PARAPANE OSTEO Film-coated tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
PARAPANE OSTEO Paracetamol.
2. Qualitative and quantitative composition
Active ingredient: Paracetamol 665 mg/tablet. <u>Excipients:</u> For the full list of excipients, see section 6.1 List of Excipients. Chemical structure Chemical name: N-acetyl-paminophenol Molecular ...
3. Pharmaceutical form
Parapane Osteo is a bi-layer white colored capsule shaped film coated tablet, engraved BPL on one side and plain on the other.
4.1. Therapeutic indications
Parapane Osteo provides effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. ...
4.2. Posology and method of administration
<u>Adults and children aged 12 years and over:</u> 2 tablets swallowed whole three times a day every 6 to 8 hours. Do not chew or suck, as it impairs the sustained release properties. Maximum of 6 tablets ...
4.3. Contraindications
Contraindicated in patients with a previous history of hypersensitivity to paracetamol or to any of the excipients.
4.4. Special warnings and precautions for use
Identified precautions Contains paracetamol. Do not use with any other paracetamol- containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions with paracetamol have been noted: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of ...
4.6. Fertility, pregnancy and lactation
Effects on fertility No data available. Use in pregnancy Pregnancy Category A. Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in ...
4.7. Effects on ability to drive and use machines
The effects of this medicine on a persons ability to drive and use machines were not assessed as part of its registration.
4.8. Undesirable effects
Reporting suspected adverse effects Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal ...
4.9. Overdose
If an overdose is taken or suspected, the patient should go to the nearest hospital straight away. This should be done even if they feel well because of the risk of delayed, serious liver damage (See Section ...
5.1. Pharmacodynamic properties
Mechanism of action Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti-pyretic activity. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, ...
5.2. Pharmacokinetic properties
Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake delays paracetamol absorption. Parapane Osteo is a unique bi-layer tablet incorporating an ...
5.3. Preclinical safety data
Genotoxicity No data available. Carcinogenicity No data available.
6.1. List of excipients
The tablets contain hydroxy ethyl cellulose, microcrystalline cellulose, povidone, pregelatinized starch, magnesium stearate, maize starch, sodium starch glycolate, stearic acid, OPADRY KB low viscosity ...
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
Alu-PVDC blister packs of 24, 48 and 96 tablets.
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Beximco Pharmaceuticals Australia, 4 Miami Key, Broadbeach Waters, QLD 4218
9. Date of first authorization / renewal of the authorization
01/11/2016
10. Date of revision of the text
15/09/2021
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