Nurofen Joint & Back Pain Relief 200mg Soft Capsules
0005 651 article 31 ibup
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V
' B INFORMATION FOR THE USER:
i
; Read all of this leaflet carefully because it contains important ! |information for you.
_]----.This medicine is available without prescription. However, you
6till need to take this medicine carefully to get the best results from it. j- Keep this leaflet. You may need to read it again.
If you have any further questions once you have read it, ask your ! doctor or pharmacist.
You must contact a doctor if your symptoms worsen or do not i Improve after 3 days (or children and adolescents between 12 j and 18 years and after 10 days for adults.
i- If any of the side effects gets serious, or if you notice any side ! effects not listed in this leaflet, please tell your doctor or ; pharmacist, jin this leaflet:
.1. What Nurofen Joint & Back Pain Relief 200mg Soft Capsules are j and what they are used for
<2. Before you take Nurofen Joint & Back Pain Relief 200mg Soft ! Capsules
|3. How to lake Nurofen Joint & Back Pain Relief 200mg Soft
i Capsules
]4. Possible side effects
6. How to store Nurofen Joint & Back Pain Relief 200mg Soft ! Capsules 6. Further information
1. What Nurofen Joint & Back Pain Relief 200mg Soft Capsules are and what they are used for
The active ingredient (which makes this medicine work) is ibuprofen. it belongs to a group of medicines known as non-steroidal ianti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling and high temperature.
Nurofen Joint & Back Pain Relief 200mg Soft Capsules are used for !the effective relief of fever and pain, such as:
* headaches and migraine pain
i* nerve pain, backache, period pain, rheumatic and muscular pain ;• cold and flu symptoms » dental pain.
2. Before you take Nurofen Joint & Back Pain Relief 200mg Soft Capsules_
bo not take these capsules If you:
!• are allergic to ibuprofen or any of the other ingredients of this ; product (see section 6), or to aspirin or other related painkillers !• have (or have had Iwo or more episodes of) a stomach ulcer, j perforation or bleeding
i» have had a worsening of asthma, allergic rash or itchy, runny j nose or facial swelling when taking similar medicines » ever had stomach bleeding or a perforation when previously ! taking NSAIDs » are taking other NSAIDs
.• are taking more than 75 mg of aspirin a day. If you are on low | dose aspirin (up to 75mg daily) speak to your doctor or i pharmacist before you take this medicine.
!• have severe live or kidney problems
• have heart problems, high blood pressure or blood coagulation i disorder
have breathing difficulties i» are in the last 3 months of pregnancy !• are under 12 years old
Check with your doctor or pharmacist before taking this medicine jlf you:
i* have or have had asthma
have kidney, heart, liver, or bowel problems » have high cholesterol or previously have had a heart attack or j stroke
» have a history of gastrointestinal disease (such as ulcerative ! colitis, Crohn's disease)
]• have systemic lupus erythematosus (a condition of the immune i system causing joint pain, skin changes and other organ j disorders)
* are a smoker
!• are in the first 6 months of pregnancy.
Jf symptoms persist or worsen, consult your doctor.
Taking other medicines
To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g.) aspirin, ibuprofen). If you are on low dose aspirin (up 1o 75mg daily), speak to your doctor or pharmacist before you take this medicine.
Nurofen may affect or be affected by some other medicines. For example:
■ as anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• 1o stimulate your heart (e.g. glycosides)
■ to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)
• to help you passing water (diuretics)
• for the temporary suppression of your immune system (e.g. methotrexate, cyclosporine, 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 Nurofen. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen with other medicines.
Other warnings
• This product belongs to a group of medicines which may Impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this product, if used occasionally, will affect your chances of becoming pregnant. However, tell you doctor before taking this medicine if you have problems becoming pregnant.
• Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
• You should discuss your treatment wilh your doctor or pharmacist before taking Nurofen 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.
• There is a risk of kidney problems in dehydrated children and adolescents.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant whilst taking this product.
Do not take the capsules if you are in the last 3 months of pregnancy. Avoid Ihe use of this medicine in the first 6 months of pregnancy, unless the doctor advises otherwise.
Speak to your doctor or pharmacist for advice before taking any medicine if you are breast-feeding.
Important Information about some of the Ingredients of Nurofen Joint & Back Pain Relief 200mg Soft Capsules
These capsules contain
• sorbitol. If you have been told by your doctor that you have an intolerance ta some sugars, contact your doctor before taking these capsules.
• potassium (18mg per capsule). To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
3. How to take Nurofen Joint & Back Pain Relief 200mg Soft Capsules
This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Adults, the elderly and children and adolescents between 12 and 18 years:
Take one or Iwo capsules (200mg - 400mg), up to Ihree times a day as required.
Leave at least 4 hours between doses and do not take more than 6 capsules in 24 hours.
Do not give to children under 12 years.
Do not take this medicine for longer than 10 days unless your doctor tells you to.
jrsympfoms persist or worsen, or it any new symptoms occur, '
consult your doctor or pharmacist.
jin children and adolescents between 12 and 18 years:
ilf in children and adolescents this medicinal product is required for jmore than 3 days, or if symptoms worsen a doctor should be consulted.
If you take more Nurofen Joint & Back Pain Relief 200mg Soft iCapsules than you should, you may feel drowsy or nauseous.
|You should seek immediate medical advice in case of an overdose, even if you feel well.
(f you forget to take Nurofen Joint & Back Pain Relief 200mg Soft ICapsules
jDo not take a double dose, to make up for a missed dose. Simply refer to the directions above on how to take the medicine and do not |take more than is advised.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen Joint & Back Pain Relief 200mg Soft jCapsules can cause side effects, although not everybody gets them. |lf you suffer from any of the following, at any time, during your treatment STOP TAKING the medicine and seek immediate fredlcal help:
» pass blood in your faeces (stools/motions)
!• pass black tarry stools
|* vomit any blood or dark particles that look like coffee grounds i* difficulty in breathing, unexplained wheezing, worsening of | existing asthma
• other allergic type reactions (e.g. swelling of the face or throat,
! low blood pressure, fast heart rate)
jSTOP TAKING the medicine and tell your doctor if you experience any of the following side effects, or anything unusual happens:
!• indigestion or heartburn
» abdominal pain (pains in your stomach) or other abnormal ! stomach symptoms.
j» a skin rash (which may be severe), itchy skin or blisters [Medicines such as Nurofen Joint & Back Pain Relief 200mg Soft Capsules may be associated with a small increased risk of heart iattack (myocardial infarction) or stroke.
I
Please tell your doctor or pharmacist if you experience any of the following side effects, they become worse or If you notice any jother effects not listed.
i* oedema (fluid retention), high blood pressure (hypertension) and j heart failure » headache
!• nausea, diarrhoea, constipation, vomiting and flatulence (wind)
<• skin peeling
i* kidney and liver disorders
j* blood disorders. The first signs can be fever, sore Ihroat, mouth 1 ulcers, 'flu-like symptoms, severe exhaustion, unexplained ! bleeding and bruising.
* meningitis symptoms such as fever and chills, severe headache, i nausea, vomiting and stiff neck (in patients with existing
j auto-immune disorders such as systemic lupus erythematosus). » worsening of colitis or Crohn's disease (inflammation of the ! bowel).
Ilf any of the side effects gets serious, or if you notice any side effects pot listed in this leaflet please tell your doctor or pharmacist.
Reporting of side effects
lit you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You lean 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 Ihe safety of this medicine.
5. How to store Nurofen Joint & Back Pain Relief 200mg Soft Capsules
keep all medicines out of the sight and reach of children.
jDo not use these capsules after the expiry date printed on the blister or carton. The expiry date refers to the tost day of that month.
|Keep the capsules in the original pack.
'Do not store above 25°C.
Iln case of poor storage conditions, this product may deteriorate, jlf you notice any signs of leakage of the capsules or change in colour, you should discard the capsules.
iMedicines should not be disposed of via wastewater or household jwaste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Nurofen Joint & Back Pain Relief 200mg Soft Capsules contains
The active ingredient is: ibuprofen 200mg.
The olher ingredients are: macrogol 600, potassium hydroxide, gelatine, sorbitol (E420), purified water, Opacode WB white NS-78-18011 (titanium dioxide (E17l), hypromellose, propylene glycol).
(see also end of Section 2"Important information about some of fhe ingredients of Nurofen Joint & Back Pain Relief 200mg Soft Capsules').
What Nurofen Joint & Back Pain Relief 200mg Soft Capsules look like and contents of the pack
Each Nurofen Joint & Back Pain Relief 200mg Soft Capsules is an oval clear capsule printed in white with a logo.
This product is available in packs of 4,10 and 16 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd 103-105 Bath Road Slough, SL1 3UH United Kingdom
Manufacturer
Reckitt Benckiser Healthcare International Lid Thane Road Nottingham NG90 2DB, UK
Banner Pharmacaps Europe B.V. De Posthoornslraat 7 Tilburg
5048 AS, The Netherlands
PL 00063/0651
Text revised: September 2015.
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1.3.1 Package Leaflet
Ibuprofen 200 mg Pain Relief Soft Capsules (Octopus) - PL-00063-0651
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