Norvasc

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Norvasc (HOPBACK), 5 mg, tablets
amlodipine
Norvasc and HOPBACK are the same brand names of the same medicine written in Polish and Bulgarian.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Norvasc is and what it is used for
2. What you should 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 its rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine relaxes 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 preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. Important information before using Norvasc

When not to use Norvasc

• if the patient has hypersensitivity (allergy) 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, redness of the skin or difficulty in 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 cannot deliver sufficient blood to the body),
• if the patient has heart failure following a recent heart attack.

Warnings and precautions
Before starting Norvasc, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has previously had:

• a recent heart attack
• heart failure
• severe high 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 hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Norvasc with 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 other medicines, or other medicines may affect Norvasc:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John's wort (herbal remedy)
• 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 increase in 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 plans to become pregnant, 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.
Before taking any medicine, consult your doctor or pharmacist.

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 their doctor immediately.

Norvasc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Norvasc

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Norvasc is available in 5 mg and 10 mg tablets.
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 regardless of meals or drinks. It is recommended to take this medicine
at the same time every day, with water. Do not take Norvasc 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 once daily.
The maximum recommended dose is 5 mg once daily. 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 seeing your doctor.

Taking more Norvasc than recommended
Taking too many tablets may cause a reduction, or even a dangerous reduction, in blood pressure.
Symptoms may include dizziness, a sensation of "emptiness" in the head, fainting, or weakness. In cases of severe
low blood pressure, shock may occur. The skin then becomes cold and clammy, and the patient may lose consciousness.
If too many tablets of Norvasc have been taken, contact your doctor immediately or go to the emergency department
of the nearest hospital.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur even 24 to 48 hours after
taking the medicine.

Missing a dose of Norvasc
Stay calm. If a patient forgets to take a tablet, skip the missed dose. 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 inform you how long you should continue taking this medicine. If you stop taking this medicine
before your doctor advises, your condition may return.
If you have any further questions 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 this medicine:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue or 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 of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, cardiac arrhythmias
• Pancreatitis, which may cause sudden 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 troublesome to the patient or if they last longer than one week , 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 troublesome to the patient or if they last longer than one week , 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, dyspepsia
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other reported adverse reactions are listed below. If any of these symptoms worsen 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 of 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
• Increase or decrease in 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 white blood cell count, 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 bloating (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 stiffness, 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 be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
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 required. 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 with bevelled edges, engraved with the code "AML 5" and a division line on one side and the "Pfizer" logo on the other side, or white or almost white, octagonal tablets with bevelled edges, engraved with the code "AML 5" and a division 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, packed in a cardboard carton.

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:
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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Bulgaria, the country of export: 20000435
Parallel import authorisation number: 126/24

This medicinal product is authorised for marketing in the European Economic Area (EEA) Member States 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