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MOSS EXTRA STRENGTH IBUPROFEN 400MG TABLETS

Active substance(s): IBUPROFEN

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PATIENT INFORMATION LEAFLET
IBUPROFEN 400mg TABLETS
Please read all this leaflet carefully before you start taking this medicine.
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Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.

WHAT IS IN YOUR IBUPROFEN 400mg TABLETS?
Ibuprofen 400mg Tablets are round, white, film coated tablets, each containing Ibuprofen BP
400mg and the inactive ingredients Pregelatinised Starch, Maize Starch, Anhydrous Silicon
Dioxide, Magnesium Stearate, Polyethylene Glycol and the colour Titanium Dioxide (E171).
Ibuprofen 400mg Tablets are available on prescription from your doctor, who will decide how
many to prescribe for you.
Ibuprofen is a non-steroidal anti-inflammatory medicine.
WHO MAKES YOUR MEDICINE?
Product Licence Holder and Manufacturer of these tablets is:
Max Remedies Ltd, William Nadin Way, Swadlincote, Derbyshire, DE11 0BB, UK
WHAT IS YOUR MEDICINE USED FOR?
Ibuprofen works by reducing the production of the chemical messengers in the body, which
cause the sensations of swelling and pain.
Ibuprofen therefore is used for its anti-inflammatory effects in the treatment of rheumatoid
arthritis, osteoarthritis and other non-rheumatoid arthropathies. Ibuprofen can also be used in
the treatment of non-articular rheumatic conditions such as frozen shoulder (capsulitis) and
lower back pains. Ibuprofen is also used in the treatment of soft tissue injuries such as sprains
and strains.
The analgesic effects of ibuprofen can be used to relieve mild to moderate pain such as dental
and postoperative pain and for the symptomatic relief of headache including migraine
headache.
BEFORE TAKING YOUR MEDICINE
If you answer YES to any of the following questions, or are not sure, DO NOT TAKE THIS
MEDICINE and contact your doctor or pharmacist, as you may need to be given another
medicine instead.



Do you or have you ever suffered from stomach or duodenal ulcers? Or you have (or have
had two or more episodes of) a stomach ulcer, perforation or bleeding.
Have you ever had a previous reaction to ibuprofen, aspirin or other "pain killers"?
This might be asthma, skin rash or itching, or inflammation (swelling) of the membranes
in your nose.




Have you ever had a reaction to any of the other ingredients in Ibuprofen 400 mg Tablets?
Check by reading the list above.
Do you suffer from any bleeding disorders?

If you suffer from any of the following, make sure that your doctor is aware of this before you
take ibuprofen tablets.






Bronchial asthma
Kidney, liver or heart problems, as you may have to take a lower dose of ibuprofen.
Stomach or intestinal disorders.
Are you are a smoker?
Are you are pregnant?

Pregnancy and breastfeeding
Ibuprofen tablets are NOT recommended if you are pregnant or breastfeeding.
Ibuprofen 400 mg Tablets may make it more difficult to become pregnant. You should inform
your doctor if you are planning to become pregnant or if you have problems becoming
pregnant.
Other medicines
Ibuprofen may affect how well other medicines work, when taken at the same time. If you
take any of these types of medicines make sure that your doctor has taken this into account:














Medicine for thinning the blood (anticoagulants).
Medicines for high blood pressure (antihypertensives) including water tablets (diuretics).
A medicine for epilepsy called Phenytoin sodium.
Lithium.
Ciclosporin or Methotrexate.
A heart medicine called Digoxin.
Medicines for inflammation e.g. Steroids (Corticosteroids).
Antibiotics containing Quinolone.
Mifepristone (to induce early termination of pregnancy).
Anti-platelet agents and serotonin reuptake inhibitors (SSRI’s).
Tacrolimus.
Zidovudine.
Anti-hypertensives.

Warnings:
Medicines such as Ibuprofen 400 mg 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 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.
If affected by any of the following symptoms, do not drive or operate machinery:
Headaches, dizziness, problems with vision, drowsiness, confusions, ringing in the ears
(tinnitus) and hallucinations.
There is a risk of renal impairment in dehydrated children and adolescents.

HOW TO USE IBUPROFEN 400mg TABLETS?
Your doctor has carefully chosen the correct dose for you and for that reason you should
always take the dose of medicine prescribed for you.
You must take your tablets as directed by your doctor. The pharmacist's label on the container
will tell you when you should take your tablets.
Ibuprofen tablets should be swallowed whole with a glass of water or milk; it is best to take
them with or after some food. The usual doses are given below:
Adults and Elderly
Take with or after food.
The recommended dosage is 3 tablets daily in separate doses. This will be adjusted by your
doctor as necessary.
If your condition becomes worse, your doctor may ask you to increase the dosage
temporarily, up to 3 tablets four times a day.
A lower dose may be prescribed for elderly patients and those with liver, kidney or heart
problems.
POSSIBLE SIDE EFFECTS
Like many medicines, Ibuprofen may occasionally cause some unwanted effects. Most people using
this medicine as directed by their doctor find it causes them no problems.
STOP TAKING the medicine and tell your doctor if you experience:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal stomach symptoms
• Headaches
• Dizziness
• Drowsiness
• Confusions
• ringing in the ears (tinnitus)
• hallucinations
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine
and seek immediate medical help:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds
• Problems with your vision
Other unwanted effects may also include stomach upsets such as feeling sick (nausea), vomiting,
diarrhoea, indigestion and stomach pains, unexplained wheezing or shortness of breath, skin rashes,
itching, tingling sensations, bruising or facial swelling, fluid retention, nervousness, depression and
insomnia.



Medicines such as Ibuprofen 400 mg Tablets may be associated with a small increased
risk of heart attack ("myocardial infarction") or stroke.
If you experience any other side effects that trouble you, tell your doctor or pharmacist as
soon as possible.





If someone else has swallowed any of your tablets, immediately tell your doctor and
contact your nearest hospital casualty department.
If you forget to take a dose, take a dose as soon as you remember, but do not take more
than the maximum dose per day.
If you take too much Ibuprofen or you feel unwell after taking Ibuprofen, tell your doctor
immediately or contact your nearest hospital casualty department.

REMEMBER: The chance of having an unwanted effect can be reduced by keeping the dose
to the minimum number of tablets possible.
FURTHER INFORMATION





Do not use after the expiry date.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
If your doctor decides to stop treatment, return any leftover tablets to your pharmacist.
Only keep them if your doctor tells you to.

Further information is available from your doctor or pharmacist.
Date of preparation November 2015
Product Licence Number: 31308/0043
POM

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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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