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PINOFEN SEVEN PLUS 200 MG/5 ML ORAL SUSPENSION

Active substance(s): IBUPROFEN / IBUPROFEN

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Package leaflet: Information for the user

Pinofen Seven Plus 200 mg/5 ml
Oral Suspension
Ibuprofen

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you and your child.
Your medicine is called Pinofen Seven Plus 200 mg/5 ml Oral
Suspension. It will be referred to throughout this leaflet as
“Pinofen Seven Plus”.
This medicine is available without prescription, but you still
need to give Pinofen Seven Plus carefully to get the best
results from it. Always use 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 pharmacist. This
includes any possible side effects not listed in this leaflet.
(See section 4).
- You must talk to your doctor if your child does not feel
better or feels worse after three days.
What is in this leaflet:
1. What Pinofen Seven Plus is and what it is used for
2. What you need to know before you give Pinofen Seven Plus
3. How to give Pinofen Seven Plus
4. Possible side effects
5. How to store Pinofen Seven Plus
6. Contents of the pack and further information

1. What Pinofen Seven Plus is and what it is
used for
Pinofen Seven Plus contains Ibuprofen as the active
ingredient. Each 5 ml of oral suspension contains 200 mg of
ibuprofen. This is twice the strength of normal ibuprofen
suspension and you should be careful that you use the
correct dose.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Pinofen Seven Plus is given to children aged 7 - 12 years
as a painkiller for relief of mild to moderate muscular pain,
headache and dental pain. It also reduces the temperature in
fever and relieves the symptoms of colds and influenza.
This medicine should not be used for more than 3 days.

2. What you need to know before you give
Pinofen Seven Plus
Do NOT give this medicine if your child:
• has an allergy or hypersensitivity to ibuprofen or any of the
other ingredients in this medicine (see Section 6 and Section
2: Important information about ingredients)
• has had an allergic reaction such as wheezing, an asthma
attack, runny nose, skin reaction or swelling after taking
aspirin or other non-steroidal anti-inflammatory painkillers
• has ever had a stomach ulcer or a history of bleeding into,
or perforation of, the intestine especially after previous
NSAID treatment
• is taking any other non-steroidal anti-inflammatory
painkillers (NSAIDs) such as naproxen.
• is taking aspirin at doses above 75 mg daily
• has ever had severe kidney, heart or liver problems
• is suffering from severe dehydration
• has an inherited intolerance to some sugars
• is less than seven years of age or weighs less than 20 kg.
Warnings and precautions
You should discuss your child’s treatment with your doctor or
pharmacist before giving this medicine if your child:
• has kidney, liver or bowel problems
• has lupus (SLE) or mixed connective tissue disease
• has a chronic inflammatory bowel disease such as
ulcerative colitis or Crohn's disease

• has asthma or allergic diseases of the lungs
• has chickenpox
If any of these apply, ask for advice from a doctor or
pharmacist before using this medicine.
Medicines such as Pinofen Seven Plus 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.
There is a risk of renal (kidney) impairment in dehydrated
children.
Drinking alcohol while taking ibuprofen may increase the risk
of certain side effects.
Other medicines and Pinofen Seven Plus

Please tell your doctor or pharmacist if your child is taking,
has recently taken or might take any other medicines,
including medicines obtained without a prescription.
Pinofen Seven Plus may affect or be affected by some
medicines. For example:
• any other ibuprofen preparations or NSAID painkillers,
including those you can buy without a prescription.
• aspirin
• medicines that are anticoagulants (i.e. thin blood/ prevent
clotting, e.g. aspirin, warfarin)
• medicines that reduce high blood pressure (ACE inhibitors
such as captopril, beta-blockers such as atenolol,
angiotensin-II receptor antagonists such as losartan)
• cardiac glycosides (used in the treatment of heart
problems, such as digoxin)
• ciclosporin or tacrolimus (used to suppress the body’s
immune system)
• corticosteroids (anti-inflammatory drugs, such as
prednisolone or beclomethasone.)
• diuretics (to help pass water such as furosemide or
bendroflumethiazide)
• lithium, or selective serotonin reuptake inhibitors (SSRIs
such as fluoxetine - used to treat mood disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis
and some cancers)
• mifepristone (used to terminate pregnancy)
• quinolone antibiotics (used to treat a wide range of
infections e.g. ciprofloxacin)
• zidovudine (used to treat HIV)
Some other medicines may also affect or be affected by the
treatment of Pinofen Seven Plus. You should therefore
always seek the advice of your child’s pharmacist or doctor
before you give Pinofen Seven Plus with other medicines.
Important information about some of the ingredients of
this medicine:

• maltitol (E965) may have a mild laxative effect (calorific
value 2.3 kcal/g). If you have been told that you or your
child has an intolerance to some sugars, contact your doctor
before taking/giving this medicine.
The following warnings are less likely to apply to children but
should be considered before giving this medicine.
• ibuprofen belongs to a group of medicines which may
impair fertility in women. This is reversible on stopping the
medicine. It is unlikely that this medicine, used occasionally,
will affect your chances of becoming pregnant, however, tell
your doctor before taking this medicine if you have problems
becoming pregnant
• you should only take this product on a doctor’s advice
during the first 6 months of pregnancy
• DO NOT take this medicine if you are in the last 3 months
of your pregnancy
• in limited studies, ibuprofen appears in the breast milk in
very low concentration and is unlikely to affect the breast-fed
infant adversely
• medicines such as Pinofen Seven Plus 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
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• you should discuss your treatment with your doctor or
pharmacist if you have diabetes, high cholesterol, high blood
pressure, 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 or feet due to narrow or blocked arteries), or any kind of
stroke (including ‘mini stroke’ or transient ischaemic attack
‘TIA’), or if you have a family history of heart disease or
stroke, or if you are a smoker.
Driving and using machines
Pinofen Seven Plus is not expected to affect your ability to
drive or operate machinery.

3. How to give Pinofen Seven Plus
This product is twice the strength of normal ibuprofen
suspension and you should be careful that you use the
correct dose.
Always use Pinofen Seven Plus exactly as described in this
leaflet or as your doctor or pharmacist has told you. Check
with your doctor or a pharmacist if you are unsure. Shake the
bottle well before measuring the dose. A measuring device is
provided to ensure accuracy.
This product is intended for short term use only. You
should use the lowest dose for the shortest time necessary
to relieve symptoms.
Age

How Much

Under seven years

Do not use

Seven - nine years

One 5 ml spoonful up to
three times in 24 hours

Ten - twelve years

One 5 ml spoonful and
one 2.5 ml spoonful up to
three times in 24 hours

• Do not give to children under 7 years of age, or
those weighing less than 20 kg
• Separate the doses evenly (every 6-8 hours).
Leave at least 4 hours between doses.
• Do not give more than 3 doses in any 24 hour period.
Warning: Do not exceed the stated dose
You must talk to your doctor or pharmacist if your child
does not get better or feels worse after three days.
If you give more medicine than you should - If your child
takes more than the stated dose (an overdose), you should
contact a doctor immediately, or go to the nearest hospital
casualty department, and take the bottle with you if you can.
If you forget to give this medicine - If you forget to give a
dose, give it as soon as you remember, unless it is almost
time for the next dose. Do not give a double dose to make
up for the missed dose.
For oral use only.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, ibuprofen can cause side effects, although
not everybody gets them. The most common side effect is
irritation of the stomach which can cause problems
in some patients.
If any of the following occur, stop giving the medicine and
seek immediate medical help:
• passing blood in the stools (faeces/motions)
• passing black tarry stools
• vomiting blood or dark particles that look like coffee grounds
• unexplained wheezing, shortness of breath, skin rash
(which may be severe and include blistering or peeling of
the skin), itching or bruising, light-headedness, racing of the
heart or fluid retention e.g. swollen ankles, not passing
enough water
• stiff neck, headache, nausea, vomiting, fever and
disorientation
• swelling of the face.
If any of the following occur, stop giving the medicine and tell
your doctor:
• if your child’s skin starts to turn red or if they develop a
painful skin reaction or their skin starts to blister or peel this is very rare

• unexplained stomach pain, indigestion, heartburn, feeling
sick and/or vomiting
• yellowing of the eyes and/or skin
• severe sore throat with high fever or unexplained bleeding,
bruising and tiredness.
Other unusual effects may include the following:
Uncommon:
• headache, dizziness, sleeplessness, agitation, irritability or
tiredness
• visual disturbances
Rare:
• flatulence, diarrhoea or constipation
• ringing in the ears (tinnitus)
• kidney damage, increased blood uric acid levels.
Very Rare:
• occasionally hypersensitivity reactions may occur which
can cause skin rashes as well as asthma attacks, swelling of
the tongue and breathlessness
• liver problems may occur with ibuprofen
• passing less urine than normal, increased proteins in the
blood (detected by tests)
• crohn's disease or ulcerative colitis or other stomach
problems may be exacerbated
• depression or psychotic reactions
• hair loss
• high blood pressure.
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 Pinofen Seven Plus
Keep this medicine out of the sight and reach of children. Do
not use this medicine after the expiry date, which is shown
on the bottle. The expiry date refers to the last day of that
month. Do not store above 25°C. Do not throw away any
medicines via wastewater. Ask your pharmacist how to
throw away any medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and further information
What Pinofen Seven Plus contains
Each 5 ml contains 200 mg of the active ingredient ibuprofen.
The other ingredients are: glycerol (E422), xanthan gum,
liquid maltitol (E965), polysorbate 80, saccharin sodium
(E954), citric acid monohydrate, sodium benzoate (E211),
magnesium aluminium silicate, purified water and strawberry
flavour (contains propylene glycol).

What Pinofen Seven Plus looks like and contents of the pack
Pinofen Seven Plus is a colour-free, white oral suspension.
This medicine comes in amber glass bottles containing 60 ml,
80 ml or 100 ml with a child-resistant closure. Not all pack
sizes may be marketed. A double ended spoon with measures
of 1.25 ml, 2.5 ml and 5 ml is provided.
This medicine should be used within three months of first opening.
Marketing Authorisation Holder
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co.
Tipperary, Ireland.
Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co.
Tipperary, Ireland.
PL Number: 04917/0099
Other sources of information
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge: 0800 198 5000
(UK only). Please be ready to give the following information:
Product name: Pinofen Seven Plus 200 mg/5 ml Oral
Suspension
Reference number: PL 04917/0099
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last updated in May 2017
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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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