Zyloric

• Medicine to treat gout
• Take tablet with food
• Drink sufficient fluids (2-3 litres a day)
• Not to be used while breastfeeding
• Only if advised by a doctor during pregnancy

Zyloric tablets contain a medicine called allopurinol. Zyloric is used to treat gout and other conditions associated with an excess of uric acid in the body, including kidney stones.

Gout is an acute inflammatory condition in the joints. Although gout attacks can occur in any joint in the body, the disease has a preference for the big toe. The inflammation causes the skin around certain joints to become sore, swollen and red. In gout, uric acid builds up in your joints and tendons as crystals. Zyloric is used to reduce or prevent the formation of urate/uric acid deposition. This helps reduce the frequency of gout attacks.

The tablets should be swallowed whole, preferably with a glass of water. Take your tablet after food. Make sure you drink sufficiently (2-3 litres a day) while taking this medicine.

Do not start taking Zyloric during an acute attack of gout.

During the first months of treatment the frequency of gout flares may increase. To prevent this, your doctor may prescribe an anti-inflammatory medicine or colchicine during this period.

Dosage

Zyloric available in tablets of 100 mg, 200 mg and 300 mg. Depending on your symptoms, your doctor will prescribe the tablet strength that is appropriate for you. General guidelines for use in adults:

• The recommended starting dose is 100 to 300 mg per day.

Your dose of allopurinol may be adjusted if necessary, depending on the severity of your condition. The maintenance dose is:

• For mild symptoms: 100-200 mg/day
• For moderate symptoms: 300-600 mg/day.
• For severe symptoms: 700-900 mg/day.

In children or patients with a reduced kidney function, the doctor may prescribe a different dose.

Note: If you develop a rash or skin symptoms, stop taking allopurinol and contact your doctor immediately. Your doctor may start with a low dose of allopurinol (e.g., 50 mg/day) after these mild symptoms subside. The dose may be increased gradually while monitoring you for skin reactions and other possible side effects. If the rash returns, then you should stop taking allopurinol due to the risk of more severe hypersensitivity reactions (see also section 'Side effects' in the package leaflet).

Alcohol/driving

This medicine does not interact with alcohol.

You may feel drowsy, giddy or have problems with your coordination. If this happens, do NOT drive or use any tools or machines, or perform other potentially dangerous activities.

Taken too much/forgot to take/stop taking Zyloric

If you (or someone else) swallow a lot of the tablets at the same time, or you think a child may have swallowed some, contact your nearest hospital casualty department or tell your doctor immediately.

If you have forgotten to take a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. Do NOT take a double dose to make up for a forgotten dose. Take your remaining doses at the usual time.

Do not stop using Zyloric without talking to a doctor first.

Do not use Zyloric you are allergic to the active substance allopurinol or to any of the ingredients in this medicine (see section 'What Zyloric contains').

When should this medicine be used with caution?

Talk to your doctor before taking this medicine if:

• You have problems with your liver or kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely.
• You have heart problems or high blood pressure and you take diuretics and/or a medicine called ACE-inhibitors.
• You are currently having an attack of gout. Treatment with Zyloric should not be started until an acute attack of gout has completely subsided.
• You are of Han Chinese, African or Indian origin.
• You have thyroid problems.
• Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking allopurinol (see the package leaflet for more information). If you develop a rash or skin symptoms, stop using allopurinol and contact your doctor immediately.
• If you have cancer or Lesch-Nyhan syndrome the amount of uric acid may increase in your urine. To prevent this, you need to assure you drink sufficiently to dilute your urine.
• In case you have kidney stones, the kidney stones will become smaller and may
• enter your urinary tract.

If you are unsure if any of the above applies to you, ask your doctor or pharmacist for advice before using allopurinol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, are planning to have a baby or breastfeeding, talk to your doctor before using this medicine.

Zyloric is not recommended unless the benefits outweigh the potential risks for your unborn child.

Allopurinol is excreted in the human breast milk. Allopurinol during breastfeeding is not recommended.

Other medicines and Zyloric

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

Tell your doctor or pharmacist if you are taking any of the following:

• 6-mercaptopurine.
• Azathiopine, ciclosporin. Please note: ciclosporin side effects occur more frequently.
• Vidarabine. Please note: vidarabine side effects occur more frequently. Take special care if these occur.
• Salicylates (e.g., aspirin).
• Pobenecid.
• Clorpropamide. Chlorpropamide dose reduction may be necessary, particularly in patients with reduced kidney function.
• Warfarin, phenprocoumon, acenocoumarol. Your doctor will monitor your blood clotting values more frequently and if necessary, reduce the dose of these medicines.
• Phenytoin.
• Theophylline. Your doctor will measure theophylline blood levels, particularly when treatment with Zyloric begins, or following any dose changes.
• Ampicillin or amoxicillin. Patients should receive other antibiotics where possible, as allergic reactions are more likely to occur.
• Didanosine.
• Medicines for heart problems or high blood pressure such as ACE inhibitors or water tablets (diuretics).

If aluminium hydroxide is taken concomitantly, allopurinol may have an attenuated effect. There should be an interval of at least three hours between taking both medicines.

For more information, see the package leaflet.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Serious side effects

If you have an allergic reaction, stop taking Zyloric and see a doctor straight away. See the package leaflet for a list of signs of an allergic reaction.

Other side effects

If you experience any of the following, stop your tablets and tell your doctor immediately:

Common (may affect up to 1 in 10 people)

• Skin rash.
• Increased level of thyroid stimulating hormone in the blood.

Uncommon (may affect up to 1 in 100 people)

• Gastrointestinal symptoms (nausea, diarrhoea, stomach ache).
• Abnormal liver tests.

Rare (may affect up to 1 in 1,000 people)

• Liver problems such as liver inflammation.
• Kidney stones (urolithiasis).

For a list of very rare side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

The active substance is allopurinol.

• Each 100-mg tablet of Zyloric 100 mg of allopurinol.
• Each 200-mg tablet of Zyloric 200 mg of allopurinol.
• Each 300-mg tablet of Zyloric 300 mg of allopurinol.

The other ingredients are: lactose monohydrate, maize starch, povidone (E1201) and magnesium stearate (E470B).

The manufacturer of Zyloric is:

Aspen Bad Oldesloe,

Industriestrasse 32-36

D-23843 Bad Oldesloe

Germany

Read the package leaflet before use.