Patient leaflet - Ibuprofen 200 mg coated tablets

1. What Ibuprofen Coated Tablets are and what they are 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.

Ibuprofen Tablets are used for the relief of:

! Headaches and migraine pain

! Dental pain and neuralgia

! Period pain

! Rheumatic, muscular and back pain

! Feverishness and symptoms of cold and flu

2. What you need to know before you take Ibuprofen Coated Tablets

Do not take these tablets if you:

are allergic to ibuprofen, aspirin or other pain killers, or
any of the other ingredients of this medicine (listed in section 6)
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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ibuprofen 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 rousing joint pain skin changes and other organ disorders);
are a smoker;
are in the first 6 months of pregnancy;
have an infection – please see heading “Infections” below. · are taking ibuprofen for longer than the recommended
time or at higher than recommended doses you are at risk of serious harm. These include serious harm to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
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 200mg Coated Tablets and contact immediately your doctor or medical emergencies if you notice any of these signs.

Take special care with Ibuprofen 200 mg Coated Tablets: Skin reactions:

Serious skin reactions have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen and seek medical attention immediately, if you develop any skin rash, lesions 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.

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 200 mg Coated Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections:

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

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

Ibuprofen may affect or be affected by some other medicines.

For example:

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

medicines that are anti-coagulants (i.e. thin blood/ prevent
clotting: e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine),
to stimulate your heart (e.g. glycosides),
medicines that 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 pass 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 Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines.

Other warnings

Ibuprofen Tablets belongs to a group of medicines which
may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 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 Ibuprofen 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.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor if you become pregnant whilst taking ibuprofen. Do not take this medicine 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. Avoid the use of this medicine in 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 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. Speak to your doctor or pharmacist before taking this medicine if you are breast feeding.

Ibuprofen Coated Tablets contain lactose and 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 Ibuprofen Coated Tablets

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).

Always take this medicine 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.

Adults, the elderly and children & adolescents between 12 and 18 years:

Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least four hours between doses. Do not take more than 6 tablets 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 forget to take Ibuprofen Coated Tablets

Simply refer to the directions above on how to take the medicine and do not take more than is advised. 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 take more Ibuprofen Coated Tablets than you should

If you take 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.

4. Possible side effects

Like all medicines, Ibuprofen 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
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).
swelling of your face, tongue or throat
chest pain, which can be a sign of a potentially serious
allergic reaction called Kounis syndrome

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). Ibuprofen, 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.

Signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or loss of consciousness. 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).

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 available data:

worsening of asthma or bronchospasm
swelling (oedema), high blood pressure, heart failure or attack
worsening of colitis and Crohn's disease
A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis). Stop using Ibuprofen if you develop these symptoms and seek medical attention immediately. See also section 2. · skin becomes sensitive to light. Medicines such as
Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

See Section 2 'Other warnings'.

Hypokalaemia
Renal tubular acidosis

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: https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Coated Tablets

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.

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 Coated Tablets contain

The active substance is Ibuprofen.

Each Ibuprofen 200mg Coated Tablet contains 200mg of the active ingredient ibuprofen.

The other ingredients are: Lactose (see section 2, “Ibuprofen Coated Tablets contain lactose and sucrose”), Povidone, Maize starch, Purified talc, Magnesium stearate, Colloidal Anhydrous Silica, Croscarmellose sodium, Macrogol, Calcium Carbonate, Sucrose (see section 2, “Ibuprofen Coated Tablets contain lactose and sucrose”), Titanium dioxide and carnauba wax.

What Ibuprofen Coated Tablets looks like and contents of the pack

Ibuprofen 200mg Coated Tablets are white, circular sugar coated tablets.

Ibuprofen 200mg Coated Tablets are supplied in PVC/Aluminium foil blister packs containing 4, 10, 12 and 16 tablets.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Ennogen Pharma Ltd,