PRESERVEX film-coated tablets
1. Name of the medicinal product
PRESERVEX® 100 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 100 mg of aceclofenac.
3. Pharmaceutical form
Preservex film-coated tablets 100 mg are presented as white round film-coated tablets, 8 mm in diameter.
4. Clinical particulars
4.1 Therapeutic indications
Preservex is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
4.2 Posology and method of administration
Preservex film-coated tablets are supplied for oral administration.
Posology
When Preservex was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Adults
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Paediatric population
There are no clinical data on the use of Preservex in children and therefore it is not recommended for use in children.
Elderly
The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
The pharmacokinetics of Preservex are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
Renal insufficiency
There is no evidence that the dosage of Preservex needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see also Precautions).
Hepatic insufficiency
There is some evidence that the dose of Preservex should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.
Method of administration
To be taken preferably with or after food. The tablets should be swallowed whole with a sufficient quantity of liquid.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Hepatic failure and renal failure (see section 4.4).
Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Active bleedings or bleeding disorders.
Preservex should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used (see section 4.6).
4.4 Special warnings and precautions for use
Undesirable effects may be mini |
