AMLODIPINA 5 mg Таблетка

Содержание инструкции

1. Amlodipina Krka 5 mg tablets, 10 mg tablets
   1. What Amlodipina Krka is and what it is used for
   2. What you need to know before taking Amlodipina Krka
   3. How to take Amlodipina Krka
   4. Possible side effects
   5. How to store Amlodipina Krka
   6. Contents of the pack and other information

Amlodipina Krka 5 mg tablets, 10 mg tablets

Amlodipina

Generic medicine

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 their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Amlodipina Krka and what it is used for
• 2. What you need to know before you take Amlodipina Krka
• 3. How to take Amlodipina Krka
• 4. Possible side effects
• 5. How to store Amlodipina Krka
• 6. Contents of the pack and other information

1. What Amlodipina Krka is and what it is used for

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

2. What you need to know before taking Amlodipina Krka

Do not take Amlodipina Krka

• If you are allergic to amlodipine, or to any of the excipients of this medicine (listed in section 6) or to other calcium channel blockers. The reaction may consist of itching, redness of the skin or difficulty breathing
• If you have very low blood pressure (hypotension)
• If you suffer from a narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide 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 Amlodipina Krka.
You must 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
• if you are elderly and your dose needs to be increased.

Children and adolescents
Amlodipina Krka has not been studied in children under 6 years of age. Amlodipina Krka should
only be used in hypertension in children and adolescents from 6 to 17 years of age (see
section 3).
For more information, please consult your doctor.

Other medicines and Amlodipina Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Amlodipina Krka can influence or be influenced by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (for infections caused by bacteria)
• Hypericum perforatum(St John's wort)
• verapamil, diltiazem (medicines for the heart)
• dantrolene (infusion for severe temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to control the immune system response)
• simvastatin (used to reduce cholesterol in the blood)
• cyclosporine (an immunosuppressant). If you are already taking other medicines for the treatment of high blood pressure, Amlodipina Krka may further reduce your blood pressure.

Amlodipina Krka with food and drink
Patients taking Amlodipina Krka should not consume grapefruit juice and grapefruit,
as these can lead to an increase in the levels of the active ingredient amlodipine in the blood, which
can cause an unpredictable increase in the blood pressure lowering effect of Amlodipina
Krka.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of amlodipine in pregnancy in women has not been established. If you think you are pregnant
or are planning a pregnancy, you should inform your doctor before taking Amlodipina Krka.

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 inform your doctor before taking Amlodipina Krka.

Driving and operating machinery
Amlodipina Krka can affect your ability to drive or operate machinery. If the tablets
cause you nausea, dizziness or fatigue, or give you a headache, do not drive or operate machinery and
contact your doctor immediately.

Amlodipina Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is equivalent to
essentially “sodium-free”.

3. How to take Amlodipina Krka

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.
The usual starting dose is 5 mg of Amlodipina Krka once a day. The dose may be increased
to 10 mg of Amlodipina Krka once a day.
The medicine can be taken before or after food and beverages. Take your medicine
at the same time each day with a glass of water. Do not take Amlodipina Krka with grapefruit
juice.

Use in children and adolescents
In children and adolescents (6-17 years) the usual recommended starting dose is 2.5 mg per
day. The maximum recommended dose is 5 mg per day.
The 2.5 mg amlodipine dose is currently not available and can be obtained by breaking
Amlodipina Krka 5 mg into two equal halves.
It is important that you continue to take the tablets. Do not wait until you finish the tablets before
returning to your doctor.

If you take more Amlodipina Krka than you should
Taking too many tablets can cause an excessive or even dangerous drop in blood pressure.
You may feel dizzy, blurred vision, fainting or weakness. If the drop in blood pressure
is severe enough, shock may occur. Your skin may be cold and clammy and you may lose
consciousness. If you have taken too many tablets of Amlodipina Krka, seek immediate medical
attention.

If you forget to take Amlodipina Krka
Do not worry. If you forget to take a tablet, simply completely skip
that dose and take your next dose at the correct time. Do not take a double dose to
make up for a missed dose.

If you stop taking Amlodipina Krka
Your doctor will tell you how long you need to take your medicine. If you stop treatment
before your doctor tells you to, your symptoms may return.
If you have any questions about using Amlodipina Krka, 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 immediatelyif you experience any of the following serious side effects
very rarely after taking this medicine:

• sudden shortness of breath, chest pain, wheezing or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat which causes severe difficulty in breathing
• severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, heart rhythm abnormalities
• inflammation of the pancreas which can cause severe pain in the abdomen and back accompanied by a feeling of unwellness. The following common side effectshave been reported. If any of these cause you problems or if they last for more than one weekyou must contact your doctor:

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

Common: may affect up to 1 in 10 people

• headache, dizziness, drowsiness (particularly at the beginning of treatment)
• palpitations (awareness of your heartbeat), flushing
• abdominal pain, feeling unwell (nausea)
• changes in bowel habits, diarrhoea, constipation, indigestion
• fatigue, weakness
• visual disturbances, double vision
• muscle cramps
• swelling of the ankles.

Other side effects that have been reported include the following list. If any of these side effects gets worse, 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, drowsiness
• tremor, altered taste, fainting
• numbness or tingling in the limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing/runny nose, caused by inflammation of the lining of the nose (rhinitis)
• cough
• dry mouth, vomiting (when ill)
• hair loss, increased sweating, itchy skin, red spots on the skin, skin discolouration
• problems with passing urine, increased need to urinate at night, increased number of times you pass urine
• inability to get an erection, discomfort or enlargement of the breasts in men
• pain, feeling unwell

• muscle or joint pain, back pain
• increase or decrease in weight.

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

• confusion.

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

• reduced number of white blood cells in the blood, reduction in platelets in the blood which may cause unusual bruising or more frequent bleeding (damage to red blood cells)
• excess sugar in the blood (hyperglycaemia)
• a nerve disorder that can cause weakness, tingling or numbness
• swelling of the gums
• swelling of the abdomen (gastritis)
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect some medical tests
• increased muscle tension
• inflammation of the blood vessels, often with skin rash
• sensitivity to light
• disorders with a combination of stiffness, tremor and/or movement disorders.

Not known: frequency cannot be estimated from the available data

• Tremor, rigid posture, facial stiffness, slow movements and dragging, unbalanced gait

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at
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 Amlodipina Krka

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 packaging after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipina Krka contains

• The active ingredient is amlodipine. Amlodipina Krka 5 mg tablets Each tablet contains 6.94 mg of amlodipine besilate equivalent to 5 mg amlodipine

Amlodipina Krka 10 mg tablets
Each tablet contains 13.88 mg of amlodipine besilate equivalent to 10 mg amlodipine

• The other ingredients (excipients) are: microcrystalline cellulose (E460), pregelatinized starch, sodium starch glycolate (type A), anhydrous colloidal silica (E551) and magnesium stearate (E470b). See Paragraph 2 “Amlodipina Krka contains sodium”

Description of the appearance of Amlodipina Krka and contents of the pack
Amlodipina Krka 5 mg tablets
The tablets are white, round, slightly biconvex, with beveled edges, notched on one side,
with a diameter of 8 mm. The tablet can be divided into two equal doses.
Amlodipina Krka 10 mg tablets
The tablets are white, round, slightly biconvex, with beveled edges, with a diameter of 10
mm.
Amlodipina Krka 5 mg and 10 mg tablets is available in packs of 10, 14, 20, 28, 30, 50, 56, 60,
90, 98, 100, 200, 250 tablets and 100 x 1 tablet (unit-dose), packaged in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: