Package Insert: Information for the Patient

Vildagliptin Alter 50 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient of this medication, vildagliptin, belongs to a group of medications called “oral antidiabetics”.

Vildagliptin is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely by diet and exercise. It helps to control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medications you are already taking if these are not effective enough to control diabetes.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not function properly. It can also appear if the body produces too much glucagon.

Insulin is a substance that helps to reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes sugar production by the liver and causes blood sugar levels to rise. Both substances are produced in the pancreas.

How Vildagliptina Alter works

Vildagliptin stimulates the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels. This medication has been shown to reduce blood sugar, which will help prevent diabetes complications. Although you start taking this medication for your diabetes, it is essential that you continue with the diet and/or exercise recommended.

Do not take Vildagliptina Alter

• if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you might be allergic to vildagliptin or any other ingredient of this medicine, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take this medicine

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking a diabetes medicine known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood sugar [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptin).
• if you are undergoing dialysis.
• if you have liver disease.
• if you have heart failure.
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop taking it due to liver disease, do not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking vildagliptin. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptin, at three-month intervals during the first year, and periodically thereafter. This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

Children and adolescents

The administration of vildagliptin is not recommended in children and adolescents under 18 years.

Other medicines and Vildagliptina Alter

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

Your doctor may change your vildagliptin dose if you are taking other medicines such as:

• thiazides or other diuretics (also called urine medicines)
• corticosteroids (usually used to treat inflammation)
• thyroid medicines
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use vildagliptin during pregnancy. It is unknown whether vildagliptin passes into breast milk. Do not take vildagliptin if you are breastfeeding or plan to breastfeed.

Driving and operating machines

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as blurred vision. This can be hazardous in situations where these skills are important (e.g., driving or operating machines). Therefore, consult your doctor if it is advisable to drive or operate machines.If you feel dizzy while taking vildagliptin, do not drive or operate tools or machines.

Vildagliptina Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Vildagliptina Alter contains sodium

This medicine 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. In case of doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptina that you should take varies depending on your condition. Your doctor will indicate exactly the number of vildagliptina tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptina is:

• 50 mg once a day in the morning, if you are taking vildagliptina along with another medication known as a sulfonylurea.
• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking vildagliptina alone, with another medication known as a glitazone.
• 50 mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to Take Vildagliptina Alter

• Swallow the tablet whole with a little water.

Duration of Treatment with Vildagliptina Alter

• Take vildagliptina every day as your doctor indicates. You may need to follow this treatment for a long period of time.
• Your doctor will perform regular checks to ensure that the treatment is having the desired effect.

If You Take More Vildagliptina Alter Than You Should

If you have taken too many vildagliptina tablets, or if someone else has taken your medication,consult your doctor immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Vildagliptina Alter

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at your usual time. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If You Interrupt Treatment with Vildagliptina Alter

Do not stop taking vildagliptina unless your doctor tells you to. If you have doubts about the duration of treatment with vildagliptina, consult your doctor.

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

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

Some symptoms require immediate medical attention

You should stop taking vildagliptin and see your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (unknown frequency): symptoms that include intense and persistent abdominal pain (stomach area), which can reach your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptin and metformin:

• Frequent (may affect up to 1 in 10 people): tremors, headache, dizziness, nausea, low blood glucose levels.
• Infrequent (may affect up to 1 in 100 people): fatigue.

Some patients experienced the following side effects while taking vildagliptin and a sulfonylurea:

• Frequent: tremors, headache, dizziness, weakness, low blood glucose levels.
• Infrequent: constipation.
• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion.

Some patients experienced the following side effects while taking vildagliptin and a glitazone:

• Frequent: weight gain, swollen hands, ankles, or feet (edema).
• Infrequent: headache, weakness, low blood glucose levels.

Some patients experienced the following side effects while taking vildagliptin only:

• Frequent: dizziness.
• Infrequent: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood glucose levels.
• Very rare: sore throat, nasal congestion, fever.

Some patients have had the following side effects while taking vildagliptin, metformin, and a sulfonylurea:

• Frequent: dizziness, tremors, weakness, low blood glucose levels, excessive sweating.

Some patients have had the following side effects while taking vildagliptin and insulin (with or without metformin):

• Frequent: headache, chills, nausea (discomfort), low blood glucose levels, stomach burning.
• Infrequent: diarrhea, flatulence.

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.

Reporting of 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 the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture. Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vildagliptina Alter

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are: microcrystalline cellulose, anhydrous lactose, carboxymethylstarch sodium (type A) (from potato), low-substitution hydroxypropyl cellulose, anhydrous colloidal silica, stearate fumarate, and sodium.

Appearance of the product and content of the packaging

White, round, flat, beveled-edge tablets, marked with “L” on one face and smooth on the other.

Packages with 28 and 56 tablets in Aluminio/Aluminio blisters.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for Manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi 10, Industrial Estate Areta

31620 Huarte, Navarra

Spain

Last review date of this leaflet: July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.