Amlodipine Zentiva Italia

Patient Information Leaflet

AMLODIPINE ZENTIVA ITALIA 5 mg tablets, 10 mg tablets

Generic medicine
Please read all of 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 give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amlodipine Zentiva Italia is and what it is used for

Amlodipine Zentiva Italia contains the active substance amlodipine, which belongs to a group of
medicines called calcium antagonists.
Amlodipine Zentiva Italia is used to treat high blood pressure (hypertension) or a type of chest
pain known as angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with hypertension, this medicine works by relaxing blood vessels so that blood can
flow more easily. In patients with angina, Amlodipine Zentiva Italia improves blood supply to the
heart muscle, providing more oxygen and thereby preventing chest pain. This medicine does not
provide immediate relief from angina-related chest pain.

2. What you need to know before taking Amlodipine Zentiva Italia

Do not take Amlodipine Zentiva Italia if

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Zentiva Italia if you have or have 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 Zentiva Italia has not been studied in children under 6 years of age. Amlodipine Zentiva Italia 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 Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Zentiva Italia may affect other medicines, or other medicines may affect Amlodipine Zentiva Italia, such as:

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

Amlodipine Zentiva Italia may lower your blood pressure even further if you are already taking other medicines for high blood pressure.
Amlodipine Zentiva Italia with food and drink
People taking Amlodipine Zentiva Italia should not consume grapefruit or grapefruit juice. This is because grapefruit and its juice can increase the levels of the active substance amlodipine in the blood, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine Zentiva Italia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of amlodipine in pregnant women has not been established.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or are about to start breastfeeding, you must inform your doctor before taking Amlodipine Zentiva Italia.
Driving and using machines
Amlodipine Zentiva Italia may affect your ability to drive or use machinery. If the tablets cause you to feel unwell, dizzy or tired, or give you headaches, do not drive or operate machinery and contact your doctor immediately.
Amlodipine Zentiva Italia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Amlodipine Zentiva Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is Amlodipine Zentiva Italia 5 mg once daily. The dose may be
increased to Amlodipine Zentiva Italia 10 mg once daily.
This medicine can be taken before or after food and drink. You should take this medicine at the same
time each day with a glass of water. Do not take Amlodipine Zentiva Italia 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
daily. The maximum recommended dose is 5 mg daily. The 2.5 mg dose can be achieved using
Amlodipine Zentiva Italia 5 mg tablets, as these tablets can be divided into two equal doses.
If you take more Amlodipine Zentiva Italia than you should
Taking too many tablets may cause your blood pressure to become low or even dangerously low. You
may experience dizziness, feel lightheaded, faint, or weak. The drop in blood pressure may be so
severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness.
If you take an excessive number of Amlodipine Zentiva Italia tablets, seek immediate medical
assistance.
If you forget to take Amlodipine Zentiva Italia
Do not worry. If you forget to take a tablet, simply skip that dose. Take the next tablet at your usual
time. Do not take a double dose to make up for the missed dose.
If you stop taking Amlodipine Zentiva Italia
Your doctor will inform you how long you should take this medicine. Your condition may return if you
stop taking this medicine before you are told to do so.
It is important to continue taking the tablets. Contact your doctor before stopping the treatment.
If you have any 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 everyone gets them.
Consult your doctor immediately if you experience any of the following side effects after
taking this medicine:

• 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 rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal and back pain associated with a marked feeling of malaise.

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

• Edema (fluid retention).

Common (may affect up to 1 in 10 people):

• Drowsiness, dizziness, headache (especially at the beginning of treatment).
• Vision disturbances, double vision.
• Palpitations (awareness of heartbeat), flushing.
• Abdominal pain, feeling unwell (nausea), changes in bowel habits, diarrhoea, constipation, indigestion.
• Swelling of the ankles, muscle cramps.
• Fatigue, weakness.

The following additional side effects have been reported.
Uncommon (may affect up to 1 in 100 people):

• Depression, mood changes, anxiety, insomnia.
• Tremor, taste disturbances, fainting, tingling or numbness in the limbs; loss of sensitivity to pain.
• Ringing in the ears (tinnitus).
• Low blood pressure.
• Cough, sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis).
• Vomiting (feeling sick), dry mouth.
• Hair loss, red patches on the skin, skin discoloration, increased sweating, skin itching.
• Joint or muscle pain, back pain.
• Urinary disorders, increased need to urinate at night, frequent need to urinate.
• Inability to achieve an erection, discomfort or breast enlargement in men.
• Pain, malaise.
• 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 lead to unusual bruising or tendency to bleed.
• High blood sugar levels (hyperglycaemia).
• Increased muscle tension.
• A nerve disorder which may cause muscle weakness, tingling or numbness.
• Inflammation of the stomach (gastritis) which may include abdominal bleeding, swollen gums.
• 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.
• Light sensitivity.

Frequency not known (frequency cannot be estimated from the available data):

• Tremor, rigid posture, facial masking, slow and uncoordinated movements, unbalanced gait.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Store below 25°C in the original packaging to protect the medicine from light.
Do not dispose of medicines 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 Amlodipina Zentiva Italia contains
Amlodipina Zentiva Italia 5 mg tablets: The active substance is amlodipine 5 mg, corresponding to 6.935 mg of amlodipine besilate per tablet.
Amlodipina Zentiva Italia 10 mg tablets: The active substance is amlodipine 10 mg, corresponding to 13.870 mg of amlodipine besilate per tablet.
The other components are: microcrystalline cellulose, sodium starch glycolate A, calcium hydrogen phosphate dihydrate, magnesium stearate.

Description of the appearance of Amlodipina Zentiva Italia and package contents
Amlodipina Zentiva Italia is available as oval tablets, white to off-white in colour, with a score line on one side, printed to the left and right of the score line with "A" and "5" or "A" and "10". The tablets can be divided into equal doses.
Pack sizes contain:
Amlodipina Zentiva Italia 5 mg: 10, 14, 15, 20, 28, 30, 50, 60, 90 or 100 tablets.
Amlodipina Zentiva Italia 10 mg: 10, 14, 15, 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7, 20121 Milan, Italy
Manufacturer
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague - Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Amlodipine Zentiva
Germany: Amlodipin Winthrop 5 mg Tabletten
Amlodipin Winthrop 10 mg Tabletten
Greece: AGEN
Italy: Amlodipina Zentiva Italia
Portugal: Amlodipina Zentiva