Teotard capsules modified-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

theophylline

Available from:

KRKA d.d.

ATC code:

R03DA04

INN (International Name):

theophylline

Dosage:

350mg

Pharmaceutical form:

capsules modified-release

Units in package:

(40/4x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-04-03

Patient Information leaflet

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Read the complete document

Summary of Product characteristics

1.3.1
Theophylline
SPC, Labeling and Package Leaflet
SmPCPIL153842_1
25.08.2020 – Updated: 25.08.2020
Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Teotard 200 mg modified-release capsules
Teotard 350 mg modified-release capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release capsule contains 200 mg or 350 mg theophylline.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Modified-release capsules.
Teotard modified-release capsules 200 mg:
The capsule body is transparent and green, the cap is non-transparent
and green; the capsules contain
white pellets.
Teotard modified-release capsules 350 mg:
The capsule body is transparent and green, the cap is non-transparent
and green; the capsules contain
white pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All types of asthma, chronic obstructive bronchitis, pulmonary
emphysema, pulmonary hypertension
in chronic cor pulmonale, centrally induced respiratory disorders
during sleep.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage must be adjusted according to the patient’s age, body mass
and individual and individual
metabolic requirements and is therefore always determined by a doctor.
The size of the dose is
determined according to the patient’s ideal body weight, as
theophylline is not distributed into adipose
tissues.
The usual dose for adults weighing more than 40 kg is 350 mg
theophylline twice daily and for
very thin adults 200 mg theophylline twice daily.
Patients with nocturnal asthma or respiratory disorders during sleep
can take one dose of Teotard
daily, at bedtime. On average, 400 to 700 mg theophylline is
sufficient. Smokers may take unequal
doses, i.e. a higher dose in the evening and a lower dose in the
morning.
The therapeutic effect and tolerability of theophylline are evaluated
on the third day of treatment. If
the therapeutic effect is good, treatment is continued with the same
dose. If not, the dose should be
increased. If undesirable effects occur, the dose should be reduced or
treatment discontinued.
The dose of the