Vildagliptin Combix 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin Combix 50 mg tablets EFG

vildagliptin

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

The active substance 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 either 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 vildagliptin 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 recommended to you.

2. What you need to know before taking Vildagliptin Combix

Do not take Vildagliptin Combix

• 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 to take Vildagliptin Combix

• 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 want 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 a pancreatic disease.

If you have previously taken 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, 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 to detect as early as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Use of Vildagliptin Combix with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

If you feel dizzy while taking this medicine, do not drive or operate tools or machinery.

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 advisable to drive or use machines.

Vildagliptin Combix contains lactose and sodium

This medicine contains lactose (milk sugar). If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take/use Vildagliptin Combix

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. 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 doses (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptin alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.

• 50 mg daily in the morning if you have moderate to severe kidney disease or are undergoing dialysis.

How to take Vildagliptin

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin

• Take vildagliptin every day as long as your doctor instructs. 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 than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, consult your doctor immediately, or call the Toxicology Information Service at telephone number 91 562 04 20. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the pack with you.

If you forget to take Vildagliptin

If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the 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 forgotten doses.

If you stop taking Vildagliptin

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.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people): 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:

• Very common: (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (edema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhea, heartburn, nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): inflammation of the pancreas.

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

• Frequency not known (cannot be estimated from available data): localized peeling of the skin or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects 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 Combix

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 outer packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows visible signs of deterioration.

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

6. Contents of the pack and other information

• Composition of Vildagliptin Combix

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.

• The other components (excipients) are:

Anhydrous lactose, sodium stearyl fumarate, microcrystalline cellulose and sodium croscarmellose.

Appearance of the product and contents of the pack

Vildagliptin Combix 50 mg are round, biconvex, white to off-white tablets, approximately 8.0 mm in diameter, available in aluminum/aluminum blisters containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets, and in multiple packs consisting of 3 packs, each containing 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 – Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat, 08950 Barcelona,

Spain

or

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

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

BG – Bulgaria ???????????? ????????? 50 mg ????????

ES – Spain Vildagliptin Galenicum 50 mg tablets

MT – Malta Vildagliptin Galenicum 50 mg tablets

LV – Latvia Vildagliptin Galenicum 50 mg tablets

HR – Croatia Vildagliptin Galenicum 50 mg tablets

EE – Estonia Vildagliptin Galenicum 50 mg tablets

DE – Germany Vildagliptin Galenicum 50 mg Tablets

Date of the most recent review of this leaflet: April 2023

Detailed 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/.