Amlodipine Hexal AG

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Amlodipine Hexal AG 5 mg tablets, 10 mg tablets

Amlodipine
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
  Contents of this leaflet:

1. What Amlodipine Hexal AG is and what it is used for
2. What you need to know before taking Amlodipine Hexal AG
3. How to take Amlodipine Hexal AG
4. Possible side effects
5. How to store Amlodipine 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 known as 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, delivering
more oxygen and thereby preventing chest pain. The medicine does not provide immediate relief from
chest pain caused by angina.

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMLODIPINE HEXAL AG

Do not take Amlodipine Hexal AG

• If you are allergic to amlodipine, to any other calcium antagonists, or to any of the excipients of this medicine (listed in section 6). The reaction may include itching, skin redness, or difficulty breathing.
• If you have severe low blood pressure (hypotension)
• If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
• If you suffer from heart failure following a heart attack

Warnings and precautions
Inform your doctor if you have or have previously had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease (hepatopathy)
• You are elderly and your dosage needs to be increased

Children and adolescents
Amlodipine Hexal AG has not been studied in children under 6 years of age. Amlodipine 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 Amlodipine Hexal AG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those obtained without a prescription.
Amlodipine Hexal AG may affect other medicines, or other medicines may affect Amlodipine Hexal AG, such as:

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

Amlodipine Hexal AG may lower your blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Amlodipine Hexal AG with food and drinks
People taking Amlodipine Hexal AG should not drink grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an enhanced hypotensive effect of Amlodipine Hexal AG.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking Amlodipine Hexal AG.
Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or intend to breastfeed, inform your doctor before taking Amlodipine Hexal AG.
Driving and using machines
Amlodipine Hexal AG may affect your ability to drive or operate machinery. If the tablets cause you to feel unwell, dizzy or fatigued, or if you experience headache, avoid driving or operating machinery and contact your doctor immediately.

3. HOW TO TAKE AMLODIPINE HEXAL AG

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is Amlodipine Hexal AG 5 mg once daily. The dose may be increased to Amlodipine Hexal AG 10 mg once daily.
This medicine can be taken before or after food and drink. You should take the medicine every day at the same time with some water. Do not take Amlodipine Hexal AG with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended usual starting dose is 2.5 mg daily. The recommended maximum daily dose is 5 mg daily.
Continue taking the tablets for as long as your doctor has told you to. Visit your doctor before stopping the tablets.
The tablet may be divided into equal doses.
If you take more Amlodipine Hexal AG than you should
If you take too many tablets, your blood pressure could drop too low, which could be dangerous. You may feel dizzy, lightheaded, weak, or faint. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness. If you have taken an excessive amount of Amlodipine Hexal AG tablets, contact your doctor immediately.
If you forget to take Amlodipine 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 the forgotten dose.
If you stop taking Amlodipine Hexal AG
You must continue taking this medicine for as long as your doctor has instructed. Stopping treatment may cause your condition to worsen.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amlodipine Hexal AG can cause side effects, although not everyone experiences 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, breathlessness or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which may cause difficulty breathing
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions
• Myocardial infarction, arrhythmia
• Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise

The following common side effects have been reported. If any of these occur or persist for more than one week, contact your doctor.
Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of 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, inform your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 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 may result in unusual bruising or tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycaemia)
• A nerve disorder which may cause weakness, tingling or numbness
• Cough, gum swelling
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Light sensitivity

Not known: frequency cannot be estimated from the available data

• tremor, rigid posture, mask-like facial expression, slow movements and shuffling gait, unsteady walking

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 above 30°C.
Bottle: store in the original container to protect the medicine from light.
Medicines must 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amlodipina Hexal AG contains

• The active substance is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine (as besylate).
• The excipients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethylstarch (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, elongated, bevel-edged tablets with a breakline on one side and engraved "5" on the opposite side.

Amlodipina Hexal AG 10 mg tablets
Elongated, white or almost white tablets with bevelled edges, a score line on one side and "10" imprinted on the other side.

The tablets are available in:

• Blister packs of 10, 14, 20, 28, 30, 50, 60, 100, 120 tablets and 50x1 tablets in unit-dose perforated blister packs;
• HDPE containers containing 20, 30, 50, 60, 100, 120, 200 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization 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 – Manufacturing 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 medicine is authorized in EEA Member States under the following names:
Austria: Amlodipin Hexal 5 mg – Tabletten
Amlodipin Hexal 7.5 mg – Tabletten
Amlodipin Hexal 10 mg – Tabletten
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 compresse
AMLODIPINA HEXAL AG 10 mg compresse
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