LINAGLIPTIN/METFORMIN STADA 2.5 mg/850 mg FILM-COATED TABLETS

2. What you need to know before you start taking Linagliptin/Metformin Stada

Do not take Linagliptin/Metformin Stada

• if you are allergic to linagliptin or 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 diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor to your breath;
• if you have ever had diabetic precoma;
• if you have a severe infection such as a lung or bronchial infection, or a kidney infection. Severe infections can lead to kidney problems, which can put you at risk of lactic acidosis (see “Warnings and precautions”);
• if you have lost a lot of body water (dehydration), for example, due to severe and prolonged diarrhea or if you have vomited several times in a row. Dehydration can lead to kidney problems, which can put you at risk of lactic acidosis (see “Warnings and precautions”);
• if you are being treated for acute heart failure or have recently had a heart attack, have severe circulatory problems (such as “shock”) or breathing difficulties. This can lead to a lack of oxygen supply to the tissues, which can put you at risk of lactic acidosis (see “Warnings and precautions”);
• if you have liver problems;
• if you drink a lot of alcohol, either every day or only occasionally (see section “Taking Linagliptin/Metformin Stada with alcohol”).

Do not take linagliptin/metformin if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take linagliptin/metformin

• if you have type 1 diabetes (your body does not produce any insulin). Linagliptin/metformin should not be used to treat this disease.
• if you are taking insulin or a diabetes medicine known as a “sulfonylurea”, your doctor may want to reduce your dose of insulin or sulfonylurea when you take it with linagliptin/metformin to avoid low blood sugar levels (hypoglycemia).
• if you have or have had a disease of the pancreas.

If you have symptoms of acute pancreatitis, such as severe and persistent stomach pain, you should consult your doctor.

If you find blisters on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking linagliptin/metformin.

If you are not sure if any of the above applies to you, consult your doctor, pharmacist, or nurse before starting to take linagliptin/metformin.

Diabetic skin problems are a common complication of diabetes. Follow the skin and foot care recommendations given by your doctor or nurse.

Risk of lactic acidosis

Linagliptin/metformin can 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, severe infections, prolonged fasting or alcohol intake, dehydration (see below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as severe and acute heart disease).

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

Stop taking linagliptin/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 linagliptin/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,
• a general feeling of being unwell, with intense fatigue,
• difficulty breathing,
• reduced body temperature and heart rate.

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

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

During treatment with linagliptin/metformin, your doctor will check your kidney function at least once a year or more often if you are an elderly patient and/or if your kidney function is deteriorating.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age. 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 Linagliptin/Metformin Stada

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, for an X-ray or other imaging procedure, you should stop taking linagliptin/metformin before or at the time of the injection. Your doctor will decide when you should stop taking linagliptin/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 linagliptin/metformin. It is especially important to mention the following:

• 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 that may change the levels of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• carbamazepine, phenobarbital, or phenytoin. These are used to control seizures (convulsions) or chronic pain;
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis;
• medicines used to treat diseases that involve inflammation, such as asthma and arthritis (corticosteroids);
• bronchodilators (beta-2 sympathomimetics) for the treatment of bronchial asthma;
• medicines that contain alcohol.

Taking Linagliptin/Metformin Stada with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 linagliptin/metformin if you are pregnant. It is not known if this medicine is harmful to the unborn child.

Metformin passes into breast milk in small amounts. It is not known if linagliptin passes into breast milk. Consult your doctor if you want to breastfeed while taking this medicine.

Driving and using machines

Linagliptin/metformin has no or negligible influence on the ability to drive and use machines.

However, taking linagliptin/metformin in combination with sulfonylureas or insulin may cause low blood sugar (hypoglycemia), which can affect your ability to drive and use machines or work without a safe support.

Linagliptin/Metformin Stada contains sodium

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

3. How to take Linagliptin/Metformin Stada

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

How much to take

The amount of linagliptin/metformin you will take varies depending on your situation and the doses of metformin and/or individual tablets of linagliptin and metformin you are currently taking. Your doctor will tell you exactly what dose of this medicine to take.

How to take this medicine

• one tablet twice a day by mouth at the dose prescribed by your doctor;
• with food to reduce the likelihood of stomach upset.

Do not exceed the maximum recommended daily dose of 5 mg of linagliptin and 2000 mg of metformin hydrochloride.

Keep taking linagliptin/metformin as long as your doctor prescribes it to help control your blood sugar levels. Your doctor may prescribe this medicine along with other diabetes medicines or insulin. Remember to take all your medicines as your doctor has told you to get the best results for your health.

During treatment with linagliptin/metformin, you should continue with your diet and be careful to distribute your carbohydrate intake evenly throughout the day. If you are overweight, continue with your low-calorie diet as advised. It is unlikely that this medicine alone will cause abnormally low blood sugar (hypoglycemia). When linagliptin/metformin is used with a sulfonylurea or insulin, low blood sugar can occur, and your doctor may reduce the dose of your sulfonylurea or insulin.

If you take more Linagliptin/Metformin Stada than you should

If you take more tablets of linagliptin/metformin than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are non-specific, such as nausea, vomiting, stomach pain with muscle cramps, a general feeling of being unwell with intense fatigue, and difficulty breathing. Other symptoms are reduced body temperature and heart rate. If this happens, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital immediately (see section 2). Bring the medicine pack 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 taken.

If you forget to take Linagliptin/Metformin Stada

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for missed doses. Never take two doses at the same time (morning or evening).

If you stop taking Linagliptin/Metformin Stada

Keep taking linagliptin/metformin until your doctor tells you to stop. This will help you keep your blood sugar levels under control.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some symptoms require immediate medical attention

Stop taking linagliptina/metformina and go quickly to your doctor if you experience the following symptoms of low blood sugar levels (hypoglycemia): tremors, sweating, anxiety, blurred vision, tingling in the lips, paleness, mood changes or confusion. Hypoglycemia (frequency: very frequent (may affect more than 1 in 10 people)) is an adverse effect identified for the combination of linagliptina/metformina plus sulfonylurea and for the combination linagliptina/metformina plus insulin.

Linagliptina/metformina 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 linagliptina/metformina and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Some patients have experienced pancreatitis (frequency rare, may affect up to 1 in 1,000 people).

STOPtaking linagliptina/metformina and consult a doctor immediately if you observe any of the following serious adverse effects:

• Severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting, as this could be a sign of an inflamed pancreas (pancreatitis).

Other adverse effects of linagliptina/metformina include:

Some patients have presented allergic reactions (frequency rare (may affect up to 1 in 1,000 people)), which can be serious, including wheezing and difficulty breathing (bronchial hyperreactivity; frequency uncommon (may affect up to 1 in 100 people)). Some patients presented with skin rash (frequency uncommon (may affect up to 1 in 100 people)), hives (urticaria; frequency rare (may affect up to 1 in 1,000 people)), and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing (angioedema; frequency rare (may affect up to 1 in 1,000 people)). If you experience any of the aforementioned disease signs, stop taking linagliptina/metformina and go quickly to your doctor. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

Some patients have experienced the following adverse effects while taking linagliptina/metformina:

• Frequent (may affect up to 1 in 10 people): diarrhea, increased blood enzyme levels (increased lipase), feeling unwell (nausea).
• Uncommon (may affect up to 1 in 100 people): inflammation of the nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), vomiting, increased blood enzyme levels (increased amylase), itching (pruritus).
• Rare (may affect up to 1 in 1,000 people): skin blisters (bullous pemphigoid).

Some patients have experienced the following adverse effects while taking linagliptina/metformina with insulin:

• Uncommon (may affect up to 1 in 100 people): liver function disorders, constipation.

Adverse effects when taking metformina alone, which were not described for linagliptina/metformina:

• Very frequent: abdominal pain.
• Frequent (may affect up to 1 in 10 people): metallic taste (taste alteration), decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, inflamed and reddened tongue (glossitis), tingling sensation (paresthesia), or pale or yellowish skin). Your doctor may request certain tests to identify the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
• Very rare (may affect up to 1 in 10,000 people): hepatitis (a liver problem), skin reactions such as skin redness (erythema).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Linagliptina/Metformina Stada

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Linagliptina/Metformina Stada

• The active ingredients are linagliptina and metformina hydrochloride.

Linagliptina/Metformina Stada 2.5 mg/850 mg film-coated tablets:

Each film-coated tablet contains 2.5 mg of linagliptina and 850 mg of metformina hydrochloride.

Linagliptina/Metformina Stada 2.5 mg/1,000 mg film-coated tablets:

Each film-coated tablet contains 2.5 mg of linagliptina and 1,000 mg of metformina hydrochloride.

• The other components are:
• Tablet core: copovidone, cornstarch, sodium carbonate anhydrous (E500), crospovidone type A (E1202), magnesium stearate (E470b), colloidal anhydrous silica (E551).
• Film coating: hypromellose 2910, 5mPa.s (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520).

Linagliptina/Metformina Stada 2.5 mg/850 mg film-coated tablets also contain yellow iron oxide (E172) and red iron oxide (E172).

Linagliptina/Metformina Stada 2.5 mg/1,000 mg film-coated tablets also contain red iron oxide (E172).

Appearance of the Product and Package Contents

Linagliptina/Metformina Stada 2.5 mg/850 mg are film-coated tablets (tablets) of beige color, oval, biconvex, with a score line on one side and engraved with “2.5/850” on the other. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Linagliptina/Metformina Stada 2.5 mg/1,000 mg are film-coated tablets (tablets) of pink color, oval, biconvex, with a score line on one side and engraved with “2.5/1000” on the other. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Blister Packs

Each Linagliptina/Metformina Stada pack is available in aluminum blister packs of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, and 120 tablets, and in single-dose aluminum blister packs of 10x1, 14x1, 28x1, 30x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1, and 120x1 tablets.

Linagliptina/Metformina Stada is also available in multiple packs of aluminum blister packs of 120 tablets (2 packs of 60), 180 tablets (2 packs of 90 or 3 packs of 60), and 200 tablets (2 packs of 100), and in multiple packs of single-dose aluminum blister packs of 120 tablets (2 packs of 60x1), 180 tablets (2 packs of 90x1 or 3 packs of 60x1), and 200 tablets (2 packs of 100x1).

Bottles

Linagliptina/Metformina Stada is also available in plastic bottles containing 60 or 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Vienna,

Austria

Date of the Last Revision of this Prospectus:August 2024

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/).