Patient leaflet - Alogliptin 25 mg film-coated tablets

1. WHAT ALOGLIPTIN IS AND WHAT IT IS USED FOR

Alogliptin contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti- diabetics”. It is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM.

Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body. It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.

Alogliptin is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines. It is important that you continue to take your other anti-diabetic medicine and continue to follow the advice on diet and exercise that your nurse or doctor has given you.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALOGLIPTIN

Do not take Alogliptin

if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6)
if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar. Symptoms of a serious allergic reaction may include rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).

Warnings and precautions

Talk to your doctor or pharmacist before taking Alogliptin :

if you have type 1 diabetes (your body does not produce insulin)
if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss
if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with
Alogliptin in order to avoid too low blood sugar (hypoglycaemia).
if you have kidney disease, you can still take this medicine, but your doctor may reduce the dose
if you have liver disease
if you suffer from heart failure
if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Alogliptin in order to avoid low blood sugar
if you have or have had a disease of the pancreas

Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop alogliptin.

Children and adolescents

Alogliptin is not recommended for children and

adolescents under 18 years due to the lack of data in these patients.

Other medicines and Alogliptin

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is no experience of using Alogliptin in pregnant women or during breast- feeding. Alogliptin should not be used during pregnancy or breast-feeding. Your doctor will help you to decide whether to continue breast-feeding or to continue using Alogliptin.

Driving and using machines

Alogliptin is not known to affect your ability to drive and use machines. Taking Alogliptin in combination with other anti-diabetic medicines called sulphonylureas, insulin or combination therapy with thiazolidinedione plus metformin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.

Alogliptin 6.25 mg, 12.5 mg and 25 mg film coated tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Alogliptin 12.5 mg and 25 mg film coated tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Alogliptin 6.25 mg and 25 mg film coated tablets contains Allura Red AC Aluminum Lake, (E129)

It may cause allergic reaction.

3. HOW TO TAKE ALOGLIPTIN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will prescribe Alogliptin together with one or more other medicines to control your blood sugar levels. Your doctor will tell you if you need to change the amount of other medicines you take.

The recommended dose is 25 mg once a day

Patients with kidney disease

If you have kidney disease your doctor may prescribe you a reduced dose. This may be 6.25 mg or 12.5 mg once a day, depending on the severity of your kidney disease.

Patients with liver disease

If you have mildly or moderately reduced liver function, the recommended dose of Alogliptin is 25 mg once a day. This medicine is not recommended for patients with severely reduced liver function due to the lack of data in these patients.

Swallow your tablet(s) whole with water. You can take this medicine with or without food.

If you take more Alogliptin than you should

If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away. Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.

If you forget to take Alogliptin

If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alogliptin

Do not stop taking Alogliptin without consulting your doctor first. Your blood sugar levels may increase when you stop taking Alogliptin .

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 Alogliptin and contact a doctor immediately if you notice any of the following serious side effects:

Not known (frequency cannot be estimated from the Package leaflet: Information for the patient Alogliptin 6.25 mg film- coated tablets Alogliptin 12.5 mg film- coated tablets Alogliptin 25 mg film- coated tablets

alogliptin

continued available data):

An allergic reaction. The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.
A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

You should also discuss with your doctor if you experience the following side effects:

Common (may affect up to 1 in 10 people):

Symptoms of low blood sugar (hypoglycaemia) may occur when Alogliptin is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or feeling confused. Your blood sugar could fall below the normal level, but can be increased again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
- Cold like symptoms such as sore throat, stuffy or blocked nose.
- Rash
- Itchy skin
- Headache
- Stomach ache
- Diarrhoea
- Indigestion, heartburn.

Not known:

Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine or yellowing of your skin or the whites of your eyes.
Inflammation of the connective tissue within the kidneys (interstitial nephritis).
Blistering of the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALOGLIPTIN

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Alogliptin contains

The active substance is alogliptin.

Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin,

The other ingredients are Mannitol, Cellulose, microcrystalline, Hydroxypropylcellulose , Croscarmellose sodium ,Magnesium stearate, Ethanol , Opadry pink YS-1- 6820 composed of: Titanium Dioxide (E171) , HPMC 2910/ Hypromellose 6cP (E 464) Sodium Lauryl Sulphate , FD&C Red # 40/ Allura Red AC, Aluminum Lake(E129), Water purified.

Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin

The other ingredients are Mannitol, Cellulose, microcrystalline, Hydroxypropylcellulose, Croscarmellose sodium, Iron oxide yellow , Magnesium stearate, Ethanol , Opadry II yellow 31K32701 composed of: Titanium Dioxide (E171) , Lactose monohydrate , HPMC 2910/ Hypromellose 15Cp (E 464) Triacetin , Quinoline yellow Aluminum Lake (E104) , Iron oxide yellow (E172) , Water purified.

Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin

The other ingredients are Mannitol, Cellulose microcrystalline, Hydroxypropylcellulose, Croscarmellose sodium, Iron oxide red , Magnesium stearate, Ethanol, Opadry II pink 31K240003: Lactose monohydrate , HPMC 2910/ Hypromellose 15cP (E 464), Titanium Dioxide (E171) , Triacetin , FD&C Red # 40/ Allura Red AC, Aluminum Lake (E129), Water purified.

What Alogliptin looks like and contents of the pack

Alogliptin 6.25 mg film-coated tablets are Pink round biconvex film coated tablet with white core. Approximately 2.5 mm in thickness and 6.0 mm in diameter
Alogliptin 12.5 mg film-coated tablets are yellow round biconvex film coated tablet with pale yellow core. Approximately 3.80 mm in thickness and 7.00 mm in diameter
Alogliptin 25 mg film-coated tablets are Pink round biconvex film coated tablet with pale pink core. Approximately 4.1 mm in thickness and 10 mm in diameter
Alogliptin is available in ALU/ALU blisters, each containing 28 tablets inside a carton box with suitable dimensions and the patient information leaflet.

Marketing Authorisation Holder

Farmak Pharmaceuticals UK Ltd

First Floor, 47 Queen Street,

Hull, HU1 1UU,

United Kingdom

Manufacturer

Ascenders Consulting Services Limited

110 Butterfield,

Great Marlings,

Luton, LU2 8DL,