Ibuprofen/Phenylephrine Clonmel 400 mg/10 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ibuprofen; Phenylephrine hydrochloride

Dostupno od:

Clonmel Healthcare Ltd

ATC koda:

R05X

INN (International ime):

Ibuprofen; Phenylephrine hydrochloride

Doziranje:

400/10 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

OTHER COLD PREPARATIONS

Status autorizacije:

Not marketed

Datum autorizacije:

2018-06-01

Uputa o lijeku

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN/PHENYLEPHRINE CLONMEL 400 MG/10 MG FILM-COATED TABLETS
Ibuprofen/Phenylephrine hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

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.
WHAT IS IN THIS LEAFLET
1. What Ibuprofen/Phenylephrine Clonmel is and what it is used for
2. What you need to know before you take Ibuprofen/Phenylephrine
Clonmel
3. How to take Ibuprofen/Phenylephrine Clonmel
4. Possible side effects
5. How to store Ibuprofen/Phenylephrine Clonmel
6. Contents of the pack and other information
1. WHAT IBUPROFEN/PHENYLEPHRINE CLONMEL IS AND WHAT IT IS USED FOR
Ibuprofen/Phenylephrine Clonmel contains ibuprofen and phenylephrine
hydrochloride, which are
effective in relieving the symptoms associated with colds and flu,
including relief of mild to moderate
pain, nasal congestion (blocked nose) and lowering of temperature.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs)
and is effective against aches and pains (including headache),
swelling and can also reduce a fever.
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in
the passages of the nose, relieving
nasal congestion and reducing the pressure which may cause a headache.
Ibuprofen/Phenylephrine Clonmel is used to treat adults and children
over 12 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN/PHENYLEPHRINE
CLONMEL
DO NOT TAKE THIS MEDICINE IF YOU:

are allergic to ibuprofen, phenylephrine hydrochloride or any of the
other ingredients of this medicine
(li

Svojstava lijeka

Health Products Regulatory Authority
07 July 2020
CRN009F3N
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen/Phenylephrine Clonmel 400 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains active substances:
400.0 mg Ibuprofen
10.0 mg Phenylephrine hydrochloride
Excipient with known effect
Each tablet contains up to 2.92 mg sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Ibuprofen/Phenylephrine Clonmel are white, oval, biconvex film-coated
tablets (tablets) with a breaking notch on one side and
10 mm diameter. The breaking notch is only to facilitate breaking for
ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain or fever and nasal
congestion related to colds and influenza in adults and
adolescents older than 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet every 8 hours. Leave at least 4 hours between doses and do
not exceed three tablets in any 24 hour period.
Adults, the elderly and adolescents over 12 years:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4). The patient should consult a doctor if
symptoms persist or worsen, or if the medicinal product is
required for more than 10 days.
Children:
Not to be given to children under 12 years.
Duration of use
Length of treatment is guided by the nature and severity of disease
and should be decided by the treating doctor.
Method of administration
For oral use
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.

Hypertension and severe coronary heart disease.

Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis, angioedema or urticaria) in
response to acetylsalicylic acid or other non-steroidal
ant