NUROFEN LONG LASTING PAIN RELIEF 300 MG PROLONGED-RELEASE CAPSULES, NUROFEN BACK PAIN 300 MG SUSTAINED RELEASE CAPSULES - patient leaflet, side effects, dosage

INFORMATION FOR THE USER

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nurofen Back Pain 300mg Sustained Release Capsules carefully to get the best results from them. Nurofen Back Pain 300mg Sustained Release Capsules will be referred to as ‘this medicine’ throughout this leaflet.

Keep this leaflet. You may want to read it again.

If you have any further questions after you have read it, ask your doctor or pharmacist.

You must contact a doctor if your symptoms worsen or do not improve after 3 days for children and adolescents between 12 and 18 years and after 10 days for adults.

If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What this medicine is and what it is used for

• 2. What you need to know before you take this medicine 3. How to take this medicine

• 4. Possible side effects

• 5. How to store this medicine

• 6. Contents of the pack and other information

1. what this medicine is and what it is used for

The active ingredient (which makes the medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature.

This medicine is used for the relief of:

• backache rheumatic pain muscular pains

2. what you need to know before you take this medicine

Do not take this medicine if you:

• are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin 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, aspirin or similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non steroidal anti-inflammatory drugs)
• are taking other NSAIDs (Non-Steroidal Anti-inflammatory Drugs)
• are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take this medicine
• have severe liver or kidney problems
• have heart problems, high blood pressure or blood coagulation disorder
• have breathing difficulties
• are in the last 3 months of pregnancy
• are under 12 years old.

Check with your pharmacist or your doctor before taking this product 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, Crohn's disease)
• have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain skin changes and other organ disorders)
• are a smoker
• are in the first 6 months of pregnancy.
• have an infection. This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

• Serious skin reactions have been reported in association with this medicine. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesion of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

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 to 75mg daily), speak to your doctor or pharmacist before you take this medicine.

This medicine may affect or be affected by other medicines.

Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:

• as anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicylic acid, warfarin, ticlopidine),
• to stimulate your heart (e.g. glycosides),
• to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan),
• to help you passing 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).

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 medicine 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.

• 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 with 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 renal impairment in dehydrated children and adolescents

Pregnancy and breast feeding

Tell your doctor if you become pregnant whilst taking this medicine.

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.

Speak to your doctor or pharmacist before taking this medicine if you are breastfeeding.

Important information about some of the ingredients:

This medicine contains Sucrose. 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 this medicine

This product is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Take 1 or 2 capsules with water, up to twice a day as required. Do not chew or suck the capsules. Leave at least 8 hours between doses. Do not take more than 4 capsules in 24 hours. Do not give to children under 12 years.

In children and adolescents between 12 and 18 years:

If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

In adults:

Do not take for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist. If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forgot to take this medicine.

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, this medicine can cause side effects, although not everybody gets them. Side effects may be minimised 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

• STOP TAKING the medicine and seek immediate medical help if you develop: 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 with neck stiffness, headache, feeling sick, being sick, fever or disorientation. Patients with autoimmune disorders (lupus, mixed connective-tissue disease) may be more likely to be affected.
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known). See also section 2. STOP TAKING the 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: may affect up to 1 in 100 people:

• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches

Rare: may affect up to 1 in 1,000 people:

• flatulence (wind), diarrhoea, constipation and vomiting

Very rare: 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
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
• liver problems

Not known: 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
• skin becomes sensitive to light

5. how to store this medicinedo not use after the expiry date stated on the carton after exp. the expiry date refers to the last day of that month.

Do not store above 25o C.

6. contents of the pack and other information

Each capsule contains the active ingredient Ibuprofen 300mg.

They also contain: Sucrose and Maize starch microgranules, Polymers of Methacrylic Acid Esters, Povidone, Polymers of Acrylic and Methacrylic Acid Esters, Talc, Colloidal Silica, Gelatine, Iron Oxide Ink (E172).

This medicine is available in packs of 12, 24, 28, 30, 36, 56, 60 in blister strips.

Not all pack sizes will be marketed.

Marketing Authorisation Holder:

Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ.

Manufacturers:

Reckitt Benckiser Healthcare International Ltd, 1 Thane Road, Nottingham, NG90 2DB, UK. RB NL Brands B.V., WTC Schiphol Airport, Schiphol Boulevard 207, 1118 BH Schiphol, NL.

Product licence number:

PL 00063/0378

Date of revision: December 2021

1.3.1 Package Leaflet – Back pain -Clean

eCTD Ibuprofen 300mg SR Hard Capsules PL 00063–0378

Page 5