Abis

Package leaflet: Information for the user

ABIS 5 mg tablets

ABIS 10 mg tablets
amlodipine
Generic medicine
Please read all of this leaflet carefully before you start 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 yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 ABIS is and what it is used for

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

2. BEFORE TAKING ABIS

Do not take ABIS

• If you are allergic (hypersensitive) to amlodipine, to any other component of this medicine (listed in section 6), or to any 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 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.

Be especially careful with ABIS
Talk to your doctor or pharmacist before taking ABIS.
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 dosage needs to be increased

Use in children and adolescents
ABIS has not been studied in children under 6 years of age. ABIS should be used only for hypertension in children and adolescents aged 6 to 17 years (see section 3). For further information, consult your doctor.
Taking ABIS with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ABIS may affect the action of other medicines, or other medicines may affect ABIS, 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 (medicines for the heart);
• dantrolene (infusion for severe disturbances in body temperature);
• simvastatin (a medicine used to treat high cholesterol levels in the blood).
• rifampicin, erythromycin, clarithromycin (antibiotics)

ABIS may lower blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Taking ABIS with food and drink
People taking ABIS should not drink grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an increased hypotensive effect of ABIS.
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you are pregnant or are planning a pregnancy, inform your doctor before taking ABIS.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or plan to breast-feed, inform your doctor before taking ABIS.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
ABIS may affect your ability to drive or operate machinery. If the tablets cause you discomfort, dizziness or fatigue, or if you experience headache, avoid driving or operating machinery 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 exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is ABIS 5 mg once daily. The dose may be increased to ABIS 10 mg once daily.
This medicine can be taken before or after food and drink. You must take the medicine at the same time every day, with a glass of water. Do not take ABIS with grapefruit juice.

Use in children and adolescents
For children and adolescents (6 to 17 years of age), the usual starting dose is 2.5 mg once daily. The maximum recommended daily dose is 5 mg. The tablet's score line is intended only to facilitate swallowing and not to divide the tablet into equal doses.

Continue taking the tablets for as long as your doctor has instructed. Contact your doctor before stopping the treatment.

If you take more ABIS than you should
If you take too many tablets, your blood pressure could 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 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 your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking ABIS
You must continue taking this medicine for the entire duration prescribed by your doctor. Stopping treatment may cause your condition to worsen.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ABIS may cause side effects, although not everyone experiences them.
If you notice any of the following very rare and serious side effects, contact 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, 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.
• 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 you experience any of these, or if they persist for more than one week, contact your doctor.
Common: may occur in 1 to 10 out of 100 patients

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

Uncommon: may occur in 1 to 10 out of 1,000 patients

• Mood changes, anxiety, depression, insomnia.
• Tremor, altered taste, fainting, weakness.
• Numbness or tingling sensation in limbs; loss of pain sensitivity.
• 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 urination.
• Inability to achieve an erection; discomfort or breast enlargement in men.
• Weakness, pain, malaise.
• Joint or muscle pain, muscle cramps, back pain.
• Weight gain or weight loss.

Rare: may occur in 1 to 10 out of 10,000 patients

• Confusion.

Very rare: may occur in fewer 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 a tendency to bleed (damage to red blood cells).
• High blood sugar levels (hyperglycaemia).
• A nerve disorder that 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, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 stated on the packaging after
EXP. The expiry date refers to the last day of the month.
Store below 25 °C.
Do not dispose of any medicine 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 ABIS tablets contain
The active substance is amlodipine besylate.
ABIS 5 mg tablets contain amlodipine besylate equivalent to 5 mg of amlodipine per tablet.
ABIS 10 mg tablets contain amlodipine besylate equivalent to 10 mg of amlodipine per tablet.
The other components are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate.

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

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

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