Sitagliptin Reddi

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

Sitagliptin
Read the package leaflet carefully before taking the medicine, as it contains important information for you.
This information is important 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 the Package Leaflet

• 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 sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high due to type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking for your diabetes, together with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not produce enough insulin, and the insulin that it does produce does not work properly. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and amputation.

2. Important information before taking Sitagliptin Reddy

When not to take Sitagliptin Reddy

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

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).
If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking sitagliptin.
Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. In these cases, the risk of pancreatitis (inflammation of the pancreas) 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, past or present;
• an allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when your blood sugar levels are low, it is unlikely to cause low blood sugar (hypoglycemia). However, if you take this medicine with a sulfonylurea or insulin, you may get low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Do not take this medicine if you are under 18 years old. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective in children under 10 years of age.

Sitagliptin Reddy with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeats and other heart conditions). When taking sitagliptin with digoxin, your doctor may check your digoxin levels in your blood.

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.
Do not take this medicine during pregnancy.
It is not known if this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you are planning to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.
However, when driving or using machines, consider that dizziness and drowsiness have been reported.

Sitagliptin Reddy contains sodium

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

3. How to take Sitagliptin Reddy

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is:

• one 100 mg film-coated tablet;
• once a day;
• taken by mouth.

If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (such as 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use blood sugar better. While taking sitagliptin, it is important to follow the diet and exercise program recommended by your doctor.

What to do if you take more Sitagliptin Reddy than you should

If you take more than the prescribed dose, contact your doctor immediately.

What to do if you miss a dose of Sitagliptin Reddy

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

What to do if you stop taking Sitagliptin Reddy

To keep your blood sugar levels under control, you should keep taking this medicine as long as your doctor tells you to. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, 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 Reddy and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
In some patients, when sitagliptin was taken in combination with metformin, the following side effects were reported (common): gastrointestinal symptoms
In some patients, when sitagliptin was taken in combination with a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
In some patients, when sitagliptin was taken with pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was taken with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was taken alone in clinical studies or when sitagliptin was taken with other anti-diabetic medicines after it was marketed:
Common: low blood sugar, headache, upper respiratory tract infections, sore throat, and pain in the bones or joints
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets in the blood
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

Reporting of side effects

If you get 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 via the national reporting system listed in the websiteor contact your local pharmacy.

5. How to store Sitagliptin Reddy

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 carton after “EXP”. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
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

What Sitagliptin Reddy contains

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

What Sitagliptin Reddy looks like and contents of the pack

Sitagliptin Reddy 25 mg film-coated tablets are white, round, film-coated tablets with “411” engraved on one side and plain on the other.
Sitagliptin Reddy 50 mg film-coated tablets are yellow, round, film-coated tablets with “417” engraved on one side and plain on the other.
Sitagliptin Reddy 100 mg film-coated tablets are brown, round, film-coated tablets with “471” engraved on one side and plain on the other.
Sitagliptin Reddy 25 mg film-coated tablets
Blister packs (OPA/Aluminium/PVC//Aluminium) of 28 film-coated tablets in a cardboard box.
Blister packs (PVC/Aclar//Aluminium) of 28 film-coated tablets in a cardboard box.
Sitagliptin Reddy 50 mg film-coated tablets
Blister packs (OPA/Aluminium/PVC//Aluminium) of 28 film-coated tablets in a cardboard box.
Blister packs (PVC/Aclar//Aluminium) of 28 film-coated tablets in a cardboard box.
Sitagliptin Reddy 100 mg film-coated tablets
Blister packs (OPA/Aluminium/PVC//Aluminium) of 28 or 98 film-coated tablets in a cardboard box.
Blister packs (PVC/Aclar//Aluminium) of 28 or 98 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Phone: +49 821 74881 0

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, 1 floor, sector 3
030138 Bucharest
Romania
DR. REDDY’S LABORATORIES ROMÂNIA SRL
ul. Nicolae Caramfil, nr 71 – 73, 1 floor, sector 1
014142 Bucharest
Romania

This medicine is authorised in the Member States of 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

Date of last revision of the package leaflet: