Dapaglin M

Dapaglin M

Dapaglin M

Anti-Diabetes drugs

 

Properties:

• Dapaglin®- M contains two different substances called dapagliflozin and

  metformin. Both belong to a group of medicines called oral anti-diabetics.  

  These are medicines taken by mouth for diabetes.

• It is used for a type of diabetes called “type 2 diabetes” in adult patients (aged

  18 years and older) and usually occurs when you are older. If you have type 2

  diabetes, your pancreas does not make enough insulin or your body is not able

  to use the insulin it produces properly. This leads to a high level of sugar

  (glucose) in your blood.

• Dapagliflozin works by removing excess sugar from your body via your urine

  and lowers the amount of sugar in your blood. It can also help prevent heart

  disease

• Metformin works mainly by inhibiting glucose production in the liver

• Diabetes mellitus refers to a group of diseases that affect how your body uses

  blood sugar (glucose). Glucose is vital to your health because it is an important

  source of energy for the cells that make up your muscles and tissues. It is also

  your brain's main source of fuel.

• The underlying cause of diabetes varies by type. But, no matter what type of

  diabetes you have, it can lead to excess sugar in your blood. Too much sugar in

  your blood can lead to serious health problems.

• Chronic diabetes conditions include type 1 diabetes and type 2 diabetes.

Indecation

 

Indications:

  To treat diabetes:

• Dapaglin®- M is taken in combination with diet and exercise.

• Dapaglin®- M is used if your diabetes cannot be controlled with other

  medicines used to treat diabetes.

• Your doctor may ask you to take this medicine on its own or together with

  other medicines to treat diabetes. This may be another medicine taken by

  mouth and/or a medicine given by injection, such as insulin or a GLP-1

  receptor agonist (helps your body to increase the production of insulin when

  your blood sugar is high).

• If you are already taking both dapagliflozin and metformin as single tablets,

  your doctor may ask you to switch to this medicine. To avoid overdose, do not

  continue taking dapagliflozin and metformin tablets, if you are taking it

Dosage & Administration

 

Dosage and administration:

• The amount of Dapaglin®- M that you will take varies depending on your

  condition and the doses you currently take of metformin and/or individual

  tablets of dapagliflozin and metformin. Your doctor will tell you exactly which

  strength of this medicine to take

• The recommended dose is one tablet twice a day

Taking this medicine

• Swallow the tablet whole with half a glass of water

• Take your tablet with food. This is to reduce the risk of side effects in the

  stomach

• Take your tablet twice daily, once in the morning (breakfast) and once in the

  evening (dinner)

Composition:

* Each film-coated tablet of Dapaglin®- M contains:

   Dapagliflozin/Metformin        5 mg/850 mg

   Dapagliflozin/Metformin        5 mg/1000 mg

Contraindications:

  Do not use Dapaglin®- M

• If you are allergic to dapagliflozin, metformin or any of the other ingredients

  of this medicine

• If you have ever had a diabetic coma

• If you have uncontrolled diabetes, with, for example severe hyperglycemia,

  nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis

• If you have severely reduced kidney function

• If you have a severe infection

• If you have lost a lot of water from your body (dehydration), e.g. due to

  long-lasting or severe diarrhea, or if you have vomited several times in a row

• If you have recently had a heart attack or if you have heart failure or serious

  problems with your blood circulation or difficulties in breathing

• If you have problems with your liver

• If you drink large amounts of alcohol, either every day or only from time to

  time

 

Drug interactions:

 Tell your doctor if you are taking, have recently taken or might take any

  other medicines:

• If you are taking medicines which increase urine production (diuretics). Your

  doctor may ask you to stop taking this medicine

• If you are taking other medicines that lower the amount of sugar in your blood

  such as insulin or a “sulphonyl urea” medicine. Your doctor may want to lower

  the dose of these other medicines, to prevent you from getting blood sugar

  levels that are too low (hypoglycemia)

• If you are taking cimetidine, a medicine used to treat stomach problems

• If you are using bronchodilators (beta-2 agonists) which are used to treat

  asthma

• If you are using corticosteroids that are given by mouth, as an injection, or

  inhaled

• If you are using medicines used to treat pain and inflammation

• If you are using certain medicines for the treatment of high blood pressure

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. You should stop taking this medicine if you become pregnant,

  since it is not recommended during the second and third trimesters (the last six

  months) of pregnancy. Talk to your doctor about the best way to control your

  blood sugar while you are pregnant.

• Talk to your doctor if you would like to or are breastfeeding before taking this

  medicine. You should not use this medicine if you are breast-feeding.

  Metformin passes into human milk in small amounts. It is not known if  

  dapagliflozin passes into human breast milk.

  Driving and using machines

  This medicine has no or negligible influence on the ability to drive and use

  machines.

 

Adverse reactions:

Common side effects (may affect up to 1 in 10 people)

• nausea, vomiting

• diarrhea or stomach ache

• loss of appetite.

  Uncommon side effects (may affect up to 1 in 100 people)

• thirst.

• constipation.

• awakening from sleep at night to pass urine.

• dry mouth.

• weight decreased.

• increases in creatinine (shown in laboratory blood tests) in the beginning of

  treatment

• increases in urea (shown in laboratory blood tests).

  Rare side effects (may affect less than 1 in 1000 people)

• decreased vitamin B12 levels in the blood.

• abnormalities in liver function tests, inflammation of the liver (hepatitis)

• redness of the skin (erythema), itching or an itchy rash (hives)

  this include any possible side effects not listed in this leaflet. you can report

  side effect directly via the: http\\www.modernpharmaye.com\adrs.pdf. and send

  to us on: adrs@modernpharmaye.com

 

Warnings and precautions:

  Talk to your doctor, pharmacist or nurse before taking Dapaglin®- M and

  during treatment:

• if you have “type 1 diabetes” – the type that usually starts when you are young,

  and your body does not produce any insulin. It should not be used to treat this

  condition

• if you experience rapid weight loss, feeling sick or being sick, stomach pain,

  excessive thirst, fast and deep breathing, confusion, unusual sleepiness or

  tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth,

  or a different odor to your urine or sweat, contact a doctor or the nearest

  hospital straight away

• if you have problems with your kidneys. Your doctor will check your kidney

  function.

• If you have very high levels of glucose in your blood, which may make you

  dehydrated (lose too much body fluid).

  Tell your doctor before you start taking this medicine if you have any of

 

Packaging:

• Dapaglin®- M 5/ 850    Tablets (Blister of 5 Tablets, Pack of 6 blisters)

• Dapaglin®- M 5/ 1000  Tablets (Blister of 5 Tablets, Pack of 6 blisters)

Storage:

• Store in a dry place at a temperature  not exceeding 25 ºC.

• Keep out of the reach of children.