WELL PHARMACEUTICALS IBUPROFEN 200 MG COATED TABLETS, IBUPROFEN 200 MG COATED TABLETS - patient leaflet, side effects, dosage

IBUPROFEN COATED TABLETS 200 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 10 days.

The product name, Ibuprofen Coated Tablets 200 mg is referred as Ibuprofen Tablets in the leaflet.

What is in this leaflet

• 1. What Ibuprofen Tablets are and what they are used for

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

• 3. How to take Ibuprofen Tablets

• 4. Possible side effects

• 5. How to store Ibuprofen Tablets

• 6. Contents of the pack and other information

• 1. What Ibuprofen Tablets are and what they are used for

  300 mm

  
  

Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs, which work by changing the body's response to pain, swelling and high temperature. These tablets are used to provide relief of headache, muscular pain, rheumatic pain, pain of non serious arthritic conditions, backache, neuralgia (nerve pain), migraine, period pain, dental pain, feverishness and the symptoms of cold and flu.

2. what you need to know before you take ibuprofen tablets

Do not take Ibuprofen Tablets if you:

• have had an allergic reaction to aspirin, Ibuprofen, any other NSAIDs or any of the ingredients (see section 6 for further information)
• 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 75 mg Aspirin a day, if you are on low dose aspirin (up to 75 mg 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 of age.

Warnings and precautions

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

• have or had asthma
• have kidney, heart, liver or bowl 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 – please see heading “Infections” below.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen Tablets treatment. You should stop taking Ibuprofen Tablets 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.

Infections

Ibuprofen Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Tablets 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 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 75 mg 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 passing water (diuretics)
• For temporary suppression of your immune system (e.g. methotrexate, ciclosporine, 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 chance 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 the treatment.
• You should discuss your treatment with your doctor or pharmacist before you take Ibuprofen if you: – have heart problems including heart failure, angina (chest pain) or if you have had 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 ischemic 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.

Do not take this medicine in the last 3 months of the pregnancy. Avoid the use of this medicine in the first 6 months of the pregnancy, unless the doctor advices otherwise.

Speak to your doctor or pharmacist before taking this medicine if you are breast-feeding.

Driving and using machinery

Taking Ibuprofen Tablets will not affect your ability to drive or use machines.

Ibuprofen Tablets contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars you should not take this medicine.

Advice for patients on a controlled sodium diet: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Taking with food and drink

Ibuprofen Tablets should be taken with water, preferably with or after food.

3. how to take ibuprofen tablets

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

This product is intended 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).

Adults, the elderly and children over 12 years

Dose for Ibuprofen:

• Take one to two tablets with water to start with, preferably with or after food, followed by one to two tablets every four hours if necessary up to three times a day
• Do not take more than six tablets in any twenty four hour period.
• You should not take Ibuprofen for longer than 10 days unless your doctor tells you to.
• If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Children under 12 years

Do not give Ibuprofen Tablets to children under 12 years old.

If you take more Ibuprofen Tablets than you should

If you have taken more Ibuprofen than you should, or if children have taken 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

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop using Ibuprofen Tablets

Please speak to your doctor or pharmacist before stopping this or any medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 get 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 reaction 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 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 consciousness, patients with auto immune 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 affect 1 in 100 users:

• 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
• Headache.

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.
• 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 generalised exanthematous pustulosis). Stop using Ibuprofen Tablets 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“.

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: 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

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

• Do not store above 25°C.
• Store in the original package to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
• 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 informationwhat ibuprofen tablets containeach tablet contains the active ingredient ibuprofen bp 200 mg.

The other ingredients are Lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, starch, colloidal anhydrous silica, magnesium stearate, sucrose, talc and titanium dioxide (E 171).

What Ibuprofen Tablets look like and contents of the pack

This product contains white round shaped sugar coated tablets. Ibuprofen is available in blister packs of 6, 12, 16, 24, 48, 84 and 96 tablets*.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House, Gorse Lane,

Widnes, Cheshire, WA8 0RP, UK.

*Not all pack sizes may be marketed.

PL 20395/0090.

Date leaflet revised: February 2021.

160 mm