What Galvus is used for

Galvus is used to lower blood sugar levels in patients with type 2 diabetes mellitus in combination with
certain other medicines (metformin, or a sulfonylurea medicine, or pioglitazone, or metformin and a
sulfonylurea, or insulin injections), when diet plus exercise plus the single or dual medicines do not
provide adequate blood sugar level control.
Type 2 diabetes mellitus
Type 2 diabetes develops if the body does not produce enough insulin, or where the insulin that your
body makes does not work as well as it should. It can also develop if the body produces too much
glucagon.
Insulin is a substance which helps to lower the level of sugar in your blood, especially after meals.
Glucagon is another substance which triggers the production of sugar by the liver, causing the blood
sugar to rise. The pancreas makes both of these substances.
Galvus is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.
Your doctor will prescribe Galvus in combination with other antidiabetic medicines if that medicine or
medicines do not sufficiently control your blood sugar level.
It is important that you continue to follow the diet and/or exercise recommended for you whilst you are
on treatment with Galvus.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend this medicine for children.
Before you take Galvus
When you must not take it
Do not take Galvus if you have an allergy to:
vildagliptin (the active ingredient) or to any of the other ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath;
wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body;
rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering.
In that case, return it to your pharmacist.
Before you start to take it
Tell your doctor if:
you have allergies to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits involved.
you are breast-feeding or plan to breast-feed.
It is not known if the active ingredient of Galvus passes into breast milk and could affect your baby.
you have any of the following medical conditions:
problems with your kidneys
problems with your liver
heart failure
type 1 diabetes (formerly called 'juvenile onset' or 'insulin-dependent' diabetes mellitus or 'IDDM'),
where the body does not produce any insulin

diabetic ketoacidosis, a condition where chemicals called ketones build up in the body due to very low
insulin levels.
Galvus is not a substitute for insulin. You should therefore not receive Galvus for the treatment of type 1
diabetes or diabetic ketoacidosis.
If you are not sure whether any of the above conditions apply to you, your doctor can advise you.
How Does Aspirin Benefit the Heart?
Aspirin benefits the heart in several ways:
Decreases inflammation. Inflammation is a component of plaque build-up and inflamed plaque
is more likely to cause a heart attack or stroke. Aspirin fights the inflammation associated with
heart disease by blocking the action of an enzyme called cyclooxygenase. When this enzyme is
blocked, the body is less able to produce prostaglandins, which are chemicals that (among
other functions) facilitate the inflammatory response.
Inhibits blood clots. Some prostaglandins in the blood trigger a series of events that cause
blood platelets to clump together and form blood clots. Thus, when aspirin inhibits
prostaglandins, it inhibits the formation of blood clots as well. Blood clots are harmful because
they can clog the arteries supplying the heart muscle and brain, increasing the risk of heart
attack and stroke. Aspirin has been shown to reduce the risk of heart attack and stroke and
reduce the short-term risk of death among people suffering from heart attacks.
Reduces the risk of death. Research has shown that regular aspirin use is associated with a
reduction in death from all causes, particularly among the elderly, people with heart disease,
and people who are physically unfit.
What Is Cyclooxygenase (COX)?
Cyclooxygenase (COX) is an enzyme that is responsible for the formation of prostanoids. The three main
groups of prostanoids -- prostaglandins, prostacyclins, and thromboxanes -- are each involved in
the inflammatory response.
Two Forms of Cyclooxygenase (COX)
In the 1990s, researchers discovered that two different COX enzymes existed, now known as COX-1 and
COX-2. Cyclooxygenase-1 (COX-1) is known to be present in most tissues. In the gastrointestinal tract,
COX-1 maintains the normal lining of the stomach. The enzyme is also involved in kidney and platelet
function. Cyclooxygenase-2 (COX-2) is primarily present at sites of inflammation.
While both COX-1 and COX-2 convert arachidonic acid to prostaglandin, resulting in pain and
inflammation, their other functions make inhibition of COX-1 undesirable while inhibiton of COX-2 is
considered desirable.
NSAIDs Inhibit COX
Nonsteroidal anti-inflammatory drugs (NSAIDs), commonly prescribed to treat arthritis, work by
inhibiting prostaglandins. Traditional NSAIDs (ibuprofen, naproxen), however, can cause gastrointestinal
problems including ulcers.
Traditional NSAIDs are considered "nonselective" because they inhibit both COX-1 and COX-2. The
inhibition of COX-2 by traditional NSAIDs accounts for the anti-inflammatory effect of the drugs while
the inhibition of COX-1 can lead to NSAID toxicity and associated side effects (ulcers, prolonged bleedng
time, kidney problems).
COX-2 Selective NSAIDs
In the late 1990s, the first COX-2 selective NSAID (Celebrex) was developed, and others soon followed.
Theoretically, drugs which were developed as COX-2 selective inhibitors -- Celebrex, Vioxx, and Bextra -should have been preferred over traditional NSAIDs.
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Vioxx and Bextra have since been removed from the market, and Celebrex remains the only available
COX-2 inhibitor available in the United States. Since the withdrawal of Vioxx, due to an increased risk of
heart attack and stroke, the FDA scrutinized the entire class of drugs (all NSAIDs and COX-2 inhibitors,
sold over-the-counter or by prescription only) and added warnings to the prescribing instructions.
Two other COX-2 inhibitors in development, Arcoxia and Prexige, have so far been rejected by the FDA.
Prexige has also been removed from the market in Australia and Canada due to related liver
complications.
Some researchers believe, after finding low levels of COX-2 in some non-inflamed tissue, that COX-2 may
also play a role in certain normal functions of the body other than inflammation. While NSAIDs and COX2 inhibitors are considered significant treatment options for arthritis patients, the benefit and risks must
be considered for each individual patient.