VILDAGLIPTIN/METFORMIN MACLEODS 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vildagliptin/Metformin Macleods 50 mg/850 mg film-coated tablets EFG

Vildagliptin/Metformin Macleods 50 mg/1,000 mg film-coated tablets EFG

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

1. What is Vildagliptin / Metformin Macleods and what is it used for

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

Vildagliptin/metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. This medicine 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 appears when the body does not produce enough insulin or when the insulin produced does not work properly. It can also appear when 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 increases blood sugar levels.

How it worksVildagliptin/Metformin

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 better. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes.

2. What you need to know before you take Vildagliptin/Metformin Macleods

Do not takeVildagliptin/Metformin Macleods

• 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, consult your doctor before taking this medicine.
• 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. 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 heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• If you have a severe reduction in kidney function.
• If you have a severe infection or severe dehydration (massive loss of body water).
• If you are going to have 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 only occasionally).
• If you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder 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 takingVildagliptin/Metforminfor 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. Consult your doctor for further instructions.

Stop takingVildagliptin/Metforminand contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, 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
• Decreased body temperature and heart rate

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

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take vildagliptin/metformin for the treatment of type 1 diabetes.

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

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you are taking a diabetes medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin 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 vildagliptin/metformin. If this happens, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking vildagliptin/metformin while the procedure is being performed and for a period after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when you can restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, 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 vildagliptin/metformin, 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 vildagliptin/metformin is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptin/Metformin Macleods

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 vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/metformin 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 glucose and kidney function tests, or your doctor may need to adjust the dose of Vildagliptin/Metformin. It is especially important to mention the following:

• glucocorticoids, 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)
• specific active substances that affect the thyroid, or
• specific active substances that affect the nervous system
• specific active substances used to treat angina (e.g., ranolazine),
• specific active substances used to treat HIV infection (e.g., dolutegravir),
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib),
• specific active substances used to treat stomach acid and peptic ulcers (e.g., cimetidine).

TakingVildagliptin/MetforminaMacleods with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, 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 medicine. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin Macleods”).

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machines.

3. How to take Vildagliptin/Metformin Macleods

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

Follow your doctor's instructions for taking this medicine exactly. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1,000 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 medicine known as a sulfonylurea.

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

When and how to takeVildagliptin/Metformin

• 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 diet for weight control in diabetics, continue with the diet while taking vildagliptin/metformin.

If you take moreVildagliptin/Metforminthan you should

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

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

If you forget to takeVildagliptin/Metformin

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 takingVildagliptin/Metformin

Continue taking this medicine while your doctor prescribes it for you to continue controlling your blood sugar. Do not stop taking vildagliptin/metformin 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 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 takingvildagliptin/metforminand go to your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 user in 10,000):

This medicine may cause a very rare but very serious side effect called lactic acidosis (see “Warnings and precautions” section). If this happens to you, you should stop takingvildagliptin/metforminand 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 vildagliptin/metformin:

• 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 (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 having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or rapid breathing, skin redness, itching; decreased levels of vitamin B12 (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), which can cause skin rashes or spots, flat, red, and round patches under the skin or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin / Metformin Macleods

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that appears on the packaging and blister after “EXP”. The expiry date is the last day of the month indicated.
• Do not store above 30°C.
• 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 the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicinal products you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Vildagliptina/Metformina Macleods

• The active ingredients are vildagliptina and metformina hydrochloride.
• • Each film-coated tablet of Vildagliptina/Metformina Macleods 50 mg/850 mg contains 50 mg of vildagliptina and 850 mg of metformina hydrochloride.
  • Each film-coated tablet of Vildagliptina/Metformina Macleods 50 mg/1,000 mg contains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride.
• The other components are: hydroxypropylcellulose, isopropyl alcohol, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000 (E1521), and talc (E553b).

Product Appearance and Container Content

Vildagliptina/Metformina Macleods 50 mg/850 mg film-coated tablets are yellow, oval, biconvex tablets, engraved with “F59” on one side and smooth on the other side.

Vildagliptina/Metformina Macleods 50 mg/1,000 mg film-coated tablets are dark yellow, oval, biconvex tablets, engraved with “F60” on one side and smooth on the other side.

Vildagliptina/Metformina Macleods is packaged in blisters (cold-formed OPA/aluminum/PVC laminates with aluminum foil). Available in packs containing 30, 60, and 180 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Macleods Pharma España S.L.U.

Avenida Diagonal, 468, 6°, puerta A

08006 Barcelona

Spain

Manufacturer:

Synoptis Industrial Sp. Z o.o

ul. Rabowicka 15

62-020 Swarzedz

Poland

Date of the Last Revision of this Prospectus:August 2024.

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