Sitagliptin reddy

Package leaflet: Information for the patient

Sitagliptin Reddy, 25 mg, film-coated tablets
Sitagliptin Reddy, 50 mg, film-coated tablets
Sitagliptin Reddy, 100 mg, film-coated tablets
Sitagliptinum
Please read this leaflet carefully before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What is Sitagliptin Reddy and what is it used for

Sitagliptin Reddy film-coated tablets contain the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2 diabetes. This medicine may be used alone or in combination with other glucose-lowering medicines (such as insulin, metformin, sulfonylurea derivatives, or glitazones) that you may already be taking, along with diet and an exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or the body produces too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Sitagliptin Reddy

When not to use Sitagliptin Reddy

• if the patient is allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of pancreatitis (see section 4) have been reported in patients taking sitagliptin.
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid.
The doctor may advise the patient to stop taking sitagliptin.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• allergic reaction to sitagliptin (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is used together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea or insulin.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Sitagliptin Reddy with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when sitagliptin is taken concomitantly with digoxin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. This medicine should not be used during breastfeeding or when breastfeeding is planned.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery.
Nevertheless, when driving and operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without safe foot support.
Sitagliptin Reddy contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Sitagliptin Reddy

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has impaired kidney function, the doctor may prescribe a lower dose of sitagliptin (e.g. 25 mg or 50 mg).

This medicine can be taken regardless of meals or drinks.

Your doctor may recommend taking only this medicine or this medicine together with certain other medicines that lower blood sugar levels.

Diet and physical exercise help the body to use sugar in the blood more effectively. While taking sitagliptin, it is important to follow the diet and perform the physical activities recommended by your doctor.

Taking more Sitagliptin Reddy than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.

Missing a dose of Sitagliptin Reddy
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping Sitagliptin Reddy
To maintain control of blood sugar levels, this medicine should be taken for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should DISCONTINUE Sitagliptin Reddy and contact your doctor immediately if any of the following severe adverse reactions occur:

• Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with the medicine should be stopped and immediate medical advice sought. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine for the treatment of diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:
Common (may occur in up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

The following adverse reactions have been reported in some patients treated with sitagliptin in combination with a sulfonylurea and metformin:
Very common (may occur in more than 1 in 10 people): low blood sugar levels
Common: constipation

The following adverse reactions have been reported in some patients treated with sitagliptin and pioglitazone:
Common: bloating, swelling of hands or feet

The following adverse reactions have been reported in some patients treated with sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or feet

The following adverse reactions have been reported in some patients treated with sitagliptin in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth

The following adverse reactions have been reported in some patients treated with sitagliptin alone in clinical trials or during post-marketing use of sitagliptin alone and (or) in combination with other antidiabetic medicines:
Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, bone and joint inflammation, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sitagliptin Reddy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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.

6. Contents of the Packaging and Other Information

What Sitagliptin Reddy Contains
The active substance is sitagliptin. Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
The other ingredients are:
In the tablet core:
Microcrystalline cellulose PH 101
Sodium croscarmellose
Povidone K-30
Calcium hydrogen phosphate
Magnesium stearate
The tablet coating contains:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide red (E172) (only in 100 mg)
Iron oxide yellow (E172) (only in 50 mg and 100 mg)

What Sitagliptin Reddy Looks Like and Contents of the Packaging
Sitagliptin Reddy 25 mg, coated tablets are white, round, film-coated tablets with the inscription "411" on one side and smooth on the other.
Sitagliptin Reddy 50 mg, coated tablets are yellow, round, film-coated tablets with the inscription "417" on one side and smooth on the other.
Sitagliptin Reddy 100 mg, coated tablets are brown, round, film-coated tablets with the inscription "471" on one side and smooth on the other.

Sitagliptin Reddy 25 mg, coated tablets
OPA/Aluminum/PVC//Aluminum foil blisters: Pack containing 28 coated tablets in a cardboard box.
PVC/Aclar//Aluminum foil blisters: Pack containing 28 coated tablets in a cardboard box.

Sitagliptin Reddy 50 mg, coated tablets
OPA/Aluminum/PVC//Aluminum foil blisters: Pack containing 28 coated tablets in a cardboard box.
PVC/Aclar//Aluminum foil blisters: Pack containing 28 coated tablets in a cardboard box.

Sitagliptin Reddy 100 mg, coated tablets
OPA/Aluminum/PVC//Aluminum foil blisters: Pack containing 28 or 98 coated tablets in a cardboard box.
PVC/Aclar//Aluminum foil blisters: Pack containing 28 or 98 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Importer/Manufacturer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
SC Rual Laboratories SRL
Splaiul Unirii nr 313, Building H, 1st floor, sector 3
030138 Bucharest
Romania
DR. REDDY’S LABORATORIES ROMÂNIA SRL
Nicolae Caramfil Street, No. 71–73, 1st floor, sector 1
014142 Bucharest
Romania

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Sitagliptin Reddy
Spain: Sitagliptina Dr. Reddys 25 mg, 50 mg, 100 mg comprimidos recubiertos con película EFG
Netherlands: Sitagliptine Reddy 25 mg, 50 mg, 100 mg filmomhulde tabletten
Germany: Sitagliptin beta 25 mg, 50 mg, 100 mg Filmtabletten
Poland: Sitagliptin Reddy
Czech Republic: Sitagliptin Reddy
Romania: Sitagliptin Dr. Reddy’s 100 mg comprimate filmate
Sweden: Sitagliptin Reddy 25 mg, 50 mg, 100 mg filmdragerade tabletter