Norvasc

Patient Information Leaflet: User Information

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

Norvasc 5 mg, tablets
amlodipine

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

• Keep this leaflet, so you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 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 supply of oxygen, 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, discuss it with your doctor or pharmacist.
Tell 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, consult a doctor.

Norvasc and other medicines

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 for 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 when taken with other blood pressure-lowering medicines.

Norvasc with food and drink

Patients taking Norvasc should not consume grapefruit juice or grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may lead to 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 you suspect you are pregnant or plan to become pregnant, 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, tell your doctor before taking Norvasc.
Before taking any medicine, 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, do not drive or operate machinery; 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg strengths.
The recommended initial 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 drinks. It is recommended to take this medicine every day at the same time, with a glass of water. Do not take Norvasc 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 daily.
The maximum recommended dose is 5 mg once daily.
Norvasc 5 mg tablets can be divided into halves to obtain a 2.5 mg dose.
It is important to take the tablets continuously. Do not wait until all the tablets have been used before visiting your doctor.

Taking more than the recommended dose of Norvasc

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. Dizziness, feeling of "emptiness" in the head, fainting, or weakness may occur. In case of a significant decrease in blood pressure, shock may occur. The skin becomes cool and moist, and the patient may lose consciousness. If you have taken too many Norvasc tablets, 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 due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Norvasc

Stay calm. If you forget to take a tablet, skip it.
Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Norvasc treatment

Your doctor will tell you how long to take this medicine. If you stop taking this medicine before your doctor tells you to, your condition may get worse.
If you have any further questions about taking this medicine, ask your 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 breathing difficulties
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and skin swelling, as well as 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 get serious 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 get serious or last more than a week, you should contact your doctor.

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 of the face
• 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 serious or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling of limbs, loss of pain sensation
• Ringing in the ears
• 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 of the skin, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Sexual dysfunction, discomfort or enlargement of the breasts in men
• Pain, malaise
• Joint or muscle pain, 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
• Gum swelling, gum bleeding
• 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, 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, unbalanced gait

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 carboxymethylcellulose (type A).

What Norvasc looks like and contents of the pack

White or almost white, octagonal tablets with "AML 5" and a score line on one side and "Pfizer" on the other side of the tablet. The tablet can be divided into equal doses.
Norvasc 5 mg, tablets are available in blisters containing 30 tablets in a cardboard box.
To obtain more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

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

Manufacturer:

R-Pharm Germany GmbH
Heinrich-Mack-Str.35, 89257 Illertissen, Germany
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
Authorization number in Croatia, the country of export:HR-H-228396781-01

Parallel import authorization number: 181/24

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 5 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos;
United Kingdom: Amlodipine

Date of approval of the leaflet: 06.05.2024

[Information about the trademark]