Andamane

Patient Information Leaflet

Andamane 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

sitagliptin
Equivalent medicine
Please read all of 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 give it to other people, even if their
symptoms are the same as yours, as 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 Andamane is and what it is used for
2. What you need to know before taking Andamane
3. How to take Andamane
4. Possible side effects
5. How to store Andamane
6. Contents of the pack and other information

1. What Andamane is and what it is used for

Andamane contains the active substance sitagliptin, which belongs to a class of medicines called
dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with type 2
diabetes mellitus.
This medicine helps increase insulin levels produced after a meal and reduces the amount of sugar
produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due
to type 2 diabetes. This medicine may be used alone or together with other medicines (insulin,
metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking to
treat your diabetes, along with a diet and exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin the
body produces does not work as well as it should. The body may also produce too much sugar. When this
happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems such as
heart disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Andamane

Do not take Andamane

• if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Andamane (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Andamane.
Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems, past or present
• an allergic reaction to Andamane (see section 4)

It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood sugar is low. However, when this medicine is taken together with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce your dose of sulphonylurea or insulin.
Children and adolescents
Children and adolescents under 18 years of age must not take this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Andamane
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in the blood when taken together with Andamane.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without a secure support.
Andamane contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Andamane

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively. While taking Andamane, it is important to continue the diet and exercise programme recommended by your doctor.

If you take more Andamane than you should
If you take more of this medicine than prescribed, contact your doctor immediately.

If you forget to take Andamane
If you forget a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose of this medicine.

If you stop taking Andamane
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. Do not stop taking this medicine without first talking to your doctor.

If you have any questions about how to use 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.
STOP taking Andamane and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area) that may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients experienced the following side effects after adding sitagliptin to metformin:
Common (may affect up to 1 in 10 people): low blood sugar level, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.
Some patients experienced different types of stomach discomfort when starting treatment with sitagliptin and metformin together (frequency is common).

Some patients experienced the following side effects when taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar level
Common: constipation

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-marketing use alone and/or with other antidiabetic medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Andamane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Andamane contains

• The active substance is sitagliptin:
  o Each Andamane 25 mg film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
  o Each Andamane 50 mg film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
  o Each Andamane 100 mg film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
• The other components are:
  o Tablet core: microcrystalline cellulose (E460), dibasic calcium phosphate (E341), sodium croscarmellose (E468), and magnesium stearate (E470b)
  o Tablet coating: poly(vinyl alcohol) (E1203), macrogol/PEG (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Description of the appearance of Andamane and pack contents

• Andamane 25 mg film-coated tablets are pink, round, with a diameter of 6.1 ± 0.2 mm, engraved with "25" on one side.
• Andamane 50 mg film-coated tablets are light beige, round, with a diameter of 8.1 ± 0.2 mm, engraved with "50" on one side.
• Andamane 100 mg film-coated tablets are beige, round, with a diameter of 10.1 ± 0.2 mm, engraved with "100" on one side.

Blister OPA/Aluminium/PVC-Aluminium and white blisters PVC/PCTFE-Aluminium. Packs containing 28,
56 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
I.B.N. Savio S.r.l.
Via del Mare 36, Pomezia (Rm), Italy

Manufacturer
Pharmathen International S.A.,
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
69300 Rodopi,
Greece
and/or
Pharmathen S.A.
Dervenakion 6
153 51 Pallini Attiki,
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names: