ABIS 5 mg Tablet

Зміст інструкції

1. ABIS 5 mg tablets
   1. What is ABIS and what is it used for
   2. BEFORE TAKING ABIS
2. ABIS has not been studied in children under the age of 6 years. ABIS must be used
   1. How to take ABIS
   2. Possible side effects
   3. How to store ABIS tablets
   4. Contents of the pack and other information

ABIS 5 mg tablets

ABIS10 mg tablets
amlodipine
Generic medicine
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is ABIS and what is it used for

ABIS contains the active substance amlodipine which belongs to a group of
medicines called calcium antagonists.
ABIS is used for the treatment of high blood pressure (hypertension) or a type
of chest pain called angina, including a rare form called Prinzmetal's angina or
variant angina.
In patients with hypertension, this medicine works by relaxing the blood vessels so that
blood can flow more easily. In patients with angina, ABIS improves the blood supply
to the heart muscle which receives more oxygen and thus prevents chest pain. The medicine does not provide immediate relief from chest pain due to
angina.

2. BEFORE TAKING ABIS

Do not take ABIS

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

Take special care with ABIS
Consult your doctor or pharmacist before taking ABIS.
Tell your doctor if you have or have suffered from the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease (hepatopathy)
• You are elderly and your dosage may need to be increased

Use in children and adolescents

ABIS has not been studied in children under the age of 6 years. ABIS must be used

only for hypertension in children and adolescents from 6 to 17 years of age (see section
3). For further information, consult your doctor.

Taking ABIS with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
ABIS may have effects on other medicines or other medicines may have effects on ABIS,
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 (heart medicines);
• dantrolene (infusion for severe alterations of body temperature);
• simvastatin (medicine used for the treatment of high cholesterol levels in the blood).
• rifampicin, erythromycin, clarithromycin (antibiotics)

ABIS may reduce blood pressure even more if you are already taking
other medicines to treat high blood pressure at the same time.

Taking ABIS with food and drink
People taking ABIS should not drink grapefruit juice as
grapefruit and its juice can induce an increase in the levels of the active substance
amlodipine in the blood, and this may lead to an increase in the hypotensive effect of
ABIS.

Pregnancy
The safety of amlodipine in pregnant women has not been established. If you believe you are
pregnant or if you are planning a pregnancy, inform your doctor before
taking ABIS.

Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are
breastfeeding or will start breastfeeding, inform your doctor before taking ABIS.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
ABIS may have an effect on your ability to drive or use machines. If the
tablets cause you to feel unwell, dizzy or tired, or give you a headache, avoid
driving or using machines and contact your doctor immediately.

Important information about some of the excipients in ABIS tablets
This medicine contains lactose. If your doctor has told you that you have an intolerance to
certain sugars, contact your doctor before taking this medicine.

3. How to take ABIS

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The usual starting dose is ABIS 5 mg once a day. The dose may be
increased to ABIS 10 mg once a day.
The medicine can be taken before or after food and beverages. You must take the medicine
every day at the same time with some water. Do not take ABIS with grapefruit juice.

Use in children and adolescents
For children and adolescents (from 6 to 17 years of age), the usual starting dose is 2.5 mg
per day. The maximum recommended daily dose is 5 mg per day. The score line on the
tablet is only intended to facilitate swallowing.
Continue taking the tablets for as long as indicated by your doctor. See your
doctor before stopping the tablets.

If you take more ABIS than you should
If you were to take an excessive number of tablets, your blood pressure could
drop too low, and this could be dangerous. You may experience dizziness, vertigo,
weakness or fainting. The drop in blood pressure could be so severe as to cause
shock. The skin may become cold and clammy and you may lose consciousness.
If you have taken an excessive number of ABIS tablets, contact
your doctor immediately .
If you forget to take ABIS
Do not worry. If you forget to take a tablet, skip the missed dose.
Take the next tablet at the usual time. Do not take a double dose to
make up for the forgotten dose.

If you stop taking ABIS
You must continue to take the medicine for as long as your doctor tells you.
Stopping treatment may cause a worsening of the condition.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ABIS can cause side effects, although not everybody gets them.
If you notice any of the following very rare and serious side effects, consult

immediatelyyour doctor:

• Sudden onset of shortness of breath, chest pain, wheezing 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 all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, arrhythmia.
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise.

The following common side effectshave been reported. If any of these occur or if it persists for more than a week, see your doctor.
Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (feeling your heartbeat), flushing.
• Abdominal pain, nausea.
• Swelling of the ankles (edema), fatigue. Also, the following side effects have been reported.

Uncommon:may affect up to 1 in 1000 people

• Mood changes, anxiety, depression, insomnia.
• Tremor, altered taste, fainting, weakness.
• Sensation of numbness or tingling in the limbs; loss of pain sensation.
• Visual disturbances, double vision, ringing in the ears.
• Low blood pressure.
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis).
• Altered bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting.
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration.
• Urinary disorders, needing to urinate at night, needing to urinate frequently.
• Inability to achieve an erection; discomfort or enlargement of the breasts in men.
• Weakness, pain, malaise.
• Joint or muscle pain, muscle cramps, back pain.
• Weight gain or loss.

Rare:may affect up to 1 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 a tendency to bleed (damage to red blood cells).
• High blood sugar levels (hyperglycemia).
• A nervous disorder that can cause weakness, tingling or numbness.
• Cough, swollen gums.
• Abdominal bloating (gastritis).
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in some clinical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rash.
• Sensitivity to light.
• Disorders related to stiffness, tremor and/or movement disorders.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 ABIS tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
EXP. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25 °C.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What ABIS tablets contain
The active ingredient is amlodipine besilate.

ABIS tablets 5 mgcontains amlodipine besilate corresponding to 5 mg of amlodipine
per tablet.

ABIS tablets 10 mgcontains amlodipine besilate corresponding to 10 mg of
amlodipine per tablet.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium starch
glycolate, magnesium stearate.

Description of the appearance of ABIS tablets and contents of the pack

ABIS tablets 5 mg: the tablets are white, round, with a score line on one
side. The score line is only intended to facilitate swallowing.

ABIS tablets 10 mg: the tablets are white, round, with a score line on one
side. The score line is only intended to facilitate swallowing.
ABIS tablets 5 mg is available in opaque Al/PVC-PVDC blisters containing 28
tablets
ABIS tablets 10 mg is available in opaque Al/PVC-PVDC blisters containing 14
tablets

Marketing Authorisation Holder
AGIPS FARMACEUTICI S.r.l. – Via Amendola, 4 – 16035 Rapallo (GE)

Manufacturer:
West Pharma Producoeos de Especialitades Farmaceuticas Sa – Rua Joao de Deus, 11 –
Venda Nova, Amadora (Portugal)