Vipidia 12.5 mg. 30 tablets

What Vipidia is and what it is used for
Vipidia contains the active substance, alloglobin, which belongs to a group of medicines called "oral antidiabetic medicines". It is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin dependent diabetes mellitus or NIDDD.
Vipidia works by increasing insulin levels in the body after eating and reducing the amount of sugar. It must be taken together with other antidiabetic medicines that your doctor will prescribe - for example, sulphonylureas (eg glipizide, tolbutamide, glibenclamide), metformin and / or thiazolidinediones (eg pioglitazone) and metformin and / or insulin.
Vipidia is taken when your blood sugar can not be adequately controlled by diet, exercise or one or more of these other antidiabetic medicines that are taken orally. It is important that you continue to take your other antidiabetic medicine and follow the advice on diet and exercise given to you by your nurse or doctor.

2. What you need to know before you take Vipidia
DO NOT take Vipidia:

if you are allergic to alloglyptin or any of the other ingredients of this medicine (listed in section 6);
if you have had a serious allergic reaction to any other similar medicines you are taking to control your blood sugar. Symptoms of a serious allergic reaction may include rash, raised red spots on the skin (hives), swelling of the face, lips, tongue and throat, which may cause breathing or swallowing difficulties.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vipidia:

if you have type 1 diabetes (your body does not produce insulin);
if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss;
if you are taking an antidiabetic medicine known as a sulphonylurea (eg glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may reduce the dose of the sulphonylurea or insulin when taking any of these with Vipidia in order to avoid excessive blood sugar (hypoglycaemia);
if you have kidney disease, you can still take this medicine, but your doctor may reduce the dose;
if you have liver disease;
if you suffer from heart failure;
if you have had allergic reactions to other medicines you take to control your blood sugar. Symptoms may include itching around the body and a feeling of warmth - affecting in particular the hairy part of the head, mouth, throat, palms of the hands or feet (Stevens-Johnson syndrome);
if you are taking insulin or an antidiabetic medicine, your doctor may reduce the dose of another antidiabetic medicine or insulin when taking any of these with Vipidia to avoid blood sugar lowering;
if you have or have had a pancreatic disease.
Children and adolescents
Vipidia is not recommended for children and adolescents under 18 due to a lack of data in these patients.

Other medicines and Vipidia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is no experience of the use of Vipidia in pregnant women or during breastfeeding. Vipidia should not be used during pregnancy or breastfeeding unless your doctor thinks it is absolutely necessary.

Driving and using machines
Vipidia is not known to affect the ability to drive and use machines. Taking Vipidia in combination with medicines called sulphonylureas, insulin or combination therapy with thiazolidinedione plus metformin can cause too much blood sugar (hypoglycaemia) that may affect your ability to drive and use machines.

3. How to take Vipidia
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will prescribe Vipidia with one or more other medicines to control your blood sugar levels. He will tell you whether you need to change the amount of other medicines you are taking.
The recommended dose of Vipidia is 25 mg once a day.

Patients with renal disease
If you have kidney disease, your doctor may prescribe a reduced dose. It can be 12.5 mg or 6.25 mg once a day, depending on the severity of your kidney disease.

Patients with liver disease
If you have mild or moderate liver function, the recommended dose of Vipidia is 2
If you take more Vipidia than you should
If you take more tablets than you should or if someone else or a child is taking your medicine, contact or go to the nearest emergency center immediately. Take this leaflet or a few tablets with you so the doctor knows exactly what you have taken.

If you forget to take Vipidia
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking Vipidia
Do not stop taking Vipidia before consulting your doctor. Your blood sugar levels may rise when you stop taking Vipidia.

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 everyone gets them.

Stop taking Vipidia and contact a doctor immediately if you notice any of the following serious side effects:
Not known (frequency can not be estimated from the available data):

Alergic reaction. Symptoms may include: rash, hives, problems with swallowing or breathing, swelling of your lips, face, throat or tongue, and a feeling of weakness;
Severe allergic reaction. Symptoms may include: whole-body itching and a feeling of warmth - affecting in particular the hairy part of the head, mouth, throat, palms of the hands or feet (Stevens-Johnson syndrome);
Severe and persistent stomach pain that can spread to the back as well as nausea and vomiting, as it may be a sign of inflammation of the pancreas.
You should talk to your doctor and if you have the following side effects:
Common (may affect up to 1 in 10 people):

Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia is taken in combination with insulin or sulphonylureas (eg glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling in the lips, pallor, mood swings or confusion. Your blood sugar may fall below the normal level, but may rise again after taking sugar. It is advisable to bring with you some sugars of lumps, sweets, biscuits or fruit juice containing sugar;
Cold-like symptoms, such as a sore throat, a runny or stuffy nose;
Rash;
Itching on the skin;
Headache;
Tummy ache;
Diarrhea;
Poor digestion, burning behind the sternum (heartburn).
Not known:

Hepatic problems such as nausea or vomiting, stomach pain, abnormal or unexplained fatigue, loss of appetite, dark urine or yellowing of the skin or whites of your eyes.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Vipidia
Keep out of the reach and sight 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.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Vipidia contains
The active substance is: alloglypine.
Each 25 mg tablet contains alloglypine benzoate, equivalent to 25 mg of alloglypine.
The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).

Each 12.5 mg tablet contains alloglypine benzoate, equivalent to 12.5 mg of alloglypine.
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Each 6.25 mg tablet contains alloglypine benzoate, equivalent to 6.25 mg of alloglypine.
The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).

What Vipidia looks like and contents of the pack
Vipidia 25 mg film-coated tablets are light red, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets with the letters "TAK" and "ALG-25" printed with gray ink on one side .
Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets with "TAK" and "ALG-12.5" printed in gray one side.
Vipidia 6.25 mg film-coated tablets are light pink, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets with "TAK" and "ALG-6.25" printed in gray ink one side.
Vipidia comes in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

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