NORVAS 10 mg TABLETS

2. What you need to know before you take Norvas

Do not take Norvas

• If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. 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 have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Norvas.

You should inform your doctor if you have or have had any of the following conditions:

• Recent heart attack

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

Children and adolescents

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

For more information, consult your doctor.

Using Norvas with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
• simvastatin (a medicine that lowers cholesterol)
• cyclosporin (an immunosuppressant)

If you are already taking other medicines 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 can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect 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 should inform your doctor before taking Norvas.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Norvas contains sodium

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

3. How to take Norvas

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 medicine before or after meals. You should take it at the same time each 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 old), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day. The 5 mg Norvas tablets can be divided into equal halves to provide a 2.5 mg dose.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Norvas than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from 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 wet, and you could lose consciousness. If you take too many Norvas tablets, consult your doctor immediately or call the Toxicology Information Service, telephone 91 562 04 20.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

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 make up for forgotten doses.

If you stop taking Norvas

Your doctor will indicate how long you should take this medicine. Your illness may recur if you stop taking this medicine before your doctor indicates.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Go to your doctor immediately if you experience any of the following side effects 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 and throat, causing great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

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

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

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

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (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, which are included in the following list. If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or breast enlargement in men
• Pain, feeling unwell
• Pain in the muscles or joints, back pain
• Weight gain or weight loss

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

• Confusion

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

• Decrease in the number of white blood cells, decrease in blood platelets, which can cause easy bleeding or unusual bruising
• Excess sugar in the blood (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis, gum bleeding
• Abdominal swelling (gastritis)

• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can have an effect on some medical tests
• Increased muscle tension
• Inflammation of the blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremor, and/or movement disorders

Frequency not known: cannot be estimated from the available data

• Tremor, rigid posture, mask-like face, slow movements, and an unsteady and unbalanced gait

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Norvas

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 pack after EXP. The expiry date is the last day of the month stated.

Do not store above 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

Composition of Norvas

The active substance of Norvas 10 mg tablets is amlodipine (as besylate).

The other ingredients are anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate type A potato.

Appearance of the product and pack contents

White to off-white tablets, emerald-shaped, 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, 500 tablets, calendar packs with 28 and 98 tablets, and in unit-dose blisters containing 50x1 and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

MEDIS INTERNATIONAL a.s., výrobní závod 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 ask for 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 under 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

Date of last revision of this leaflet: July 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/