Ibuprofen Tablets 400mg PACKAGE LEAFLET: INFORMATION FOR THE USER – patient leaflet, side effects, dosage

1. WHAT IBUPROFEN TABLETS 400MG ARE AND WHAT THEY ARE USED FOR

Ibuprofen Tablets 400mg contain the active ingredient ibuprofen. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

They work by relieving pain, reducing inflammation, swelling and fever.

Ibuprofen Tablets 400mg are used to treat mild to moderate pain including:

! Rheumatic and muscular pain

! Backache

! Headache

! Dental pain

! Migraine

! Neuralgia

! Period pain

! Symptoms of colds and flu

! Fever.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS 400MG

Do not take Ibuprofen Tablets 400mg if you:

! Are allergic to ibuprofen or any of the other ingredients of

this medicine (listed in section 6).

! Have previously had a reaction e.g. asthma, runny nose,

itchy skin or swelling of the lips, face or throat after taking these types of medicines (NSAIDs including aspirin) ! Have (or have had two or more episodes of) a stomach

ulcer, perforation or bleeding in the past

! Have had gastrointestinal bleeding or perforation when

previously taking NSAIDs (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

! Have severe liver or kidney problems or have heart failure ! Are in the last 3 months of pregnancy

! Have a condition which increases your tendency to

bleeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ibuprofen Tablets 400mg if you:

! Have an infection - please see heading "Infections" below. ! Have or have had asthma

! Have kidney, heart, liver or bowel problems ! Have Systemic Lupus Erythematosus (SLE) a condition of

the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs ! Are currently taking other NSAIDs

! Have a history of gastrointestinal disease (such as

ulcerative colitis or Crohn's disease)

! Are in the first 6 months of pregnancy

! Have heart problems, have had a previous stroke or think

that you may be at risk of these conditions (for example if you have high blood pressure or are a smoker). ! Have signs of an allergic reaction to this medicine,

including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen Tablets 400mg and contact immediately your doctor or medical emergencies if you notice any of these signs.

If you are taking Ibuprofen Tablets 400mg for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Infections

Ibuprofen Tablets 400mg may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Tablets 400mg 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.

Other warnings

Ibuprofen Tablets 400mg belongs to a group of medicines which may impair female fertility. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 400mg 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 like 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 Ibuprofen Tablets 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 or 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.

There is an increased risk of the elderly having side effects.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen Tablets 400mg and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and IbuprofenTablets 400mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticodipine), some medicines that reduce blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor if you are taking any of the following medicines in addition to those mentioned above.

Ibuprofen Tablets 400mg may affect or be affected by some other medicines. For example:

! Aspirin or other non-steroidal anti-inflammatory drugs

(NSAIDs) for pain relief

! Corticosteroids (e.g hydrocortisone) given to treat a

variety of conditions such as allergies and hormone imbalances

! Quinolones e.g ciprofloxacin (antibiotics used to treat

infections) may cause fits and aminoglycosides (e.g. gentamicin) used to treat infections

! Ginko biloba the herbal extract used to treat memory

disturbances

! Cardiac glycosides such as digoxin (used for some heart

conditions) may worsen heart failure

! Diuretics (water tablets) effects may be decreased.

Potassium sparing diuretics may increase the blood level of potassium

! Ciclosporin or tacrolimus (medicines used to prevent

rejection after transplant) may harm kidney function ! Lithium (medicine to treat depression) or digoxin

(medicine to treat impaired heart function) increase in blood levels of these medicines

! Selective serotonin reuptake inhibitors (SSRIs) e.g

fluoxetine used to treat depression

! Mifepristone (used to induce abortion). NSAIDs should

not be used 8-12 days after taking mifepristone as NSAIDs can reduce mifepristone's effectiveness ! Methotrexate (to treat psoriasis, rheumatoid arthritis and

certain tumors)

! Medicines to treat HIV (e.g. zidovudine)

! Medicines known as sulphonylureas such as

glibenclamide (used to treat diabetes)

! Medicines to treat fungal infections such as voriconazole or

fluconazole

! Medicines that are anti-coagulants (i.e. thin blood/prevent

clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine) ! Medicines that reduce high blood pressure (ACE-inhibitors

such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).

Some other medicines may also affect or be affected by treatment with Ibuprofen Tablets 400mg. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Tablets 400mg with other medicines.

Pregnancy, breast-feeding and fertility

Tell your doctor if you become pregnant while taking Ibuprofen Tablets. Do not take Ibuprofen Tablets 400mg if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Ibuprofen Tablets 400mg during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Ibuprofen Tablets 400mg can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

You should talk to your doctor or pharmacist before taking these tablets if you are breast-feeding.

Driving and using machines

These tablets may make you feel dizzy, drowsy, tired or have visual disturbances. If you think that you are affected after taking these tablets do not drive, operate tools or machinery.

Ibuprofen Tablets 400mg contain sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE IBUPROFEN TABLETS 400MG

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

These tablets are 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). Swallow the tablets whole with a glass of water.

Adults, the elderly and children over 12 years:

! Take 1 tablet up to three times a day as required. ! Leave at least 4 hours between doses. Do not take more

than 3 tablets in 24 hours.

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

Do not give to children under 12 years old.

If you take more Ibuprofen Tablets 400mg than you should

If you have taken more Ibuprofen Tablets 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 forget to take Ibuprofen Tablets 400mg

Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

STOP TAKING Ibuprofen Tablets 400mg and seek immediate medical help if you experience:

! Signs of aseptic meningitis such as severe headache, high

temperature, stiffness of the neck or intolerance to bright light.

! Signs of intestinal bleeding such as

, Passing blood in your faeces (stools/motions) , Passing black tarry stools

, Vomiting any blood or dark particles that look like coffee

grounds.

! Reddish non-elevated, target-like or circular patches on the

trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). ! Widespread rash, high body temperature and enlarged

lymph nodes (DRESS syndrome).

! A red, scaly widespread rash with bumps under the skin and

blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).

TELL YOUR DOCTOR AND STOP TAKING IBUPROFEN TABLETS 400MG IF YOU EXPERIENCE:

! Unexplained stomach pain (abdominal pain) or other

abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting

! Unexplained wheezing, shortness of breath, skin rash,

itching or bruising (these may be symptoms of an allergic reaction)

! Yellowing of the eyes and/or skin (jaundice)

! Severe sore throat with high fever (these may be symptoms

of a condition known as agranulocytosis)

! Blurred or disturbed vision (visual impairment) or

seeing/hearing strange things (hallucinations) ! Fluid retention e.g. swollen ankles (this may be a sign of

kidney problems)

! Severe spreading skin rash (Stevens-Johnson Syndrome

and erythema multiforme, symptoms include severe skin rash, blistering of skin, including inside mouth, nose and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches and feverishness)

! 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).

! Liver, kidney problems or difficulty urinating

Ibuprofen Tablets 400mg, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Medicines such as Ibuprofen Tablets 400mg have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Medicines such as Ibuprofen Tablets 400mg have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles.

Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.

Very rarely Ibuprofen Tablets 400mg may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).

Ibuprofen Tablets 400mg have also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.

Other side effects

Common (may affect up to 1 in 10 people):

! Rash

! Feeling dizzy or tired

! Stomach pain, indigestion, diarrhoea, feeling sick, being

sick, wind, constipation

! Headache - if this happens while you are taking this

medicine it is important not to take any other medicines for pain to help with this.

Uncommon (may affect up to 1 in 100 people):

! Feeling drowsy

! Feeling anxious

! Feeling a tingling sensation or 'pins and needles'

! Difficulty sleeping

! Hives, itching

! Skin becomes sensitive to light

! Visual disturbances, hearing problems

! Hepatitis, yellowing of your skin or eyes, reduced liver function

! Reduced kidney function, inflammation of the kidneys, kidney failure

! Sneezing, blocked, itchy or runny nose (rhinitis) ! Stomach or gut ulcer, hole in the wall of the digestive tract

! Inflammation of your stomach lining

! Small bruises on your skin or inside your mouth, nose or ears

! Difficulty breathing, wheezing or coughing, asthma or worsening of asthma

! Ringing in ears (tinnitus)

! Sensation of feeling dizzy or spinning (vertigo) ! Mouth ulcers

! Serious allergic reaction which causes swelling of the face or throat.

Rare (may affect up to 1 in 1000 people):

! Feeling depressed or confused

! Fluid retention (oedema)

! A brain infection called 'non-bacterial meningitis' ! Loss of vision

! Changes in blood count - the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, bleeding from the nose and the skin ! Reduction in blood cells (anaemia)

! Serious allergic reaction which causes difficulty in breathing or dizziness

! Severe sore throat with high fever (agranulocytosis).

Very rare (may affect up to 1 in 10,000 people):

! Liver failure

! Heart failure

! Heart attack

! Inflammation of the pancreas

! Skin problems (which can also affect inside your mouth, nose or ears) such as 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis' or 'erythema multiforme' ! High blood pressure.

Not known (frequency cannot be estimated from available data):! Worsening of ulcerative colitis or Crohn's Disease

(inflammation of the colon).

! Renal tubular acidosis

! Hypokalaemia

! Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE IBUPROFEN TABLETS 400MG

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a cool dry place protected from moisture below 25°C.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen Tablets 400mg contain

Ibuprofen Tablets 400mg contain the active substance Ibuprofen 400mg in each tablet.

The other ingredients are: Colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, sucrose, E171, E127, sodium starch glycollate, Opaseal (polyvinyl acetate phthalate, stearic acid (E570)).

What Ibuprofen Tablets 400mg look like and contents of the pack

Ibuprofen Tablets 400mg are pink sugar coated bi-convex tablets.

Ibuprofen Tablets 400mg are packed into packs of 12 or 16 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate

Riverside Way, Dartford

DA1 5BS, UK

Manufacturer

Pharmaserve Limited

Clifton Technology Park

Wynne Avenue, Swinton

Manchester, M27 8FF

United Kingdom

This leaflet was last revised in January 2024.

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