Skip to Content

UK Edition. Click here for US version.

ORBIFEN COLD & FLU ORAL SUSPENSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

3024/4

Patient Information Leaflet

Orbifen Cold and Flu
Oral Suspension

Ibuprofen
Pseudoephedrine hydrochloride
Read all of this leaflet carefully because it contains important information on how to use
this medicine.
This medicine is available without a prescription. However, you still need to use Orbifen
Cold and Flu Oral Suspension (Now called Orbifen Cold and Flu throughout the leaflet)
carefully to get the best results from it.
● Keep this leaflet. You may need to read it again.
● Ask your pharmacist if you need more information or advice.
● For children 6 years -12 years you must contact a doctor if your child’s symptoms worsen
or do not improve after 3 days.
● For adults or children over 12 years you must contact a doctor if your child’s symptoms
worsen or do not improve after 10 days.
● If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What is Orbifen Cold and Flu and what it is used for
2. Before using Orbifen Cold and Flu
3. How to use Orbifen Cold and Flu
4. Possible side effects
5. Storing Orbifen Cold and Flu
6. Further information

1. What is Orbifen Cold and Flu
and what it is used for

2. Before using Orbifen Cold and

Orbifen Cold & Flu contains Ibuprofen and
Pseudoephedrine hydrochloride.
Ibuporfen belongs to a group of medicines
known as non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs provide relief by
changing the body's response to pain, swelling
and high temperature.
Pseudoephedrine belongs to a group of drugs
called vasoconstrictors, which act on the
blood vessels in the nose to relieve nasal
congestion.

This medicine is suitable for most people but
a few people should not use it. If you are in
any doubt, talk to your doctor or pharmacist.

Orbifen Cold & Flu is effective in clearing a
blocked nose and sinuses, relieving aches,
pains, headache and feverishness, and easing
discomfort of a sore throat.

Flu

X

Do not take this medicine if you or your
child ………......
• have ever had a bad reaction to any of the
ingredients (see section 6).
• have or have ever had a stomach ulcer or
other gastric complaint.
• have or have ever had an allergic reaction
or wheezing after taking Ibuprofen, Aspirin
or other anti-inflammatory pain killers.
• is taking other NSAID painkillers or Aspirin
with a daily dose above 75mg.
• suffers from severe kidney, liver or heart
problems, diabetes, a condition called
phaeochromocytoma (a tumour which

causes increased blood pressure, palpitations,
increased heart rate and headaches),
glaucoma or prostate enlargement.
• If you are pregnant.
Talk to your doctor or pharmacist before
taking Orbifen Cold and Flu if you or your
child….....

!

• have asthma or has suffered from asthma.
• have kidney, liver, heart or blood pressure
problems.
• have bowel problems.
• have Systemic Lupus Erythematosus (SLE)
a condition to the immune system affecting
connective tissue resulting in joint pains,
skin changes and disorder of other organs.
• smoke.

!

Taking other medicines

Tell your doctor or pharmacist if you or your
child are taking or have recently taken any
other medicines including those obtained
without a prescription. This includes herbal
medicines. This is because Orbifen Cold and
Flu can affect the way some medicines work.
Also, some other medicines can affect the way
Orbifen Cold and Flu works.
In particular, do not give this medicine and tell
your doctor or pharmacist if you or your child
are taking any of the following:
•Aspirin
•Other NSAIDs
•Medicines used to thin the blood such as
Warfarin
•Water tablets (diuretics)
•Medicines for high blood pressure
•Corticosteroids
•Medicines for depression such as:
- Selective serotonin reuptake inhibitors
(SSRIs) such as paroxetine and fluoxetine
- Lithium
- tricyclics such as amitriptyline
- monoamine oxidase inhibitors (MAOIs)
such as phenelzine.
•Medicines to prevent blood clots from
forming such as Clopidogrel
•Digoxin (for heart failure)
•Methotrexate (for arthritis, psoriasis or some
cancers)
•Tacrolimus (for transplant and eczema)
•Ciclosporin (for transplant, arthritis or
psoriasis)

•Mifepristone (for termination of pregnancy)
•Antibiotics called Quinolones (such as
Ciprofloxacin)
•Zidovudine (used to treat HIV infection).
•Decongestants or appetite suppressants
If you are not sure about the medicine you or
your child are taking, show the bottle or pack
to your pharmacist.

! Pregnancy and Breast-feeding
• Do not take this medicine if you are
pregnant
• If you are planning to become pregnant.
Ibuprofen belongs to a group of medicines
which may impair fertility in women. This
effect is reversible on stopping the medicine.
It is unlikely that ibuprofen, used occasionally,
will affect your chances of becoming
pregnant, however, tell your doctor before
taking this medicine if you have problems
becoming pregnant.
• If you are breast feeding.
Speak to a doctor or pharmacist before
taking Orbifen Cold and Flu. Small amounts
of Orbifen Cold and Flu may get into the
breast milk.

Important

• Medicines which contain Ibuprofen may be
associated with a small increased risk of
heart attack (”myocardial infarction”) or
stroke. Any risk is more likely with high doses
and prolonged treatment. Do not exceed the
recommended dose or duration of treatment
(see the next two points). If you have heart
problems, previous stroke or think that you
might be at risk of these conditions (for
example if you have high blood pressure,
diabetes or high cholesterol or are a smoker)
you should discuss your treatment with your
doctor or pharmacist.
• If you are an adult or a child over 12 years
you must contact a doctor if your symptoms
worsen or do not improve after 10 days.
• If you are giving this medicine to children
under 12 years, you must contact a doctor if
your child’s symptoms worsen or do not
improve after 3 days.
Driving and operating machinery

!

• This medicine is unlikely to affect your
ability to drive or to operate machinery.
Continued, please turn over

Important information about some of the
ingredients of Orbifen Cold and Flu
• Maltitol liquid(E965): If you have been told
by your doctor that you or your child have
intolerance to some sugars, contact your
doctor before giving this medicinal product.
• Sodium methyl parahydroxybenzoate (E219)
and sodium propyl parahydroxybenzoate
(E217): May cause allergic reactions
(possibly delayed).

3. How to use this medicine
Orbifen Cold and Flu Oral Suspension should
be taken by mouth preferably with or after
food. Shake the bottle well before measuring
the dose. A measuring spoon is provided to
ensure accuracy.
• Do not take more than the stated dose
shown below.
• The medicine should be used for the
shortest time possible and at the lowest
dose to relieve your symptoms.
Age

Dosage

Children 6 - 12 years

10mls three times a day

Children over 12 years
and adults

10ml to 20mls every four
to six hours. Do not take
more than 60mls in 24 hrs

Under 6 years

Not Recommended

• Do not give to children under 6 years of age
• Doses should usually be given every 6-8
hours as required. Leave at least 4 hours
between doses.
• Short term use only:
♦ For adults and children over 12 years
of age: Do not take for more than 10 days.
♦ For children 6-12 years: Do not give for
more than 3 days.
• If symptoms persist or worsen, consult your
doctor promptly.
! If you take more Orbifen Cold and Flu Oral
Suspension than you should
If you, your child or someone you know
accidentally takes alot more than the stated
dose (an overdose) of this medicine, either
call your doctor straight away, or go to your
nearest hospital casualty department.
Always take any remaining medicine, the
container and the label with you, so that the
medicine can be identified.

! If you forget to give Orbifen Cold and Flu
Oral Suspension
If you forget to give a dose, give the next dose
as soon as you remember unless it is time for
the next dose. Don't give two doses at the
same time.
If you are worried, or not sure of when or how
to use this medicine, ask your doctor or
pharmacist for advice.

4. Possible side effects
Like all medicines, Orbifen Cold and Flu Oral
Suspension can have side effects although
not everyone gets them.
If you experience any of the following, stop
using the medicine and seek immediate
medical help:
•Blood in your faeces (stools / motions).
•Black tarry stools.
•Vomiting any blood or dark particles that
look like ground coffee.
•Chest pains.
•Unexplained wheezing, shortness of breath,
skin rash (which may be severe and include
blistering or peeling of the skin), swelling of
mouth or tongue, mouth ulcers, itching or
bruising, lightheadedness, racing heart or
fluid retention, e.g. swollen ankles.
•Stiff neck, headache, nausea, vomiting,
fever and disorientation.
If you experience any of the following, stop
using the medicine and talk to your doctor:
• Unexplained stomach pain, indigestion,
heartburn, feeling sick and / or vomiting.
• Yellowing of the eye and/or skin, which may
be a sign of liver problems.
• Severe sore throat with high fever.
• Unexplained bruising, bleeding or tiredness
or getting more infections (such as colds)
than usual.
• Difficulties passing water.
• Fast irregular heart beat.
• Muscle weakness.
• Hallucinations.
Other effects which occur are listed below:
Uncommon:
• Headache
• Sweating
• Difficulty sleeping, excitability, restlessness,
anxiety, tremor, irritability, giddiness.
• Dry mouth, thirst and loss of appetite.

Rare:
• Diarrhoea, wind or constipation.
If any of these become troublesome or last
more than a few days, tell your doctor.
Very rare:
• Kidney problems.
• Stroke or heart problems may occur with
Ibuprofen
• Worsening of colitis and Crohn's disease.
Other effects reported include:
• High blood pressure
Medicines which contain Ibuprofen may be
associated with a small increased risk of
heart attack (myocardial infarction) or stroke.

The Marketing Authorisation holder and
manufacturer for Orbifen Cold and Flu
suspension (PL 17862/0004) is Orbis
Consumer Products Ltd, Cunard Road,
Park Royal, London NW10 6PN.

Contact us at the above address for
information in large print, audio or
Braille
This leaflet was updated in August 2009

Orbis

If you notice any side effects not mentioned in
this leaflet, please inform your doctor or
pharmacist.

5. Storing your medicine
•Keep out of the reach and sight of children
•Do not store above 25°C. Store in the
original container.
•Do not use Orbifen Cold and Flu Oral
Suspension after the expiry date which is
stated on the bottle after Exp:. The expiry
date refers to the last day of that month.
• Medicines should not be disposed via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6. Further information
Orbifen Cold and Flu suspension is a white
cherry flavoured suspension.
Each 5 ml of Orbifen Cold and Flu contains
100mg Ibuprofen and 15mg of
Pseudoephedrine hydrochloride.
It also contains the following inactive
ingredients: Glycerol, polysorbate 80, xanthan
gum (E415), maltitol liquid (E965), sodium
saccharin (E954), citric acid monohydrate,
sodium methyl parahydroxybenzoate (E219),
sodium propyl parahydroxybenzoate (E217),
cherry flavour and purified water.
Each bottle contains 100ml of oral suspension.
A double ended 5ml and 2.5ml polypropylene
spoon is also included to help measure the
dose.

3024/4

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide