Vipidia 12,5 mg comprimidos recubiertos con pelicula

Prospect: Patient Information

Vipidia 25mg Film-Coated Tablets

Vipidia 12,5mg Film-Coated Tablets

Vipidia 6,25mg Film-Coated Tablets

alogliptina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other peoplealthough they may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Vipidia and what it is used for

2.What you need to know before starting to take Vipidia

3.How to take Vipidia

4.Possible adverse effects

5.Storage of Vipidia

6.Contents of the pack and additional information

Do not take Vipidia

• if you are allergic to alogliptin or any of the other ingredients in this medication (listed in section 6).
• if you have had a severe allergic reaction to another medication similar to Vipidia that you take to control your blood sugar levels. Symptoms of a severe allergic reaction may include rash, raised red patches on the skin (urticaria), facial, lip, tongue, and throat inflammation, which may cause difficulty breathing or swallowing. Other symptoms may include general itching (pruritus) and a sensation of heat, especially affecting the scalp, mouth, throat, palms of the hands, and soles of the feet (Stevens-Johnson syndrome).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 cannot metabolize glucose because it does not have enough insulin). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.
• if you are taking a diabetes medication called a sulfonylurea (e.g., glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may need to reduce your dose of sulfonylurea or insulin if you take either of these medications with Vipidia, to avoid excessively low blood sugar (hypoglycemia).
• if you have kidney disease; you may take this medication, but your doctor may reduce the dose.
• if you have liver disease.
• if you have heart failure.
• if you are taking insulin or another diabetes medication, your doctor may reduce your dose of the other medication or insulin when you take either of them with Vipidia, to avoid low blood sugar.
• if you have or have had a pancreatic disease.

Contact your doctor if blisters appear on your skin, as this could be one of the signs of a condition called bullous pemphigoid. Your doctor will ask you to stop treatment with alogliptin.

Children and adolescents

Vipidia is not recommended for use in children and adolescents under 18 years of age, due to a lack of efficacy in these patients.

Other medications and Vipidia

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is no experience with the use of Vipidia in pregnant women or during breastfeeding.Vipidia should not be used during pregnancy or breastfeeding. Your doctor will help you decide whether to continue breastfeeding or using Vipidia.

Driving and operating machinery

It is not known whether Vipidia affects the ability to drive and operate machinery.The combination of Vipidia with other diabetes medications called sulfonylureas, insulin, or combined therapy with thiazolidinedione plus metformin may cause excessively low blood sugar (hypoglycemia), which could affect your ability to drive and operate machinery.

Vipidia contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will prescribe Vipidia along with one or more additional medications to control your blood sugar levels.Your doctor will inform you if you need to adjust the amount of the other medications you take.

The recommended dose of Vipidia is 25mg once a day.

Patients with kidney disease

If you have kidney disease, your doctor may recommend a reduced dose. This may be 12.5mg or 6.25mg once a day, depending on the severity of your kidney disease.

Patients with liver disease

If your liver function is mildly or moderately reduced, the recommended dose of Vipidia is 25mg once a day. This medication is not recommended for patients with severely reduced liver function, due to the lack of data in these patients.

Swallow the whole tablets with water.You can take this medication with or without food.

If you take more Vipidia than you should

If you take more tablets than you should, or if someone else or a child takes your medication, contact or go immediately to the nearest emergency center.Bring this leaflet or some tablets with you, so your 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 a missed dose.

If you interrupt treatment with Vipidia

Do not stop taking Vipidia without first consulting your doctor. Your blood sugar levels may increase if you stop taking Vipidia.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP taking Vipidia and contact your doctor immediatelyif you notice any of the followingserious side effects:

Of unknown frequency(cannot be estimated from available data):

• Allergic reaction. Symptoms may include: skin rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, and feeling faint.
• Severe allergic reaction:skin lesions or skin patches, which may progress to a ring-shaped ulcer surrounded by pale or erythematous rings, with blisters and/or skin peeling, possibly accompanied by symptoms such as itching, fever, general feeling of discomfort, joint pain, vision problems, burning, pain, or itching in the eyes, and mouth ulcers (Stevens-Johnson syndrome and Erythema multiforme).
• Intense and persistent abdominal pain(stomach area) that may extend to the back, as well as nausea and vomiting,which could be a sign of pancreatitis.

You should alsoconsult your doctorif you experience any of the following side effects:

Frequent(may affect up to 1 in 10people):

• Low blood sugar symptoms(hypoglycemia), which may appear when Vipidia is administered in combination with insulin or sulfonylureas (e.g., glipizide, tolbutamide, glibenclamide).Symptoms may include: shakiness, sweating, anxiety, blurred vision, tingling in the lips, paleness, change in mood, or feeling confused. Your blood sugar level may drop below the normal value, but you can raise it again by consuming sugar. It is recommended that you carry some sugar cubes, candies, biscuits, or fruit juice with sugar.
• Symptoms similar to the flu or common cold, such as sore throat, congested or runny nose
• Skin rash
• Itching on the skin
• Headache
• Stomach pain
• Diarrhea
• Indigestion, heartburn

Of unknown frequency:

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Vipidia

• Theactive principleis alogliptina.

Each 25mg tablet contains alogliptina benzoate equivalent to 25mg of alogliptina.

• Theother componentsare: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), iron oxide red (E172), macrogol 8000, shellac, and iron oxide black (E172).

Each 12.5mg tablet contains alogliptina benzoate equivalent to 12.5mg of alogliptina.

• Theother componentsare: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, hypromellose, iron oxide yellow (E172), macrogol 8000, shellac, and iron oxide black (E172).

Each 6.25mg tablet contains alogliptina benzoate equivalent to 6.25mg of alogliptina.

• Theother componentsare: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, hypromellose, iron oxide red (E172), macrogol 8000, shellac, and iron oxide black (E172).

Appearance of the product and contents of the pack

• Vipidia 25mg film-coated tablets are film-coated, oval-shaped (approximately 9.1mm in length by 5.1mm in width), biconvex, light red in color, with the inscription “TAK” and “ALG‑25” printed in grey ink on one face.
• Vipidia 12.5mg film-coated tablets are film-coated, oval-shaped (approximately 9.1mm in length by 5.1mm in width), biconvex, yellow in color, with the inscription “TAK” and “ALG‑12.5” printed in grey ink on one face.
• Vipidia 6.25mg film-coated tablets are film-coated, oval-shaped (approximately 9.1mm in length by 5.1mm in width), biconvex, light pink in color, with the inscription “TAK” and “ALG‑6.25” printed in grey ink on one face.

Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100tablets.

Only some pack sizes may be marketed.

of the pack.

Marketing Authorization Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Responsible for Manufacturing

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.