AMLODIPINA 5 mg Tablet

Зміст інструкції

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

Amlodipina Aurobindo 5 mg tablets

Amlodipina Aurobindo 10 mg tablets
Generic medicine

Read this leaflet carefully before taking this medicine as 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amlodipina Aurobindo contains the active ingredient amlodipine, which belongs to a group of medicines called calcium
channel blockers.
Amlodipina Aurobindo is used for the treatment of high blood pressure (hypertension) or for a particular
type 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 the
blood can flow more easily. In patients with angina, Amlodipina Aurobindo works by improving the blood supply
to the heart muscle, which thus receives more oxygen, preventing chest pain. This medicine does not
provide immediate relief from chest pain caused by angina.

2. What you need to know before taking Amlodipina Aurobindo

Do not take AMLODIPINA AUROBINDO

• If you are allergic to amlodipine, or to any of the excipients of this medicine (listed in section 6), or to any other calcium channel blocker. The reaction may lead to itching, redness of the skin or difficulty in breathing.
• If you have severely low blood pressure (hypotension)
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body).
• If you suffer from heart failure after a heart attack

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

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver diseases
• If you are elderly and your dose needs to be increased

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

Other medicines and Amlodipina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Amlodipina Aurobindo can influence or be influenced by other drugs, 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 temperature abnormalities)
• tacrolimus (medicine used to alter your immune system activity)
• simvastatin (medicine for high cholesterol in the blood)
• cyclosporine (an immunosuppressant)

Amlodipina Aurobindo may lower your blood pressure even more if you are already taking other medicines to
treat high blood pressure.

Amlodipina Aurobindo with food and drink
Grapefruit or grapefruit juice should not be consumed by people taking Amlodipina
Aurobindo. This is because both grapefruit and grapefruit juice can lead to an increase in blood levels of the active
ingredient amlodipine, which can cause an unpredictable hypotensive effect of Amlodipina Aurobindo.

Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnancy has not been established. If you think you may be pregnant, or are planning to
become pregnant, you should inform your doctor before taking Amlodipina Aurobindo.

Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or are about to start
breastfeeding, you should inform your doctor before taking Amlodipina Aurobindo.

Driving and using machines
Amlodipina Aurobindo may affect your ability to drive or operate machinery. If the medicine makes you feel unwell,
dizzy, tired or gives you a headache, do not drive or operate machinery and contact your doctor immediately.

3. How to take Amlodipina Aurobindo

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

Use in children and adolescents
For children and adolescents (6-17 years), the initial, usual, recommended dose is 2.5 mg per day. The maximum
recommended dose is 5 mg per day. Amlodipina 2.5 mg is not currently available and a dose of 2.5 mg cannot
be obtained with Amlodipina Aurobindo 5 mg tablets because these tablets are not produced to be
divided into two equal halves.
It is important to continue taking the tablets. Do not wait for the tablets to run out before seeing your doctor.

If you take more Amlodipina Aurobindo than you should
Taking too many tablets can cause a lowering, sometimes dangerous, of blood pressure. You may
experience dizziness, lightheadedness, fainting or weakness. If the drop in blood pressure is particularly severe, it can
cause shock. The skin may become cold and clammy and you may lose consciousness. If you have taken
an excessive number of Amlodipina Aurobindo tablets, contact a doctor immediately.

If you forget to take Amlodipina Aurobindo
Do not worry. If you forget to take a tablet, do not take the forgotten dose. Take the next
dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amlodipina Aurobindo
Your doctor will advise you how long to take this medicine. If you stop treatment with this
medicine prematurely, the symptoms may reappear. If you have further questions 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.
Contact your doctor immediatelyif you experience any of the following effects 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 causing severe difficulty in breathing
• Severe skin reactions including intense rash, urticaria, 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) or other allergic reactions
• Heart attack, heart rhythm abnormalities
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe discomfort.

The following very common side effects have been reported. If this causes you problems or if the effect lasts for more than
one week, you should contact your doctor.

Very common:may affect more than 1 in 10 people
Edema (fluid retention)
The following common side effectshave been reported. If any of these causes you problems or lasts for more than one
week, you should contact 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), hot flushes
Abdominal pain, feeling unwell (nausea)
altered bowel habits, diarrhea, constipation, indigestion

• Fatigue and weakness
• Visual disturbances, double vision
• Muscle cramps, swelling of the ankles. Other side effects that have been reported are included in the following list. If any of these worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. Not common: may affect up to 1 in 100
• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting, weakness
• Sensation of numbness or tingling in the limbs, loss of pain sensation
• Tinnitus (ringing in the ears)
• Low blood pressure
• Sneezing / runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Dry mouth, vomiting (feeling sick)
• Hair loss, increased sweating, itchy skin, red spots on the skin, changes in skin color
• Difficulty urinating, increased need to urinate at night, increased number of times to urinate
• Inability to get an erection, discomfort or enlargement of the breasts in men
• Weakness, pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or loss

Rare:may affect up to 1 in 1000
Confusion

Very rare: may affect less than 1 in 10,000

• Decreased number of white blood cells, decreased platelets in the blood which can cause bruising or easy bleeding
• Excess sugar in the blood (hyperglycemia)
• Nervous system disorders that can cause muscle weakness, tingling or numbness
• Cough, swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can have an effect on some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining rigidity, tremor, and / or movement disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the Website:
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Amlodipina Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported on the carton or the bottle after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipina Aurobindo contains

• The active ingredient is amlodipine as amlodipine besilate.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate

Description of the appearance of Amlodipina Aurobindo and contents of the pack
Tablets.

5 mg: white or almost white, flat, bevelled, cylindrical shaped tablet with “C” imprinted on one side and “58”
on the other side. The size is 7.9 mm x 5.6 mm.

10 mg: white or almost white, flat, bevelled, round [diameter 9.5 mm] tablet with “C” imprinted on one side and
“59” on the other side.
Blisters in Aluminium-PVC/ PVdC.
7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 120, 200, 250, 300 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 – Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany Amlodipin Aurobindo 5 mg/ 10 mg Tablets
Spain Amlodipino Aurobindo 5 mg/ 10 mg comprimidos EFG
Ireland Amlodipine Aurobindo 5 mg/ 10 mg tablets
Italy Amlodipina Aurobindo 5 mg/10 mg compresse
Malta Amlodipine Aurobindo 5 mg/ 10 mg Tablets
Poland Amlodipine Aurobindo
Portugal Amlodipina Aurobindo
Romania Amlodipina Aurobindo 5 mg/ 10 mg comprimate
Sweden Amlodipin Aurobindo 5 mg/ 10 mg tabletter
United Kingdom Amlodipine 5 mg/ 10 mg tablets