Medofed 30 mg/1.25 mg per 5 ml, oral solution

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE

Disponible desde:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Código ATC:

R01BA52

Designación común internacional (DCI):

PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1.25 mg

formulario farmacéutico:

ORAL SOLUTION

Composición:

PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg TRIPROLIDINE HYDROCHLORIDE 1.25 mg

tipo de receta:

OTC

Área terapéutica:

NASAL PREPARATIONS

Estado de Autorización:

Authorised

Fecha de autorización:

2016-02-09

Información para el usuario

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PILmedofsyrcom2.2-MT
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDOFED 30 MG/1.25 MG PER 5 ML, ORAL SOLUTION
Pseudoephedrine hydrochloride
Triprolidine hydrochloride
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 Medofed is and what it is used for
2.
What you need to know before you take Medofed
3.
How to take Medofed
4.
Possible side effects
5.
How to store Medofed
6.
Contents of the pack and other information
1.
WHAT MEDOFED IS AND WHAT IT IS USED FOR
Medofed is a medicine which is used to relieve the symptoms of colds
and allergies including
sneezing, runny nose, watery eyes, nasal congestion and blocked
sinuses. The liquid contains
pseudoephedrine hydrochloride, which is a decongestant that relieves
nasal and sinus congestion and
triprolidine hydrochloride which is an antihistamine that helps stop
sneezing, runny nose and watery
eyes.
This medicine is for use in adults and children aged 6 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDOFED
This medicine is suitable for most adults and children aged 6 years
and over but a few people should
not use it. If you are in any doubt, talk to your doctor or
pharmacist.
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PILmedofsyrcom2.2-MT
DO NOT TAKE MEDOFED:
•
If you are allergic to pseudoephedrine hydrochloride, triprolidine
hydrochloride or any of the
other ingredients of this medicine (listed in section 6).
•
If you have high blood pressure or heart disease.
•
If you are taking beta blockers (used to treat high blood pressure)
•
If you are

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medofed 30 mg/1.25 mg per 5 ml, oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains 30 mg pseudoephedrine hydrochloride and
1.25 mg triprolidine
hydrochloride.
Excipients with known effect: sucrose, methyl para-hydroxybenzoate,
tartrazine yellow lake.
Each 5 ml of oral solution contain 3500 mg sucrose, 5 mg methyl
para-hydroxybenzoate and 0.08 mg
tartrazine yellow lake.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, yellow, flavoured solution for oral administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Medofed contains a decongestant and antihistamine and is indicated for
the management of upper
respiratory tract conditions such as the common cold, hay fever,
allergic and vasomotor rhinitis and
aerotitis (otitis barotrauma).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended.
_Adults and children over 12 years _
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10 ml every 4 - 6 hours up to 4 times a day. Maximum daily dose: 40 ml
_Children 6 - 12 years _
Medofed can only be used on the advice of a physician in children 6-12
years.
Oral: 5 ml every 4 - 6 hours, up to 3 times a day. Maximum daily dose:
15 ml.
A pharmacist or other healthcare professional should be consulted
before use in children aged 6 to 12
years.
_Children under 6 years: _
This medicine is contraindicated in children under 6 years. (See
section 4.3)
_Elderly _
There have been no specific studies of pseudoephedrine or triprolidine
in the elderly. Experience has
indicated that normal adult dosage is appropriate.
_Patient with hepatic impairment _
Caution should be exercised when administering Medofed to patients
with severe hepatic impairment.
_Patients with renal impairment _
Caution should be exercised when administering Medofed to patients
with mild to moderate renal
impairment