Amlopol

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMLOPOL 5 mg tablets, 10 mg tablets

Amlodipine
Equivalent 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, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT AMLOPOL IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMLOPOL

Do not take Amlopol
If you are allergic to amlodipine, or to any of the other ingredients of this
medicinal product (listed in section 6), or to any other calcium antagonists.
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
Talk to your doctor or pharmacist before taking Amlopol.
Inform your doctor 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 dose needs to be increased
Children and adolescents
Amlopol has not been studied in children under 6 years of age. Amlopol 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 Amlopol
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
Amlopol may affect or be affected by other medicines, such as:
ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used for the
treatment of HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
verapamil, diltiazem (medicines for the heart)
dantrolene (infusion for severe disturbances in body temperature)
simvastatin (a cholesterol-lowering medicine)
Tacrolimus (used to control the immune response, to allow the body to accept a transplanted organ)
Clarithromycin (for bacterial infections)

• Ciclosporin (an immunosuppressant)

Amlopol may lower blood pressure even further if you are already taking other
medicines for the treatment of hypertension.
Amlopol with food and drink
People taking Amlopol 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 Amlopol.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you
might be pregnant or are planning a pregnancy, inform your doctor before taking
Amlopol.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are
breastfeeding or planning to breastfeed, you must inform your doctor before taking
Amlopol.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlopol may affect your ability to drive or operate machinery. If the tablets cause you
to feel unwell, dizzy or tired, or give you headaches, avoid driving or operating machinery and contact your doctor immediately.
Amlopol contains lactose
Amlopol contains lactose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking this medicine.

3. HOW TO TAKE AMLOPOL

Take this medicine exactly as directed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
The recommended starting dose is Amlopol 5 mg once daily. The dose may be
increased to Amlopol 10 mg once daily.
This medicine may be taken before or after food and drink. You must take the
medicine every day at the same time with a glass of water. Do not take Amlopol 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 daily.
Amlopol 5 mg may be divided into two equal parts to obtain a 2.5
mg dose.
Continue taking the tablets for as long as your doctor has instructed. See your
doctor before stopping the tablets.
If you take more Amlopol than you should
If you take too many tablets, your blood pressure may drop too low, which can be dangerous. You may experience dizziness, vertigo, weakness, or fainting. 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 have taken an excessive number of Amlopol tablets, contact your doctor immediately.
If you forget to take Amlopol
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 Amlopol
You must continue taking the medicine for as long as your doctor has instructed.
Stopping treatment may cause your condition to worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not
everyone experiences them.
Consult your doctor immediately if you experience any of the following adverse
reactions 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 skin rash, hives, redness of the skin over the
entire 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 very common adverse reactions have been reported. If any of these
occur, or if they persist for more than one week , consult your doctor.
Very common: may affect more than 1 in 10 people

• Swelling of the ankles (oedema)

The following common adverse reactions 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 in 100 people:
Headache, dizziness, drowsiness (especially at the beginning of treatment)
Palpitations (awareness of heartbeat), flushing
Abdominal pain, nausea
Changes in bowel habits, diarrhoea, constipation, indigestion
Swelling of the ankles, fatigue, weakness
Muscle cramps
Visual disturbances, double vision

In addition, the following adverse reactions have been reported:
Uncommon: may affect from 1 to 10 in 1,000 people:
Mood changes, anxiety, depression, insomnia
Tremor, altered taste, fainting
Sensation of numbness or tingling in limbs; loss of sensitivity to pain
Ringing in the ears
Low blood pressure
Cough
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Dry mouth, vomiting
Hair loss, increased sweating, skin itching, urticaria, 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
Pain, malaise
Joint or muscle pain, back pain
Weight gain or weight loss

Rare: may affect from 1 to 10 in 10,000 people:
Confusion

Very rare: may affect less than 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 (damage to red blood cells)
High blood sugar levels (hyperglycaemia)
A nervous system disorder which may cause weakness, tingling or numbness
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 lead to changes in certain clinical tests
Increased muscle tension
Inflammation of blood vessels, often with skin rash
Sensitivity to light

Not known: frequency cannot be estimated from the available data:

• Tremor, rigid posture, mask-like facial expression, slow movements, and unbalanced, shuffling gait

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult
your doctor or pharmacist. You may also report adverse reactions directly via the
national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of
this medicine.

5. HOW TO STORE AMLOPOL

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.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Amlopol contains
The active substance in Amlopol 5 mg tablets is amlodipine (as besylate).
The active substance in Amlopol 10 mg tablets is amlodipine (as besylate).
The other components are: Sodium starch glycolate, Microcrystalline cellulose, Lactose monohydrate (see section 2. Amlopol contains lactose), Magnesium stearate.

Description of the appearance of Amlopol and contents of the pack
AMLOPOL 5 mg – white, round, flat tablets with a score line on one side – 28 divisible tablets
AMLOPOL 10 mg – white, round, flat tablets with a score line on one side – 14 tablets
AMLOPOL 10 mg – white, round, flat tablets with a score line on one side – 30 tablets

Marketing Authorization Holder
Polifarma S.p.A. – Viale dell’Arte, 69– 00144 Rome, Italy

Manufacturer
Atlantic Pharma - Produções Farmaceuticas SA
Rua da Tapada Grande, n.2, Abrunheira, 2710 –228 Sintra - Portugal