Daleron COLD3 325 mg/30 mg/15 mg film-coated (2024)

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 LEAFLETPACKAGE LEAFLET: INFORMATION FOR THE PATIENTDALERON COLD3 325 MG/30 MG/15 MG FILM-COATED TABLETSparacetamol/pseudoephedrine hydrochloride/dextromethorphanhydrobromideREAD ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THISMEDICINE BECAUSE IT CONTAINS IMPORTANTINFORMATION FOR YOU.Always take this medicine exactly as described in this leaflet or asyour 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. Thisincludes any possible side effectsnot listed in this leaflet. See section 4.-You must talk to a doctor if you do not feel better or if you feelworse after 5 days.WHAT IS IN THIS LEAFLET1.What Daleron COLD3 is and what it is used for2.What you need to know before you take Daleron COLD33.How to take Daleron COLD34.Possible side effects5.How to store Daleron COLD36.Contents of the pack and other information1.WHAT DALERON COLD3 IS AND WHAT IT IS USED FORDaleron COLD3 is a combination ofparacetamol, pseudoephedrine hydrochloride and dextromethorphanhydrobromide. Paracetamol reduces fever and relieves pain.Pseudoephedrine reduces nasal discharge andrelieves the feeling of nasal stuffiness. Dextromethorphan soothesirritating cough due to throat irritationassociated with a cold.Daleron COLD3 relieves signs and symptoms of cold and flu:-It relieves mild to moderate pains (headache, pain in the muscles andjoints, 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 ofa*ge.You must talk to a doctor if you do not feel better or if you feelworse after 5 days.2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALERON COLD3DO NOT TAKE DALERON COLD3-if you are allergic to paracetamol, pseudoephedrine hydrochloride,dextromethorphan hydrobromide orany of the o  Read the complete document  

Summary of Product characteristics

 SUMMARY OF PRODUCT CHARACTERISTICS1.NAME OF THE MEDICINAL PRODUCTDaleron COLD3 325 mg/30 mg/15 mg film-coated tablets2.QUALITATIVE AND QUANTITATIVE COMPOSITIONEach film-coated tablet contains 325 mg paracetamol, 30 mgpseudoephedrine hydrochloride and 15 mgdextromethorphan hydrobromide.Excipient with known effect:Quinoline yellow (E104)0.08535 mg/tabletFor the full list of excipients, see section 6.1.3.PHARMACEUTICAL FORMFilm-coated tabletThe tablets are light green, oval and biconvex. Tablet length:approximately 15 mm.4.CLINICAL PARTICULARS4.1THERAPEUTIC INDICATIONSDaleron COLD3 relieves signs and symptoms of cold and flu in adultsand 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.4.2POSOLOGY AND METHOD OF ADMINISTRATIONPosology_Adults and children over 12 years of age _The recommended dose for adults and children over 12 years of age is 2tablets. The dose can be repeated upto 4 times daily. The dosing interval should be at least 4 hours. Themaximum daily dose of paracetamol is 4g.The recommended doses should not be exceeded._Paediatric population _The drug is contraindicated in children under 12 years of age (seesection 4.3)._Patients with renal insufficiency _The drug should be given with caution to patients with renalinsufficiency (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 hepaticdysfunction (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 administrationOral use.The tablet should be swallowed with liquid.4.3CONTRAINDICATIONSHypersensitivity to the active substances or to any of the excipientslisted in section 6.  Read the complete document