ACARPHAGE 50 mg Coated Tablet

Зміст інструкції

1. Acarphage 50 mg tablets, 100 mg tablets
   1. What is Acarphage and what is it used for
   2. What you need to know before taking Acarphage
   3. How to take Acarphage
   4. Possible side effects
   5. How to store Acarphage
   6. Contents of the pack and other information

Acarphage 50 mg tablets, 100 mg tablets

acarbose
Generic Medicine
Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Acarphage and what is it used for

The active ingredient of this medicine is acarbose, which belongs to a group of medicines
called alpha-glucosidase inhibitors. It is used to treat adults with non-insulin-dependent diabetes mellitus (type 2 diabetes). Your doctor may prescribe Acarphage when diet and exercise
alone are not sufficient to control blood glucose levels. Acarphage works
by slowing down the digestion of carbohydrates (complex sugars) after each meal, lowering the level of
glucose in the blood.

2. What you need to know before taking Acarphage

Do not take Acarphage:

• if you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6);
• if you have a chronic intestinal condition that causes digestive problems or malabsorption of food;
• if you have a condition that may be worsened by an increase in gas production in the intestine, such as Roemheld syndrome, large intestinal hernias, narrowing and ulceration of the intestine;
• if you suffer from inflammation or ulceration of the intestine;
• if you have an intestinal obstruction or are likely to have one;
• if you suffer from severe kidney failure;
• if you suffer from severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acarphage if you have undergone gastric resection.
It is possible that Acarphage will act faster. It is unlikely to cause you problems, but
if you do not feel well after taking Acarphage, you should contact your doctor.

During treatment
If you feel tired, nervous and shaky, and have a fast heartbeat, cold sweat, or hunger cramps during the
taking of this medicine, you may have low blood glucose levels
(hypoglycemia). You need to take glucose as soon as possible to stop the worsening of the
symptoms. If blood sugar levels continue to fall, you may experience a feeling of
confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat and
may even fall into a state of unconsciousness. Since acarbose delays the absorption of
sucrose, sucrose and artificial sweeteners should not be used. Glucose tablets, syrup or sweets are available from your pharmacist.
If you have persistent constipation, reduced appetite, a bloated stomach and vomiting, you may have an
intestinal blockage. Contact your doctor or go immediately to the nearest emergency room.
You should regularly check your blood glucose and urine levels.
Your doctor may need to regularly check your liver function, especially
during the first 6-12 months of treatment.
You should continue to follow the dietary advice given to you by your doctor and make sure you eat
carbohydrates regularly throughout the day.

Children and adolescents
Since the available information on the effects and tolerability of Acarphage in children and
adolescents under the age of 18 is still insufficient, Acarphage is not recommended in
patients under the age of 18.

Other medicines and Acarphage
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Acarphage can alter the effect of other medicines or, conversely, some medicines can alter
the effect of Acarphage:

• other antidiabetic medicines e.g. insulin, metformin, sulfonylureas; it may be necessary to adjust the dosage of these medicines;
• intestinal gas absorbents e.g. activated charcoal;
• medicines used to aid digestion (including antacids, amylase, pancreatin);
• medicines used to lower cholesterol levels (cholestyramine);
• digoxin (medicines for the treatment of heart failure);
• medicines for the treatment of high blood pressure or for the prevention of fluid retention (thiazides or diuretics);
• anti-inflammatory medicines (corticosteroids);
• medicines for the thyroid;
• female sex hormones (estrogens), oral contraceptives;
• medicines for treating spasms or schizophrenia (phenytoin, phenothiazines);
• medicines for lowering high fat values in the blood (nicotinic acid);
• medicines used for the treatment of high blood pressure or heart disorders (calcium-channel blockers);
• medicines for increasing the heartbeat (sympathomimetics);
• medicines for the treatment of tuberculosis (isoniazid);
• neomycin, an antibiotic.

Acarphage with food and drink
Sucrose (cane sugar) and foods containing sucrose are often the cause of intestinal
disorders or even diarrhea, due to the fermentation of carbohydrates in the colon during
treatment with acarbose.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Acarphage if you are pregnant or breastfeeding.
It is not known whether Acarphage is present in human milk.

Driving and operating machinery
Taking Acarphage alone (monotherapy) does not lower blood glucose levels (hypoglycemia)
and therefore does not impair the ability to drive or operate machinery.
Taking Acarphage in combination with medicines such as sulfonylurea, insulin or metformin for
the treatment of diabetes can cause hypoglycemia and therefore impair the ability to drive and operate
machinery or work safely. Do not drive or operate machinery if this applies to you.

3. How to take Acarphage

Always take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:

Adults:
Take one Acarphage 50 mg tablet three times a day (corresponding to 150 mg
daily).
To reduce the likelihood of stomach problems, some patients may start with one
Acarphage 50 mg tablet, one or two times a day (corresponding to 50 mg to 100 mg
daily). The doctor may slowly increase the dose if necessary up to 2 Acarphage 50 mg tablets or 1 Acarphage 100 mg tablet three times a day (corresponding to 300
mg daily). The maximum recommended dose is 2 Acarphage 100 mg tablets three times a day
(corresponding to 600 mg per day).
Swallow the tablets whole with a glass of water immediately beforea meal or
chew them with the first bite of food.
The score line on the 50 mg tablet is only to facilitate breaking the tablet if you
have difficulty swallowing it whole.
The 100 mg tablet can be divided into equal parts.

If you take more Acarphage than you should
You may experience undesirable effects such as bloating, excessive flatulence or diarrhoea if you have taken
acarbose together with drinks or food containing carbohydrates. In this case, do not eat or drink food or
drinks containing carbohydrates for 4 to 6 hours. Go to your doctor or the nearest
hospital immediately. Bring the container and all remaining tablets with you.

If you forget to take Acarphage
Do not take a double dose to make up for a missed tablet. Take the next
dose with the next meal.

If you stop taking Acarphage
If you suddenly stop taking Acarphage, your blood glucose level may
increase. Consult your doctor before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think you have any of the following side effects, stop taking this medicine and
seek immediate medical attention or go to the nearest hospital emergency room:

• yellowing of the white part of the eyes or skin (jaundice), (rare, may affect up to 1 in 1,000 people);
• inflammation of the liver (hepatitis). If you feel unwell (nausea), are sick (vomiting), have loss of appetite, fever, itching, jaundice (see above), pale stools or dark urine (frequency cannot be estimated based on available data);
• persistent constipation, loss of appetite, bloated stomach and feeling unwell (vomiting) (ileus) (frequency cannot be defined based on available data);
• allergic reactions such as skin rash, redness of the skin, skin eruptions or itching.

Other possible side effects:
Very common(may affect more than 1 in 10 people)

• flatulence;
• stomach rumbling;
• feeling of fullness.

Common(may affect up to 1 in 10 people)

• diarrhoea;
• stomach pain or abdominal pain.

These side effects occur more frequently after a meal containing sugar
(sucrose). Symptoms may be reduced by avoiding the ingestion of foods and beverages containing
sugar (sucrose, cane sugar). If diarrhoea does not disappear, your doctor may
reduce the dose or, in some cases, stop treatment. Do not take remedies for indigestion
to relieve side effects as this may worsen symptoms.

Uncommon(may affect up to 1 in 100 people)

• feeling unwell (nausea);
• being sick (vomiting);
• indigestion;
• increased liver enzymes (transaminases) in the blood.

Rare(may affect up to 1 in 1,000 people)

• swelling of the skin (edema).

Not known(frequency cannot be estimated based on available data)

• bruising or bleeding more frequently than normal. These may be symptoms of low levels of platelets in the blood;
• constipation;
• gas-filled sacs in the intestinal wall (intestinal pneumatosis cystoides);
• skin rash with pustules/blisters filled with pus (acute generalized pustular exanthem).

In addition, side effects such as liver diseases, abnormal liver function and
liver damage have been reported, especially in Japan. Single cases of a rapid and fatal form of liver disease
have been reported in Japan, however, it is not clear whether these are the result of taking
acarbose.

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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after
Exp.. The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC. Store in the original packaging to
protect the medicine from humidity.
Do not dispose of any medicine in wastewater 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 Acarphage tablets contain
The active ingredient is acarbose. Each tablet contains 50 mg or 100 mg of acarbose.
The other ingredients are microcrystalline cellulose (E460), corn starch, colloidal anhydrous silica
(E551) and magnesium stearate (E572).

Description of the appearance of Acarphage tablets and contents of the pack
Acarphage 50 mg tablets are white to almost white, round, imprinted with ‘AA
(incision line) 50’ on one side and with ‘G’ on the other side.
Acarphage 100 mg tablets are white to almost white, oval shaped imprinted with
‘AA (fracture line) 100’ on one side and with ‘G’ incision line on the other side.
Acarphage is available in blisters of 20, 21, 30, 40, 50, 90, 100, 105, 120, 180 tablets and
multipack containing 105 (3 packs of 35) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bruno Farmaceutici S.p.A. via delle Ande 15, 00144 Roma

Manufacturer
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1, 03012 - Anagni, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Czech Republic “Akarboza Mylan”
Germany “Acarbose dura 50mg/100mg Tablets”
Italy “Acarphage”
Portugal “Acarbose Mylan”
Spain “Acarbosa Mylan 50mg/100mg tablets”