Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

ROBISINUS & CONGESTION RELIEF 200 MG 30 MG TABLETS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

RobiSinus & Congestion Relief 200 mg, 30 mg Tablets
Ibuprofen, Pseudoephedrine hydrochloride

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take RobiSinus &
Congestion Relief exactly as described in this leaflet in order 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.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in
this leaflet.
- You must contact a doctor if you do not feel better or if you feel worse after 3 days.
If any of the side effects get serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What RobiSinus & Congestion Relief is and what it is used for
2. What you need to know before you take RobiSinus & Congestion Relief
3. How to take RobiSinus & Congestion Relief
4. Possible side effects
5. How to store RobiSinus & Congestion Relief
6. Contents of the pack and other information
1. WHAT ROBISINUS & CONGESTION RELIEF IS AND WHAT IT IS USED FOR
RobiSinus & Congestion Relief is used for the relief of nasal/sinus congestion with headache, fever
and pain associated with the common cold and flu.
This medicine contains ibuprofen, a Non-Steroidal Anti-Inflammatory Drug (NSAID) which works
by relieving pain and reducing high temperature and fever. The tablets also contain pseudoephedrine
hydrochloride, a decongestant, which helps clear the nasal passages and ease nasal congestion.
Only use this product if you have a blocked nose together with headache, pain and/or fever. Do not
use it if you have only one of the symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROBISINUS & CONGESTION
RELIEF
Do not take RobiSinus & Congestion Relief if you:
• are allergic to or have previously experienced skin rash, hives, itching, difficulty breathing,
tightness in the chest, swelling of the mouth, face, lips or tongue on taking ibuprofen, aspirin,
other NSAIDs, or any ingredients contained in this product
• suffer from, or have suffered from stomach ulcers, stomach bleeding or perforation in the past
• suffer from diabetes, prostate problems, thyroid disease, glaucoma or phaeochromocytoma
(i.e. tumour on the adrenal gland)
• have severe kidney disease (kidney failure), severe liver disease, heart disease, severe heart
failure, high blood pressure or circulatory problems (angina)
• are taking medicine for the treatment of depression called mono-amine oxidase inhibitors or
tricyclic anti-depressants (or if you have taken them in the past 14 days)
• have any other bleeding problems
• have a history of stroke
• are taking other NSAIDs, aspirin, pain relievers, or decongestants




are under 12 years of age
are pregnant or breast feeding

Warnings and precautions
Take special care and talk to a pharmacist or your doctor before taking this medicine if you
have or are:
• suffering from heart problems, have had a previous stroke or think that you may be at risk of
these conditions (for example, if you have high blood pressure, diabetes or high cholesterol,
or you are a smoker) Medicines containing 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
• suffering from bleeding disorders
• suffering from stomach ulcers or inflammatory bowel disease (e.g. ulcerative colitis or
Crohn’s disease
• asthmatic, suffer from allergies
• disease of the heart, kidney, liver or prostate
• elderly – elderly people are more likely to experience unwanted side effects such as stomach
bleeding and perforation which may be fatal
• Systemic Lupus Erythematosus (SLE) – an illness affecting the immune system causing joint
pain, skin changes and other problems
• trying to become pregnant
• 12-17 years old as there is a risk of renal impairment. Therefore ask a doctor before use if a
12-17 year old has not been drinking fluids or has lost fluids due to continuous vomiting or
diarrhoea
• Consumption of alcohol should be avoided during treatment
• Pseudoephedrine hydrochloride may cause a positive reaction in tests conducted during antidoping checks
Children and adolescents
RobiSinus & Congestion Relief is for use by adults and adolescents over 12 years of age. RobiSinus
& Congestion Relief is not for use in children younger than 12 years.
Other medicines and RobiSinus & Congestion Relief
Do not use this medicine if you are:
• taking other NSAID painkillers, or more than 75 mg aspirin a day
• taking decongestants (nasal or oral)
• taking or have taken in the last two weeks drugs for depression known as Monoamine
Oxidase inhibitors (MAOIs)
• taking tricyclic antidepressants (used to treat depression)
Talk to your doctor or pharmacist if you are taking:
• blood clotting agents (anti-platelet agents) generally used to thin the blood to help prevent
stroke or heart problems (e.g. warfarin, ticlopidine or aspirin)
• tablets to reduce blood pressure (e.g. ACE inhibitors - captopril, beta-blockers – atenolol or
losartan) or any water tablets (diuretics)
• cardiac glycosides such as digoxin (digitalis) or quinidine for a heart condition
• phenytoin (a medicine for epilepsy)
• lithium (used to treat mood disorders)
• methotrexate (used to treat arthritis)




















Antacids
cyclosporins (used to suppress the body’s immune system e.g. following a transplant)
mifepristone (used in pregnancy terminations)
quinolone antibiotics (used to treat a wide range of infections)
tacrolimus (a transplant drug)
medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
corticosteroids (a type of anti-inflammatory drug e.g. hydrocortisone)
selective serotonin reuptake inhibitors (SSRIs e.g. fluoxetine)
aminoglycosides (e.g. gentamicin or amikacin)
the antibacterial agent furazolidone
zidovudine (used to treat HIV)
guanethidine, reserpine or methyldopa.
sulfinpyrazone and probenecid
potassium sparing diuretics
ergot derivatives
dopamine receptor agonists
having an anaesthetic, stop treatment beforehand and inform the anaesthetist
heparins, Gingko biloba

Please tell your pharmacist or doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
This product should not be taken if you are pregnant or breastfeeding.
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Ibuprofen belongs to a group of medicines, NSAIDs, which may impair fertility in women. This effect
is reversible upon 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.
Driving and using machines
There are no known effects on driving or on use of machines. RobiSinus & Congestion Relief may
cause side effects such as dizziness, hallucinations, unusual headaches and visual or hearing
disturbances in some people. If you are affected by any of these side effects it is best not to drive or
use machinery.
Important information about some of the ingredients of your medicine
• each coated tablet contains less than 23 mg sodium per dose, and so is essentially sodium free
if you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product, as it contains sucrose
this product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
which may cause allergic reaction (possibly delayed).
3. HOW TO TAKE ROBISINUS & CONGESTION RELIEF
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
For oral administration and short term use only.

Adults, the elderly and children over 12 years of age: The minimum effective dose should be
used for the shortest time necessary to relieve symptoms.
The recommended dose is: 1 or 2 tablets every 4 to 6 hours as required. The tablets should be taken
with water. Take only as much as you need and leave at least 4 to 6 hours between each dose. Do not
take more than 6 tablets in any 24 hour period. If symptoms persist for more than 3 days, contact your
doctor.
Do not give to children under 12 years of age.
Do not exceed the stated dose.
If you take more RobiSinus & Congestion Relief than you should:
If you take too many tablets, contact your doctor or hospital immediately. Bring the remaining tablets
with you to show the doctor.
Discontinue use in the case of accidental overdose.
If you forget to take RobiSinus & Congestion Relief
Do not take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, RobiSinus & Congestion Relief can cause side effects, although not
everybody gets them.
You can reduce the chances of experiencing side effects by using the minimum dose required.
If you experience any of the following side effects then STOP taking this medicine immediately
and contact your doctor or pharmacist:
Common
Uncommon

• feeling sick (nausea)
• bleeding of the stomach or bowel (vomiting blood or blood in faeces,
black discolouration of faeces)
• severe headaches or headaches that are worse than usual

Very Rare

• heart attack
• fast heartbeat or palpitations
• allergic reaction to RobiSinus & Congestion Relief, signs include skin
rash, hives, itching, difficulty breathing, tightness in the chest, swelling of
the mouth, face, lips or tongue.
• blistering lesions on the skin or mucous membranes such as the inside of
your mouth, signs include burning feeling, with redness, blisters and ulcers.

Not Known

• stroke
• behavioural problems such as feeling excited, agitated, anxious, restless or
nervous

In addition to the above, the following side effects may occur during treatment.
Common

• Indigestion, stomach ache, vomiting, diarrhoea, constipation, wind

Uncommon

• stomach ulcer
• not being able to sleep
• feeling drowsy or tired
• feeling dizzy or irritable
• problems with your sight
• headaches that do not go away
• breakouts on the skin (rash, itching)
•inflamed stomach or bowel, worsening of existing inflammatory bowel
disease
• hypersensitivity such as wheezing and difficulty
breathing in patients who have ever had bronchial asthma or allergic disease.

Rare

• kidney problems
• hearing disturbances (tinnitus)

Very Rare

• depression
• heart failure
• kidney failure
• high blood pressure
• sore or inflamed mouth
• inflamed pancreas (pancreatitis)
• narrowing of the gut (intestinal stricture)
• aseptic meningitis, worsening of infectious inflammations
• problems with your blood cells – you may be more likely to bruise or get
infections
• liver problems including abnormal liver function, hepatitis or jaundice
(yellowing of the skin or eyes).

Not Known

• chest pain
• dry mouth, feeling thirsty
• abnormal spasm, seizures
• spinning sensation (vertigo)
• Haematocrit decreased and haemoglobin decreased
• seeing or hearing things that are not there (hallucinations)
• skin rash, red or purple skin discolouration, fluid retention (oedema)
• passing urine less often, blood or protein in your urine (shown in tests)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ROBISINUS & CONGESTION RELIEF
Keep out of the sight and reach of children.
Do not use RobiSinus & Congestion Relief after the expiry date shown on the blister and carton.
The expiry date refers to the last day of the month.
Do not store above 250C.
Medicines should not be disposed of 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
What RobiSinus & Congestion Relief contains?
Each coated tablet contains the following active substances:
Ibuprofen 200 mg
Pseudoephedrine hydrochloride 30 mg
Each coated tablet also contains: Maize starch, Pregelatinised starch (maize), Croscarmellose sodium,
Colloidal anhydrous silica, Sodium laurilsulfate, Stearic acid. The tablet coating contains: Sucrose,
Microcrystalline cellulose, Carnauba wax, Shellac, Povidone, Acetylated monoglyceride, Industrial
methylated spirits, Titanium dioxide (E171), Iron oxide (E172), Methyl Parahydroxybenzoate
(E218), Propyl Parahydroxybenzoate (E216). Black printing ink contains shellac, iron oxide (E172),
propylene glycol or shellac, iron oxide (E172), propylene glycol and ammonium hydroxide.
What RobiSinus & Congestion Relief looks like?
The tablet is oval shaped, butterscotch coloured, sugar coated and imprinted with ‘200/30’ in black
ink on one face. The medicine is available only from your pharmacist in a pack size of 2, 4, 10, 12, 20
and 24. Not all pack sizes may be marketed.
Who makes the medicine?
Manufactured by:
Wyeth Lederle, Via Nettunense 90, Aprilia, Italy.
Marketing Authorisation Holder
Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
0333 555 2526
carelineUK@pfizer.com
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic, Slovakia: RobitussiGrip
Belgium: Ibuprofen/Pseudoephedrine
Hungary, Ireland, Luxembourg, Poland: - Advil
United Kingdom: RobiSinus

This leaflet was last revised in July 2014

+ 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