Vildagliptin Stada 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Vildagliptin Stada 50 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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 may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Vildagliptina Stada, vildagliptine, belongs to a group of medicines called "oral antidiabetics".

Vildagliptine 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 vildagliptine 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 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 Stada works

Vildagliptine 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 from your diabetes. Even after starting 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 Stada

Do not take vildagliptin:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking vildagliptin if you:

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

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 advice regarding 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 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 Stada

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 affecting the nervous system.

Pregnancy and breastfeeding

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

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

Driving and use of machines

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

Vildagliptin Stada contains lactose and sodium

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

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

3. How to take Vildagliptin Stada

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

Dosage

The dose of vildagliptin required varies depending on the individual's condition. Your doctor will tell you exactly how many tablets of vildagliptin 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 50 mg in the evening, if you are taking vildagliptin alone, with another medicine known as metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin (with or without metformin).

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

How to take Vildagliptin Stada

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin Stada

Take vildagliptin every day as directed by your doctor. You may need to continue this treatment for a long period of time.

Your doctor will carry out periodic checks to ensure that the treatment is having the desired effect.

If you take more Vildagliptin Stada than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, consult your doctor immediately.

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

You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the packaging with you.

If you forget to take Vildagliptin Stada

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 Stada

Do not stop taking this medicine unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine may cause 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 include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives
• liver disease (hepatitis) (rare). Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or darkening of the urine
• inflammation of the pancreas (pancreatitis) (frequency not known). Symptoms include severe and persistent abdominal (stomach area) pain, 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:

Common (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:

Common

• 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:

Common

• 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:

Common

• 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:

Common

• 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):

Common

• headache, chills, nausea (malaise), low blood glucose levels, stomach burning

Uncommon

• diarrhea, flatulence

Since the product was marketed, 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
• liver disease (hepatitis): usually resolves when treatment is discontinued. Symptoms include yellow skin and eyes, nausea, loss of appetite, or dark urine.
• abnormal liver function tests, usually reversible when treatment is stopped.

Reporting of adverse effects

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

5. Storage of Vildagliptin Stada

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 following "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Vildagliptin Stada 50 mg tablets EFG

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), sodium starch glycolate (type A) (from potato) and magnesium stearate (E470b).

Appearance of the product and contents of the container

Vildagliptin Stada 50 mg tablets EFG are round, white to pale yellow, flat tablets with bevelled edges and a diameter of 8.0 ± 0.2 mm.

Vildagliptin Stada 50 mg tablets EFG are available in cardboard packs containing either standard or unit-dose blisters of 14, 28, 30, 56, 60, 90, 105, 112 or 180 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of the most recent review of this leaflet: April 2021

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