Leaflet: information for the user

Norvas 10 mg tablets

amlodipino

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceside effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What isNorvasand what it is used for

2.What you need to knowbeforestarting totakeNorvas

3.How to takeNorvas

4.Side effects

5.Storage ofNorvas

6.Contents of the pack and additional information

Norvascontains the active substance amlodipine whichbelongs to a group of medications known ascalcium antagonists.

Norvasis used to treathigh blood pressure(hypertension)or a certain type of chest pain called angina, which includes a less common type known asPrinzmetal's anginaor variant angina.

In patients withhigh blood pressure, this medication works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina,Norvasimproves blood flow to the heart muscle, which receives more oxygen as a result, thereby preventing chest pain. This medication does not provide immediate relief from chest pain due to angina.

Do not take Norvas

• If you are allergic (hypersensitive) to amlodipine, or any of the other components of this medication (listed in section 6), or to any other calcium antagonist.This may cause itching, skin redness, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Norvas.

You must inform your doctor if you have or have had any of the following diseases:

• Recent heart attack

• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are an elderly person and your dose needs to be increased

Children and adolescents

Norvas has not been studied in children under 6 years of age.Norvas should only be used to treat high blood pressure in children and adolescents from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Use of Norvas with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Norvas may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (intravenous for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• simvastatin (cholesterol-lowering medication)
• ciclosporin (immunosuppressant)

If you are already taking other medications to treat high blood pressure, Norvas may lower your blood pressure even further.

Taking Norvas with food and drinks

People taking Norvas should not consume grapefruit or grapefruit juice.This is because grapefruit and grapefruit juice may lead to an increase in the blood levels of the active ingredient amlodipine, which may cause an unpredictable increase in the effect of lowering blood pressure of Norvas.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established.If you think you may be pregnant, or are planning to become pregnant, you must inform your doctor before taking Norvas.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts.If you are breastfeeding, or are about to start, you must inform your doctor before taking Norvas.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Norvas may affect your ability to drive or operate machinery.If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or operate machinery and consult your doctor immediately.

Norvas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 5 mg of Norvas, once a day. The dose can be increased to 10 mg of Norvas, once a day.

You can take this medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Norvas with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day. Norvas 5 mg tablets can be divided in half to provide a dose of 2.5 mg.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets run out to visit your doctor.

If you take more Norvas than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, dazed, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and moist and could lose consciousness.

If you take too many Norvas tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

Excess fluid can accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after consumption.

If you forget to take Norvas

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Norvas

Your doctor will indicate for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek medical attention immediately if you experience any of the following side effects after taking this medicine.

• Sudden hissing sounds when breathing (sibilant breathing), chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, severe itching, blister formation, skin peeling, and skin inflammation, or other allergic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Heart attack, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great sense of discomfort

The following side effect has been reported as very frequent.If this causes problems or lasts more than a week, consult your doctor.

Very frequent: can affect more than 1 in 10 people

• Edema (fluid retention)

The following side effects have been reported as frequent.If any of these cause problems or last more than a week, consult your doctor.

Frequent: can affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, sense of discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following side effects have been reported.If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent: can affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the extremities, loss of pain sensation
• Tinnitus in the ears
• Decreased blood pressure
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast enlargement in men
• Pain, sense of discomfort
• Pain in the muscles or joints, back pain
• Weight gain or loss

Rare: can affect up to 1 in 1,000 people

• Confusion

Very rare: can affect up to 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, numbness, or tingling
• Gingivitis, bleeding gums
• Abdominal swelling (gastritis)

• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movement disorders combining rigidity, tremor, and/or movement disorders

Unknown frequency: cannot be estimated from available data

• Tremor, stiff posture, mask-like face, slow movements, and a dragging, unsteady gait

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Askyour pharmacist how to dispose of the packaging and medications you no longer need. In this way,you will help protect the environment.

Composition ofNorvas

The active ingredient of Norvas 10 mg tablets is amlodipine (as besilate).

The other components are anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate Type A.

Appearance of the product and contents of the package

White to off-white tablets, in the shape of an emerald, marked with AML-10 on one face and VLE on the other face.

Norvas 10 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, and 500 tablets, calendar packs with 28 and 98 tablets, and in single-dose blisters containing 50x1 and 500x1 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

MEDIS INTERNATIONAL a.s., production plant Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Tablets:

Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sweden: Norvasc

Czech Republic: Zorem

Ireland, Malta, United Kingdom: Istin

Ireland: Amlodipine Pfizer 5 mg tablets, Amlodipine Pfizer 10 mg tablets

Italy: Amlodipina Pfizer Italia

Spain: Norvas 5 mg tablets, Norvas 10 mg tablets

United Kingdom: Amlodipine 5 mg tablets. Amlodipine 10 mg tablets

Last review date of thisleaflet: July 2022

The detailed information about this medicine is availableonthe website of the Spanish Agency for Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/