Sitagliptin Almus 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptin Almus 50 mg film-coated tablets EFG

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 symptoms 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 this leaflet

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

1. What Sitagliptina Almus is and what it is used for

Sitagliptina Almus contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking for your diabetes, along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body does produce 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 amputation.

2. What you need to know before taking Sitagliptina Almus

Do not take Sitagliptina Almus

If you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptina Almus (see section 4).

If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Inform your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication causing high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems currently or in the past
• an allergic reaction to sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar because it does not act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Almus

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). It may be necessary to monitor digoxin levels in your blood if you are taking sitagliptin.

Taking Sitagliptina Almus with food and drink

Sitagliptina Almus can be taken with or without food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take this medicine during pregnancy.

It is unknown whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

The effect of this medicine on the ability to drive or use machines is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptina Almus contains sodium

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

3. How to take Sitagliptin Almus

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• orally

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).

You may take this medicine with or without food and drinks.

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

Diet and exercise can help the body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking Sitagliptin Almus.

If you take more Sitagliptin Almus than you should

If you take more of this medicine than prescribed, contact your doctor immediately.

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

If you forget to take Sitagliptin Almus

If you forget a dose, take it as soon as you remember. If you do not remember until the time for your next dose, then skip the missed dose and continue with your regular dosing schedule.

Do not take a double dose of this medicine.

If you stop treatment with Sitagliptin Almus

Keep taking this medicine for as long as your doctor continues to prescribe it, so that it can continue helping control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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 may cause adverse effects, although not everyone experiences them.

STOP taking Sitagliptin Almus and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will change your diabetes treatment.

Some patients experienced the following adverse effects when sitagliptin was added to metformin treatment:

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

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

Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together (classified as common frequency).

Some patients experienced the following adverse effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar

Common: constipation.

Some patients experienced the following adverse effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or legs.

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or legs.

Some patients experienced the following adverse effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: influenza-like illness.

Uncommon: dry mouth.

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during post-marketing use alone and/or in combination with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in the arm or leg.

Uncommon: dizziness, constipation, itching.

Rare: reduction in platelet count.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Sitagliptin Almus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister, and bottle, after "EXP". The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original container to protect from moisture.

Do not use this medicine if you notice changes in the appearance of the tablet or if the packaging shows signs of tampering or deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Keep the medicine in its original packaging until the time of use.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Almus 50 mg film-coated tablets EFG

• The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptine hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
• The other components (excipients) are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium croscarmellose (E468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E470b)

Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).

Nature and content of the container

Round, light beige film-coated tablets with an "S" engraved on one side.

Opaque blisters (PVC/PE/PVDC and aluminium). Pack sizes of 14, 28, 30 and 56 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36,

28750 San Agustín de Guadalix (Madrid)

Spain

Galenicum Health, S.L.

Avda. Cornellá 144, 7th floor, 1st office, Edificio Lekla

08950 Esplugues de Llobregat (Barcelona)

Spain

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

Malta: Sitagliptin Diagonalis 50 mg film-coated tablets

Germany: Sitagliptin Diagonalis 50 mg Filmtabletten

Portugal: Sitagliptina Diagonalis

Netherlands: Sitagliptine Diagonalis 50 mg filmomhulde tabletten

Italy: Sitagliptin Diagonalis

Poland: Sitagliptin Diagonalis

France: Sitagliptine Almus 50 mg, comprimé pelliculé

Date of the most recent revision of this leaflet: April 2022

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