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

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Package leaflet: Information for the user
Ibuprofen and Phenylephrine 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.
What is in this leaflet
1. What Ibuprofen and Phenylephrine 200mg/5mg film coated tablets is and what it is
used for
2. What you need to know before you take
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
3. How to take
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
4. Possible side effects
5. How to store
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
6. Contents of the pack and other information
1. What
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets is and what it is used for
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
contains ibuprofen and phenylephrine hydrochloride, which are effective in relieving the
symptoms associated with colds and flu., including relief of aches and pains, sore throats,
headache, 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 200mg/5mg film coated tablets
DO NOT take this medicine if you:
• are allergic to ibuprofen, phenylephrine hydrochloride or any of the other ingredients of
this medicine (see 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
• are under 12 years old
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
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
Medicines such as
Ibuprofen and Phenylephrine 200mg/5mg film-coated tablets
may be associated with a small increased risk of heart attack (myocardial infarction) or
stroke. Any risk is more likely with high doses or prolonged treatment.
Do not exceed the recommended dose or duration of treatment (10 days).
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.
Other medicines and
Ibuprofen and Phenylephrine 200mg/5mg film-coated tablets
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.
Some medicines may affect the way in which ibuprofen and phenylephrine hydrochloride
work or may themselves be affected by this medicine.

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).
• to thin your blood or prevent clotting (e.g. warfarin)
• to stimulate your heart (e.g. glycosides) or treat high blood pressure (e.g. captopril,
atenolol, 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)
Talk to your doctor or pharmacist before taking this product with other medicines.
Pregnancy, breast-feeding and fertility
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
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 Name> 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 200mg/5mg film coated tablets
Do not take this medicine in the last 3 months of pregnancy. Avoid the use of 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 breast-feeding.

3. How to take
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
Always take this medicine exactly as described in this leaflet or as your doctor or 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.
Do not take Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
for longer than 10 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 200mg/5mg film coated tablets than you
should:
You may feel drowsy or nauseous. You should seek immediate medical advice, even if you
feel well.
If you forget to take Ibuprofen and Phenylephrine 200mg/5mg film coated tablets
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.

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 200mg/5mg film coated tablets
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 200mg/5mg film coated tablets
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 200mg/5mg film coated tablets 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
• sodium stearyl fumarate
• purified water
The film consists of:
• opadry 200 white 200F280000 (consisting of polyvinyl alcohol, talc, macrogol, titanium
dioxide, methacrylic acid copolymer, sodium bicarbonate,)
• purified water
What Ibuprofen and Phenylephrine 200mg/5mg film coated tablets looks like and
contents of the pack
Ibuprofen and Phenylephrine 200mg/5mg film coated tablets are white, round, biconvex,
film-coated tablets.
The product is available in cartons of 12, 16, 20 and 24 tablets.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastr. 2-8
61118 Bad Vilbel
Germany
This leaflet was last revised in December 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.

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