SITAGLIPTIN/METFORMIN DR REDDYS 50 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptin/Metformin Dr. Reddys 50 mg/850 mg film-coated tablets EFG

Sitagliptin/Metformin Dr. Reddys 50 mg/1000 mg film-coated tablets EFG

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

1. What Sitagliptin/Metformin Dr. Reddys is and what it is used for

This medicine contains two different medicines called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a class of medicines called biguanides.

They work together to control the levels of sugar in the blood in adult patients with a form of diabetes called “type 2 diabetes mellitus”. This medicine helps to increase the amounts of insulin produced after a meal and reduces the amount of sugar produced by your body.

Together with diet and exercise, this medicine helps to lower your blood sugar levels. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin and the insulin that your body produces does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as diseases that affect the heart, diseases that affect the kidneys, blindness, and amputations.

2. What you need to know before you take Sitagliptin/Metformin Dr. Reddys

Do not take Sitagliptin/Metformin Dr. Reddys:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• 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 condition in which substances called “ketone bodies” build up 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 a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a contrast agent. You will need to stop taking sitagliptin/metformin at the time of the X-ray and for 2 or more days after, as directed by your doctor, depending on your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as “shock” or breathing difficulties
• if you have liver problems
• if you drink excessive amounts of alcohol (either every day or only occasionally)
• if you are breast-feeding.

Do not take sitagliptin/metformin if you are affected by any of the above conditions and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking sitagliptin/metformin.

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin/metformin (see section 4).

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin/metformin.

Risk of lactic acidosis

Sitagliptin/metformin 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 by uncontrolled diabetes, serious infections, prolonged fasting, or alcohol intake, dehydration (see more information below), liver problems, and any medical condition in which a part of your body has a reduced supply of oxygen (such as acute and severe heart diseases).

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

Stop taking sitagliptin/metformin for a short period of time if you have a condition 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 taking sitagliptin/metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of being unwell, with intense tiredness
• difficulty breathing
• reduction in body temperature and heart rate

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

Talk to your doctor immediately for further instructions if:

• You know you have a hereditary condition that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or hereditary maternal diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Consult your doctor or pharmacist before starting sitagliptin/metformin:

• if you have or have had a pancreatic disease (such as pancreatitis)
• if you have or have had gallstones, alcohol dependence, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This condition is also known as insulin-dependent diabetes
• if you have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medicines, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider it necessary to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop taking sitagliptin/metformin during the procedure and for some time after. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

If you are not sure if any of the above conditions apply to you, consult your doctor or pharmacist before taking sitagliptin/metformin.

During treatment with sitagliptin/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.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents from 10 to 17 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Dr. Reddys

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

Tell your doctor or pharmacist 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 sitagliptin/metformin. It is especially important to mention the following:

• medicines (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, such as asthma and arthritis (corticosteroids)
• 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)
• medicines used to treat bronchial asthma (beta-sympathomimetics)
• iodinated contrast agents or medicines containing alcohol
• certain medicines used to treat stomach problems, such as cimetidine
• ranolazine, a medicine used to treat angina pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (for treating irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin Dr. Reddys with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breast-feeding. See section 2, Do not take Sitagliptin/Metformin Dr. Reddys.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, there have been reports of dizziness and drowsiness during treatment with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a secure support.

Sitagliptin/Metformin Dr. Reddys contains sodium

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

3. How to take Sitagliptin/Metformin Dr. Reddys

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Take one tablet:
• • twice a day by mouth
  • with food to reduce the chance of stomach upset
• Your doctor may need to increase the dose to control your blood sugar levels.
• If you have reduced kidney function, your doctor may prescribe a lower dose.

You should continue with the diet recommended by your doctor during treatment with this medicine and be careful to distribute your carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medicine is taken with a sulfonylurea or insulin, so your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Dr. Reddys than you should

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

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

If you forget to take Sitagliptin/Metformin Dr. Reddys

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time for your next dose, skip the missed dose and continue with your normal treatment schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin Dr. Reddys

Keep taking this medicine for as long as your doctor tells you to, so that it can help control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking sitagliptin/metformin, your blood sugar levels may increase again.

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 can cause adverse effects, although not all people suffer from them.

STOP taking sitagliptin/metformin and go to the doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis.

Sitagliptin/metformin may cause a very rare (may affect up to 1 in 10,000 people) but very serious adverse effect called lactic acidosis (see section "Warnings and Precautions"). If this happens to you, you must stop taking sitagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/exfoliative dermatitis, and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will

change the medicine for the treatment of diabetes.

Some patients who took metformin have experienced the following adverse effects after starting treatment with sitagliptin:

Frequent (may affect up to 1 in 10 people): low blood sugar, nausea, gas, vomiting.

Infrequent (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients have experienced diarrhea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (frequency classified as frequent).

Some patients have experienced the following adverse effects when taking this medicine with a sulfonylurea such as glimepiride:

Very frequent (may affect more than 1 in 10 people): low blood sugar levels. Frequent: constipation.

Some patients have experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet.

Some patients have experienced the following adverse effects while taking this medicine in combination with insulin:

Very frequent: low blood sugar levels.

Infrequent: dry mouth, headache.

Some patients have experienced the following adverse effects during clinical trials while taking sitagliptin alone (one of the medicines that contains this medicine or during use after approval of this medicine or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthritis, pain in the arm or leg.

Infrequent: dizziness, constipation, itching.

Rare: reduction in platelet count.

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

Some patients have experienced the following adverse effects after taking metformin alone: Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear.

Frequent: metallic taste, decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and sore tongue, tingling, or pale or yellowish skin). Your doctor may schedule some tests to discover the cause of your symptoms because some of these can also be caused by diabetes or other unrelated health problems.

Very rare: reduction in vitamin B12 levels, hepatitis (a liver problem), hives, skin redness (rash), or itching.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin Dr. Reddys

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptin/Metformin Dr. Reddys

• The active ingredients are sitagliptin and metformin.
• Sitagliptin/Metformin Dr. Reddys 50 mg/850 mg film-coated tablets:

Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

• Sitagliptin/Metformin Dr. Reddys 50 mg/1,000 mg film-coated tablets:

Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• Other components are:

• Tablet core:

Povidone, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.

• Coating:

Polyvinyl alcohol (E123), macrogol (E1521), talc (E553b), titanium dioxide (E171).

Only for 50 mg/1,000 mg: red iron oxide (E172) and yellow iron oxide (E172).

Product Appearance and Package Contents

Sitagliptin/Metformin Dr. Reddys 50 mg/850 mg are oval, biconvex, white film-coated tablets with "|" engraved on one face and smooth on the other face.

Approximate tablet dimensions: 20 mm x 10 mm x 6 mm.

Sitagliptin/Metformin Dr. Reddys 50 mg/1,000 mg are oval, biconvex, brown film-coated tablets with a "7" engraved on one face and smooth on the other face.

Approximate tablet dimensions: 21 mm x 10 mm x 7 mm.

OPA/Alu/PVC-Alu blister pack.

Pack sizes of 28, 56, 112, and 196 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38.

08029 Barcelona,

Spain.

Phone: 93.355.49.16.

Fax: 93.355.49.61.

Manufacturer

betapharm Arzneimittel GmbH.

Kobelweg 95.

86156 Augsburg.

Germany.

or

Rual Laboratories SRL.

313, Splaiul Unirii, Building H, 1st floor, sector 3,

030138 Bucharest.

Romania.

or

Dr Reddy’s Laboratories Romania SRL.

71-73 Nicolae Caramfil, 1st floor, sector 1.

014142 Bucharest.

Romania.

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park.

Paola PLA 3000 Malta.

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

Date of the last revision of this prospectus:March 2025.

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