DIACOL 1,8 mg/ml syrup

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 9 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 9 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2023-08-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIACOL 1,8 mg/ml syrup.
dextromethorphan hydrobromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What DIACOL is and what it is used for
2. What you need to know before you take DIACOL
3. How to take DIACOL
4. Possible side effects
5. How to store DIACOL
6. Contents of the pack and other information
1.
WHAT DIACOL IS AND WHAT IT IS USED FOR
DIACOL contains the active substance dextromethorphan hydrobromide.
DIACOL belongs to a group of medicines called antitussives and is used
for the
temporary relief of dry coughs due to irritation of the upper or lower
respiratory tract.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIACOL
DO NOT TAKE DIACOL
-
if you are allergic to active substance or any of the other
ingredients of this
medicine (listed in section 6).
-
if you have
cough with expectoration
.
-
if
you
are
taking
medicines
belonging
to
the
class
of
monoamine
oxidase
(MAO)
inhibitors.
WARNINGS AND PRECAUTIONS
This medicine can lead to dependence. Therefore, the treatment should
be of short
duration.
DIACOL should be used with caution in patients with bronchial asthma
or allergies.
Use with caution in
debilitated
or with hepatic disease patients.
If cough persists for more than 1 week, if it recurs or if it is
accompanied by high fever,
skin rash or intense headache, check with the doctor.
DIACOL contains 121.64 g of sucrose per 200 ml of syrup. A 15 ml dose
contains
approximately 9.1 g of sucrose. This information should be taken i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DIACOL 1,8 mg/ml syrup.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 ml of syrup contains 27 mg of dextromethorphan hydrobromide.
Excipients with known effect:
Each ml of syrup contains 13.75 mg of ethanol.
Each ml of syrup contains 608.2 mg of sucrose.
Each ml of syrup contains 1 mg of methylparaben.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of dry coughs due to irritation of the upper
or lower respiratory tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adolescents, the elderly and adults: _
15 ml every 6 to 8 hours. Maximum daily dose of 60 ml.
_Children between 2 and 12 years of age: _
dose according to doctor instructions. Between 6 and
12 years of age the maximum daily dose is 30 ml, and between 2 and 6
years of age the
maximum daily dose is 15 ml.
_Children under 2: _
not recommended for use in this age group.
DIACOL may be administered every 4 hours, reducing the amount of syrup
per take, so as not
to exceed the maximum daily dosage.
Do not exceed the recommended doses or use continuously for extended
periods of time.
Method of administration:
Oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1..
Productive cough.
Concomitant treatment with monoamine oxidase inhibitors.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DIACOL should be used with caution in atopic or asthmatic patients, as
it may trigger the
release of histamine.
Use with caution in sedated or frail patients.
Patients with hepatic impairment may suffer changes in metabolism.
Cases of dextromethorphan abuse and dependence have been reported.
Caution is particularly
recommended for adolescents and young adults as well as in patients
with a history of drug
abuse or psychoactive substances.
If cough persists for longer than 1 week, recurs or is accompanied by
high fever, skin rash o