Amlodipine Aurobindo

Package leaflet: Information for the user

Amlodipine Aurobindo 5 mg tablets, 10 mg tablets

Generic medicine
Please read all of 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. Never give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amlodipine Aurobindo contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine Aurobindo is used to treat 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, allowing blood to flow more easily. In patients with angina, Amlodipine Aurobindo improves blood supply to the heart muscle, thereby providing more oxygen and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Amlodipine Aurobindo

Do not take Amlodipine 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 antagonist. The reaction may cause itching, skin redness, or difficulty breathing.
• if you have severe low blood pressure (hypotension)
• if you have aortic valve narrowing (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply 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 Amlodipine Aurobindo
if you have or have had any of the following conditions:

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

Use in children and adolescents
Amlodipine Aurobindo has not been studied in children under 6 years of age. Amlodipine Aurobindo should be
used only for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.
Other medicines and Amlodipine Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Amlodipine Aurobindo may affect or be affected 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 serious abnormalities in body temperature)
• tacrolimus (a medicine used to alter the activity of your immune system)
• simvastatin (a medicine for high cholesterol in the blood)
• ciclosporin (an immunosuppressant)

Amlodipine Aurobindo may lower your blood pressure even further if you are already taking other medicines for
high blood pressure.
Amlodipine Aurobindo with food and drink
Grapefruit or grapefruit juice must not be consumed by people taking Amlodipine Aurobindo. This is because both grapefruit and its juice can lead to increased blood levels of the active substance amlodipine, which may cause an unpredictable hypotensive effect of Amlodipine Aurobindo.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant, or if you plan to become pregnant, you must inform your doctor before taking Amlodipine Aurobindo.
Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or are about to start breastfeeding, you must inform your doctor before taking Amlodipine Aurobindo.
Driving and using machines
Amlodipine Aurobindo may affect your ability to drive or use machinery. If you feel unwell, dizzy, or experience tiredness or headache, do not drive or operate machinery and contact your doctor immediately.

3. How to take Amlodipine Aurobindo

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

The recommended starting dose of Amlodipine Aurobindo is 5 mg once daily. The dose may be increased to 10 mg of Amlodipine Aurobindo once daily.

This medicine can be taken before or after meals and drinks. Take this medicine at the same time each day with a glass of water. Do not take Amlodipine Aurobindo with grapefruit juice.

Use in children and adolescents
For children and adolescents (6–17 years), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is currently not available, and the 2.5 mg dose cannot be obtained with Amlodipine Aurobindo 5 mg tablets, as these tablets are not manufactured to be divided into equal halves.

It is important to continue taking the tablets. Do not wait until you have run out of tablets before seeing your doctor.

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

If you forget to take Amlodipine Aurobindo
Don't worry. If you forget to take a tablet, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amlodipine Aurobindo
Your doctor will advise you on how long to take this medicine. If you stop treatment with this medicine too early, your symptoms may return. If you have any further questions about the use of this medicine, consult 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 immediately if you experience any of the following side effects after taking this medicine:

• Sudden breathlessness, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat causing severe breathing difficulties
• Severe skin reactions including intense rash, hives, widespread redness of the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a strong feeling of malaise.

The following very common side effects have been reported. If these cause you problems or if the effect lasts for more than one week, you must contact your doctor.
Very common: may affect more than 1 in 10 people
Edema (fluid retention)

The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you must 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, diarrhoea, constipation, indigestion

• Fatigue and weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects that have been reported are listed below. If any of these worsen, or if you notice any side effects 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
• Sensation of numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears (tinnitus)
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Dry mouth, vomiting (feeling sick)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin colour changes
• Difficulty urinating, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Weakness, pain, malaise
• Joint or muscle pain, back pain
• Weight gain or weight loss

Rare: may affect up to 1 in 1,000 people
Confusion

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

• Decrease in white blood cell count, decrease in platelets in the blood which may cause bruising or easy bleeding
• High blood sugar levels (hyperglycaemia)
• Nervous system disorders which may cause muscle weakness, tingling or numbness
• Cough, 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 certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often associated with skin rashes
• Light sensitivity
• Disorders combining stiffness, tremor, and/or movement disturbances

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 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 Amlodipine Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton or bottle after EXP. The expiry date refers to the
last day of that month.
Do not dispose of any medicine via 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 Amlodipine Aurobindo contains

• The active substance is amlodipine as amlodipine besylate.
• The other components are: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

Description of the appearance of Amlodipine Aurobindo and package contents
Tablets.
5 mg: white or almost white, flat, bevelled, cylindrical tablet, engraved with "C" on one side and "58" on the other. Size: 7.9 mm x 5.6 mm.
10 mg: white or almost white, flat, bevelled, round tablet [diameter 9.5 mm], engraved with "C" on one side and "59" on the other.
Aluminum-PVC/PVdC blisters.
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 Authorization 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 authorized in the European Economic Area Member States under the following names:
Germany Amlodipin Aurobindo 5 mg/ 10 mg Tabletten
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