Acarphage

Patient Information Leaflet

Acarphage 50 mg tablets, 100 mg tablets

acarbose
Generic Medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Acarphage is and what it is used for

The active substance 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 physical exercise alone are not sufficient to control blood glucose levels. Acarphage works
by slowing down the digestion of carbohydrates (complex sugars) after each meal, thereby reducing blood glucose levels.

2. What you need to know before taking Acarphage

Do not take Acarphage:

• if you are allergic to acarbose or to any of the other ingredients of this medicine (listed in section 6);
• if you have a chronic intestinal disease causing digestive problems or malabsorption of food;
• if you have a condition that could be worsened by increased intestinal gas production, such as Roemheld syndrome, large intestinal hernias, intestinal narrowing or ulceration;
• if you have inflammation or ulceration of the intestine;
• if you have intestinal obstruction or are likely to develop it;
• if you have severe renal insufficiency;
• if you have serious liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acarphage if you have had gastric resection.
Acarphage may act more quickly in you. This is unlikely to cause problems, but if you feel unwell after taking Acarphage, you should contact your doctor.
During treatment
If you feel tired, nervous and shaky, have a rapid heartbeat, cold sweats, or hunger cramps while taking this medicine, you may have low blood glucose levels (hypoglycaemia). You must take glucose as soon as possible to prevent symptoms from worsening. If blood sugar levels continue to fall, you may experience confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, and you may even lose consciousness. Since acarbose delays the absorption of sucrose, sucrose and artificial sweeteners must not be used. Glucose tablets, syrup, or sweets are available from your pharmacist.
If you have persistent constipation, reduced appetite, bloated stomach, and vomiting, you may have intestinal obstruction. Contact your doctor or go immediately to the nearest emergency department.
You should regularly monitor your blood and urine glucose levels.
Your doctor may need to regularly monitor your liver function, especially during the first 6–12 months of treatment.
You must continue to follow the dietary advice given by your doctor and ensure you eat carbohydrates regularly throughout the day.
Children and adolescents
Since available data on the effects and tolerability of Acarphage in children and adolescents under 18 years of age are still insufficient, Acarphage is not recommended for patients under 18 years of age.
Other medicines and Acarphage
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Acarphage may alter the effect of other medicines or, conversely, some medicines may alter the effect of Acarphage:

• other antidiabetic medicines, e.g. insulin, metformin, sulfonylureas; dosage adjustments of these drugs may be necessary;
• intestinal gas adsorbents, e.g. activated charcoal;
• medicines used to aid digestion (including antacids, amylase, pancreatin);
• medicines used to reduce cholesterol levels (cholestyramine);
• digoxin (medicines for the treatment of heart failure);
• medicines for high blood pressure or to prevent fluid retention (thiazides or diuretics);
• anti-inflammatory medicines (corticosteroids);
• thyroid medicines;
• female sex hormones (oestrogens), oral contraceptives;
• medicines for treating spasms or schizophrenia (phenytoin, phenothiazines);
• medicines to reduce high blood fat levels (nicotinic acid);
• medicines used for high blood pressure or heart disorders (calcium antagonists);
• medicines to increase heart rate (sympathomimetics);
• medicines for the treatment of tuberculosis (isoniazid);
• neomycin, an antibiotic.

Acarphage with food and drinks
Sucrose (cane sugar) and foods containing sucrose may often cause intestinal disturbances or even diarrhoea due to carbohydrate fermentation in the colon during acarbose treatment.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Acarphage if you are pregnant or breastfeeding.
It is not known whether Acarphage is present in human breast milk.
Driving and using machines
Taking Acarphage alone (monotherapy) does not lower blood glucose levels (hypoglycaemia) and therefore does not impair your ability to drive or use machines.
However, taking Acarphage together with other antidiabetic medicines such as sulfonylureas, insulin, or metformin may cause hypoglycaemia and thus impair your ability to drive or use machines safely. Do not drive or operate machinery if you are affected by this condition.

3. How to take Acarphage

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults:
Take one 50 mg Acarphage tablet three times a day (corresponding to 150 mg
daily).
To reduce the likelihood of stomach problems, some patients may start with one
50 mg Acarphage tablet once or twice daily (corresponding to 50 mg to 100 mg
daily). Your doctor may gradually increase the dose if necessary up to two
50 mg Acarphage tablets or one 100 mg Acarphage tablet three times a day (corresponding to 300
mg daily). The maximum recommended dose is two 100 mg Acarphage tablets three times a
day (corresponding to 600 mg per day).
Swallow the tablets whole with a glass of water immediately before each meal, or chew them
together with the first bite of food.
The break line on the 50 mg tablet is only intended to facilitate breaking the tablet if you have
difficulty swallowing it whole.
The 100 mg tablet may be divided into equal parts.
If you take more Acarphage than you should
You may experience side effects such as bloated stomach, excessive flatulence, or diarrhea, especially
if acarbose has been taken together with food or drinks containing carbohydrates. In this case, avoid
eating or drinking any carbohydrate-containing food or beverages for 4 to 6 hours. Contact your doctor
immediately or go to the nearest hospital. Bring the container and any remaining tablets with you.
If you forget to take Acarphage
Do not take a double dose to make up for the forgotten tablet. Take the next dose with the following meal.
If you stop taking Acarphage
If you suddenly stop taking Acarphage, your blood glucose levels may rise. Consult your doctor before
stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you think you are experiencing any of the following side effects, stop taking the medicine and
contact your doctor immediately or go to the nearest hospital emergency department:

• yellowing of the whites of the eyes or of the 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 from the available data);
• persistent constipation, reduced appetite, bloated stomach and feeling unwell (vomiting) (ileus) (frequency cannot be estimated from the 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;
• sensation of bloating.

Common (may affect up to 1 in 10 people)

• diarrhoea;
• stomach pain or intestinal pain.

These side effects occur more frequently after a meal containing sugar (sucrose). Symptoms may be reduced by avoiding the intake of foods and drinks containing sugar (sucrose, cane sugar). If diarrhoea does not resolve, your doctor may reduce the dose or, in some cases, discontinue treatment. Do not take indigestion remedies to relieve these 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 (oedema).

Not known (frequency cannot be estimated from the available data)

• unexplained bruising or bleeding more frequently than normal. These may be symptoms of low platelet levels in the blood;
• constipation;
• gas pockets in the intestinal wall (intestinal pneumatosis);
• skin rash with pustules/vesicles filled with pus (generalised pustular eruption).

In addition, side effects such as liver disorders, abnormal liver function and liver damage have been reported, particularly in Japan. Individual cases of a rapidly progressing and fatal form of liver disease have been reported in Japan; however, it is unclear whether these were caused by taking acarbose.
Reporting of side effects
If you experience any side effects, 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: 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp.. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
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 Acarphage tablets contain
The active substance is acarbose. Each tablet contains 50 mg or 100 mg of acarbose.
The other components are microcrystalline cellulose (E460), maize starch, colloidal anhydrous silica (E551) and magnesium stearate (E572).

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

Marketing Authorization Holder
Bruno Farmaceutici S.p.A., via delle Ande 15, 00144 Rome, Italy

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 authorized in the European Economic Area countries under the following names:
Czech Republic: “Akarboza Mylan”
Germany: “Acarbose dura 50mg/100mg Tabletten”
Italy: “Acarphage”
Portugal: “Acarbose Mylan”
Spain: “Acarbosa Mylan 50mg/100mg comprimidos”