Norvasc

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Norvasc (HOPBACK) 10 mg, tablets
amlodipine
Norvasc and HOPBACK are the same trade names for the same medicine written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific 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 tell 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 called 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

Warnings and precautions

Before starting to take Norvasc, you should discuss it with your doctor or pharmacist.
You should inform your doctor if you have or have 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, you should consult a doctor.

Norvasc and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Norvasc may interact with other medicines or other medicines may interact with Norvasc:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (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 body temperature disorders)
• 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 you are taking other antihypertensive 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 using amlodipine during pregnancy. If you suspect pregnancy or plan to become pregnant, you should tell your doctor before taking Norvasc.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, you should tell your doctor before taking Norvasc.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Norvasc may affect your ability to drive and use machines. If the tablets cause nausea, dizziness, or fatigue, or headache, you should not drive or operate machinery; you should contact your 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 according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg doses.
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 regardless of meals and drinks. It is recommended to take this medicine every day at the same time, with water. You should not take Norvasc with grapefruit juice.

Use in children and adolescents

In children and adolescents (6-17 years old), the usual recommended initial dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day. Norvasc 5 mg tablets can be divided into halves to obtain a 2.5 mg dose.
It is essential to take the tablets continuously. You should not wait until all the tablets have been used before visiting your 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. You 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 wet, and you may lose consciousness. If you have taken too many Norvasc tablets, you should contact your 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

You should remain calm. If you forget to take a tablet, you should skip it.
You should take the next dose at the usual time. You should not take a double dose to make up for the 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 recommends, your illness may recur.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Norvasc can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you experience any of the following side effects 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 increased rash, hives, redness of the skin, 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 the side effects are troublesome for you or last more than a week, you should contact your doctor.

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 the side effects are troublesome for you or last more than a week, you should contact your doctor.

Common side effects: occurring in no more 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 worsen or if you experience any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling of limbs, lack of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/rhinitis caused by inflammation of the nasal mucosa (rhinitis)
• 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
• Erectile dysfunction, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, back pain
• Weight gain or loss

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

• Disorientation

Very rare side effects: occurring in fewer 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, gingival bleeding
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, jaundice, increased liver enzyme activity, found in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremors, and/or difficulty moving

Frequency not known: cannot be estimated from the available data

• Tremors, stiff posture, mask-like face, slow movements, and a shuffling, unsteady gait

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norvasc

The medicine should be stored out of sight and reach of children.
You should not use this medicine 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. You should 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 of Norvasc is amlodipine.
Each tablet contains 10 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

White or almost white, octagonal tablets with beveled edges, with the inscription "AML-10" on one side and the "Pfizer" logo on the other side or white or almost white, octagonal tablets with beveled edges, with the inscription "AML-10" on one side, without markings on the other side.
Norvasc 10 mg, tablets are available in blisters containing 30 tablets in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands

Manufacturer:

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20000436

Parallel import authorization number: 127/24

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 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 10 mg comprimidos;
United Kingdom: Amlodipine

Date of approval of the leaflet: 20.03.2024

[Information about the trademark]