NORVASC 5 мг Таблетка

Содержание инструкции

1. What is Norvasc and what is it used for
2. What you need to know before taking Norvasc
3. How to take Norvasc
4. Possible side effects
5. How to store Norvasc
6. Package Contents and Other Information

Norvasc 5 mg and 10 mg tablets
amlodipine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Norvasc is and what it is used for
• 2. What you need to know before you take 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 is Norvasc and what is it used for

Norvasc contains the active ingredient amlodipine which belongs to a group of medicines called
calcium antagonists.
Norvasc is used for the treatment of high blood pressure (hypertension) or a type of chest pain
called angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with hypertension, this medicine works by relaxing the blood vessels so that blood
can flow more easily. In patients with angina, Norvasc improves the blood supply to the heart muscle which receives more oxygen and thus prevents chest pain. This medicine does not
provide immediate relief from chest pain due to angina.

2. What you need to 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 other calcium antagonists. The reaction may be itching, skin redness or difficulty breathing.
• If you have severely low blood pressure (hypotension)
• If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide the body with sufficient blood).
• If you suffer from heart failure following a heart attack

Warnings and precautions
Talk to your doctor or pharmacist before taking Norvasc.
Tell your doctor if you have or have suffered from the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease (hepatopathy)
• You are elderly and your dose may need to be increased

Children and adolescents
Norvasc has not been studied in children under the age of 6 years. 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
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Norvasc can have effects on other medicines or other medicines can have effects on Norvasc, such as:

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

Norvasc may lower blood pressure even further if you are already taking
other medicines to treat hypertension at the same time.

Norvasc with food and drink
People taking Norvasc should not drink grapefruit juice as grapefruit and
grapefruit juice can increase the levels of the active ingredient amlodipine in the blood, and this may
lead to an increase in the blood pressure-lowering 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, tell your doctor before taking Norvasc.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding
or are about to start breastfeeding, you should tell your doctor before taking Norvasc.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Norvasc may have an effect on the ability to drive or operate machinery. If the tablets make you
feel unwell, dizzy or tired, or give you a headache, do not drive or operate
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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended initial dose is Norvasc 5 mg once a day. The dose may be increased to
Norvasc 10 mg once a day.
This medicine can be taken before or after food and drinks. You must take this medicine
every day at the same time with some water. Do not take Norvasc with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended initial dose is 2.5 mg per
day. The maximum recommended daily dose is 5 mg per day. Norvasc 5 mg can be
divided into two equal parts to obtain a dose of 2.5 mg.
It is important to continue taking the tablets for the entire time indicated by your doctor. See your
doctor before stopping the tablets.

If you take more Norvasc than you should
If you were to take an excessive number of tablets, your blood pressure could drop too low and this
could be dangerous. You may experience dizziness, mental confusion, weakness or fainting. The
blood pressure drop could be so severe as to cause you shock. Your skin may become cool 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 the usual time. Do not take a double dose to make up for a 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 tells you to do so.
If you have any doubts 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.
If you notice any of the following side effects, consult your doctor immediately:

• Sudden onset of dyspnea, 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, widespread skin redness, severe itching, blisters, peeling and skin swelling, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas which can cause severe abdominal and back pain combined with a feeling of severe malaise

The following very common side effectshave been reported. If any of these effects occur or
persistfor more than one week, consult yourdoctor.
Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The following common side effectshave been reported. If any of these effects occur or if

persistfor more than one week, consult yourdoctor.
Common: may affect up to 1 in 10 people

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

In addition, the following side effects have been reported.
If any of these side effects worsen, or if you notice any other effect

Not common: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Sensation of numbness or tingling in the limbs; loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration
• Urinary disorders, need to urinate at night, frequent urination
• Inability to achieve an erection; discomfort or enlargement of the breasts in men
• Pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or 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 lead to unusual bruising or a tendency to bleed
• High blood sugar levels (hyperglycemia)
• A nervous disorder that can cause muscle weakness, tingling or numbness
• Swelling of the gums, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can lead to changes in some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

Not known: frequency cannot be estimated from the available data

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly to 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 pack after ‘EXP’. The expiry
date refers to the last day of that month.
Tablets
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 ingredient of Norvasc 5 mg tablets is amlodipine (as besylate).
The active ingredient of Norvasc 10 mg tablets is amlodipine (as besylate).
The excipients are: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and
sodium glycolate starch.

Description of the appearance of Norvasc and contents of the pack
5 mg tablets: tablets of colour from white to off-white, octagonal with imprinted AML 5 and
notch on one side and Pfizer logo on the other side.
10 mg tablets: tablets of colour from white to off-white, octagonal with imprinted AML-10 on
one side and Pfizer logo on the other side.
5 mg tablets: tablets of colour from white to off-white, octagonal with imprinted AML 5 and
notch on one side and white on the other side.
10 mg tablets: tablets of colour from white to off-white, octagonal with imprinted AML-10 on
one side and white on the other side.
Norvasc 5 mg tablets is 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 divisible unit dose blister strips
50x1 and 500x1 tablets.
Norvasc 10 mg tablets is 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 divisible unit dose blister
strips 50x1 and 500x1 tablets.
Not all pack sizes may be marketed.

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

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 authorised in the Member States of the European Economic Area with the
following denominations:
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