AMLODIPINA 5 mg Coated Tablets

Зміст інструкції

1. Amlodipina Hexal AG 5 mg tablets, 10 mg tablets
   1. WHAT AMLODIPINA HEXAL AG IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING AMLODIPINA HEXAL AG
   3. HOW TO TAKE AMLODIPINA HEXAL AG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE AMLODIPINA HEXAL AG

Amlodipina Hexal AG 5 mg tablets, 10 mg tablets

Amlodipina

Generic medicine

Read this leaflet carefully before you start 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 Hexal AG is and what it is used for
• 2. What you need to know before you take Amlodipina Hexal AG
• 3. How to take Amlodipina Hexal AG
• 4. Possible side effects
• 5. How to store Amlodipina Hexal AG
• 6. Contents of the pack and other information

1. WHAT AMLODIPINA HEXAL AG IS AND WHAT IT IS USED FOR

Amlodipina Hexal AG belongs to a group of medicines called calcium antagonists.
Amlodipina Hexal AG is used:

• for the treatment of high blood pressure (hypertension);
• for the treatment of 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, Amlodipina Hexal AG improves blood supply to the heart muscle, which receives
more oxygen and thus prevents chest pain. The medicine does not provide immediate relief from
chest pain due to angina.

2. WHAT YOU NEED TO KNOW BEFORE TAKING AMLODIPINA HEXAL AG

Do not take Amlodipina Hexal AG

• If you are allergic to amlodipine, to any calcium antagonists or to any of the excipients of this medicine (listed in section 6). The reaction may be itching, skin redness or difficulty breathing.
• If you have severe 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 the body with sufficient blood).
• If you suffer from heart failure following a heart attack

Warnings and precautions
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 dosage may need to be increased

Children and adolescents
Amlodipina Hexal AG has not been studied in children under 6 years of age. Amlodipina Hexal AG 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 Amlodipina Hexal AG
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Amlodipina Hexal AG may have effects on other medicines or other medicines may have effects on
Amlodipina Hexal AG, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used for the treatment of HIV)
• rifampicin, erythromycin (antibiotics)
• Hypericum perforatum (St John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe alterations in body temperature)
• simvastatin (used to lower high cholesterol levels in the blood)
• clarithromycin (for infections caused by bacteria)
• tacrolimus (used to control the immune response, to allow the body to accept the transplanted organ).

Amlodipina Hexal AG may reduce blood pressure even further if you are already taking
other medicines to treat high blood pressure.

Amlodipina Hexal AG with food and drink
People taking Amlodipina Hexal AG should not drink grapefruit juice as grapefruit and its juice can lead to an increase in the levels of the active substance amlodipine in
the blood, and this may result in an increase in the hypotensive effect of Amlodipina Hexal AG.

Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you are pregnant, if you think you
may be pregnant or if you are planning to have a baby, ask your doctor or pharmacist for advice
before taking Amlodipina Hexal AG.

Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or will start breastfeeding, inform your doctor
before taking Amlodipina Hexal AG.

Driving and using machines
Amlodipina Hexal AG may have an effect on your ability to drive or operate machinery. If the tablets
cause you to 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 HEXAL AG

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 Amlodipina Hexal AG 5 mg once a day. The dose may be increased
to Amlodipina Hexal AG 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 Amlodipina Hexal AG with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual recommended starting dose is 2.5 mg per
day. The maximum recommended daily dose is 5 mg per day.
Continue taking the tablets for as long as your doctor tells you. See your doctor before
stopping the tablets.
The tablet can be divided into equal doses.

If you take more Amlodipina Hexal AG 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 feel dizzy, lightheaded, weak or faint. 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 Hexal
AG tablets, contact your doctor immediately .
If you forget to take Amlodipina Hexal AG
Do not worry. If you forget to take a tablet, skip the missed dose. Take the next tablet
at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Amlodipina Hexal AG
You must continue to take the medicine for as long as your doctor tells you. Stopping the
treatment may cause your condition to worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amlodipina Hexal AG can cause side effects, although not everybody gets them.
If you notice any of the following very rare and serious side effects, consult your doctor immediately:

• 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 skin rash, hives, 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 accompanied by a feeling of severe unwellness

The following common side effectshave been reported. If any of these occur or persist for more than a week, see 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
• Swelling of the ankles (edema), fatigue

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 leaflet, tell your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting, weakness
• Sensation of numbness or tingling in the limbs; loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Altered bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration
• Urinary disorders, needing to urinate at night, needing to urinate frequently
• Inability to achieve an erection; discomfort or enlargement of the breasts in men
• Weakness, pain, malaise
• Joint or muscle pain, muscle cramps, back pain
• Weight gain or loss

Rare:may affect up to 1 in 1000 people

• Confusion

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

• Low levels of white blood cells and platelets in the blood which can lead to unusual bruising 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
• Cough, swollen gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (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 from the available data

• tremor, rigid posture, face that looks like a mask, slow movements and a shuffling gait, unsteady walking

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 Italian Medicines Agency, 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 HEXAL AG

Keep the 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 the month.
Blister: keep the blister in the outer packaging to protect the medicine from light. Do not store at a
temperature above 30°C.
Bottle: store in the original packaging to protect the medicine from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6CONTENTS OF THE PACK AND OTHER INFORMATION
What Amlodipina Hexal AG contains

• The active ingredient is amlodipine. Each tablet contains 5 mg, 10 mg of amlodipine (as besilate).
• The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethylcellulose (type A) and magnesium stearate.

Description of the appearance of Amlodipina Hexal AG and contents of the pack
Amlodipina Hexal AG 5 mg tablets
White or off-white, oblong tablets, with bevelled edges, with a break line on one side and
marked with “5” on the opposite side.
Amlodipina Hexal AG 10 mg tablets
Oblong tablets, white or whitish in colour, with bevelled edges, with a score line on one
side and “10” imprinted on the other side.
The tablets are available in:

• blisters of 10, 14, 20, 28, 30, 50, 60, 100, 120 tablets and 50x1 tablets contained in perforated unit-dose blisters;
• HDPE tablet containers of 20, 30, 50, 60, 100, 120, 200 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
HEXAL AG - Industriestrasse, 25 – 83607 Holzkirchen (Germany)

Representative for Italy:
Sandoz S.p.A.- Largo U. Boccioni, 1 21040 Origgio (VA)

Manufacturers responsible for batch release
LEK S.A. ul. Podlipie 16, 95010 Strykow, Poland – Production sites: ul. Domaniewska 50 C – PL-02-672 –
Warsaw and Ul. Podlipie 16 95 010 Strykow – Poland
Salutas Pharma GmbH Otto-von-Guericke Allee 1 – D-39179 Barleben – Germany
Salutas Pharma GmbH Dieselstrasse, 5 - 70839 Gerlingen – Germany
Lek Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana – Slovenia
ROWA Pharmaceuticals Ltd – Bantry – Co. Cork – Ireland
S.C. Sandoz S.r.l., Str. Livezeni 7A – 540472 Targu Mures - Romania

This medicinal product is authorised in the Member States of the EEA with the following denominations:
Austria: Amlodipin Hexal 5 mg – Tablets
Amlodipin Hexal 7.5 mg – Tablets
Amlodipin Hexal 10 mg – Tablets
Denmark: Amlohexal
Germany: Amlodipin HEXAL 5 mg Tabletten
Amlodipin HEXAL 7.5 mg Tabletten
Amlodipin HEXAL 10 mg Tabletten
Ireland: Amlode 5 mg Tablets
Amlode 10 mg Tablets
Italy: AMLODIPINA HEXAL AG 5 mg tablets
AMLODIPINA HEXAL AG 10 mg tablets
Luxembourg: Amlodipin HEXAL 5 mg Tabletten
Amlodipin HEXAL 7.5 mg Tabletten
Amlodipin HEXAL 10 mg Tabletten
Poland: AMLOPIN 5 tabletki
AMLOPIN 10 tabletki
Spain: Amlodipino Bexal 5 mg comprimidos EFG
Amlodipino Bexal 10 mg comprimidos EFG
Hungary: Amlodipin Sandoz 5 mg tabletta
Amlodipin Sandoz 10 mg tabletta