DALTEX 50 MG/1000 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Daltex 50 mg/850 mg film-coated tablets EFG

Daltex 50 mg/1000 mg film-coated tablets EFGvildagliptin/metformin hydrochloride

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 others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Daltex and what is it used for

The active substances of Daltex, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.

Daltex is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus.

Daltex is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

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

Insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and increases blood sugar levels.

HowDaltex works

Both active substances, vildagliptin and metformin, help to control blood sugar levels. The active substance vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active substance metformin helps the body to use insulin better. This medicine has been shown to reduce blood sugar, which will help to prevent complications of your diabetes.

2. What you need to know before you take Daltex

Do not take Daltex

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, talk to your doctor before taking Daltex.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. The symptoms include stomach pain, rapid and deep breathing, drowsiness, or your breath developing an unusual fruity odor.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney impairment.
• if you have a severe infection or severe dehydration (massive water loss from the body).
• if you are going to have a contrast radiography (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink excessive alcohol (daily or only occasionally).
• if you are breast-feeding (see also “Pregnancy and breast-feeding”).

Warnings and precautions

Risk of lactic acidosis

Daltex may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol intake, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, talk to your doctor for more instructions.

Stop taking Daltex for a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Talk to your doctor for more instructions.

Stop taking Daltex and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction of body temperature and heart rate. Lactic acidosis is a medical emergency and should be treated in a hospital.

Daltex is not a substitute for insulin. Therefore, you should not take Daltex to treat type 1 diabetes.

Talk to your doctor, pharmacist, or nurse before starting to take Daltex if you have or have had a pancreatic disease.

Talk to your doctor, pharmacist, or nurse before starting to take Daltex if you are taking a diabetes medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with Daltex to avoid low blood sugar (hypoglycemia).

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

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care. Pay special attention to the appearance of blisters or ulcers while taking Daltex. If this happens, you should talk to your doctor immediately.

If you need to undergo major surgery, you should stop taking Daltex during the procedure and for a period after it. Your doctor will decide when you should stop taking Daltex and when you can restart it.

Liver function tests should be performed before starting treatment with Daltex, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes as soon as possible.

During treatment with Daltex, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Your doctor will periodically check your blood and urine sugar levels.

Children and adolescents

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

Taking Daltex with other medicines

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Daltex before the injection or at the time of the injection. Your doctor will decide when you should stop taking Daltex and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust your Daltex dose. It is especially important to mention the following:

• corticosteroids, usually used to treat inflammation
• beta-2 agonists, usually used to treat respiratory disorders
• other active substances used to treat diabetes
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain active substances that affect the thyroid
• certain active substances that affect the nervous system
• certain active substances used to treat angina (e.g., ranolazine)
• certain active substances used to treat HIV infection (e.g., dolutegravir)
• certain active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain active substances used to treat stomach acidity and peptic ulcers (e.g., cimetidine).

Taking Daltex with alcohol

Avoid excessive alcohol intake while taking Daltex, as this can increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

• If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will inform you about the potential risks of taking Daltex during pregnancy.
• Do not take Daltex if you are pregnant or breast-feeding (see also “Do not take Daltex”). Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

If you feel dizzy while taking Daltex, do not drive or use tools or machines.

3. How to take Daltex

The dose of Daltex that you should take varies depending on your condition. Your doctor will tell you exactly what dose of Daltex you should take.

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, talk to your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg film-coated tablet twice a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medicine known as a sulfonylurea.

Your doctor may prescribe this medicine alone or with certain medicines that lower your blood sugar levels.

How to take Daltex

• Swallow the tablets whole with a glass of water
• Take one tablet in the morning and the other in the evening with meals or after meals. Taking the tablet after meals will reduce the risk of digestive discomfort.

Follow your doctor's dietary advice. In particular, if you follow a weight-control diet for diabetics, continue with the diet while taking this medicine.

If you take more Daltex than you should

If you have taken too many Daltex tablets, or if someone else has taken your tablets, talk to your doctor, pharmacistor call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used .You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the package and this leaflet with you.

If you forget to take Daltex

If you forget to take a tablet, take it with your next meal, unless it is already time for your usual dose. Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop taking Daltex

Continue taking this medicine while your doctor prescribes it for you to continue controlling your blood sugar. Do not stop taking Daltex unless your doctor tells you to.

If you have any doubts about the duration of treatment, talk to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Daltex and see your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Daltex may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you should stop taking Daltex and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.
• 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 rash or hives, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while taking Daltex:

• Common (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, tremors, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, acidity, stomach pain, and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood sugar, loss of appetite, swollen hands, ankles, or feet (edema), chills, pancreatitis, muscle pain.
• Very rare (may affect up to 1 in 10,000 people): signs of high lactic acid levels in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory changes).

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

Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rashes or spots, flat, red, and round patches under the skin surface or bruises.

Reporting of side effects

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

5. Storing Daltex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month shown.
• This medicine does not require any special storage temperature. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Container Content and Additional Information Composition of Daltex

Composition of Daltex

• The active ingredients are vildagliptin and metformin hydrochloride.
• Daltex 50 mg/850 mg film-coated tablets: each tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
• Daltex 50 mg/1000 mg film-coated tablets: each tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
• The other components are: microcrystalline cellulose, copovidone K 25, crospovidone (Type B), hydroxypropylcellulose, hypromellose (E 464), magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol/PEG 8000 (E 1521), and talc (E 553b).

Appearance of the Product and Container Content

Daltex 50 mg/850 mg: oval, yellow, film-coated tablet with beveled edges, smooth surface on both sides with dimensions of approximately 20.7 X 8.8 mm.

Daltex 50 mg/1000 mg: oval, yellow, film-coated tablet with beveled edges, smooth surface on both sides with dimensions of approximately 21.3 X 10.1 mm.

Daltex is available in containers with 10, 30, 60, 120, 180, or 360 film-coated tablets.

Only some package sizes and doses may be marketed.

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd. - Factory AZ

2 Michael Erakleous Street, Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101,

Cyprus

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus:November 2023.

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/