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IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200 MG/5 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the user
Ibuprofen and phenylephrine hydrochloride 200mg/5mg 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.
 Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has 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, or
- if this medicine is required for more than 5 days in adults
- if this medicine is required for more than 3 days in children over 12 years
What is in this leaflet
1. What Ibuprofen and phenylephrine hydrochloride 200mg/5mg is and what it is used for
2. What you need to know before you take Ibuprofen and phenylephrine hydrochloride
200mg/5mg
3. How to take Ibuprofen and phenylephrine hydrochloride 200mg/5mg
4. Possible side effects
5. How to store Ibuprofen and phenylephrine hydrochloride 200mg/5mg
6. Contents of the pack and other information

1. What Ibuprofen and phenylephrine hydrochloride 200mg/5mg is and what it is used
for
Ibuprofen and phenylephrine hydrochloride 200mg/5mg 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.

2. What you need to know before you take Ibuprofen and phenylephrine hydrochloride
200mg/5mg
DO NOT take this medicine if you:
 are allergic to ibuprofen, phenylephrine hydrochloride or any of the other ingredients of
this medicine (listed in section 6), or to acetylsalicylic acid or other painkillers
 have ever had a stomach ulcer, perforation or bleeding
 have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when
previously taking ibuprofen, acetylsalicylic acid or similar medicines
 have had gastrointestinal bleeding or perforation when previously taking NSAIDs (NonSteroidal Anti-Inflammatory Drugs)
 are taking other NSAID painkillers

 are taking more than 75 mg of acetylsalicylic acid a day. If you are on low-dose
acetylsalicylic acid (up to 75 mg daily) talk to your doctor or pharmacist before you take
this medicine.
 have severe liver or kidney problems
 have severe heart problems (severe heart failure), high blood pressure or blood
coagulation disorder
 have breathing difficulties
 have an overactive thyroid
 are taking or have taken within the last 14 days a medicine called a monoamine oxidase
inhibitor (usually used to treat depression)
 are in the last 3 months of pregnancy (please see also section 2 “Pregnancy, breastfeeding and fertility”)
 are under 12 years old
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen and phenylephrine hydrochloride
200mg/5mg if you:
 have or have had asthma
 have kidney, heart, liver or bowel problems
 have high cholesterol or previously have had a heart attack or stroke
 have a history of gastrointestinal disease (such as ulcerative colitis or Crohn’s disease)
 have Systemic Lupus Erythematosus (a condition of the immune system causing joint
pain, skin changes or other organ disorders)
 are a smoker
 are in the first 6 months of pregnancy
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke, particularly when used at
high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen
and phenylephrine hydrochloride 200mg/5mg if you:
 have heart problems including heart failure, angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to
narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
 have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
Adolescents
There is a risk of renal impairment in dehydrated adolescents.
Other medicines and Ibuprofen and phenylephrine hydrochloride 200mg/5mg
To reduce the risk of side effects, do not take this medicine with other NSAID containing
products (e.g. acetylsalicylic acid, ibuprofen). If you are on low-dose acetylsalicylic acid (up
to 75 mg daily) talk to your doctor or pharmacist before you take this medicine.
Ibuprofen and phenylephrine hydrochloride 200mg/5mg may affect or be affected by some
other medicine. For example:
Avoid taking this medicine with medicines
 used for the treatment of asthma and various inflammatory conditions (corticosteroid
tablets, e.g. prednisolone, beclomethasone)
 to treat certain bacterial infections (quinolone antibiotics, e.g. ciprofloxacin, norfloxacin,
levofloxacin).

 that are anti-coagulants (i.e. thin your blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
 to stimulate your heart (e.g. glycosides) or that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan)
 to help you pass water (diuretics)
 for the temporary suppression of your immune system (e.g. methotrexate, ciclosporin,
tacrolimus)
 for mania or depression (e.g. lithium or SSRIs)
 for pregnancy termination (e.g. mifepristone)
 for HIV treatment (e.g. zidovudine)
Some other medicines may also affect or be affected by the treatment of Ibuprofen and
phenylephrine hydrochloride 200mg/5mg. You should therefore always seek the advice of
your doctor or pharmacist before you use Ibuprofen and phenylephrine hydrochloride
200mg/5mg with other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Ibuprofen and phenylephrine hydrochloride 200mg/5mg belongs to a group of medicines
which may affect fertility in women. Fertility goes back to normal when you stop taking this
medicine. It is unlikely that if you only take Ibuprofen and phenylephrine hydrochloride
200mg/5mg occasionally it will affect your chances of becoming pregnant. If you have
problems becoming pregnant talk to your doctor before taking this medicine.
Tell your doctor if you become pregnant whilst taking Ibuprofen and phenylephrine
hydrochloride 200mg/5mg. DO NOT take this medicine in the last 3 months of
pregnancy.
DO NOT use this medicine in the first 6 months of pregnancy unless the doctor
advises otherwise.
Talk to your doctor or pharmacist BEFORE taking this medicine if you are breastfeeding.

3. How to take Ibuprofen and phenylephrine hydrochloride 200mg/5mg
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.
Method of administration
Tablets must be swallowed whole with water.
It is important to drink plenty of fluids when suffering from colds and flu.
Dosage
Adults, the elderly and children over 12 years:
Take two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed 6
tablets in any 24 hour period.
Duration of treatment
This medicine is for short-term use only. Take the lowest dose for the shortest time
necessary to relieve your symptoms.
Adults:

Do not take Ibuprofen and phenylephrine hydrochloride 200mg/5mg for longer than 5
days.
Children over 12 years:
Do not take Ibuprofen and phenylephrine hydrochloride 200mg/5mg for longer than 3
days.
If you do not get better, or get worse, talk to your doctor.
Do not give to children under 12 years.
If you take more Ibuprofen and phenylephrine hydrochloride 200mg/5mg than you
should:
You may feel drowsy or nauseous. You may experience muscle weakness, tingling feelings
such as “pins and needles”, and feel your heartbeat (due to raised levels of potassium in the
blood which can be detected by blood tests). You should seek immediate medical advice,
even if you feel well.
If you forget to take Ibuprofen and phenylephrine hydrochloride 200mg/5mg
Refer to the directions above on how to take this medicine and do not take more than is
advised. DO NOT take a double dose to make up for forgotten tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be minimized by taking the lowest dose for the shortest time necessary to
relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below).
If you get any of the following at any time during treatment STOP TAKING this medicine
and seek immediate medical help:
 signs of intestinal bleeding such as:
- bright red faeces (stools/motions), black tarry stools
- vomiting blood or dark particles that look like coffee grounds
 signs of serious allergic reaction such as:
- difficulties in breathing or unexplained wheezing
- dizziness or faster heartbeat
- severe forms of skin reactions such as itchiness, skin rash with redness, peeling,
flaking or blistering (e.g. Steven-Johnson syndrome)
- swelling of your face, tongue or throat
 signs of kidney problems such as:
- passing less or more urine
- cloudy urine or blood in urine
- pain in the back and/or swelling (particularly in the legs)
 signs of aseptic meningitis such as:
- neck stiffness
- headache
- feeling sick, being sick
- fever or disorientation. Patients with autoimmune disorders (Systemic Lupus
Erythematosus, mixed connective-tissue disease) may be more likely to be affected.
STOP TAKING this medicine and tell your doctor if you experience the following
uncommon side effects which may affect up to 1 in 100 people:
 indigestion, heartburn or feeling sick

 pains in your stomach (abdomen) or other abnormal stomach problems
TELL YOUR DOCTOR if you have any of the following side effects, they become worse
or you notice any effects not listed:
Uncommon side effects which may affect up to 1 in 100 people:
 allergic reactions, such as skin rashes (urticaria), itching, peeling
 headaches, dizziness, tinnitus (ringing in the ears)
Rare side effects which may affect up to 1 in 1,000 people:
 flatulence (wind), diarrhoea, constipation and vomiting
Very rare side effects which may affect up to 1 in 10,000 people:
 blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat,
mouth ulcers, flu-like symptoms and severe exhaustion
 drop in blood pressure or irregular heart beat
 liver problems
Side effects for which the frequency cannot be estimated from the available data:
 worsening of asthma or bronchospasm
 swelling (oedema), high blood pressure, heart failure or attack
 worsening of colitis and Crohn´s disease
 difficulties in passing urine (in men only)
Medicines such as Ibuprofen and phenylephrine hydrochloride 200mg/5mg may be
associated with a small increased risk of heart attack (myocardial infarction) or stroke. See
section 2 “Warnings and precautions”.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Ibuprofen and phenylephrine hydrochloride 200mg/5mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP month/year) which is stated on the pack.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Ibuprofen and phenylephrine hydrochloride 200mg/5mg contains
The active substances are:
 ibuprofen
 phenylephrine hydrochloride

Each film-coated tablet contains:
 200 mg ibuprofen
 5 mg phenylephrine hydrochloride
The other ingredients are:
The core consists of:
 microcrystalline cellulose
 sodium starch glycolate
 hypromellose 6 mPa.s
 sodium stearyl fumarate
The film consists of:
 opadry white 200F280000 (consisting of polyvinyl alcohol, talc, macrogol, titanium dioxide,
methacrylic acid copolymer, sodium bicarbonate)

What Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets
looks like and contents of the pack
Ibuprofen and phenylephrine hydrochloride 200mg/5mg are white, round, biconvex, filmcoated tablets with a score line on one side and 10 mm diameter. The score line is not
intended for breaking the tablet.
The product is available in cartons of 12, 16, 20 and 24 tablets.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicinal product is authorised in the Member States of the EEA under the
following names:
UK:
ES:
HR:
IT:
PL:
SK:

Ibuprofen 200 mg and Phenylephrine hydrochloride 5 mg film-coated tablets
Grippostad con Ibuprofeno 200 MG/5 MG COMPRIMIDOS RECUBIERTOS CON
PELICULA
Ibufix 200 mg/5 mg filmom obložene tablete
Ibuprofene e Fenilefrina EG
FLUSTAD
IBUGRIPP

This leaflet was last revised in 2016.

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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.

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