SITAGLIPTINA 100 mg Film-Coated Tablets
How to use SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Sitagliptina Alter 25 mg film-coated tablets EFG
Sitagliptina Alter 50 mg film-coated tablets EFG
Sitagliptina Alter 100 mg film-coated tablets EFG
Sitagliptina
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
- What is Sitagliptina Alter and what is it used for
- What you need to know before you take Sitagliptina Alter
- How to take Sitagliptina Alter
- Possible side effects
- Storage of Sitagliptina Alter
Contents of the pack and other information
1. What is Sitagliptina Alter and what is it used for
Sitagliptina Alter 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 to increase the amount of insulin produced after a meal and decreases the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, along with your diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a disease where your body does not produce enough insulin, and the insulin it 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 amputation.
2. What you need to know before you take Sitagliptina Alter
Do not take Sitagliptina Alter
- if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take sitagliptin.
There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin (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 this medicine.
Tell your doctor if you have or have had:
- a pancreatic disease (such as pancreatitis)
- gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
- any kidney problem you have now or have had 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 work when blood sugar levels are low. However, when this medicine is used in combination with a medicine that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.
Children and adolescents
Children and adolescents under 18 years of age should not use this medicine. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Other medicines and Sitagliptina Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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). Your doctor may need to check your digoxin levels if you are taking sitagliptin.
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.
This medicine should not be taken during pregnancy.
It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.
Driving and using machines
The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar, which may affect your ability to drive or use machines or work without a safe support.
3. How to take Sitagliptina Alter
Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
- one 100 mg film-coated tablet
- once a day
- by mouth
If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).
You can take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.
Diet and exercise can help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking sitagliptina.
If you take more Sitagliptina Alter than you should
If you take more of this medicine than you should, contact your doctor immediately.
In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.
If you forget to take Sitagliptina Alter
If you forget a dose, take it as soon as you remember. If you do not remember until the time for the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for forgotten doses.
If you stop taking Sitagliptina Alter
Keep taking this medicine while your doctor tells you to, so it can continue to help control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking sitagliptin and contact a doctor immediatelyif you notice any of the following serious side effects:
- Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of pancreatitis.
If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/peeling of the skin, and swelling of the face, lips, tongue, and throat that may 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 change your medicine for diabetes treatment.
Some patients experienced the following side effects after adding sitagliptin to their treatment with metformin:
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, diarrhea, constipation, somnolence.
Some patients experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency classified as common).
Some patients experienced the following side 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 side effects while taking sitagliptin and pioglitazone: Common: flatulence, swelling of hands or feet
Some patients experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or feet
Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients experienced the following side effects while taking sitagliptin alone during clinical trials or after approval, alone and/or with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg
Uncommon: dizziness, constipation, itching
Rare: reduced 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)
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Sitagliptina Alter
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 after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should 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.
6. Contents of the pack and other information
Composition of Sitagliptina Alter
- The active substance is sitagliptin.
Sitagliptina Alter 25 mg: Each film-coated tablet contains 28.3423 mg of sitagliptin hydrochloride equivalent to 25 mg of sitagliptin.
Sitagliptina Alter 50 mg: Each film-coated tablet contains 56.685 mg of sitagliptin hydrochloride equivalent to 50 mg of sitagliptin.
Sitagliptina Alter 100 mg: Each film-coated tablet contains 113.370 mg of sitagliptin hydrochloride equivalent to 100 mg of sitagliptin.
- The other ingredients are: In the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, and sodium fumarate. The tablet coating contains: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), red iron oxide (E172) (25 mg and 100 mg), and yellow iron oxide (E172) (50 mg and 100 mg).
Appearance and packaging
Sitagliptina Alter 25 mg: Film-coated tablet, round, biconvex, pink.
Sitagliptina Alter 50 mg: Film-coated tablet, round, biconvex, light yellow.
Sitagliptina Alter 100 mg: Film-coated tablet, round, biconvex, beige.
PVC/PVDC-aluminum blisters.
Sitagliptina Alter 25 mg: Packs of 28 film-coated tablets.
Sitagliptina Alter 50 mg: Packs of 14, 28, 30, 56, 84, 90, and 98 film-coated tablets.
Sitagliptina Alter 100 mg: Packs of 14, 28, 30, 56, 84, 90, and 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Spain Sitagliptina Alter film-coated tablets EFG
France SITAGLIPTINE ALTER, film-coated tablet
Date of last revision of this leaflet:November 2018.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
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- Country of registration
- Dosage formTABLET, 100 mg
- ATC codeA10BH01
- Average pharmacy price26.52 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionCROSCARMELOSA SODICA (9.680 mg mg), FUMARATO DE ESTEARILO Y SODIO (14.080 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETSDosage form: TABLET, 100 mgActive substance: sitagliptinManufacturer: Laboratorios Alter S.A.Prescription requiredDosage form: TABLET, 25 mgActive substance: sitagliptinManufacturer: Laboratorios Alter S.A.Prescription requiredDosage form: TABLET, 50 mgActive substance: sitagliptinManufacturer: Laboratorios Alter S.A.Prescription required
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Frequently Asked Questions
Is a prescription required for SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS?
SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS?
The active ingredient in SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS is sitagliptin. This information helps identify medicines with the same composition but different brand names.
How much does SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS is around 26.52 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS?
SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS is manufactured by Laboratorios Alter S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
How to buy SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS in Spain?
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
What are the alternatives to SITAGLIPTIN ALTER 100 mg FILM-COATED TABLETS?
Other medicines with the same active substance (sitagliptin) include DISIT 100 mg FILM-COATED TABLETS, DISIT 25 mg FILM-COATED TABLETS, DISIT 50 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
