REMEDOL Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Remedol 500 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 500 mg paracetamol.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White, round, flat tablets, with "Remedol" embossed on one side.
4.1. Therapeutic indications
Remedol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, ...
4.2. Posology and method of administration
Posology
Adults
Two tablets up to four times daily as required.
Children
6-12 years:
Half to one tablet three or four times daily as required. Not suitable for children under six years of age. Chi...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal im...
4.5. Interaction with other medicinal products and other forms of interaction
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks...
4.6. Pregnancy and lactation
Pregnancy
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero...
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at thera...
4.9. Overdose
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk fac...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Analgesics, Other Analgesics and Antipyretics
ATC code:
N02BE01
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin...
5.2. Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1-4 hours after the...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Conventional studies using the currently accepted standards...
6.1. List of excipients
Povidone
Maize starch
Glycerol
Cellulose microcrystalline
Magnesium stearate
Silica colloidal anhydrous
Talc
Croscarmellose sodium
6.2. Incompatibilities
None.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack sizes of 20, 60, 100 and 1000 tablets.
PP containers with PE closure. Pack sizes of 100, 500 and 1000 tablets.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19665
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 May 2005
Date of latest renewal: 28 February 2011
10. Date of revision of the text
09/05/2022
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