Daltex 50 mg/1000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Daltex 50 mg/850 mg film-coated tablets EFG
Daltex 50 mg/1000 mg film-coated tablets EFG
vildagliptin/metformin hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Daltex is and what it is used for

The active substances in 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 may also occur when the body produces too much glucagon.

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

How Daltex works

Both active substances, vildagliptin and metformin, help 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 use insulin more effectively. This medicine has been shown to reduce blood sugar, which will help prevent complications from your diabetes.

2. What you need to know before starting Daltex

Do not take Daltex

• if you are allergic to vildagliptin, metformin, or any of the other components of this medicine (listed in section 6). If you think you might be allergic to any of these components, consult your doctor before taking Daltex.
• if you have uncontrolled diabetes, for example, with severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity odour on your breath.
• if you have recently had a heart attack or if you have heart failure, severe circulatory problems, or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a severe infection or severe dehydration (major loss of body water).
• if you are due to undergo contrast radiography (a specific type of X-ray diagnostic test using an injectable contrast agent). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink alcohol to excess (either daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

Daltex may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further 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 diseases).

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

Contact your doctor promptly for guidance if:

• You are known to have a genetic inherited disease affecting the mitochondria (the components responsible for energy production within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or deafness.

Stop taking Daltex temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with profound fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

Daltex is not a substitute for insulin. Therefore, you should not take Daltex for the treatment of type 1 diabetes.

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

Consult your doctor, pharmacist, or nurse before starting Daltex if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may wish to reduce your sulfonylurea dose when taken together with Daltex to prevent low blood glucose levels (hypoglycemia).

If you have previously taken vildagliptin but had to discontinue it 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. Pay special attention to the development of blisters or ulcers while taking Daltex. If this occurs, you must consult your doctor immediately.

If you require major surgery, you must stop taking Daltex during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart Daltex treatment.

Liver function tests should be performed before starting treatment with Daltex, at three-month intervals during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating elevated liver enzymes.

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

Your doctor will periodically monitor 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 receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Daltex before or at the time of the injection. Your doctor will decide when you should interrupt treatment with Daltex and when to restart it.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine. You may require more frequent blood glucose and kidney 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 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 affecting the thyroid gland
• certain active substances affecting the nervous system
• certain active substances used to treat angina pectoris (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 acid and peptic ulcers (e.g., cimetidine).

Taking Daltex with alcohol

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

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 breastfeeding (see also “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 machinery.

3. How to take Daltex

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

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

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

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

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

Dosage and administration of Daltex

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

Follow your doctor's dietary advice. In particular, if you are on a diabetic weight control diet, continue this diet while taking this medication.

If you take more Daltex than you should

If you have taken too many Daltex tablets, or if someone else has taken your tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, bring the pack 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 treatment with Daltex is interrupted

Continue taking this medicine for as long as your doctor prescribes it, so that your blood sugar remains under control. Do not stop treatment with Daltex unless your doctor instructs you to do so.

If you have any questions about how long the treatment should last, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Daltex may cause a very rare but serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Daltex and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
• 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) (uncommon: may affect up to 1 in 100 people): 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) (uncommon: may affect up to 1 in 100 people): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients have experienced the following adverse 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, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhea, flatulence, heartburn, stomach pain and pain in the abdominal area (abdominal pain).
• Uncommon (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, inflammation of the pancreas, muscle pain.
• Very rare (may affect up to 1 in 10,000 people): signs of 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 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Daltex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after "CAD"/"EXP". The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their packaging at the Punto Sigre collection point at the pharmacy. This way, you will help protect the environment.

6. Contents of the pack and other information Composition of Daltex

Composition of Daltex

• The active substances 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 (equivalent 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 (equivalent 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 medicinal product and contents of the pack

Daltex 50 mg/850 mg: yellow, oval, film-coated tablet with bevelled edges, smooth surface on both sides, approximately 20.7 x 8.8 mm in size.

Daltex 50 mg/1000 mg: yellow, oval, film-coated tablet with bevelled edges, smooth surface on both sides, approximately 21.3 x 10.1 mm in size.

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

Only certain pack sizes and strengths may be marketed.

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer responsible for production

Medochemie Ltd. - Factory AZ

2 Michael Erakleous Street, Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101,

Cyprus

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch office in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

Spain

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

Date of the most recent review of this leaflet: May 2025

Other sources of information

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