Amlodipine Teva Italia

Package leaflet: Information for the user

Amlodipine Teva Italia 5 mg tablets, 10 mg tablets

Equivalent medicine
Please read all of 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 adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amlodipine Teva Italia contains the active substance amlodipine, which belongs to a group of
medicines called calcium antagonists.
Amlodipine Teva Italia is used to treat high blood pressure (hypertension) or a particular type of
chest pain called angina, including Prinzmetal's angina or variant angina.
In patients with high blood pressure, this medicine works by relaxing blood vessels and making it
easier for blood to flow through them. In patients with angina, Amlodipine Teva Italia works by
improving blood supply to the heart muscle, thereby delivering more oxygen; this helps prevent
the occurrence of chest pain. This medicine does not provide immediate relief of chest pain due to angina.

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

Do not take Amlodipine Teva Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Teva Italia.
You must 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
• You are elderly and your dosage needs to be increased.

Children and adolescents
Amlodipine has not been studied in children under 6 years of age. In children and adolescents aged 6 to 17 years, Amlodipine Teva Italia should be used only for hypertension (see section 3). For further information, please consult your doctor.
Other medicines and Amlodipine Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Teva Italia may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV virus)
• rifampicin, erythromycin, clarithromycin (antibiotics for bacterial infections)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for serious disturbances in body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works)
• simvastatin (a medicine to lower cholesterol)
• ciclosporin (an immunosuppressant).

Amlodipine Teva Italia may cause an increased reduction in blood pressure if you are already taking other medicines for the treatment of hypertension.
Amlodipine Teva Italia with food and drink
People taking Amlodipine Teva Italia should not drink grapefruit juice or eat grapefruit, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the hypotensive effect of amlodipine.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you may be pregnant or are planning a pregnancy, you must inform your doctor before taking Amlodipine Teva Italia.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine Teva Italia.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amlodipine Teva Italia may affect your ability to drive or use machinery. If the tablets make you feel unwell, dizzy, tired, or if you develop a headache, avoid driving or using machinery and contact your doctor immediately.
Amlodipine Teva Italia contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Amlodipine Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 1 tablet of Amlodipine Teva Italia 5 mg once daily.
The dose may be increased to 1 tablet of Amlodipine Teva Italia 10 mg once daily.
This medicine can be taken before or after food and drinks. Take this medicine at the same time each day. Swallow the tablets immediately with a glass of water. Do not take Amlodipine Teva Italia with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged between 6 and 17 years), the recommended starting dose is 2.5 mg daily. The recommended maximum dose is 5 mg daily.
Amlodipine Teva Italia 5 mg tablets may be divided into two equal parts to achieve a dose of 2.5 mg.
Amlodipine Teva Italia 10 mg tablets may also be divided into two equal parts.
If your doctor has instructed you to take ½ (half) tablet daily, it is recommended not to use any device to split the tablet. Please follow the instructions below on how to split the tablet:
Place the tablet on a flat, hard surface (for example, a table or worktop), with the imprint facing upwards. Break the tablet by pressing down with both index fingers placed along the break line.

It is important that you take the tablets continuously. Do not wait until you have run out of tablets before contacting your doctor.

If you take more Amlodipine Teva Italia than you should
Taking too many tablets may cause excessive lowering of blood pressure, sometimes to dangerous levels. You may feel dizzy, lightheaded, faint, or weak.
If the drop in blood pressure is very severe, shock may occur. The skin may become cold and clammy, and you may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary oedema), causing breathlessness, which may develop up to 24–48 hours after ingestion.
If you have taken too many Amlodipine Teva Italia tablets, seek immediate medical attention.

If you forget to take Amlodipine Teva Italia
Do not worry. If you forget to take a tablet, simply skip that dose. Take the next dose at the usual scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking Amlodipine Teva Italia
Your doctor will tell you how long to take this medicine. Your condition may return if you stop taking this medicine earlier than advised.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking this medicine and/or seek immediate medical advice if you experience any of the following side effects after taking this medicine:

• Sudden onset of breathlessness, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that may cause difficulty breathing
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas that may cause severe abdominal and back pain accompanied by a strong feeling of malaise

The following very common side effects have been reported. If any of these side effects cause you problems or persist for more than one week, consult your doctor.
Very common: may affect up to 1 in 10 people

• Edema (fluid retention)

The following common side effects have been reported. If any of these side effects cause you problems or persist for more than one week, consult 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, feeling unwell (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

In addition, other side effects have been reported, listed below. If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling sensations in limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling of malaise)
• Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
• Urination difficulties, need to urinate at night, frequent need to urinate
• Inability to achieve an erection, discomfort or breast enlargement in men
• Pain, discomfort
• 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 up to 1 in 10,000 people:

• Decrease in white blood cell and platelet counts, which may lead to unusual bruising or bleeding tendency
• High blood sugar levels (hyperglycaemia)
• A nerve disorder that may cause muscle weakness, tingling, or numbness
• Swollen gums, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain laboratory tests
• Increased muscle tension
• Inflammation of blood vessels, often associated with skin rash
• Light sensitivity

Not known: frequency cannot be estimated from the available data

• Tremor, rigid posture, mask-like face, slow movements, and shuffling gait.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may 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 Teva 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.
Plastic bottles
Validity after first opening: 4 months.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice signs of discoloration or deterioration of the tablets.
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 Amlodipine Teva Italia contains:
The active substance is amlodipine (as besylate).
Amlodipine Teva Italia 5 mg tablets
Each tablet contains 5 mg of amlodipine (as besylate).
Amlodipine Teva Italia 10 mg tablets
Each tablet contains 10 mg of amlodipine (as besylate).
The other components are microcrystalline cellulose, dibasic calcium phosphate, sodium starch glycolate, and magnesium stearate.

Description of the appearance of Amlodipine Teva Italia and package contents
Amlodipine Teva Italia 5 mg tablets are white, round tablets, 8 mm in diameter. One side is slightly concave, with a break line and engraved with the characters “A 5”. The other side is slightly convex and smooth.

• Available cardboard packages: 15, 20, 28, 30, 30 (3 x 10), 50, 56, 84, 90, 98, 100, 112, 120, 200, 250 and 300 (10 x 30) tablets
• Calendar pack: 28 tablets
• Hospital pack: 50 tablets
• Plastic bottles: 30, 98 and 100, 200 and 250 tablets, with tamper-evident screw cap

Amlodipine Teva Italia 10 mg tablets are white, round tablets, 11 mm in diameter. One side is slightly concave, with a break line and engraved with the characters “A 10”. The other side is slightly convex and smooth.

• Available cardboard packages: 14, 15, 20, 28, 30, 30 (3 x 10), 50, 56, 84, 90, 98, 100, 112, 120, 200 and 250 tablets
• Calendar pack: 28 tablets
• Hospital pack: 50 tablets
• Plastic bottles: 30, 98 and 100, 200 and 250 tablets, with tamper-evident screw cap

Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano, Italy

Manufacturer
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Pharmachemie B.V. - Swensweg 5 - P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Czech Industries s.r.o. - Ostravaská 29, č.p. 305, 747 70 Opava-Komárov (Czech Republic)
Teva Operation Poland Sp. z.o.o, Mogilska 80 Str. 31-546 Kraków (Poland)