Allopurinol tablets 300 mg, Uricto 300 mg tablets – patient leaflet, side effects, dosage

1. What Uricto Tablets are and what they are used for

! If you have any further questions, ask your

doctor or pharmacist or nurse.

2. What you need to know before you take Uricto Tablets

What is in this leaflet:

1. 3. How to take Uricto Tablets
2. 4. Possible side effects
3. 6. Contents of the pack and other information
4. 1. WHAT URICTO TABLETS ARE AND WHAT THEY ARE USED FOR

! To prevent gout. This is a disease where

your body produces too much of a substance called 'uric acid'. The uric acid builds up in your joints and tendons and forms crystals. These cause an

inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. Severe pain may also be felt on slight movement of the joint Uricto Tablets are used:-

1. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URICTO TABLETS

Do not take Uricto Tablets if you:

! Are hypersensitive to

allopurinol or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, or pharmacist or nurse before taking Uricto Tablets if you:

! Have liver or kidney problems. Your doctor

may give you a lower dose or ask you to take it less often each day. You will also be monitored more closely

! Have heart problems or high blood pressure

and you take diuretics and/or a medicine called ACE inhibitors

! You are of Han Chinese, African or Indian

origin.

! You have thyroid problems

! Are currently having an attack of gout ! Have been told by your doctor that you

have an intolerance to some sugars as this medicine contains lactose

Serious skin rashes (hypersensitivity syndrome, Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Uricto Tablets.

In case you have kidney stones, the kidney These serious skin reactions can be more common in people of Han Chinese, Thai or Korean origin. Chronic kidney disease may increase the risk in these patients additionally. If you develop a rash or these skin symptoms, stop taking Uricto Tablets 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 to drink sufficiently to dilute your urine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza like symptoms, fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin. Uricto 100mg and 300mg Tablets

[Allopurinol]

PACKAGE LEAFLET: INFORMATION FOR THE USER

! Theophylline (to treat asthma)

In particular tell your doctor if you are taking any of the following:

! Cyclophosphamide, doxorubicin, bleomycin

or procarbazine (drugs used to treat leukaemias and some cancers)

! Phenytoin (used in epilepsy)

Driving and using machines

stones will become smaller and may enter your urinary tract.

Use in children is rarely indicated, except in some types of cancer (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.

! Diuretics (water tablets) or ACE inhibitors

such as captopril (used in high blood pressure)

! Vidarabine, used to treat herpes or

chickenpox.

! Aspirin or related medicines (salicylates)

With administration of allopurinol

and cytostatics (e.g.

cyclophosphamide, doxorubicin,

bleomycin, procarbazine, alkyl

halogenides), blood dyscrasias occur more frequently than when these active substances are administered alone.

Blood count monitoring should therefore be performed at regular intervals.

Pregnancy and breast-feeding

3. HOW TO TAKE URICTO TABLETS

Use in children and adolescents: Other medicines and Uricto Tablets

! Azathioprine (to treat rheumatoid arthritis

and after organ transplants)

Children and adolescents

! Probenecid (used in gout)

! Drugs to prevent blood from clotting (such

as warfarin)

! Chlorpropamide (used in diabetes) ! Didanosine (antiviral)

! Ciclosporin (to treat psoriasis, rheumatoid

arthritis or after organ transplants) Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

! 6-mercaptopurine (used to treat some

cancers and bowel diseases)

! Ampicillin or amoxicillin (antibiotics)

If aluminium hydroxide is taken

concomitantly, allopurinol may

have an attenuated effect. There

should be an interval of at least 3

hours between taking both

medicines.

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breast-feeding. Please check with your doctor if you are taking these tablets and want to breast-feed your baby. Allopurinol is excreted in the human breast milk. Allopurinol during breastfeeding is not recommended.

Uricto Tablets contain lactose

Uricto Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Uricto 300mg Tablets contain sodium

This medicine contains less that 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Always take Uricto Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

These tablets can cause some people to feel drowsy, giddy or have problems with co-ordination. If you are affected do not drive or operate machinery as your alertness may be impaired.

Swallow the tablet with a drink of water Take with or just after food.

Adults:

The usual starting dose is 100 to 200mg each day. Your doctor will monitor the uric acid levels in your blood or urine at regular intervals and will adjust the dose to suit you as necessary. The maintenance dose is usually 200mg to 600mg daily. The maximum single dose is 300mg. It is unlikely that you will be prescribed more than 900mg per day.

The dose in children is based on 10mg to 20mg/kg of body weight/day up to a maximum of 400mg daily. Your doctor will prescribe the

correct dosage. Use in children is mainly for certain types of cancers and enzyme disorders.

Elderly patients:

Your doctor will prescribe the lowest dose of Uricto Tablets that best controls your symptoms.

Patients with severe kidney problems:

You may be asked to take less than 100mg a day, or you may be asked to take 100mg at a longer interval than each day. The exact dose will be prescribed by your doctor.

? any changes to your skin, for example

ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling If you take more Uricto Tablets than you should

A reduced dose will be prescribed by your doctor.

Hypersensitivity

Uncommon (may affect up to 1 in 100 people):

! very rarely signs may include sudden

wheeziness, fluttering or tightness in the chest and collapse.

Patients with liver problems:

Rare (may affect up to 1 in 1,000 people): If you forget to take Uricto Tablets

! serous hypersensitivity reactions including

? fever, joint pain, abnormalities in blood

and liver function tests (these may be signs of a multi-organ sensitivity disorder)

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Do not stop taking Uricto Tablets without consulting your doctor.

If you are receiving kidney dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400mg which will be to take straight away after your dialysis.

If you stop taking Uricto Tablets

If you have any further questions on use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

If you have forgotten to take a dose, take it as soon as you remember it. However, if it is almost time to take your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

If you have a hypersensitivity reaction, stop

taking Uricto Tablets and see a doctor straight way.

The signs may include:

! flaking skin, boils or sore lips and mouth

The following side effects may happen with this medicine:

? fever and chills, headache, aching

muscles (flu like symptoms) and generally feeling unwell

? bleeding in the lips, eyes, mouth, nose or

genitals.

? serious allergic reaction which causes

swelling of the face or throat

? serious potentially life-threatening allergic

reaction

Do not take any more tablets unless your doctor tells you to do so.

Other side effects

Common (may affect up to 1 in 10 people):

! Increased level of thyroid stimulating

hormone in the blood.

! feeling or being sick (occasionally with blood)

Rare (may affect up to 1 in 1,000 people) ! liver problems such as liver inflammation

Very rare (may affect up to 1 in 10,000 people):

! Uricto Tablets may affect the Lymph Nodes ! changes in liver function tests.

Very rare (may affect up to 1 in 10,000 people):

! weakness, numbness, 'pins and needles',

'spinning' sensation, unable to move muscles ! skin rash

Uncommon (may affect up to 1 in 100 people):

! occasionally Uricto Tablets may affect your

blood, which can manifest as bruising more easily than usual, or you may develop a sore throat or other signs of an infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.

Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

What Uricto 300mg Tablets contain

! 300mg of the active substance Allopurinol Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

5. HOW TO STORE URICTO TABLETS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

! 100mg of the active substance Allopurinol

What Uricto Tablets look like and contents of the pack

Blister packs: Do not store above

25°C. Keep the blister in the outer carton to protect from light and moisture.

Securitainers: Store in a cool, dry place and protect from light.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Uricto 100mg Tablets are white, circular biconvex, uncoated tablets, with A1 embossed on one side. Diameter: 9.5mm.

Uricto 300mg Tablets are white, circular, biconvex, uncoated tablets, with ‘A’ & ‘2’ debossed on either side of score line on one side and plain on other side. Diameter: 11.00mm.

Uricto 100mg Tablets are supplied in packs of 28, 30, 56, 60, 84, 90 or 250 tablets.

! The other ingredients are lactose, maize starch, povidone, magnesium stearate and sodium starch glycollate

Keep this medicine out of the sight and reach of children.

What Uricto 100mg Tablets contain

Do not use this medicine if you notice any visible signs of deterioration.

! The other ingredients are lactose, maize starch, povidone and magnesium stearate

Uricto 300mg Tablets are packed into packs of 28, 30, 56, 60, 84, 90 or 250 tablets.

Unit G4, Riverside Industrial Estate,

This leaflet was last revised in February 2019.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited

Riverside Way, Dartford, DA1 5BS, UK.

( p a r a l y s i s ) , d r o w s i n e s s , l o s s o f consciousness

! high levels of cholesterol in the blood

(hyperlipidaemia)

! depression

! feeling thirsty, tired and losing weight; these may be signs of diabetes, taste changes, build up of fluid leading to swelling (oedema) particularly of your ankles

! chest pain (angina) or slow pulse

! blood in the urine (haematuria), a change in bowel habit

! high temperature, a general feeling of being unwell, headache, dizziness

! hair loss or discolouration

! high blood pressure

! sensation of tingling, prickling or burning skin

(paraesthesia)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

! cataracts, changes in vision

! abnormal glucose metabolism (diabetes).

Your doctor may wish to measure the level of sugar in your blood to check if this is happening

! enlarged breasts in men and women, difficulty maintaining erection, infertility

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card

! lack of voluntary coordination of muscle movements (ataxia)

! Occasionally Allopurinol tablets may affect your blood, which can manifest as bruising more easily than usual, or you may develop a sore throat or other signs of an infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.

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