Norvasc

Patient Information Leaflet: User Information

Warning! The leaflet should be kept. 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 drug.

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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. Package contents 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 drugs 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 drug 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 drug 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 drug 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 patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they have or have had:

• a recent heart attack,
• heart failure,
• a significant increase in blood pressure (hypertensive crisis),
• liver disease,
• a need 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 patient should consult their doctor.

Norvasc and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Norvasc may interact with other drugs or other drugs may interact with Norvasc:

• ketokonazole, itraconazole (antifungal drugs),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort,
• verapamil, diltiazem (drugs used to treat heart conditions),
• dantrolene (used in severe body temperature disorders),
• tacrolimus, sirolimus, temsirolimus, and everolimus (drugs that suppress the patient's immune system),
• simvastatin (a drug that lowers cholesterol levels),
• cyclosporine (an immunosuppressive drug).

Norvasc may lower blood pressure more if the patient is taking other antihypertensive drugs.

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 drug, the patient should consult their 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; they should contact their doctor immediately.

Norvasc contains sodium

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

3. How to take Norvasc

This drug should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their 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 drug can be taken with or without food and drinks. It is recommended to take this drug 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 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. The patient should not wait until all the tablets have been used before visiting their 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 the case of a significant decrease in blood pressure, shock may occur. The skin becomes cold and wet, and the patient may lose consciousness. If the patient has taken too many Norvasc tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.
Even 24-48 hours after taking the drug, shortness of breath due to 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. The patient should not take a double dose to make up for the missed dose.

Stopping Norvasc treatment

The doctor will inform the patient how long they should take this drug. If the patient stops taking this drug before their doctor advises, the illness may recur.
If the patient has any further doubts about taking this drug, they should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Norvasc may cause side effects, although not everybody gets them.
The patient should immediatelycontact their doctor if they experience any of the following side effects after taking Norvasc:

• 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 in breathing,
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense 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 last more than a week, they should contact their 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 these side effects are troublesome for the patient or last more than a week, they should contact their 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,
• change in bowel movements, diarrhea, constipation, indigestion,
• fatigue, weakness,
• vision 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,
• tremors, taste disturbances, fainting,
• numbness or tingling of limbs, lack of pain sensation,
• ringing in the ears,
• low blood pressure,
• coughing/runny nose due to 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,
• erectile dysfunction, discomfort or enlargement of the breasts in men,
• pain, poor general condition,
• joint or muscle pain, back pain,
• weight gain or loss.

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

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and easier bleeding,
• high blood sugar levels (hyperglycemia),
• nerve disorders that may cause muscle weakness, tingling, or numbness,
• gum swelling, gum bleeding,
• abdominal distension (gastritis),
• abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests,
• increased muscle tension,
• inflammation of blood vessels, often with skin rash,
• sensitivity to light,
• disorders including stiffness, tremors, and (or) difficulty in movement.

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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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 collected on the safety of the drug.

5. How to store Norvasc

The drug should be stored out of sight and reach of children.
The drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
The drug should not be stored at temperatures above 25°C.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Norvasc contains

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

What Norvasc looks like and what the package contains

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

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 83/374/01-C

Parallel import authorization number: 361/17

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 leaflet approval:27.02.2024
[Information about the trademark]