Adenuric

Before taking Adenuric

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken.

For these reasons, before you start taking febuxostat it is important that your doctor or pharmacist knows:

• If you are pregnant, trying for a baby or breast-feeding.
• If you have any problems with your heart, such as heart disease or heart failure.
• If you have any problems with your thyroid, liver or kidneys.
• If you have ever had an organ transplant. (This is because there is no experience of febuxostat in transplant patients.)
• If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• If you have ever had an allergic reaction to any medicine.

How do I take Adenuric?

• Treatment with Adenuric should not be started during an acute attack of gout, as it could initially worsen the attack. It should not be started until the attack has completely subsided.
• When you first start treatment your doctor should normally prescribe you a suitable anti-inflammatory medicine, or colchicine, for at least the first six months of treatment, as febuxostat may cause an attack of gout in the early stages of treatment. If you do get a new attack of gout after you have started treatment with Adenuric you should keep taking it while the attack is treated with a suitable anti-inflammatory medicine. This is because the Adenuric will still be working to lower uric acid. Over time, your attacks will become less frequent and less painful as long as you continue to take the Adenuric every day.
• Adenuric tablets should be taken once a day, preferably at the same time each day.
• The tablets should be swallowed with a drink and can be taken either with or without food.
• If you forget to take a dose just take your next dose as usual. Don't take a double dose to make up for a missed dose.

Use with caution in

• People with reduced kidney function.
• People with reduced liver function.
• People with an overactive or underactive thyroid gland.
• People taking theophylline.
• People with a history of allergic reactions to allopurinol (Zyloric).

Not to be used in

• Pregnancy.
• Breastfeeding.
• People taking the medicines mercaptopurine or azathioprine.
• People with heart failure or ischaemic heart disease, eg angina or a history of heart attack.
• There is insufficient information regarding the safety and effectiveness of this medicine in people who have had an organ transplant. It is not recommended for people who have had an organ transplant.
• This medicine is not recommended for people being treated for high uric acid levels as a result of cancer or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood).
• There is insufficient information regarding the safety and effectiveness of this medicine in children. Adenuric tablets are not recommended for children or adolescents.
• Adenuric tablets contain lactose and are unsuitable for people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Diarrhoea.
• Nausea.
• Rash.
• Alteration in results of liver function tests.
• Gout flares.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Dizziness.
• Sleepiness.
• Difficulty sleeping (insomnia).
• Fatigue.
• Pins and needles or numb sensations.
• Reduced sense of smell.
• Changes in taste.
• Dry mouth.
• Disturbances of the gut such as vomiting, abdominal pain or bloating, indigestion, heartburn, constipation, flatulence (wind).
• Pain or inflammation in the joints.
• Muscle spasms, weakness, tightness or pain.
• Weakness on one side of the body.
• Skin reactions, such as dermatitis, hive-like rash, itching, skin discolouration.
• Decreased appetite.
• Increased weight.
• Increased levels of fats such as cholesterol or triglycerides in the blood (hyperlipidaemia).
• Diabetes.
• Kidney stones (nephrolithiasis).
• Kidney failure.
• Increased urine production, blood in the urine.
• Gallstones.
• High blood pressure.
• Irregular heartbeat (atrial fibrillation) or awareness of your heartbeat (palpitations).
• Chest pain.
• Hot flushes.
• Shortness of breath, cough.
• Decreased sex drive, erectile dysfunction.
• Increased levels of thyroid stimulating hormone.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Blurred vision.
• Mouth ulcers.
• Hair loss.
• Excessive sweating.
• Feeling thirsty.
• Weight loss.
• Increased appetite or loss of appetite.
• Sensation of ringing or other noise in the ears (tinnitus).
• Nervousness.
• Severe allergic reactions, including anaphylaxis and severe skin reactions.
• Decreased numbers of platelets in the blood (thrombocytopenia).
• Inflammation of the pancreas (pancreatitis).
• Jaundice or inflammation of the liver (hepatitis).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

• It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
• Adenuric increases the effects of azathioprine and mercaptopurine. This medicine should not be used in combination with azathioprine or mercaptopurine.
• Adenuric may increase the blood level of theophylline. If you are taking theophylline your doctor should check your theophylline blood level after you start treatment with this medicine.

How to store Adenuric

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children

Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.patient.co.uk/medicine/Febuxostat.htm

http://www.netdoctor.co.uk/aches-and-pains/medicines/adenuric.html

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000777/WC500021812.pdf

http://www.medicines.ie/medicine/14607/SPC/Adenuric+film-coated+tablets/

http://www.nhs.uk/medicine-guides/pages/selectorshow.aspx?medicine=Adenuric

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON155758