Daleron COLD3 325 mg/30 mg/15 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

N02BE71

INN (International Name):

PARACETAMOL 325 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg DEXTROMETHORPHAN HYDROBROMIDE 15 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PARACETAMOL 325 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg DEXTROMETHORPHAN HYDROBROMIDE 15 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-01-07

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALERON COLD3 325 MG/30 MG/15 MG FILM-COATED TABLETS
paracetamol/pseudoephedrine hydrochloride/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 Daleron COLD3 is and what it is used for
2.
What you need to know before you take Daleron COLD3
3.
How to take Daleron COLD3
4.
Possible side effects
5.
How to store Daleron COLD3
6.
Contents of the pack and other information
1.
WHAT DALERON COLD3 IS AND WHAT IT IS USED FOR
Daleron COLD3 is a combination of
paracetamol, pseudoephedrine hydrochloride and dextromethorphan
hydrobromide. Paracetamol reduces fever and relieves pain.
Pseudoephedrine reduces nasal discharge and
relieves the feeling of nasal stuffiness. Dextromethorphan soothes
irritating cough due to throat irritation
associated with a cold.
Daleron COLD3 relieves signs and symptoms of cold and flu:
-
It relieves mild to moderate pains (headache, pain in the muscles and
joints, pain in the throat).
-
It reduces fever.
-
It reduces nasal discharge and eases breathing in nasal stuffiness.
-
It soothes irritating cough.
Daleron COLD3 is indicated in adults and children over 12 years of
age.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALERON COLD3
DO NOT TAKE DALERON COLD3
-
if you are allergic to paracetamol, pseudoephedrine hydrochloride,
dextromethorphan hydrobromide or
any of the o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daleron COLD3 325 mg/30 mg/15 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 325 mg paracetamol, 30 mg
pseudoephedrine hydrochloride and 15 mg
dextromethorphan hydrobromide.
Excipient with known effect:
Quinoline yellow (E104)
0.08535 mg/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The tablets are light green, oval and biconvex. Tablet length:
approximately 15 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daleron COLD3 relieves signs and symptoms of cold and flu in adults
and children over 12 years of age:
-
It relieves mild to moderate pains (headache, myalgia and arthralgia,
throat pain).
-
It reduces fever.
-
It reduces nasal discharge and eases breathing in nasal congestion.
-
It soothes irritating cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over 12 years of age _
The recommended dose for adults and children over 12 years of age is 2
tablets. The dose can be repeated up
to 4 times daily. The dosing interval should be at least 4 hours. The
maximum daily dose of paracetamol is 4
g.
The recommended doses should not be exceeded.
_Paediatric population _
The drug is contraindicated in children under 12 years of age (see
section 4.3).
_Patients with renal insufficiency _
The drug should be given with caution to patients with renal
insufficiency (see section 4.4).
The drug is contraindicated in patients with severe renal impairment
(see section 4.3).
_Patients with hepatic impairment _
The drug should be given with caution to patients with hepatic
dysfunction (see section 4.4).
The drug is contraindicated in patients with severe hepatic impairment
(see section 4.3).
_Elderly _
Caution is required in the elderly.
Method of administration
Oral use.
The tablet should be swallowed with liquid.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.