АМЛОДИПИНА 5 мг Таблетка

Содержание инструкции

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

Amlodipina Mylan 5 mg tablets, 10 mg tablets

amlodipine

Generic medicine
Read 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 pass it on to others, even if their symptoms are the same as yours, as 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 Amlodipina Mylan is and what it is used for
• 2. What you need to know before you take Amlodipina Mylan
• 3. How to take Amlodipina Mylan
• 4. Possible side effects
• 5. How to store Amlodipina Mylan
• 6. Contents of the pack and other information

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

Amlodipina Mylan tablets contain amlodipine, which belongs to a group of medicines called
calcium antagonists.
Amlodipine is used to treat high blood pressure (hypertension) or certain types of chest pain called angina, a rare form of which 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 through them more easily. In patients with angina, amlodipine works by increasing
the supply of blood to the heart muscle, which therefore receives more oxygen and consequently prevents
chest pain.
This medicine does not provide immediate relief from angina chest pain.
Talk to your doctor if you do not feel well or if you feel worse.

2. What you need to know before taking Amlodipina Mylan

Do not take Amlodipina Mylan

• If you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist
• If you have severely low blood pressure (hypotension)
• If the blood flow from the left side of your heart is blocked (e.g. you have a narrowing of the aortic valve (aortic stenosis))
• If you have heart failure following a heart attack
• If you suffer from cardiogenic shock (a condition where your heart is unable to pump enough blood to your body).

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

• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease.

During treatment
Talk to your doctor:

• If you are elderly and your dose needs to be increased as special care must be taken when increasing the dosage in elderly patients.

Children and adolescents
Amlodipine has not been studied in children under 6 years of age. Amlodipine should only be
used for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For more information, talk to your doctor.

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

• antifungal medicines (e.g. ketoconazole, itraconazole)
• so-called protease inhibitors used to treat HIV (e.g. ritonavir, indinavir, nelfinavir)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• hypericum perforatum(St John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe temperature abnormalities)
• simvastatin (a medicine used to lower cholesterol levels in the blood)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the response of your immune system). Amlodipine can increase the levels of these medicines in your blood.
• cyclosporine (if you have had a kidney transplant and are taking cyclosporine) as amlodipine can alter the amount of this medicine in your blood.

Amlodipine may lower your blood pressure even further if you are already taking other medicines
to treat your high blood pressure.

Amlodipina Mylan with food and drink
Grapefruit juice and grapefruit must not be consumed by people taking amlodipine.
This is because grapefruit and grapefruit juice can lead to an increase in the levels in the blood of the
active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of amlodipine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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.
The safety of amlodipine in human pregnancy has not been established.
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or are about to
start breastfeeding, you must inform your doctor before taking this medicine. Your doctor will
advise you to take this medicine only if the benefits of treatment outweigh the risks to the
child.

Driving and using machines
Amlodipine can affect your ability to drive vehicles or operate machines. If the tablets cause
nausea, dizziness or fatigue, or give you a headache, do not drive vehicles or use machines. These
side effects can occur especially at the beginning of therapy.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Amlodipina Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended initial dose is Amlodipina Mylan 5 mg once a day. The dose may be increased
to Amlodipina Mylan 10 mg once a day.
Your medicine can be taken before or after food or drinks. Take your medicine at the same time each
day with a glass of water.
Patients with liver disorders
Your doctor may ask you to take a lower dose and perform frequent checks if you suffer from
liver problems.

Use in children and adolescents
For children and adolescents (between 6 and 17 years), the usual recommended initial dose is 2.5 mg per day.
The recommended maximum dose is 5 mg per day.
The tablet can be divided into two equal doses.
It is important to continue taking the tablets. Do not wait for your tablets to run out before
seeing your doctor.

If you take more Amlodipina Mylan than you should
Taking too many tablets may cause your blood pressure to become low or dangerously
low. You may experience dizziness, feel faint, feel like you are going to faint or feel weak or have a fast
heartbeat. If the drop in blood pressure is severe enough, you may experience shock. Your skin may
appear cold and clammy and you may lose consciousness. Excess fluid may accumulate in the lungs
(pulmonary edema) causing shortness of breath which may develop up to 24-48 hours after taking it.
Seek immediate medical assistance if you take too many amlodipine tablets.

If you forget to take Amlodipina Mylan
Do not worry. If you forget to take a tablet, completely skip that dose. 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 Mylan
The doctor will inform you how long you will need to take your medicine. You may return to your
initial conditions if you stop using your medicine before you have been told to.
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.
manifest.

If you notice any of the following side effects, stop taking this medicine and contact your
doctor or go immediately to the nearest emergency room:

• Swelling of eyelids, face, lips, tongue and throat which can cause severe difficulty in breathing or swallowing.
• Severe skin reactions including intense skin rashes, urticaria, redness of the skin all over the body, severe itching, formation of blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack or abnormal or irregular heartbeat, rapid heart rate
• Inflamed pancreas which can cause severe abdominal or back pain accompanied by a strong feeling of unwellness
• Yellowing of the skin or eyes, pale stools, dark urine or stomach pain (these can be signs of liver problems such as liver inflammation (hepatitis) or jaundice)
• Difficulty speaking or swallowing, loss of balance control, face like a mask, shuffling gait, stiffness of arms and legs, tremor or agitation of hands or fingers (extrapyramidal syndrome).

Other possible side effects:

Very common(may affect more than 1 in 10 people)

• Swelling which may be due to fluid retention in the tissues

Common(may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling of heartbeat), flushing
• Abdominal pain, nausea, altered bowel habits, including diarrhea and constipation, indigestion
• Swelling of the ankles, fatigue, unusual weakness
• Visual disturbances including double vision
• Shortness of breath, muscle cramps

Uncommon(may affect up to 1 in 100 people)

• Mood changes (including feeling anxious), depression, insomnia
• Tremor, taste abnormality, fainting
• Sensation of numbness or tingling in the limbs; decreased sensitivity
• Tinnitus (ringing in the ears)
• Decreased heart rate
• Low blood pressure
• Sneezing/runny nose caused by inflammation of the nasal mucous membranes (rhinitis), cough
• Dry mouth, vomiting (feeling unwell)
• Hair loss, increased sweating, itchy skin, red blisters on the skin, skin discoloration, rash and urticaria, purple spots on the skin
• Urination disorders, increased frequency of urination at night, more frequent urination
• Inability to achieve an erection; discomfort or enlargement of the breasts in men
• Pain, chest pain, malaise
• 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)

• An increase in infections or fever e.g. sore throat, mouth ulcers that develop (due to a decrease in the number of white blood cells), or if you notice bruising or bleeding more easily or for no explanation (due to a decrease in the number of platelets in the blood)
• Excess sugar in the blood (hyperglycemia)
• Nerve disorder that can cause weakness, numbness or tingling
• Swelling of the gums
• Bleeding of the gums (gingival bleeding)
• Abdominal bloating (gastritis)
• Increased liver enzymes which may be caused by liver disorders such as blockage in the bile duct
• “Measles”-like skin rash. This may be associated with high fever and joint pain (erythema multiforme).
• Scaling of the skin over large areas of the body
• Inflammation of the blood vessels, often with skin rash
• Skin sensitivity to light
• Concomitant disorders of rigidity, tremor and/or movement disorders

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package, bottle or blister
after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice any discoloration of the tablets.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate
the medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Amlodipina Mylan contains

• The active ingredient is amlodipine.
• Each tablet contains 5 mg or 10 mg of amlodipine (as besilate).
• The other excipients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

Description of the appearance of Amlodipina Mylan and package contents
Amlodipina Mylan 5 mg tablets are white, round, biconvex, with "5" inscribed on one
side and a fracture line on the opposite side. The tablet can be divided into two equal halves.
Amlodipina Mylan 10 mg tablets are white, round, biconvex, with "10" imprinted on
one side and a fracture line on the opposite side. The tablet can be divided into two equal halves.
Amlodipina Mylan is packaged in blisters containing 10, 14, 28, 30, 50, 56, 60, 90, 100 and 180 tablets.
Amlodipina Mylan is packaged in bottles containing 28, 30, 56, 100, 180 and 500 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer responsible for batch release
Generics [UK] Limited, Station close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Viatris UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium Amlodipine besilate Viatris 5 mg tablets
Amlodipine besilate Viatris 10 mg tablets
Czech Republic Amlodipin Viatris 5 mg, tablets
Amlodipin Viatris 10 mg, tablets
Germany Amlodipin dura B 5 mg Tablets
Amlodipin dura B 10 mg Tablets
Ireland Amlodipine Viatris 5mg tablets
Amlodipine Viatris 10mg tablets
Italy Amlodipina Mylan 5 mg tablets
Amlodipina Mylan 10 mg tablets
Poland Amlomyl
Spain Amlodipino Viatris 5 mg comprimidos EFG
Amlodipino Viatris 10 mg comprimidos
EFG
Netherlands Amlodipine (as besilaat) Viatris 5 mg
tablets
Amlodipine (as besilaat) Viatris 10 mg
tablets
United Kingdom Amlodipine 5 mg tablets
Amlodipine 10 mg tablets