LORINASE Syrup 5/60

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Loratidine , Pseudoephedrine

Available from:

SPIMACO ADDWAEIH, KINGDOM OF SAUDI ARABIA

ATC code:

Systemic nasal decongstants

INN (International Name):

Loratidine + Pseudoephedrine

Dosage:

5/60

Pharmaceutical form:

Syrup

Manufactured by:

Spimaco Addwaeih, KINGDOM OF SAUDI ARABIA

Product summary:

Physical description: A colourless to yellowish syrup with a characteristic strawberry odour and taste, free from foreign matter; Local technical representative: Wide Spectrum (T) Limited (5975)

Authorization status:

Registered/Compliant

Authorization date:

2021-11-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
Lorinase
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOR LORINASE SYRUP:
Active ingredients: Loratadine Micronized USP 5 mg and Pseudoephedrine
sulfate 60 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A colourless to yellowish syrup with a characteristic strawberry odour
and taste, free from
foreign matter.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Lorinase syrup is indicated for the symptomatic treatment of seasonal
allergic rhinitis when
accompanied by nasal congestion.
4.2.
Posology and method of administration
Adults and children 6-12 years of age (body weight > 30 Kg): 5 ml
syrup (one tea spoonful)
twice a day (every 12 hours).
Do not give to children below 6 years of age.
4.3.
Contraindications
- Hypersensitivity to the active substance or to any of the
excipients.
Since Lorinase syrup containing pseudoephedrine, it is also
contraindicated in patients receiving
monoamine oxidase enzyme (MAO) inhibitors or within 14 days after
discontinuation of MAO
inhibitors in patients with narrow-angle glaucoma, urinary retention,
cardiovascular diseases,
such as
for
example.
Coronary
ischemia,
tachyarrhythmia
and
severe
hypertension,
or
hyperthyroidism.
Lorinase syrup should not be given to children under the age of 6
years.
4.4.
Special warnings and precautions for use
In patients taking digitalis, patients with cardiac arrhythmias,
hypertension, myocardial infarction,
diabetes, stenosing peptic ulcer, pyloroduodenal
obstruction, prostatic hypertrophy or bladder
neck obstruction, or bronchospasm in patients with a history of
caution. Special caution
is
required in patients aged 60 years
or more, it is for people in this age group are more likely
adverse reactions to sympathomimetics. In this case, the dose should
be reduced. The dose
should be reduced in the case of severe renal insufficiency.
Caution should be exercised in patients treated with other
sympathomimetic agents, including
decongestants,
drugs
t