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MANDAFEN 600MG

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Patient Information leaflet

MANDAFEN 600mg
(Ibuprofen)
Read all of this leaflet carefully because it contains
important information for you.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more
information or advice.
1. WHAT MANDAFEN TABLETS ARE AND WHAT
THEY ARE USED FOR
Mandafen tablets contain ibuprofen which belongs to
a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Mandafen 600mg tablets are used to treat mild to

moderate pain including period pains, headache,
migraine and toothache; pain after operations;
rheumatoid arthritis (including juvenile arthritis or
Still’s disease) and other muscle or bone disorders.
2. BEFORE YOU TAKE MANDAFEN TABLETS
Do NOT take Mandafen tablets if:
• you are allergic (hypersensitive) to ibuprofen or
any of the other ingredients of this medicine
(listed in section 6)
• you have a history of allergy to aspirin, ibuprofen or
NSAIDs, which includes attacks of asthma, swelling
of the nose and throat, skin rash or runny nose
• you have an active or history of recurrent peptic
ulcers (more than two)
• you have a history of stomach bleeding or
perforation related to the use of NSAIDs

• you have an increased tendency for bleeding
• you have severe heart, kidney or liver failure
• you are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before you take
this medicine if:
• you have systemic lupus erythematous (SLE) or
connective tissue disease
• you have heart, kidney or liver problems
• you have a history of heart failure or high blood
pressure
• you have asthma or have a history of asthma
• you have a history of stomach or bowel disorders
(e.g. ulcerative colitis, Crohn’s disease)
• you are in the first 6 months of pregnancy or are
trying to become pregnant
• Mandafen 600mg tablets may make it more

difficult to become pregnant. Tell your doctor if
you have problems becoming pregnant
• you are breast-feeding.
Warning: Medicines such as Mandafen 600mg
tablets 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.
If you have heart problems, previous stroke or
think 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.

Taking other medicines
Talk to your doctor or pharmacist before you take
Mandafen if you are taking, or have recently
taken, any of the following:
• medicines for high blood pressure or heart
failure, such as diuretics (water tablets)
• medicines for thinning the blood (anticoagulants e.g. warfarin)
• medicines for depression such as SSRIs or
lithium
• corticosteroids
• certain antibiotics (quinolones e.g. ciprofloxacin)
• other NSAIDs, aspirin or other painkillers
• methotrexate (used to treat some cancers,
psoriasis or arthritis)
• ciclosporin and tacrolimus (used to prevent

rejection of organ transplants)
• mifepristone (used to induce abortion)
• zidovudine (used to treat viral infection)
• aminoglycosides (a type of antibiotic)
• colestyramine (used to lower cholesterol)
• medicines known as sulfonylureas (used to treat
diabetes)
• voriconazole or fluconazole (anti-fungal medicines)
• Ginkgo biloba (a herbal medicine).
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast feeding
Use in pregnancy or breast feeding should be
avoided and only used on advice of your doctor.
Ibuprofen should not be used in the last 3 months

of pregnancy.
Driving and using machines
Side effects such as dizziness, drowsiness,
tiredness and visual disturbances are possible after
taking NSAIDs. If affected, you should not drive or
operate machinery.
Important information about some of the
ingredients of this medicine
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE MANDAFEN TABLETS
Your doctor has carefully chosen the correct
dosage for you. Always follow your doctor’s

instructions and those on the pharmacy label. Ask
your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with a
glass of water or milk, with or after food. Do not
chew, suck, crush or break the tablets to avoid
mouth discomfort and throat irritation.
The usual doses are given below:
Adults: initially 2 to 3 tablets daily in divided
doses; increased if necessary to a maximum of 4
tablets daily. A maintenance dose of 1 to 2 tablets
daily may be adequate.
Elderly: a lower dose should be considered and the
patient should be monitored for gastro-intestinal
bleeding for 4 weeks after starting the tablets.
Children: 20mg per kg body weight daily, in
divided doses. For juvenile rheumatoid arthritis, up

to 40mg per kg daily, in divided doses.
Children under 30kg must not receive more than
500mg per day even in divided doses.
Ibuprofen 600mg Tablets should NOT be taken by
children weighing less than 7 kg.
• Always use the lowest dose for the shortest time
necessary to relieve your symptoms.
• If symptoms persist or worsen consult your doctor.
If you or anyone else takes too many tablets
Contact your doctor immediately or go to your
nearest hospital casualty department. Please take
this leaflet, any remaining tablets and the container
with you.
If you forget to take a tablet take one as soon as
you remember, unless it is nearly time to take the
next dose. Do not take a double dose to make up

for a forgotten dose and do not take more than the
maximum dose per day.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mandafen can cause side
effects, although not everybody gets them.
Side effects will be minimised by using the lowest
dose for the shortest time necessary to control your
symptoms. The incidence of gastro-intestinal side
effects may be greater in the elderly.
STOP TAKING the tablets and seek immediate
medical help if you experience any of the following:
• Stomach irritation or bleeding with any of the
following symptoms:
– pass blood in your faeces (stools/motions)
– pass black tarry stools

– vomit any blood or dark particles that look like
coffee grounds.
• Allergic reactions with any of the following
symptoms:
– asthma, worsening of asthma, wheezing or
difficulty breathing; skin rashes or itching;
swelling of the lips, tongue or face; fast heart
rate, low blood pressure, collapse.
• Severe skin reaction with blistering and peeling.
STOP TAKING the tablets and tell your doctor if
you experience:
• Indigestion or heartburn
• Stomach pains or other abnormal stomach
symptoms.
Medicines such as Mandafen 600mg may be
associated with a small increased risk of heart

attack (“myocardial infarction”) or stroke.
Other side effects:
• nausea, vomiting, diarrhoea, flatulence,
constipation
• inflammation of the pancreas causing severe
stomach and back pain
• blood disorders (symptoms may include
unusual bleeding or bruising, sore throat, fever,
exhaustion or anaemia)
• liver problems such as hepatitis and jaundice
(yellowing of the skin or whites of the eyes)
• kidney problems and swelling caused by fluid
retention, very rarely kidney failure
• high blood pressure and heart failure
• headache, visual disturbances or blurring,
ringing in the ears, impaired hearing

• depression, confusion, hallucination, anxiety
• rhinitis (blocked, runny nose)
• numbness or tingling of the hands or feet
• vertigo, dizziness, tiredness, drowsiness,
malaise, insomnia
• sensitivity of the skin to the sun
• single cases of aseptic meningitis have been
reported
• worsening of symptoms of colitis or Crohn's
disease.
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 MANDAFEN TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use after the expiry date printed on the pack.
6. FURTHER INFORMATION
What Mandafen 600mg tablets contain:
• The active ingredient in each tablet is ibuprofen
600mg.
• The other ingredients are maize starch, cellulose
microcrystalline, sodium starch glycollate (type
A), povidone, alginic acid, silica colloidal
anhydrous, magnesium stearate, croscarmellose
sodium, sodium lauryl sulphate.

• The tablet coating contains lactose monohydrate,
hypromellose, titanium dioxide (E171), Macrogol
4000 and erythrosine lake (E127).
What Mandafen 600mg tablets look like and
contents of the pack:
They are pink, oval shaped, film-coated tablets with
“M” and “A” either side of a break line on one side
and “600” on the other.
They are available in plastic containers of 7, 12, 14,
16, 24, 28, 32, 48, 50, 56, 60, 72, 84, 96, 100, 250
and 500 tablets.
Marketing Authorisation Holder and Manufacturer:
M & A Pharmachem Ltd, Bolton BL5 2AL, UK.
Date of last revision: July 2013
PL 04077/0173

Mandafen
(Ibuprofen)

Please read this leaflet carefully
before taking these tablets. Ask your
doctor or pharmacist if you are not
sure about something.
Each tablet contains 600mg of
Ibuprofen.
Also contains maize starch, cellulose
microcrystalline, sodium starch
glycollate, povidone, alginic acid,
silica colloidal anhydrous, magnesium
stearate, croscarmellose sodium,
sodium lauryl sulphate, erythrosine
(E127), hypromellose (E464), lactose
monohydrate, titanium dioxide
(E171) and Macrogol 4000.
Mandafen 600mg tablets are
available in packs of 84 and 100 and
in dispensing packs.
They are used for the treatment of
rheumatic disease (including juvenile
arthritis) and other muscule or bone
disorders; mild to moderate pain
including period pains; pain after
operations; migraine; fever and pain
in children.
MAHolder and Manufacturer
M&A Pharmachem Ltd,
Bolton BL5 2AL, UK.
PL04077/0173

635 6

(Ibuprofen)


PEEL HERE

Mandafen

PP2353

Please read this leaflet carefully
before taking these tablets. Ask your
doctor or pharmacist if you are not
sure about something.
Each tablet contains 600mg of
Ibuprofen.
Also contains maize starch, cellulose
microcrystalline, sodium starch
glycollate, povidone, alginic acid,
silica colloidal anhydrous, magnesium
stearate, croscarmellose sodium,
sodium lauryl sulphate, erythrosine
(E127), hypromellose (E464), lactose
monohydrate, titanium dioxide
(E171) and Macrogol 4000.
Mandafen 600mg tablets are
available in packs of 84 and 100 and
in dispensing packs.
They are used for the treatment of
rheumatic disease (including juvenile
arthritis) and other muscule or bone
disorders; mild to moderate pain
including period pains; pain after
operations; migraine; fever and pain
in children.
MAHolder and Manufacturer
M&A Pharmachem Ltd,
Bolton BL5 2AL, UK.
PL04077/0173

Mandafen
Base Label:

55mm x 100mm

Leaflet Page 1:

55mm x 65mm

Right Hand Opening

(Ibuprofen)



Left Hand Opening
Overall Leaflet Size:
Page Sizes:

65

63

55 x 501
63

61

61

63

63

62

mandafen
600mg

Please read this leaflet carefully
before taking these tablets. Ask your
doctor or pharmacist if you are not
sure about something.
Each tablet contains 600mg of
Ibuprofen.
Also contains maize starch, cellulose
microcrystalline, sodium starch
glycollate, povidone, alginic acid,
silica colloidal anhydrous, magnesium
stearate, croscarmellose sodium,
sodium lauryl sulphate, erythrosine
(E127), hypromellose (E464), lactose
monohydrate, titanium dioxide
(E171) and Macrogol 4000.
Mandafen 600mg tablets are
available in packs of 84 and 100 and
in dispensing packs.
They are used for the treatment of
rheumatic disease (including juvenile
arthritis) and other muscule or bone
disorders; mild to moderate pain
including period pains; pain after
operations; migraine; fever and pain
in children.
MAHolder and Manufacturer
M&A Pharmachem Ltd,
Bolton BL5 2AL, UK.
PL04077/0173

+ 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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