TICINAN SUSTAINED RELEASE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-06-2024
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Active ingredient:
MORPHINE HYDROCHLORIDE
Available from:
Lannacher Heilmittel Ges.m.b.H
Dosage:
100mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
2000-01-21
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ticinan 100 mg prolonged release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 100 mg
morphine hydrochloride trihydrate equivalent to 75.95 mg morphine.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Yellow orange tablets, round and biconvex.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prolonged relief of severe and most severe pain (such
as cancer pain), resistant to lower level analgesics.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The prolonged release tablets should be swallowed completely with
some liquid.
Ticinan prolonged release tablets must not be divided
or dissolved before administration. Dissolving or parting of the
Ticinan prolonged release tablets will damage the prolonged
release system and lead to rapid release of morphine
which may entail substantial side effects.
The treatment is initiated by titration with an
immediate release morphine formulation
(tablets or mixture) to a
morphine dose which gives adequate pain control. Thereafter,
the patient is transferred to the same daily dose of
Ticinan prolonged release tablets. Breakthrough pain should
be treated with immediate release morphine.
Ticinan prolonged release tablets should be used at 12-hourly
intervals. The dosage is dependent upon the severity of
the pain, the patient’s age and previous history
of analgesic requirements.
For adults and adolescents from the age of 12 years:
A patient presenting with severe pain should normally be started
on 10-30 mg morphine hydrochloride 12-hourly,
patients with low body-weight (weighing less than 70
kg) requiring a small starting dose.
Caution should be exercised and the initial dose should
be reduced in elderly patients and patients with impaired
hepatic or renal function.
Increasing severity of pain will require a
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