Dextromethorphan Tussilene, 2 mg/ml, Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Laboratorios Azevedos - Industria Farmaceutica SA Estrada Nacional 117-2 Alfragide, 2614-503 Amadora, Portugal

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 2 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 2 mg/ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXTROMETHORPHAN TUSSILENE 2 MG/ML, ORAL SOLUTION
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 have 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 after 5 days.
WHAT IS IN THIS LEAFLET:
1. What Dextromethorphan Tussilene is and what it is used for
2. What you need to know before you take Dextromethorphan Tussilene
3. How to take Dextromethorphan Tussilene
4. Possible side effects
5. How to store Dextromethorphan Tussilene
6. Contents of the pack and other information
1. WHAT DEXTROMETHORPHAN TUSSILENE IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: 5.2.1. Cough suppressants
This medicine is presented as an oral solution.
The active substance is dextromethorphan hydrobromide, which is
synthetic morphine derivative with
central antitussive action. The antitussive action begins 30 minutes
after oral administration, lasting for 4 to
5 hours.
Dextromethorphan Tussilene is indicated for:
Symptomatic treatment of irritant, non-productive cough.
If you do not feel better or if you feel worse after 5 days, you
should talk to your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXTROMETHORPHAN TUSSILENE
Do not take Dextromethorphan Tussilene:
- If you are allergic to dextromethorphan hydrobromide or any of the
other ingredients of Dextromethorphan
Tussilene (listed in section 6);
- If you suffer from respiratory insufficiency;
- If you suffer from asthma;
- In case of productive cough;
- If you are or had been up to 14 days ago under treatment with
monoamine oxidase inhibitors (

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dextromethorphan Tussilene, 2 mg/ml, Oral Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of Dextromethorphan Tussilene, oral solution contains
2 mg of dextromethorphan
hydrobromide as active substance.
Excipients with known effect:
Maltitol liquid: 0.75 mg/ml
Amaranth (E 123): 0.033 mg/ml
For full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of irritant, non-productive cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 12 years:
The usual dosage is 5-10 ml (1-2 measuring-spoons with 5 ml) of
Dextromethorphan Tussilene
per dose, every 4 to 6 hours.
The maximum daily dose of dextromethorphan hydrobromide is 120 mg
(equivalent to 12
measuring-spoons with 5 ml each).
Children from 6 to 12 years:
The usual dosage is 30 to 60 mg/20 to 35 Kg boy weight/day.
The usual dose is 2.5-5 ml of Dextromethorphan Tussilene, every 4 to 6
hours.
The maximum daily dose of dextromethorphan hydrobromide is 60 mg
(equivalent to 6
measuring-spoons of 5 ml each).
Children from 2 to 6 years:
The usual dosage is 15 to 30 mg/12 to 20 Kg body weight/day.
The usual dose is 1.25-2.5 ml of Dextromethorphan Tussilene, every 4
to 6 hours.
The maximum daily dose of dextromethorphan hydrobromide is 30 mg
(equivalent to 3
measuring-spoons of 5 ml each).
Elderly or patients with hepatic and / or renal failure:
The starting dose should be reduced to half of the recommended dose
and, if necessary, may be
increased, depending on tolerability.
The treatment period should not exceed 5 days.
Treatment should be limited to cough occurrence period without ever
exceeding the
recommended doses.
For a proper administration, the device for administration should be
used.
4.3 CONTRAINDICATIONS
Dextromethorphan is contraindicated in cases of:
- Hypersensivity to dextromethorphan or to any of the excipients of
this medicine.
- Respiratory failure.
- Acute