Claversal 500 mg

100 tablets
Active substance: mesalazine

WHAT IS Claversal® 500 mg tablets AND WHAT IT IS USED FOR?

Claversal® 500 mg tablets is a treatment for inflammatory bowel disease.
application areas
Acute treatment and recurrent prophylaxis (preventive treatment) of ulcerative colitis (chronic inflammatory disease of the colon).
Acute treatment of Crohn's disease (chronic inflammatory disease).

What should you watch out for before use?

Claveral® 500 mg tablets should not be taken,
- Hypersensitivity to salicylic acid and its derivatives
- severe liver and kidney disorders
- gastric and duodenal ulcers (ventricular ulcer and duodenal ulcer)
- increased bleeding tendency (hemorrhagic diathesis).
Take special care with Claversal® 500 mg tablets
Claversal® 500 mg tablets should be administered under medical supervision. A blood and urine status should be collected at the discretion of the attending physician before and during treatment. As a guideline, controls are recommended 14 days after the start of treatment, then 2 to 3 times after a further 4 weeks. In the case of normal findings, immediate control examinations are necessary every quarter or when additional signs of disease occur.
In the determination of the blood and urine status, the urea (BUN) and creatinine determination in the serum and an examination of the urine sediment are recommended for checking the renal function.
Observe changes in the blood color values (increased methaemoglobin values).
In the presence of a pulmonary function disorder, especially asthma, careful monitoring of the patient is recommended during treatment with Claversal® 500 mg tablets.
In patients with known hypersensitivity to sulfasalazine-containing preparations, treatment with mesalazine-containing drugs such as Claversal® 500 mg tablets should only be started with careful medical supervision. If acute symptoms of intolerance, such as convulsions, acute abdominal pain, fever, severe headaches and skin rashes occur, discontinue treatment immediately.
One tablet contains 2.1 mmol (47.7 mg) of sodium. If you have a low salt diet, you should consider this.
Claversal® 500 mg tablets should not be used for the treatment of infants and small children as there is not sufficient experience in this age group.

pregnancy and breast feeding period
During pregnancy, Claversal® 500 mg tablets may only be taken by the treating physician after careful consideration of the risk / benefit ratio. For the beginning of a pregnancy, women with childhood should wait as long as possible for a phase in which no or a low dose medication is required. If the disease happens, the treatment should be suspended in the last 2-4 weeks of pregnancy.
The active ingredient goes into the mother's milk in small quantities. However, there is as yet no adequate experience during lactation. If breast-feeding is necessary, breast-feeding should be discontinued.

Driving and using machines:
It has not been reported to affect the ability to actively participate in road traffic or to reduce the ability to handle machines and equipment by taking mesalazine.
Important information about some of the ingredients of Claversal® 500 mg Tablets
One tablet contains 2.14 mmol (47.7 mg) of sodium. If you have a low salt diet, you should consider this.

How is it used?

HOW TO TAKE Claversal® 500 mg tablets?
Always take Claversal® 500 mg tablets exactly as your doctor has told you. Please consult your doctor or pharmacist if you are not sure.
Please observe the instructions for use as Claversal® 500 mg tablets may not work properly.

If the doctor does not prescribe otherwise, the usual dose is:
Acute treatment of ulcerative colitis:
Depending on the clinical requirements of the individual case, 3 to 6 tablets of Claversal® 500 mg daily (equivalent 1.5 - 3.0 g of mesalazine per day) are distributed between 2 and 3 items.
Recurrent prophylaxis of ulcerative colitis:
3 x daily 1 tablet of Claversal® 500 mg (equivalent to 1.5 g of mesalazine per day).
Acute treatment of Crohn's disease:
Depending on the clinical requirements of the individual case, 3 - 9 tablets of Claversal® 500 mg daily (equivalent 1.5 - 4.5 g of mesalazine per day) are distributed to 2 - 3 individual items.

type of application
The tablets which are resistant to gastric juices are to be taken in the morning, at noon and in the evening, approximately 1 hour before the meal.

Duration of application
The duration of the application is determined by the treating physician.
The treatment with Claversal® 500 mg tablets should be carried out reliably and consistently during the acute inflammatory stage as well as in the long-term therapy, as this is the only way to achieve the desired healing success.
If you take more Claveral® 500 mg tablets than you should
Even when taking larger amounts of Claversal® 500 mg tablets, the symptoms of poisoning are not necessarily due to the properties of mesalazine.
In principle, similar symptoms should occur as are known from poisoning with salicylic acid derivatives (eg with acetylsalicylic acid). The poisoning phenomena known to the group of medicines referred to include an initial excessive increase in the activity of the breath (hyperventilation), severe perspiration and irritability with later increasing respiratory paralysis, unconsciousness and exsikkose (dehydration by removal of the body water); Hyperventilation leads to respiratory alkalosis (reduction of carbon dioxide in the blood); With progressive poisoning, a metabolic acidosis (acidification of the blood due to the increased occurrence of acidic metabolic products) occurs.
If you have taken more tablets than prescribed, please contact a doctor immediately.

If you forget to take Claversal 500 mg tablets
If you miss a dose, please take the dose as soon as possible; However, the stated maximum daily doses should not be exceeded.

If you stop taking Claversal® 500 mg tablets
In the case of premature interruption or termination of the therapy, especially in the case of the preventive treatment of the ulcerative colitis, there may be a flare-up or recurrence of the symptoms. Therefore, talk to your treating physician before taking such a step.

What are possible side effects?

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
What are the interactions between Claversal® 500 mg tablets and other medicines?
Treatment with Claversal® 500 mg tablets may cause interactions with the following medicinal products:
Anticoagulants of anticoagulants of the coumarine type:
Possible enhancement of the anticoagulant effect (increase of the risk of bleeding in the gastrointestinal tract).
Blood-sugar lowering agents (sulfonylureas):
Possible enhancement of the blood glucose lowering effect.
Methotrexate:
Possible increase in methotrexate toxicity.
Probenecid / sulfinpyrazone (the excretion of uric acid excipients):
Possible (uricuric) effect of uric acid excretion.
Spironolactone / Furosemide (certain diuretics):
Possible diminution of the diuretic (increasing urine excretion).
Rifampicin (anti-tuberculosis agents):
Possible reduction of the tuberculostatic (tubercle-bacteria-inhibiting) effect.
Glucocorticoids (certain anti-inflammatory agents):
Possible enhancement of the gastric-specific adverse effects.
In one case, a severe reduction in the blood cell count of all systems (pancytopenia) has occurred under mesalazine treatment in combination with mercaptopurine.
Please note that this information may also apply to recently used medicines.

WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Claversal® 500 mg tablets can cause side effects, although not everybody gets them.
The following frequencies are used for the assessment of side effects:
Very common: more than 1 in 10 patients
Common: less than 1 in 10, but more than 1 in 100 patients
Uncommon: less than 1 in 100, but more than 1 in 1000 patients
Rare: less than 1 in 1000, but more than 1 in 10,000 people
Very rare: less than 1 out of 10,000 patients, or unknown

Possible side effects:
Gastrointestinal tract:
Occasionally (0.1% - <1%), abdominal pain, diarrhea, flatulence as well as nausea and vomiting are reported. These can also be signs of the underlying disease.
Central and peripheral nervous system:
In rare cases, neuropathies (nerve problems, eg with sensory disturbances) are associated with central nervous symptoms such as headache, dizziness, and rare (0.01% - <0.1%) under the treatment with Claversal® ).
Kidney:
Uncommon (0.1% - <1%), renal function disorders including acute and chronic inflammation of the renal connective tissue (interstitial nephritis) and renal insufficiency were observed during treatment with mesalazine-containing drugs.
Hypersensitivity reactions:
Occasionally (0.1% - <1%)
Salicylic acid and its derivatives are common, dose-independent hypersensitivity reactions such as allergic skin reactions including pruritus, urticaria, medication fever, bronchospasm, pericarditis, myocarditis and pancreatic inflammation (acute pancreatitis) Occasional cases.
Uncommon (0.1% - <1%), inflammation of the pulmonary arteries (allergic alveolitis) was observed with the use of mesalazine-containing drugs.
Some medicines with drugs that have a chemical structure similar to mesalazine may cause a lupus erythematosus-like syndrome (butterfly lichen). The occurrence of this syndrome can therefore not be excluded under the treatment with Claversal® 500 mg tablets.
Very rarely (0.01% - <0.1%) inflammation can spread to the entire colorectal region (pancolitis).
Other possible side effects:
Uncommon (0.1% - <1%) muscle and joint pain (myalgia or arthralgia) and conjunctivitis (conjunctivitis) occur.
Changes in the blood color values (increased methaemoglobin values) can not be ruled out due to the chemical composition of the active substance.
Very rare (0.01% - <0.1%) changes in the blood count (neutropenia, leucopenia, thrombocytopenia and aplastic anemia) have been observed after application of mesalazine-containing drugs.
Very rare (<0.01%) has been reported from changes in liver function parameters (liver values) and the occurrence of hepatic inflammation with or without hepatitis, as well as from partial to complete hair loss.
Countermeasures
If any side effects occur, please inform your doctor so that further procedures can be taken.
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.

How should it be stored?

Store drug out of reach of children.
Do not use after the expiry date which is stated on the carton and the pack. The expiration date refers to the last day of the month.
Storage conditions:
Do not store above 30C!

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