Stoptussin

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

butamirate (butamirate citrate), guaifenesin

Available from:

TEVA Czech Industries s.r.o.

INN (International Name):

butamirate (butamirate citrate), guaifenesin

Dosage:

4mg+100mg

Pharmaceutical form:

tablets

Prescription type:

OTC

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
STOPTUSSIN TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Butamirate citrate 4.0 mg, guaifenesinum 100.0 mg in one tablet.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablets
Tablet of a round shape and white colour fitted with a halving groove.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dry, irritative, difficult to control cough of various aetiology; it
is used for relief of cough before and
after an operation.
The preparation can be administered to adults and children over 12
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be adjusted according to the patient’s body weight as
follows:
Up to 50 kg of body weight
1/2 tablet 4 times a day
50 kg – 70 kg
1 tablet 3 times a day
70 kg – 90 kg
1 1/2 tablets 3 times a day
90 kg and above
2 tablets 3 times a day
The interval between the doses should be 4 – 6 hours.
The preparation should be administered after meal. The tablets should
be swallowed with a sufficient
volume of liquid (water, tea, juice, etc.).
4.3 CONTRAINDICATIONS
Hypersensitivity
to
guaifenesin,
butamirate
citrate
or
to
any
of
the
excipients
of
the
product,
myasthenia gravis, the first trimester of pregnancy, children below 12
years of age.
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE
Patients should avoid alcoholic beverages during treatment.
Stoptussin should not be used by patients with a productive cough and
/ or persistent or chronic cough
associated with smoking, asthma, chronic bronchitis or emphysema.
If the cough persists or worsens, the treatment should be
reconsidered.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Guaifenesin increases the analgesic effect of paracetamol and
acetylsalicylic acid; it also enhances
both the inhibitory effect of alcohol, sedatives, hypnotics and
general anaesthetics to CNS and the
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muscle relaxant effect. Urinary determinations of vanillyl-mandelic
acid and 5-hydroxyindoleacetic
acid may be