AMLOPOL 5 мг Таблетка

Содержание инструкции

1. AMLOPOL 5 mg tablets
   1. WHAT AMLOPOL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING AMLOPOL
   3. HOW TO TAKE AMLOPOL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE AMLOPOL
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

AMLOPOL 5 mg tablets

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

1. WHAT AMLOPOL IS AND WHAT IT IS USED FOR

Amlopol contains the active substance amlodipine which belongs to a group of medicines
called calcium antagonists.
Amlopol 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, Amlopol improves
the blood supply to the heart muscle which receives more oxygen and thus prevents
chest pain. Q u e s t o medicine does not provide immediate relief from chest
pain due to angina.

2. WHAT YOU NEED TO KNOW BEFORE TAKING AMLOPOL

Do not take Amlopol
If you are allergic 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
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 Amlopol
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
Amlopol has not been studied in children under 6 years of age. Amlopol 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 Amlopol
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Amlopol can have effects on other medicines or other medicines can have effects on
Amlopol, such as:
ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used for the
treatment of HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St John's Wort)
verapamil, diltiazem (heart medicines)
dantrolene (infusion for severe body temperature alterations)
simvastatin (cholesterol-lowering medicine)
Tacrolimus (used to control the immune response, to allow
the body to accept the transplanted organ)
Clarithromycin (for infections caused by bacteria)

• Cyclosporine (an immunosuppressant)

Amlopol can lower blood pressure even more if you are already taking
other medicines to treat high blood pressure at the same time.

Amlopol with food and drink
People taking Amlopol should not drink grapefruit juice as grapefruit and its juice can lead to an increase in the levels of the active
ingredient amlodipine in the blood, and this may result in an increase in the blood pressure lowering effect of Amlopol.

Pregnancy and breastfeeding

Pregnancy
The safety of amlodipine in pregnant women has not been established. If you believe you
are pregnant or are planning a pregnancy, tell your doctor before
taking Amlopol.

Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or
plan to start breastfeeding, tell your doctor before taking Amlopol.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Amlopol can have an effect on your ability to drive or operate machinery. If
the tablets make you feel unwell, dizzy or tired, or give you a headache,
avoid driving or operating machinery and contact your doctor immediately.

Amlopol contains lactose
Amlopol contains lactoseif your doctor has told you that you have an intolerance to some
sugars, contact them before taking this medicine.

3. HOW TO TAKE AMLOPOL

Take this medicine following exactly the instructions of your doctor. If you have any
doubts, consult your doctor or pharmacist.
The recommended initial dose is Amlopol 5 mg once a day. The dose may be
increased to Amlopol 10 mg once a day.
The medicine can be taken before or after food and drinks. You must take the
medicine every day at the same time with a little water. Do not take Amlopol with
grapefruit juice.

Use in children and adolescents
For children and adolescents (from 6 to 17 years of age), the usual initial dose is 2.5
mg per day. The maximum recommended daily dose is 5 mg per day.
Amlopol 5 mg can be divided into two equal parts to obtain a dose of 2.5
mg.
Continue taking the tablets for as long as indicated by your doctor. See your
doctor before stopping the tablets.

If you take more Amlopol than you should
If you should take an excessive number of tablets, your blood pressure may drop
too low and this may be dangerous. You may experience dizziness, vertigo, weakness or
fainting. The drop in blood pressure may 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 Amlopol tablets, contact your doctor immediately .
If you forget to take Amlopol
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
compensate for the missed dose.

If you stop taking Amlopol
You must continue to take the medicine for as long as your doctor tells you.
Stopping treatment may cause a worsening of the condition.
If you have any further questions on 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 everyone will experience 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 can cause difficulty breathing
Severe skin reactions including intense rash, urticaria, redness
all over the body, severe itching, blisters, peeling and swelling of the
skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or
other allergic reactions
Myocardial infarction, arrhythmia
Inflammation of the pancreas which can cause severe abdominal and back pain along with a feeling of severe malaise
The following very common side effectshave been reported. If any of these effects occur or if they persist for more than a week, see your doctor.
Very common:may affect more than 1 in 10 people

• Swelling of the ankles (edema)

The following common side effectshave been reported. If any of these effects occur or if they persist for more than a week, see your doctor.
Common:may affect between 1 and 10 patients out of 100:
Headache, dizziness, drowsiness (especially at the beginning of treatment)
Palpitations (feeling your heartbeat), flushing
Abdominal pain, nausea
Altered bowel habits, diarrhea, constipation, indigestion
Swelling of the ankles, fatigue, weakness
Muscle cramps
Visual disturbances, double vision
In addition, the following side effects have been reported.

Uncommon:may affect between 1 and 10 patients out of 1,000:
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
Cough
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Dry mouth, vomiting
Hair loss, increased sweating, skin itching, urticaria, 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, malaise
Joint or muscle pain, back pain
Weight gain or loss

Rare:may affect between 1 and 10 patients out of 10,000:
Confusion

Very rare:may affect less than 1 in 10,000 patients:
Low levels of white blood cells and platelets in the blood which can determine
an unusual appearance of bruises or a tendency to bleed (damage to red blood cells)
High blood sugar levels (hyperglycemia)
A nervous disorder that can cause weakness, tingling or numbness
Swelling of the gums
Abdominal bloating (gastritis)
Abnormal liver function, liver inflammation (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 skin rash
Sensitivity to light

Not known:frequency cannot be estimated based on available data:

• tremor, rigid posture, mask-like face, slow movements and an unbalanced, shuffling gait Reporting of side effects

If you experience any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information
about the safety of this medicine.

5. HOW TO STORE AMLOPOL

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.
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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amlopol contains
The active ingredient of Amlopol 5 mg tablets is amlodipine (as besilate).
The active ingredient of Amlopol 10 mg tablets is amlodipine (as besilate).
The other ingredients are: Sodium glycolate starch, Microcrystalline cellulose, Lactose
monohydrate (see section 2. Amlopol contains lactose), Magnesium stearate.

Description of the appearance of Amlopol and contents of the pack
AMLOPOL 5 mg – white, round, flat tablets with a score line on one side - 28
divisible tablets
AMLOPOL 10 mg – white, round, flat tablets with a score line on one side - 14
tablets.

Marketing Authorisation Holder
Polifarma S.p.A. – Viale dell’Arte, 69– 00144 Rome

Manufacturers
West Pharma – Produções Especialidades Farmacêuticas, S.A.
Rua João de Deus, n° 11, Venda Nova, 2700 Amadora -Portugal
Atlantic Pharma - Produções Farmaceuticas SA
Rua da Tapada Grande, n.2, Abrunheira, 2710 – 089 Sintra - Portugal