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

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the Patient

Linagliptin/Metformin Pharos 2.5mg/850mg film-coated tablets EFG

Linagliptin/Metformin Pharos 2.5mg/1000mg film-coated tablets EFG

linagliptin/metformin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

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

1. What is Linagliptin/Metformin Pharos and what is it used for

The name of your tablet is Linagliptin/Metformin Pharos. It contains two different active substances: linagliptin and metformin.

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

How Linagliptin/Metformin Pharos works

The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called “type 2 diabetes mellitus”. Along with diet and exercise, this medication helps improve insulin levels and effects after a meal and reduces the amount of sugar produced by your body.

This medication can be used alone or with certain diabetes medications such as sulfonylureas, empagliflozin, or insulin.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin 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 heart disease, kidney disease, blindness, and amputations.

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

Do not take Linagliptin/Metformin Pharos

• if you are allergic to linagliptin or metformin or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney function impairment.
• 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 disorder 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 on the 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 large amount 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 have 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 excessive alcohol, either every day or from time to time (see section “Taking Linagliptin/Metformin Pharos with alcohol”).

Do not take Linagliptin/Metformin if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

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 Pharos should not be used to treat this disease;
• if you are taking insulin or taking an antidiabetic medication known as a “sulfonylurea”, your doctor may want to reduce your insulin or sulfonylurea dose when you take either of them with Linagliptin/Metformin to avoid low blood sugar levels (hypoglycemia);
• if you have or have had a pancreatic disease.

If you have symptoms of acute pancreatitis, such as severe and persistent abdominal 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 unsure whether 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 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 intake, 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 severe and acute heart diseases).

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

Stop taking Linagliptin/Metformin Pharos for 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 taking Linagliptin/Metformin Pharos and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder can lead to coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• a 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.

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

During treatment with Linagliptin/Metformin, your doctor will check your kidney function at least once a year or more frequently if you are an elderly patient and/or if your kidney function is worsening.

Children and adolescents

This medication is not recommended for children and adolescents under 18 years of age.

Other medications and Linagliptin/Metformin Pharos

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 other imaging examination, you should stop taking Linagliptin/Metformin before or at the time of the injection. Your doctor will decide when you should stop and restart treatment with Linagliptin/Metformin.

Tell your doctor if you are taking, have recently taken, or might take any other medications. 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:

• medications that increase urine production (diuretics);
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medications for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
• medications that may alter metformin levels in the 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;
• medications used to treat diseases involving inflammation, such as asthma and arthritis (corticosteroids);
• bronchodilators (β sympathomimetics) for the treatment of bronchial asthma;
• medications containing alcohol.

Taking Linagliptin/Metformin Pharos with alcohol

Avoid excessive alcohol consumption while taking Linagliptin/Metformin Pharos, 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Linagliptin/Metformin if you are pregnant. It is not known whether this medication is harmful to the fetus.

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

Driving and using machines

The influence of Linagliptin/Metformin on the ability to drive and use machines is negligible or non-existent.

However, taking Linagliptin/Metformin in combination with medications called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without a secure support.

Linagliptin/Metformin Pharos contains sodium

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

Linagliptin/Metformin Pharos contains propylene glycol

For Linagliptin/Metformin Pharos 2.5 mg/850 mg film-coated tablets EFG:

This medication contains 0.85 mg of propylene glycol in each unit dose.

For Linagliptin/Metformin Pharos 2.5 mg/1,000 mg film-coated tablets EFG:

This medication contains 1.0 mg of propylene glycol in each unit dose.

3. How to take Linagliptin/Metformin Pharos

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult 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 linagliptin and metformin tablets you are currently taking. Your doctor will tell you exactly what dose of this medication you should take.

How to take this medication

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

You should not exceed the maximum recommended daily dose of 5 mg of linagliptin and 2,000 mg of metformin hydrochloride.

Continue taking Linagliptin/Metformin as long as your doctor prescribes it to help control your blood sugar levels. Your doctor may prescribe this medication along with other antidiabetic medications or insulin. Remember to take all medications as directed by your doctor to achieve 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 directed. It is unlikely that this medication alone will cause abnormally low blood sugar levels (hypoglycemia). When Linagliptin/Metformin is used with a medication containing a sulfonylurea or with insulin, low blood sugar levels and hypoglycemia may occur, and your doctor may reduce the dose of your sulfonylurea or insulin.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take more Linagliptin/Metformin Pharos than you should

If you take more Linagliptin/Metformin tablets 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 discomfort with intense fatigue, and difficulty breathing. Other symptoms include 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 medication immediately and contact a doctor or the nearest hospital immediately(see section 2). Bring the medication packaging 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.

If you forget to take Linagliptin/Metformin Pharos

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 Pharos

Continue 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 about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

Stop taking Linagliptin/Metformin and go to your doctor immediately if you experience the following symptoms of low blood sugar levels (hypoglycemia): trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion. Hypoglycemia (frequency: very common [may affect more than 1 in 10 people]) is a side effect identified for the combination of Linagliptin/Metformin with sulfonylurea and for the combination Linagliptin/Metformin with insulin.

Linagliptin/Metformin may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you should stop taking Linagliptin/Metformin 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).

STOP taking Linagliptin/Metformin and consult a doctor immediately if you notice any of the following serious side 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 Pharos include:

Some patients have presented allergic reactions (rare frequency [may affect up to 1 in 1,000 people]), which can be severe, including wheezing (“whistling” when breathing) and difficulty breathing (bronchial hyperreactivity; infrequent frequency [may affect up to 1 in 100 people]). Some patients have presented with exanthema (skin reaction; infrequent frequency), hives (urticaria; rare frequency [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; rare frequency [may affect up to 1 in 1,000 people]). If you experience any of the aforementioned disease signs, stop taking Linagliptina/Metformina Pharos and call your doctor immediately. 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 enzymes (increased lipase), feeling unwell (nausea).
• Infrequent (may affect up to 1 in 100 people): inflammation of the nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), vomiting, increased blood enzymes (increased amylase), itching (pruritus).
• Rare (may affect up to 1 in 1,000 people): blisters on the skin (bullous pemphigoid).

Some patients have experienced the following adverse effects while taking Linagliptina/Metformina with insulin:

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

Adverse effects when taking metformin alone, which were not described for Linagliptina/Metformina Pharos:

• Very frequent (may affect up to 1 in 10 people): 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, 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 medication.

5. Storage of Linagliptina/Metformina Pharos

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

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

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Linagliptina/Metformina Pharos

• The active ingredients are linagliptin and metformin hydrochloride.
• Each film-coated tablet of Linagliptina/Metformina Pharos 2.5 mg/850 mg contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Linagliptina/Metformina Pharos 2.5 mg/1,000 mg contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
• The other components are:
• Tablet core: copovidone, cornstarch, anhydrous sodium carbonate (E500), crospovidone type A (E1202), magnesium stearate (E470b), and anhydrous colloidal silica (E551).
• Film coating: hypromellose 2910, 5 mPa·s (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520).

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

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

Appearance of the product and package contents

Linagliptina/Metformina Pharos 2.5 mg/850 mg are film-coated tablets of beige color, oval, biconvex, with a dividing line on one face and engraved with the inscription "2.5/850" on the other face. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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

Blister packs

Each package of Linagliptina/Metformina Pharos contains 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, and 120 tablets in aluminum blisters.

Linagliptina/Metformina Pharos is also available in multiple packages containing 120 tablets (comprising 2 packages, each with 60 tablets), 180 tablets (comprising 2 packages, each with 90 tablets or 3 packages, each with 60 tablets), and 200 tablets (comprising 2 packages, each with 100 tablets) in aluminum blisters or in single-dose pre-cut aluminum blisters.

Bottles

Linagliptina/Metformina Pharos 2.5 mg/850 mg and 2.5 mg/1,000 mg are also available in plastic bottles containing 60 or 180 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Pharmaceutical Oriented Services Ltd

Lesvou str. (end), Thesi Loggos Industrial Zone

GR14452 – Metamorfossi Attikis – Greece

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000, Malta

This medication is authorized in the member states of the European Economic Area under the following names:

Spain Linagliptina/Metformina Pharos 2.5 mg/850 mg film-coated tablets EFG

Linagliptina/Metformina Pharos 2.5 mg/1,000 mg film-coated tablets EFG

Hungary Linagliptin/Metformin HCl PharOS 2.5mg/500mg film tablet

Linagliptin/Metformin HCl PharOS 2.5mg/850mg film tablet

Linagliptin/Metformin HCl PharOS 2.5mg/1,000mg film tablet

Malta Linagliptin/Metformin HCl PharOS 2.5mg/500mg film-coated tablets

Linagliptin/Metformin HCl PharOS 2.5mg/850mg film-coated tablets

Linagliptin/Metformin HCl PharOS 2.5mg/1,000mg film-coated tablets

Portugal Metformina + Linagliptina PharOS

Date of the last revision of this prospectus:September 2024

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