AMLODIPINA 5 mg Coated Tablets

Зміст інструкції

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

Amlodipina Accord 5 mg tablets, 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 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Amlodipina Accord contains the active ingredient amlodipine which belongs to a group of medicines
called calcium antagonists.
Amlodipina Accord is used to treat 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 high blood pressure, this medicine works by relaxing the blood
vessels, so that blood can flow more easily. In patients with angina, Amlodipina
Accord works by improving the blood supply to the heart muscle, which receives more oxygen and thus prevents chest pain. This medicine does not provide immediate relief from pain caused
by angina.

2. What you need to know before taking Amlodipina Accord

Do not take Amlodipina Accord

• 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 channel blockers. 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 valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough 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 Accord. You must inform your
doctor 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 disease
• You are elderly and your dose may need to be increased

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

Other medicines and Amlodipina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Amlodipina Accord can influence or be influenced by other medicines, 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 (a medicine used to change the way your immune system works)
• simvastatin (a medicine used to reduce cholesterol)
• cyclosporine (immunosuppressant)

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

Amlodipina Accord with food and drink
People taking Amlodipina Accord should not consume grapefruit and 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 unpredictable increase in the blood
pressure lowering effect of Amlodipina Accord.

Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you might be
pregnant or are planning a pregnancy, tell your doctor before taking Amlodipina Accord.

Breastfeeding
It has been shown that amlodipine passes into breast milk. If you are breastfeeding or are about to
start breastfeeding, you must inform your doctor before taking Amlodipina Accord.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Amlodipina Accord may affect 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.

3. How to take Amlodipina Accord

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 5 mg once a day. The dose may be increased to 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 a little water. Do not take Amlodipina Accord with grapefruit
juice.

Use in children and adolescents
For children and adolescents (from 6 to 17 years of age), the usual recommended initial 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 2.5 mg dose cannot be obtained with Amlodipina Accord 5 mg,
because these tablets are not produced to be divided into two equal halves.
It is important that you continue to take the tablets. Do not wait for the tablets to run out before
seeing your doctor.

If you take more Amlodipina Accord 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, lightheadedness, weakness or fainting. The drop in
blood pressure may be so severe as to cause you shock. Your skin may
become cold and clammy and you may lose consciousness. If you have taken an excessive number
of Amlodipina Accord tablets, contact your doctor immediately.

If you forget to take Amlodipina Accord
Do not worry. If you forget to take a tablet, completely skip the missed dose.
Take the next dose at the correct time.
Do not take a double dose to make up for a missed dose.

If you stop taking Amlodipina Accord
Your doctor will tell you how long you should take this medicine. Your condition may
recur if you stop treatment before you have been advised.
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, after taking this medicine, you notice any of the following side effects, consult

immediatelyyour doctor:

• Sudden onset of shortness of breath, chest pain, wheezing 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, 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) or other allergic reactions
• Myocardial infarction, abnormal heart rhythm
• Inflammation of the pancreas which can cause severe abdominal and back pain together with a feeling of severe malaise. The following side effects have been reported very common. If this causes you problems or if they persist for more than a week, contact your doctor.

Very common:may affect more than 1 in 10 people

• Edema (fluid retention)

The following side effects have been reported common. If this causes you problems or if they persist
for more than a week, contact your doctor.

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 side effect not listed in this

Uncommon: 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
• Tinnitus (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, increased 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 up to 1 in 1,000 people

• Confusion

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

• Reduced number of white blood cells, reduced platelets in the blood which may determine unusual bruising or a tendency to bleed
• Excessive amount of sugar in the blood (hyperglycemia)
• A nervous disorder that can cause muscle weakness, tingling or numbness
• Swelling of the gums
• Abdominal swelling (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 blood vessels, often with a rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una -sospetta-reazione-avversa. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Amlodipina Accord

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 package and on the blister after
“Exp.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package Contents and Other Information

What Amlodipina Accord contains

Amlodipina Accord 5 mg tablets:
The active ingredient is amlodipine. Each tablet contains 5 mg of amlodipine (as besilate).
The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium
hydrogen citrate, crospovidone, sodium croscarmellose.

Amlodipina Accord 10 mg tablets:
The active ingredient is amlodipine. Each tablet contains 10 mg of amlodipine (as besilate).
The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium
hydrogen citrate, crospovidone, sodium croscarmellose.

Description of the appearance of Amlodipina Accord and package contents

Amlodipina Accord 5 mg tablets:
Biconvex, round tablets, white in colour and with a diameter of 6.6 mm

Amlodipina Accord 10 mg tablets:
Biconvex, round tablets, white in colour and with a diameter of 8.5 mm
Pack sizes
blister packs:
5 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets
10 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, HA1 4HF
Middlesex
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Member StateMedicinal Product Name
Austria Amlodipin Accord 5/10 mg Tabletten
Belgium Amlodipine Accord Healthcare 5/10 mg Comprimés/ Tabletten
Czech Republic Amlodipin Accord 5/10 mg Tablety
Germany Amlodipin Accord 5/10 mg Tabletten
Denmark Amlodipin Accord 5/10 mg Tabletter
Estonia Amlodipine Accord 5/10 mg
Greece Amlodipine Accord 5/10 mg δισκία
Italy AMLODIPINA ACCORD 5 /10 MG COMPRESSE
Lithuania Amlodipine Accord 5/10 mg tabletės
Latvia Amlodipine Accord 5/10 mg tablets
Netherlands Amlodipine (as besilaat) Accord 5/10 mg tabletten
Poland Amlodipine Accord
Portugal Amlodipina Accord
Romania Amlodipina Accord 5/10 mg comprimate
Sweden Amlodipin Accord 5/10 mg tabletter