SINECOD Syrup 7.5 mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUTAMIRATE CITRATE

Available from:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC code:

R05DB13

INN (International Name):

BUTAMIRATE CITRATE 1.5 mg/ml

Pharmaceutical form:

SYRUP

Composition:

BUTAMIRATE CITRATE 1.5 mg/ml

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-04-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINECOD 7.5 MG/5 ML SYRUP
Butamirate citrate
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must talk to a doctor if your signs of illness worsen or do not
improve.
-
If of the side effects gets serious, or if you notice any side effects
not listed in this leaflet please tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1. What Sinecod is and what it is used for
2. What you need to know before you use Sinecod
3. How to use Sinecod
4. Possible side effects
5. How to store Sinecod
6. Other information
1. WHAT SINECOD IS AND WHAT IT IS USED FOR
Sinecod is an antitussive administered for the treatment of dry
non-productive cough. Unlike other antitussives,
it suppresses the cough without causing an addiction. Unlike narcotic
antitussives, Sinecod lacks the risk of
their side effects without lacking the antitussive action.
2. BEFORE YOU TAKE SINECOD
DO NOT TAKE SINECOD
- If you are allergic to butamirate citrate or any of the other
ingredients of Sinecod
USING - TAKING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken any
other medicines, including those obtained
without a prescription. Simultaneous use of other cough medicines
should be avoided, because may lead to
retention of mucus in the respiratory system, which can increase the
risk of bronchospasm and airway infection.
TAKING SINECOD
WITH FOOD AND DRINKS
No interation studies have been performed. If possible, Sinecod
must be taken before meals.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before taking any medicine.
USE DURING PREGNANCY:
As there are no sufficient studies in pregnant women, the use of
Sinecod
should be avoided during the first
trimester of pregnancy. For the following month of pregnancy Sinecod
may be used according to the doctor’s
judgement and instructions.
USE DURING BREAST-FEEDING

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg
ipratropium bromide.
1 puff
(
approx. 140 microliters
)
contains 70 micrograms xylometazoline hydrochloride and
84 micrograms ipratropium bromide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion and rhinorrhea in connection
with common colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
1 puff in each nostril up to 3 times daily. At least 6 hours should
elapse between two doses. Do
not exceed 3 applications daily into each nostril.
The treatment duration should not exceed 7 days (see section 4.4).
Do not exceed the stated dose. The lowest dose necessary to achieve
efficacy should
be used for the shortest duration of treatment.
It is recommended to stop treatment, when the symptoms have
diminished, even
before the maximum duration of treatment of 7 days, in order to
minimize the risk of
adverse reactions (see section 4.8).
_Paediatric population_
Otrivine Extra Dual Relief is not recommended for use in children and
adolescents below 18 years of age
due to lack of sufficient documentation.
_Geriatrics _
There is only limited experience of use in patients above 70 years of
age.
Method of administration
Two fingers vertically actuated pump:
Before the first application, prime the pump by actuating 4 times.
Once primed the pump will normally
remain charged throughout regular daily treatment periods.
1.
Clear the nose.
2.
Hold the bottle upright with thumb under base and nozzle between two
fingers.
3.
Lean forward slightly and insert the nozzle into a nostril.
4.
Spray and breathe in gently through the nose at the same time.
5. Repeat this procedure in the other nostril.
6. Clean and dry the nozzl