.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Norvasc can cause side effects, although not everybody gets them.
The doctor should be contacted immediatelyif any of the following side effects 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 severe difficulty breathing
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and skin swelling, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, arrhythmias
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition

The following very common side effectshave been reported. If any of these side effects are troublesome for the patient or if they last for more than a week, the doctor should be contacted.

Very common side effects: occurring in at least 1 in 10 patients

• Swelling (fluid retention)

The following common side effectshave been reported. If any of these side effects are troublesome for the patient or if they last for more than a week, the doctor should be contacted.

Common side effects: occurring in less than 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other reported side effects are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Uncommon side effects: occurring in less than 1 in 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, lack of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/rhinitis (inflammation of the nasal mucosa)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Sexual disorders, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, back pain
• Weight increase or decrease

Rare side effects: occurring in less than 1 in 1,000 patients

• Disorientation

Very rare side effects: occurring in 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 sugar levels (hyperglycemia)
• Nerve disorders that can cause muscle weakness, tingling, or numbness
• Gingival swelling, bleeding gums
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremor, and (or) difficulty in movement

Frequency not known: cannot be estimated from the available data

• Tremor, stiff posture, mask-like face, slow movements, and a shuffling, unbalanced gait

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 181 C Jerozolimskie Avenue, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Norvasc

The medicine should be kept out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Norvasc contains

The active substance of Norvasc is amlodipine.
Each tablet contains 5 mg of amlodipine (as amlodipine besylate).
The other ingredients are: calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, sodium carboxymethylcellulose (type A).

What Norvasc looks like and contents of the pack

5 mg tablets: White or almost white, octagonal tablets with "AML 5" and a score 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 with "AML 5" and a score line on one side, without any marking on the other side.
The tablet can be divided into equal doses.
Norvasc 5 mg, tablets are available in blisters containing 30 tablets in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in the Czech Republic, the 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
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Parallel importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/374/01-C
Parallel import authorization number:28/19

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of approval of the leaflet: 18.01.2024

[Information about the trademark]