PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

AMLODIPINE ALTER 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 they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amlodipine Alter is and what it is used for
What you need to know before taking Amlodipine Alter
How to take Amlodipine Alter
Possible side effects
How to store Amlodipine Alter
Contents of the pack and other information

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

Amlodipine Alter contains the active substance amlodipine, which belongs to a group of
medicines called calcium antagonists.
Amlodipine Alter is used to treat high blood pressure (hypertension) or 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 blood vessels so that blood can flow more easily. In patients with angina, Amlodipine Alter improves blood supply to the heart muscle, providing more oxygen and thereby preventing chest pain. The medicine does not provide immediate relief from angina-related chest pain.

2. What you need to know before taking Amlodipine Alter

Do not take Amlodipine Alter

If you are allergic to the active substance or to any of the other ingredients 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 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 suffer from heart failure following a heart attack.

Warnings and precautions
Talk to your doctor before taking Amlodipine Alter.
Inform your doctor if you currently 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 may need adjustment.

Children and adolescents
Amlodipine Alter has not been studied in children under 6 years of age. Amlodipine
Alter 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 Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Alter may interact with or be affected by other medicines, such as:

Ketoconazole, itraconazole (antifungal medicines)
Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
Rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
Verapamil, diltiazem (heart medicines)
Dantrolene (infusion for severe disturbances in body temperature).

Amlodipine Alter may lower blood pressure even more if you are already taking other medicines for hypertension.
Simvastatin: co-administration of repeated doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin to 20 mg daily in patients receiving amlodipine.
Amlodipine Alter with food and drinks
People taking Amlodipine Alter should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially enhancing the hypotensive effect of Amlodipine Alter.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, inform your doctor before taking Amlodipine Alter.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine Alter may affect your ability to drive or operate machinery. If the tablets cause you discomfort, dizziness, fatigue, or headache, avoid driving or operating machinery and contact your doctor immediately.

3. How to take Amlodipine Alter

Always take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is Amlodipine Alter 5 mg once daily. The dose may be increased to Amlodipine Alter 10 mg once daily.
This medicine may be taken before or after food and drinks. You must take the medicine every day at the same time with a glass of water. Do not take Amlodipine Alter with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual starting dose is 2.5 mg daily. The maximum recommended daily dose is 5 mg. Amlodipine 2.5 mg is not currently available, and the 2.5 mg dose cannot be achieved with Amlodipine Alter 5 mg tablets, as these tablets are not designed to be divided into equal parts.
In children and adolescents (aged 6 to 17 years), the recommended usual dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.

If you take more Amlodipine Alter than you should
If you take too many tablets, your blood pressure may drop too low, which could be dangerous. You may experience dizziness, vertigo, weakness, or fainting. 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 Alter tablets, contact your doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take Amlodipine Alter
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 Alter
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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, 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, urticaria, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) 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 if they persist for more than one week, consult your doctor.
Common: may affect from 1 to 10 out of 100 patients:

Headache, dizziness, drowsiness (especially at the beginning of treatment)
Flushing
Abdominal pain, nausea
Swelling of the ankles (oedema), 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 from 1 to 10 out of 1,000 patients:

Palpitations (awareness of heartbeat)
Mood changes, anxiety, depression, insomnia
Tremor, taste disturbances, 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 the 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 enlargement of the breast in men
Weakness, pain, malaise
Joint or muscle pain, muscle cramps, back pain
Weight gain or weight loss
Alopecia, purpura, skin dyschromia, hyperhidrosis, pruritus, rash, exanthema

Rare: may affect from 1 to 10 out of 10,000 patients:

Confusion

Very rare: may affect less than 1 out of 10,000 patients:

Low levels of white blood cells and platelets in the blood which may lead to 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, swelling of the gums
Abdominal swelling (gastritis)
Liver dysfunction, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to abnormalities in certain clinical tests
Increased muscle tension
Inflammation of blood vessels, often associated with skin rash
Light sensitivity
Disorders related to 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 national reporting system at the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Alter

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 that month.
Do not store above 25°C.
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 Alter contains

The active substance in Amlodipine Alter 5 mg tablets is amlodipine (as besylate).
The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.
The active substance in Amlodipine Alter 10 mg tablets is amlodipine (as besylate).
The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

Description of the appearance of Amlodipine Alter and package contents
Tablets
Blister pack containing 28 tablets of 5 mg.
Blister pack containing 14 or 30 10 mg scored tablets.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan, Italy
Manufacturer
Laboratorios Alter S.A. – C/Mateo Inurria, 30 – 28036 Madrid (Spain)