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Each gastro-resistant tablet contains:
Mesalazine ………………………………………500 mg.
The excipients are sodium carbonate anhydrous, glycine, povidone K30, microcrystalline cellulose, sodium carboxymethylcellulose, colloidal silica, calcium stearate, methacrylic acid copolymer (Eudragit L and Eudragit S), micronized talc, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), red iron oxide (E172), isopropyl alcohol.
WHAT IS ASACOL (CLAVERSAL)
Film-coated tablets. Packs containing 100 tablets of 500 mg.
Mesalazine belongs to a group of medications called intestinal anti-inflammatory agents.
ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets acts against inflammation caused by inflammatory bowel disease (ulcerative colitis and Crohn's disease).
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BEFORE TAKING ASACOL (CLAVERSAL)
Do not take ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets:
- If you are hypersensitive (allergic) to mesalazine or any other ingredient in ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets.
- If you have a stomach or duodenal ulcer.
- If you are hypersensitive (allergic) to aspirin or other salicylates.
- If you hemorrhage easily.
Take special care with ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets:
Before you start to take this medication inform your doctor:
- If you are pregnant or if you are planning to become pregnant.
- If you are breastfeeding.
- If you have liver or kidney problems.
ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets should not be administered to children younger than 5 years of age.
If you experience an allergic reaction (eg. skin rash, pruritus) or fever during the course of treatment, stop taking the tablets and inform your doctor immediately.
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Use in the elderly
Use of ASACOL (CLAVERSAL) in the elderly should be cautious and subject to patients having normal renal function.
Use in children
Safety and effectiveness in children have not been established.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medication.
The use of ASACOL (CLAVERSAL) during pregnancy is not recommended unless your doctor considers it to be absolutely necessary.
Effects on ability to drive and use machines:
No adverse effects on ability to drive and use machines have been reported.
Taking or using other medications:
You can usually continue treatment with other medications while you take ASACOL (CLAVERSAL). However always tell your doctor or pharmacist which medicines you are taking including those you have bought yourself without a prescription.
Some medications may cause unexpected effects if administered concomitantly with ASACOL (CLAVERSAL). In particular:
- Medications used to decrease blood sugar levels (antidiabetic agents)
- Medications used to decrease blood pressure (antihypertensives / diuretics)
- Medications used to treat or prevent gout attacks.
- Medications that promote bowel movements (laxatives containing lactulose).
- Medications used to help prevent clotting of blood (anticoagulants).
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HOW TO TAKE ASACOL (CLAVERSAL)
Follow your doctor's instructions about how and when to take your tablets otherwise you will not fully benefit from your medicine.
Remember to use your medication.
Your doctor will indicate the duration of your treatment with ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets. Keep taking your tablets for as long as the doctor has instructed even if you feel better. Your symptoms may come back if you stop your treatment too early.
Always follow the prescribed course exactly as indicated by your doctor during acute treatment as well as maintenance treatment.
Unless your doctor has indicated otherwise the usual recommended dosage is as follows:
- A maximum of 3 tablets of 500 mg. per day, taken orally in the morning, at midday and the third tablet before going to bed.
If you think that the action of this medication is too weak or too strong for you inform your doctor or pharmacist.
If you take more ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets than you should:
If you have taken more ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets than you should, immediately contact your doctor or pharmacist or local poison control centre (Servicio de Información Toxicológica. Telephone: 91 562 04 20).
No cases of acute overdose have been reported. In the event of an overdose, gastric lavage and symptomatic treatment at hospital are required.
If you forget to take ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets:
If you forget to take a dose at the right time, take it as soon as you remember. Then go on as before, but do not take a double dose to make up for the dose that you missed.
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POSSIBLE SIDE EFFECTS
Like all medications, ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets may have side effects.
Some people may occasionally experience adverse effects when using ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets.
On rare occasions you may experience some unwanted effects during treatment with this medication.
These effects include:
- headache
- muscle and joint pain
- feeling sick (nausea)
- skin rash (urticaria)
- abdominal pain and diarrhoea (increased frequency of defecation)
- hepatitis
- cardiac disorders
Consult your doctor if any of these symptoms are ongoing or become severe.
If you experience any other adverse reaction not mentioned in this leaflet, tell your doctor or pharmacist.
STORAGE OF ASACOL (CLAVERSAL)
Keep ASACOL (CLAVERSAL) 500 mg. Gastro-resistant tablets out of the reach and sight of children.
Do not store above 25°C.
Expiry:
This medication must not be used after the expiry date indicated on the carton.
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