REMEDOL Suppository (2022)
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Περιεχόμενα
1. Name of the medicinal product
Remedol 125 mg suppositories.
Remedol 250 mg suppositories.
Remedol 500 mg suppositories.
2. Qualitative and quantitative composition
Remedol 125 mg suppositories:
Each suppository contains 125 mg paracetamol.
Remedol 250 mg suppositories:
Each suppository contains 250 mg paracetamol.
Remedol 500 mg suppositories:
Each supposi...
3. Pharmaceutical form
Suppository.
Off-white, torpedo-shaped suppositories.
4.1. Therapeutic indications
For the treatment of mild to moderate pain and fever.
4.2. Posology and method of administration
Posology
Remedol 125 mg suppositories
The dosage depends on the patient's age and body weight. The single dose is between 10 mg and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about ...
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
They have no influence on reactivity.
4.8. Undesirable effects
Redness of the skin has rarely been seen. Very rare cases of allergic reactions associated with rash have been reported.
Further hypersensitivity reactions such as Quincke's oedema, fall in bl...
4.9. Overdose
Overdosing may result in toxicity signs having a latency of 24 to 48 hours. Disorders of liver function due to hepatocellular necrosis including hepatic coma with fatal outcome may occur. In other ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Analgesics, Other Analgesics and Antipyretics
ATC code:
N02BE01
Paracetamol is an analgesic for the treatment of mild to moderate pain and a member of the group of ani...
5.2. Pharmacokinetic properties
After rectal administration, paracetamol is absorbed almost completely from paracetamol suppositories.
Remedol 125 mg suppositories:
As compared with the oral dosage form, its relative bioavailabi...
5.3. Preclinical safety data
The LD
50
of paracetamol varies with species and the route of administration, ranging from 310 mg/kg after subcutaneous injection in the mouse to 2620 mg/kg after oral administration in the guinea...
6.1. List of excipients
Hard fat
6.2. Incompatibilities
None.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC strips. Pack size of 10 suppositories.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Remedol 125 mg suppositories: 19737
Remedol 250 mg suppositories: 14626
Remedol 500 mg suppositories: 14627
9. Date of first authorization / renewal of the authorization
Remedol 125 mg suppositories:
Date of first authorisation: 08 November 2005
Date of latest renewal: 20 April 2011
Remedol 250 mg suppositories:
Date of first authorisation: 10 February 1994
Date ...
10. Date of revision of the text
09/05/2022
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