Vildagliptin Alter 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vildagliptin Alter 50 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Vildagliptin Alter is and what it is used for
2. What you need to know before taking Vildagliptin Alter
3. How to take Vildagliptin Alter
4. Possible adverse effects
5. How to store Vildagliptin Alter
6. Contents of the pack and other information

1. What Vildagliptina Alter is and what it is used for

The active substance in this medicine, vildagliptin, belongs to a group of medicines called "oral antidiabetics".

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

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It may also occur when the body produces too much glucagon.

Insulin is a substance that helps lower 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 control blood sugar levels. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes. Even if you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise regimen that has been recommended to you.

2. What you need to know before taking Vildagliptin Alter

Do not take Vildagliptin Alter

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting 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 an antidiabetic medicine known as a sulfonylurea (your doctor may wish to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood glucose levels [hypoglycaemia]).
• 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 pancreatic disease.

If you previously took vildagliptin but had to stop due to liver disease, you must 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, 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 early as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medicines and Vildagliptin Alter

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

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

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medications
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

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

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

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycaemia or hyperglycaemia, such as blurred vision. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is safe for you to drive or operate machinery. If you feel dizzy while taking vildagliptin, do not drive or operate tools or machines.

Vildagliptin Alter contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Vildagliptin Alter contains sodium

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

3. How to take Vildagliptin Alter

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin required varies depending on the individual's condition. Your doctor will tell you exactly how many vildagliptin tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin is:

• 50 mg once daily in the morning, if you are taking vildagliptin together with another medicine known as a sulfonylurea.
• 100 mg daily in two divided doses of 50 mg in the morning and evening, if you are taking vildagliptin alone or with another medicine known as a glitazone.
• 50 mg daily in the morning, if you have moderate or severe kidney disease or are undergoing dialysis.

How to take Vildagliptin Alter

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin Alter

• Take vildagliptin every day as long as your doctor tells you to. You may need to continue this treatment for a long period of time.
• Your doctor will carry out periodic checks to ensure the treatment is having the desired effect.

If you take more Vildagliptin Alter than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin Alter

If you forget to take a dose of this medicine, 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 a missed dose.

If you stop taking Vildagliptin Alter

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

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

4. Possible adverse effects

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

Some symptoms require immediate medical attention

You must stop taking vildagliptin and contact your doctor immediately if you experience any of the following adverse effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (frequency not known): symptoms including severe and persistent pain in the abdomen (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

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

• Frequent (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, decreased blood glucose.
• Uncommon (may affect up to 1 in 100 people): fatigue.

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

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

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

• Frequent: weight gain, swollen hands, ankles or feet (edema).
• Uncommon: headache, weakness, decreased blood glucose.

Some patients experienced the following adverse effects while taking vildagliptin alone:

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

Some patients experienced the following adverse effects while taking vildagliptin, metformin and a sulfonylurea:

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

Some patients experienced the following adverse effects while taking vildagliptin and insulin (with or without metformin):

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

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

• Frequency not known (cannot be estimated from available data): itchy rash, inflammation of the pancreas, localized skin peeling or blistering, muscle pain.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Alter

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin Alter

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are: microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch (type A) (from potato), low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, stearyl fumarate sodium.

Appearance of the product and contents of the pack

White, round, flat tablets with bevelled edges, marked with "L" on one side and smooth on the other.

Aluminum/Aluminum blister packs containing 28 and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the most recent revision of this leaflet: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.