Sadapron 100, 100 mg tablets

Sadapron 300 mg tablets

 

1. WHAT SADAPRON IS AND WHAT IT IS USED FOR

Sadapron tablets contain a medicine called allopurinol. It works by slowing down the speed of certain chemical reactions in your body.

Sadapron is used:

• 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 as crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You can also find you get severe pain when the joint is moved.
• to prevent other conditions where there is a build up of uric acid in the body. These include kidney stones and certain other types of kidney problem and when you are having treatment for cancer.

 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SADAPRON

Do not take Sadapron

• if you are allergic (hypersensitive) to allopurinol or any of the other ingredients of Sadapron tablets (listed in section 6).

Do not take Sadapron if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Sadapron.

Warnings and precautions

Talk to your doctor or pharmacist before taking your 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.
• you are currently having an attack of gout.

Serious skin rashes which have been reported with the use of allopurinol that can be more common in patients with chronic renal impairment and in people of Han Chinese or Thai Origin. Serious skin rashes which include hypersensitivity syndrome, Stevens- Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of allopurinol. 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. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

Other medicines and Sadapron

Tell your doctor if you are taking, have recently taken or might take any other medicines, particularly if you are taking any of the following:

• aspirin.
• theophylline, used for breathing problems.
• medicines used for fits (epilepsy).
• antibiotics.
• didanosine, used to treat HIV infection.
• medicines for cancer.
• medicines used to reduce your immune response (immunosuppressants).
• medicines used to treat diabetes.
• medicines for heart problems or high blood pressure such as ‘ACE inhibitors’ or water tablets (diuretics).
• medicines used to thin your blood (anticoagulants), such as warfarin.
• any other medicine to treat gout.

Sadapron with food and drink

Take Sadapron with food and water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy, giddy or have problems with your co-ordination. If this happens, do not drive or use any tools or machines.

Sadapron 100 contains 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.

 

3. HOW TO TAKE SADAPRON

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Swallow the tablet with a drink of water.
• Take with or just after food.
• The tablet can be divided into equal doses.

Children (under 15 years old)

The usual dose ranges from 100 to 400 mg each day.

Adults (over 18 years)

The usual dose ranges from 100 to 900 mg each day. You will usually start on a dose of 100 to 300 mg each day. 

Elderly (over 65 years)

Your doctor will prescribe the lowest dose of Sadapron tablets that best controls your symptoms.

If you have a serious kidney problem

• you may be asked to take less than 100 mg each day.
• or you may be asked to take 100 mg at longer intervals than 1 day. 

If you have dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg which is to be taken straight after your dialysis.

If you take more Sadapron than you should

If you take more Sadapron than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you.

If you forget to take Sadapron

• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Sadapron

Do not stop taking your Sadapron without talking to your doctor.

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

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people):

If you have an allergic reaction, stop taking Sadapron and see a doctor straight way. The signs may include:

• skin rash, flaking skin, boils or sore lips and mouth.
• very rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse.

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

If you experience any of the following, stop your tablets and tell your doctor as soon as possible:

Rare (affects less than 1 in 1000 people):

• joint pain or painful swelling in your groin, armpits or neck.
• yellowing of the skin and eyes (jaundice).
• liver or kidney problems.
• feeling sick (nausea) or being sick (vomiting), occasionally with blood.
• any changes to your skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling.
• fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell.
• serious hypersensitivity reactions involving fever, skin rash, joint pain and abnormalities in blood and liver function tests (these may be signs of multi-organ sensitivity disorder).
• bleeding in the lips, eyes, mouth, nose or genitals.

Very rare (affects less than 1 in 10,000 people):

• bruising more easily than usual or you may develop a sore throat or other signs of an infection. Tell your doctor as soon as possible. Occasionally Sadapron tablets may affect your blood or lymph system. These effects usually occur in people with liver or kidney problems.
• high temperature.
• blood in your urine (haematuria).
• high levels of cholesterol in your blood (hyperlipidaemia).
• a general feeling of being unwell.
• weakness, numbness, unsteadiness on your feet, feeling unable to move muscles (paralysis) or loss of consciousness.
• headache, dizziness, drowsiness or disturbance of your vision.
• chest pain, high blood pressure or a slow pulse.
• male infertility or erectile dysfunction.
• enlargement of the breasts, in men as well as women.
• a change in your normal bowel habit.
• a change in taste.
• cataracts.
• hair loss or discolouration.
• convulsions.
• depression.
• build up of fluid leading to swelling (oedema) particularly of your ankles.
• feeling thirsty, tired and losing weight; these may be symptoms of diabetes. Your doctor may wish to measure the level of sugar in your blood to check if this is happening.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Cyprus

Pharmaceutical Services

Ministry of Health

CY-1475 Nicosia

Fax: + 357 22608649

Website: www.moh.gov.cy/phs

 

5. HOW TO STORE SADAPRON

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

Store below 25 °C. Protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the label and carton after the word “EXP”. The expiry date refers to the last day of that month.

 

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sadapron contains

• The active ingredient is allopurinol.

Sadapron 100, 100 mg tablets: Each tablet contains 100 mg allopurinol.

Sadapron 300 mg tablets: Each tablet contains 300 mg allopurinol.

• The other ingredients are:

Sadapron 100, 100 mg tablets: povidone, lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, talc.

Sadapron 300 mg tablets: povidone, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, talc.

What this medicine looks like and contents of the pack

Sadapron 100, 100 mg tablets: White, round, normal convex, scored tablets with Remedica’s logo on one side.

Sadapron 300 mg tablets: White, round, normal convex, scored tablets.

Pack sizes:

Sadapron 100, 100 mg tablets:

PVC/Aluminium blisters. Pack-sizes of 50 and 100 tablets.

PP containers with PE closure. Pack-sizes of 100, 250, 500 and 1000 tablets.

Sadapron 300 mg tablets:

PVC/Aluminium blisters. Pack-sizes of 30 tablets.

PP containers with PE closure. Pack-sizes of 100, 250 and 1000 tablets.

Not all pack-sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Remedica Ltd

Aharnon Str., Limassol Industrial Estate,

3056 Limassol, Cyprus