Adenuric (Febuxostat) 28 Film Tablets

Active ingredient
80 mg febuxostat.

Excipients
Lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, croscarmellose sodium, silica colloidal hydrate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

This medication is subject to additional monitoring. This triangle will enable fast identification of new safety information. You can help by reporting any side effects that occur. You can see the end of Chapter 4 to learn how to report side effects.
2. What is ADENURIC and what is it used for?

ADENURIC tablets contain the active ingredient febuxostat and are used in the treatment of gout, which is associated with the excessive presence of a chemical called uric acid (urate) in the body. In some people, uric acid accumulates in the blood and can reach levels that are too high to remain soluble. When this condition occurs, urate crystals can form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling in the joints (this is known as a gout attack). If left untreated, larger deposits called tophi can occur in and around joints. These tophi can cause joint and bone damage.

ADENURIC works by lowering uric acid levels. Using ADENURIC once a day helps to keep uric acid levels low, halt crystal accumulation and reduce symptoms over time. Keeping uric acid levels low enough over a long enough period can also cause tophi to shrink.
3. How to use ADENURIC?

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

The usual dose is one tablet per day. The days of the week are written on the back of the blister pack to help you check that you are taking a dose each day.

For Gout Treatment:

ADENURIC is available as 80 mg tablets or 120 mg tablets. Your doctor will have prescribed the dose best suited for you.

Continue to take ADENURIC every day when you do not have a gout flare or attack.
Application route and method

The tablets should be taken by mouth and can be taken with or without food.
Different age groups
Use in children

The safety and efficacy of this medicine in children under the age of 18 have not been established, so do not give the medicine to children under the age of 18.
Use in the elderly

Dose adjustment is not required in the elderly.

If you have an impression that the effect of ADENURIC is too strong or too weak, talk to your doctor or pharmacist.
If you use more ADENURIC than you should

In case of accidental overdose, ask your doctor what to do or contact the nearest accident and emergency department.

If you have used more than you should use from ADENURIC, talk to a doctor or pharmacist.
4. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in ADENURIC.

If the following side effects occur, which are rare (may affect up to 1 in 1000 people), stop taking this medicine and contact your doctor immediately or go to an emergency room near you, because these side effects may result in a severe allergic reaction:
Anaphylactic reactions, drug hypersensitivity (see also section 2 "Warnings and precautions")
Formation of blisters and rashes on the skin and inner surfaces of body cavities (e.g. mouth and reproductive organs), characterized by painful ulcers in the mouth and / or genitals accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome / Toxic Epidermal Necrolysis) or enlarged lymph nodes, liver enlargement, hepatitis (may lead to liver failure), characterized by an increase in the number of white blood cells in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS), skin rash that can be life-threatening (see section 2)
General skin rashes

Common side effects (may affect up to 1 in 10 people) are:
Abnormal liver test results
Diarrhea
Headache
Rash (including various types of rash; see below "uncommon side effects" and "rare side effects" sections)
Nausea
Increased gout symptoms
Regional swelling (edema) due to fluid retention in tissues

Other side effects not mentioned above are listed below.

Uncommon side effects (may affect up to 1 in 100 people) are:
Decreased appetite, changes in blood sugar levels (diabetes) (in such cases excessive thirst), increased blood fat levels, weight gain
Loss of sex drive
Difficulty sleeping, sleepiness
Dizziness, numbness, tingling, decreased or altered sensation (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)