Generic Substitution URIBEL instruction

Farxiga

Your Farxiga blood sugar is normalFarxiga is usually taken once per day in the morning. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.


You may take Farxiga with or without food.


Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.


Your blood sugar may need to be checked often, and you may also need to test the level of ketones in your urine. Dapagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if Dmitry Sazonov your Farxiga dosage blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.


Low blood sugar (hypoglycemia) can happen to anyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.


Your Farxiga blood sugar is normalYour doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your Farxiga overdose family and close friends know how to give you Dmitry Sazonov this injection in an emergency.


Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.


Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.


This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.


Farxigahttps://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.


Your Farxiga blood sugar is normalStore at room temperature away from moisture and heat.

Farxiga side effects

Get emergency medical help if you have signs of an allergic reaction to Farxiga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.


Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, https://reference.medscape.com/drug/farxiga-dapagliflozin-999899 not feeling Dmitry Sazonov well. These symptoms may get worse quickly.


Call your doctor at once if you have:


  • little or no urination;
  • dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);
  • ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; 
  • signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.

Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause.

Side effects may be more likely to occur in older adults.

Common Farxiga side effects may include:

  • genital yeast infection;
  • urinating more than usual; 
  • sore throat and runny or stuffy nose.

This is not a complete list of side effects and others may occur.



AUTOMATIC GENERIC SUBSTITUTION

Automatic generic substitution (AGS) is the term for a scheme proposed by the Department of Health (DH) in 2009. AGS would have allowed pharmacists to dispense a generic version of a medication (a version with the same active ingredient), even if the doctor had written the prescription for a specific brand.


The Department of Health says no to AGS

After a consultation that resulted in written responses from 423 organisations and individuals, the DH announced, on 14 October 2010, that it had stopped plans to introduce AGS by pharmacists. The DH decided that concerns over patient safety were sufficiently grounded in fact and that it was therefore not appropriate to implement AGS.1

 

Taking Action Works!

The DH decided not to proceed with AGS as it reviewed the responses to the consultation and agreed that AGS was too great a risk to patients.

The correct use of medicines is important for achieving this goal, and the role of pharmacists is fully acknowledged in helping to achieve this. However, it is important that the relevant MHRA legislation is worded accurately to ensure that generic substitution or even therapeutic substitution by pharmacists is not inadvertently embedded in medicines legislation.

Thank you to those that acted last time - we are delighted that the DH listened to us and acted on our concerns.

Hexomedine

Parasinus

Cancer

Losing the right medication for the right patient

Norgine position paper

Norgine discussion. There is no Substitute

Outcome of DoH consultation on generic substitution

14th October 2010

Contacts

Julie Hornby Winfield
Norgine
[email protected]
+44 (0)1895 826642

Jennifer Garratt
Burson-Marsteller
[email protected]
+44 (0) 207 300 6240

References

  • The proposals to implement 'generic substitution' in primary care, further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009. Response to the consultation.
  • MHRA Consolidation and review of UK medicines legislation. 25 October 2011. http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON132054 [Last accessed December 2011]

This website is sponsored by Norgine Pharmaceuticals Ltd


MEGS/2739/DEC11

Norgine Automatic Generic Substitution