Package leaflet: Information for the user

Norvasc 5 mg and 10 mg tablets

amlodipine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Norvasc is and what it is used for
What you need to know before taking Norvasc
How to take Norvasc
Possible side effects
How to store Norvasc
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 antagonists.
Norvasc is used to treat high blood pressure (hypertension) or a type of chest pain called angina, including a rare form known as Prinzmetal's angina or variant angina.
In patients with high blood pressure, this medicine works by relaxing blood vessels so that blood can flow more easily. In patients with angina, Norvasc improves blood supply to the heart muscle, providing more oxygen and thereby preventing chest pain. This medicine does not provide immediate relief from angina-related chest pain.

2. What you should know before taking Norvasc

Do not take Norvasc

If you are allergic (hypersensitive) to amlodipine, or to any of the other ingredients of this medicine listed in section 6, or to any of the other calcium antagonists. The reaction may include itching, skin redness, or difficulty breathing.
If you have severe low blood pressure (hypotension)
If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
If you suffer from heart failure following a heart attack

Warnings and precautions
Talk to your doctor or pharmacist before taking Norvasc.
Inform your doctor if you have or have had any of the following conditions:

Recent heart attack
Heart failure
Severe high blood pressure (hypertensive crisis)
Liver disease (hepatopathy)
You are elderly and your dose needs to be increased

Children and adolescents
Norvasc has not been studied in children under 6 years of age. Norvasc should only be used for
hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult your doctor.
Other medicines and Norvasc
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
Norvasc may affect other medicines, or other medicines may affect Norvasc, such as:

ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV treatment)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
verapamil, diltiazem (medicines for the heart)
dantrolene (infusion for severe disturbances in body temperature)
tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the way the immune system works)
simvastatin (cholesterol-lowering medicine)
cyclosporine (an immunosuppressant)

Norvasc may lower blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Norvasc with food and drink
People taking Norvasc should not drink grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an increased hypotensive effect of Norvasc.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you may be pregnant or are planning a pregnancy, inform your doctor before taking Norvasc.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to start breastfeeding, you must inform your doctor before taking Norvasc.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Norvasc may affect your ability to drive or use machinery. If the tablets cause you discomfort, dizziness or fatigue, or give you headaches, avoid driving or using machinery and contact your doctor immediately.
Norvasc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Norvasc

Take this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is Norvasc 5 mg once daily. The dose may be increased to
Norvasc 10 mg once daily.
This medicine can be taken before or after food and drinks. You should 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
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg
daily. The maximum recommended daily dose is 5 mg. Norvasc 5 mg tablets can be
split into two equal parts to achieve a 2.5 mg dose.
It is important to continue taking the tablets for the entire duration indicated by your doctor. Contact
your doctor before stopping the tablets.
If you take more Norvasc than you should
If you take too many tablets, your blood pressure may drop too low, which could be dangerous. You
may experience dizziness, mental confusion, weakness, or fainting. The drop in blood pressure could be
so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness.
If you have taken an excessive number of Norvasc tablets, contact your doctor immediately.
If you forget to take Norvasc
Do not worry. If you forget to take a tablet, skip the missed dose. Take the next tablet at your usual time.
Do not take a double dose to make up for the missed dose.
If you stop taking Norvasc
Your doctor will tell you how long to take the medicine. Your condition may return if you
stop treatment before your doctor advises you to do so.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, consult your doctor immediately:

Sudden onset of breathlessness, chest pain, shortness of breath, or difficulty breathing
Swelling of the eyelids, face, or lips
Swelling of the tongue and throat which may cause difficulty breathing
Severe skin reactions including intense rash, urticaria, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
Heart attack, abnormal heart rhythm
Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise

The following very common side effects have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.
Very common: may affect more than 1 in 10 people

Edema (fluid retention)

The following common side effects have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.
Common: may affect up to 1 in 10 people

Headache, dizziness, drowsiness (especially at the beginning of treatment)
Palpitations (awareness of your heartbeat), flushing
Abdominal pain, nausea
Changes in bowel habits, diarrhoea, constipation, indigestion
Fatigue, weakness
Visual disturbances, double vision
Muscle cramps
Swelling of the ankles

In addition, the following side effects have also been reported.
If any of these side effects worsen, or if you notice any side effect not listed 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
Sensation of numbness or tingling in the limbs; loss of pain sensitivity
Ringing in the ears (tinnitus)
Low blood pressure
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Cough
Dry mouth, vomiting
Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
Urinary disorders, need to urinate at night, frequent need to urinate
Inability to achieve an erection; discomfort or breast enlargement in men
Pain, malaise
Joint or muscle pain, 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

Low levels of white blood cells and platelets in the blood which may result in unusual bruising or tendency to bleed
High blood sugar levels (hyperglycaemia)
A nerve disorder which may cause muscle weakness, tingling or numbness
Swollen gums, bleeding gums
Abdominal swelling (gastritis)
Liver function abnormalities, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory tests
Increased muscle tension
Inflammation of blood vessels, often with skin rash
Light sensitivity
Disorders related to stiffness, tremor and/or movement disturbances

Not known: frequency cannot be estimated from the available data

Tremor, rigid posture, mask-like facial expression, slow movements, and unbalanced, shuffling gait

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 carton after 'EXP'. The expiry date refers to the last day of that month.
Tablets
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Norvasc contains
The active substance in Norvasc 5 mg tablets is amlodipine (as besylate).
The active substance in Norvasc 10 mg tablets is amlodipine (as besylate).
The excipients are: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Description of the appearance of Norvasc and contents of the pack
5 mg tablets: white to off-white, octagonal tablets, engraved with "AML 5" and a score line on one side and the Pfizer logo on the other side.
10 mg tablets: white to off-white, octagonal tablets, engraved with "AML-10" on one side and the Pfizer logo on the other side.
5 mg tablets: white to off-white, octagonal tablets, engraved with "AML 5" and a score line on one side and white on the other side.
10 mg tablets: white to off-white, octagonal tablets, engraved with "AML-10" on one side and white on the other side.

Norvasc 5 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets, in calendar packs containing 28 and 98 tablets, and in single-dose divisible blister strips of 50x1 and 500x1 tablets.
Norvasc 10 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, 500 tablets, in calendar packs containing 28 and 98 tablets, and in single-dose divisible blister strips of 50x1 and 500x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturers
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35,
89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Freiburg site
Mooswaldallee 1
79090 Freiburg
Germany

This medicinal product is authorized in the European Economic Area countries 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
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos, Norvas 10 mg comprimidos
United Kingdom: Amlodipine