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 this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

The active principles of Daltex, vildagliptin and metformin, belong to a group of medications 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 with diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

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

HowDaltex works

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

Do not take Daltex

• If you are allergic to vildagliptin, metformin, or any of the other components of this medication (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking Daltex.
• If you have uncontrolled diabetes, 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 condition in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath.
• If you have recently had a heart attack or if you have severe heart failure or circulatory problems or breathing difficulties that may be a sign of heart problems.
• If you have severe kidney function reduction.
• If you have a severe infection or severe dehydration (massive loss of body water).
• If you are undergoing a contrast radiology (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the "Warnings and precautions" section.
• If you have liver problems.
• If you drink excessive alcohol (daily or occasionally).
• If you are breastfeeding (also see "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

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

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Daltex for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

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

The symptoms of lactic acidosis include:

• vomiting
• abdominal pain (stomach 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, do not take Daltex for the treatment of type 1 diabetes.

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

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

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

Diabetic skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care and pay special attention to the appearance of blisters or ulcers while taking Daltex. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, stop taking Daltex while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt Daltex treatment and when to restart it.

Tests of liver function 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 deteriorating.

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

Children and adolescents

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

Taking Daltex with other medications

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or an examination, stop taking Daltex before the injection or at the time of the injection. Your doctor will decide when to interrupt Daltex treatment and when to restart it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and renal function tests, or your doctor may need to adjust the dose of Daltex.It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory disorders
• other active principles used to treat diabetes
• diuretics, which increase urine production
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• specific medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• specific active principles that affect the thyroid
• specific active principles that affect the nervous system
• specific active principles used to treat angina pectoris (for example, ranolazine)
• specific active principles used to treat HIV infection (for example, dolutegravir)
• specific active principles used to treat a specific type of thyroid cancer (medullary thyroid cancer) (for example, vandetanib)
• specific active principles used to treat stomach acid and peptic ulcers (for example, cimetidine).

Taking Daltex with alcohol

Avoid excessive alcohol consumption while taking Daltex, as this may increase the risk of lactic acidosis (see "Warnings and precautions" section).

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will inform you about the potential risks of taking Daltex during pregnancy.
• Do not take Daltex if you are pregnant or breastfeeding (also see "Do not take Daltex"). Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

The dose of Daltex that each person should take varies depending on their condition. Your doctor will tell you exactly how much Daltex you should take.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Your doctor may prescribe this medication alone or with certain medications that lower blood sugar levels.

Daltex Usage Form

• Swallow the tablets whole with a glass of water
• Take one tablet in the morning and the other at night 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 are following a weight control diet for diabetics, continue with the diet while taking this medication.

If You Take Too Much Daltex

If you have taken too many Daltex tablets, or if someone else has taken your tablets, consult your doctor, pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging and this leaflet with you.

If You Forget to Take Daltex

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

Stopping Treatment with Daltex

Continue taking this medication as long as your doctor prescribes it for you to continue monitoring your blood sugar levels. Do not stop taking Daltex unless your doctor tells you to.

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

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

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

You muststop 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 serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you muststop taking Daltex and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to 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 hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (infrequent: may affect up to 1 in 100 people): 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 (infrequent: may affect up to 1 in 100 people): 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 have experienced the following side effects while taking Daltex:

• Frequent (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled trembling, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain, and abdominal pain.
• Infrequent (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, 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 having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pale skin, fatigue, mental symptoms such as confusion or memory alterations).

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

Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface, or hematomas..

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.
• Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”/”EXP”. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at thePharmacy Take-Back Point. By doing so, you will help protect the environment.

Composition ofDaltex

• The active principles 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 contents of the package

Daltex 50 mg/850 mg: oval-shaped, yellow, beveled-edge film-coated tablet with smooth surfaces on both sides, approximately 20.7 x 8.8 mm in size.

Daltex 50 mg/1000 mg: oval-shaped, yellow, beveled-edge film-coated tablet with smooth surfaces on both sides, approximately 21.3 x 10.1 mm in size.

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

Only some package sizes and dosages may be commercially available.

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Responsible for manufacturing

Medochemie Ltd. - Factory AZ

2 Michael Erakleous Street, Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101,

Cyprus

You can request more information about this medicine 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 medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November 2023.

Other sources of information

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