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IBUPROFEN TABLETS BP 200 MG - patient leaflet, side effects, dosage

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Patient leaflet - IBUPROFEN TABLETS BP 200 MG

1. what ibuprofen tablets is and what it is used for

Ibuprofen belongs to a group of medicines called NSAID (non-steroidal antiinflammatory drugs) which work by reducing pain inflammation and fever.

Ibuprofen is used for the symptomatic treatmen of mild to moderate pain including migraine headache period pain and/or fever. In addition, Ibuprofen is used for the symptomatic treatmen of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and inflammation aftersoft tissue injuries.

2. what you need to know before you take ibuprofen tablets you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

  • If you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past
  • If you have suffered from gastrointestinal bleeding or perforation related to previous use of drugs for pain and inflammation (NSAIDs)

If you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs).

  • If you are in the last 3 months of pregnancy
  • You have severe problems with your liver, kidney or heart
  • If you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
  • If you have any active bleeding (including in the brain)
  • If you suffer from a condition of unknown origin resulting in abnormal formation of blood cells

Do not give Ibuprofen to children below 20 kg body weight or younger than 6 years. Do not give Ibuprofen 600 mg and tablets to children and adolescents younger than 15 years.

Warnings and precautions

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

  • If you have an infection – please see heading “Infections” below.
  • If you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases
  • You suffer from liver, kidney or heart problems
  • You suffer from rare conditions known as systemic lupus erythematosus (SLE) or mixed connective tissue disorder.
  • If you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive disorders of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater
  • You have recently undergone major surgery
  • If you have inherited a disorder of the red blood pigment haemoglobin (porphyria)
  • If you have disturbances in the formation of blood cells
  • If you have problems with normal blood clotting mechanism
  • If you are in the first six months of pregnancy
  • If you are breast-feeding

Elderly

If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal.

Ulcers, perforation and bleeding in the stomach or intestines

If you have earlier had an ulcer in the stomach or intestines, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment.

This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped.

Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal.

The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see other medicines and ibuprofen, below).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen treatment.

You should stop taking Ibuprofen tablet 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.

During varicella it is advisable to avoid use of this drug.

Effects on the heart and brain

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 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, or have a family history of heart disease or stroke, or if you are a smoker

Effects on the kidneys

Ibuprofen may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals.

Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery.

Aseptic meningitis (inflammation of the brain membrane without bacterial infection) During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been seen. Although it is probably more likely to occur in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue diseases, it has been reported in patients who do not have an existing long-term disease.

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 precautions

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking Ibuprofen and tell immediately to your doctor.

Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.

Prolonged use of any type of pain killer for headaches can make them worse. If this situation is experienced or suspected, stop taking ibuprofen and consult your doctor. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure.

Ibuprofen may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time.

Ibuprofen may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Children and adolescents

Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age (See section 3).

Ibuprofen may cause kidney problems in children and adolescents who are dehydrated.

Other medicines and Ibuprofen Tablets

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

Ibuprofen may affect or be affected by some other medicines, such as:

  • other NSAIDs including COX-2 inhibitors, since this may increase the risk of gastrointestinal ulcers and bleeding

Medicines that reduce high blood pressure (ACE-inhibitors e.g. captopril betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)^ Lithium (used to treat depression or mania) since the effect of lithium may be enhanced.

  • Methotrexate (used in the treatment cancer and auto-immune diseases).
  • Ciclosporine, tacrolimus (for immunosuppression after organ transplant)since kidney damage may occur.
  • Mifepristone (used to produce an abortion) since NSAIDs can reduce the effect of mifepristone.
  • Anticoagulants (against clotting) such as warfarin or heparin, since the effect of the anticoagulant may be enhanced
  • A group of antibiotics known as quinoline antibiotics (e.g. ciprofloxacin) since the risk of convulsions (fits) may be increased
  • Selective serotonin reuptake inhibitors (SSRI) (medicines used to treat depression) such as paroxetin, sertralin, citalopram as these may increase risk of gastrointestinal bleeding
  • Zidovudine or ritanovir (a medicine used to treat viral infections with the Human Immunodeficiency Virus (HIV)).
  • Platelet aggregation inhibitors (against clotting) such as clopidogrel and ticlodipine
  • Digoxin (for treatment of various heart conditions) since the effect of digoxin may be enhanced
  • Phenytoin (used in prevention of the occurrence of epileptic seizures) since the effect of phenytoin may be enhanced
  • Diuretics (water tablets) since the effect of the diuretics may be weakened
  • Potassium-sparing diuretics since this may lead to hyperkalaemia
  • Cholestyramine (used in the treatment of high cholesterol)
  • Aminoglycosides (medicines against certain types of bacteria) since NSAIDs may decrease excretion of aminoglycosides
  • Probenecid or sulfinpyrazone (for treating gout) since the excretion of ibuprofen may be delayed
  • Sulphonylureas (to treat type 2 diabetes) since the blood sugar levels can be affected
  • Glucocorticoids (used against inflammations) since this may increase the risk of gastrointestinal ulcers or bleeding
  • Bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels)
  • Oxpentifylline ((pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms)
  • Baclofen (a muscle relaxant) because of elevated baclofen toxicity
  • Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
  • Voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), since the effect of ibuprofen may increase. Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is used with either voriconazole or fluconazole.

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.

Ibuprofen with alcohol

Avoid alcohol since it may enhance the side effects of Ibuprofen, especially those affecting the stomach, intestines or central nervous system.

Pregnancy, breast-feeding and fertility

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. Ibuprofen must not be taken in the last 3 months of pregnancy since it may cause major heart, lung and kidney disorders in the unborn child. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions delaying the onset of delivery.

Treatment during the first 6 months of pregnancy will only be prescribed by your doctor if clearly necessary

Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Ibuprofen appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered.

Driving and using machines

Ibuprofen generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced, the ability to take part actively in road traffic or operate machinery may be impaired in individual cases.

This effect is potentiated by simultaneous consumption of alcohol.

Ibuprofen contain Sodium

This medicine contains less than 1 mmol sodium (23 mg) per 200 mg/ 400 mg/ 600mg tablets, that is to say essentially ‘sodium-free’.

3. how to take ibuprofen tablets

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

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).

The treating physician decides on the duration of treatment.

In rheumatic diseases the use of Ibuprofen can be required for a longer period.

Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age. (See section 2).

Ibuprofen 200 mg Tablets

The ibuprofen dose depends on the patient’s age and body weight. The maximum single dose for adults should not be greater than 800 mg of ibuprofen (4 tablets). The recommended dose is:

Mild to moderate pain and fever

Adults and adolescents older than 12 years (>40 kg):

1–2 tablets given as a single dose or 3–4 times a day with an interval of 6 hours. The maximum daily dose should not exceed 6 tablets (1200 mg).

Use in children and adolescents:

Children 6–12 years (>20 kg):

Children 6–9 years (20–29 kg): 1 tablet 1–3 times a day with intervals of 4 to 6 hours as required. The maximum number of tablets should not exceed 3 tablets in one day.

Children 10–12 years (30–40 kg):

  • 1 tablet 1–4 times a day with intervals of 4 to 6 hours as required. The maximum number of tablets should not exceed 4 tablets in one day.

Migraine headache

Adults and adolescents older than 12 years (>40 kg):

  • 2 tablets given as a single dose, if necessary 2 tablets with intervals of 4 to 6 hours.

The maximum daily dose should not exceed 6 tablets (1200 mg).

Period pain

Adults and adolescents over 12 years of age:

1–2 tablets 1–3 times a day, with an interval of 4–6 hours, as needed. The maximum daily dose should not be more than 6 tablets (1200 mg).

Rheumatic diseases

Adults:

The recommended dose is 2–3 tablets daily in divided doses. Lower doses may be prescribed by your doctor. Due to the nature and severity of your condition, the doctor may increase your medication to a maximum of 12 tablets (2400 mg) daily, taken in 3 or 4 divided doses.

Use in children and adolescents:

Adolescents from 15 to 17 years of age :

The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses.

The tablet should be swallowed with a glass of water, preferably after a meal. Patients with sensitive stomach are recommended to take Ibuprofen during a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves.

If a child or adolescent requires this medicine for more than 3 days, or if symptoms worsen, a doctor should be consulted.

Ibuprofen 400 mg Tablets

The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not be greater than 800 mg of ibuprofen (2 tablets).

The recommended dose is:

Mild to moderate pain and fever

Adults and adolescents >40 kg (12 years and above):

^ (half tablet) to 1 tablet given as a single dose or 3–4 times a day with an interval of 6 hours as required. The maximum daily dose should not exceed 3 tablets (1200 mg).

Use in children and adolescents

Children >20 kg body weight (6–11 years):

Other preparations may be more suitable for this age group. Your doctor will advise you accordingly.

Children 20–29 kg (6–9 years):

^ half tablet 1–3 times a day with intervals of 6 hours as required. The maximum number of tablets should not exceed m (one and half) tablet in one day.

Children 30–39 kg body weight (10–11 years):

^ half tablet 1–4 times a day with intervals of 6 hours as required. The maximum number of tablets should not exceed 2 tablets in one day.

Migraine headache

Adults and adolescents >40 kg body weight (12 years and above):

  • 1 tablet given as a single dose, if necessary 1 tablet with intervals of 6 hours.

The maximum daily dose should not exceed 3 tablets (1200 mg).

Period pain

Adults and adolescents >40 kg body weight (12 years of age and above): ^ (half tablet) –1 tablet 1–3 times a day, with an interval of 6 hours as needed.

The maximum daily dose should not be more than 3 tablets (1200 mg).

Rheumatic diseases

Adults :

The recommended dose is 3 –4^ (four and half) tablets (1200 mg- 1800 mg) daily in divided doses. Lower doses may be prescribed by your doctor.

Due to the severity of your condition, the doctor may increase your medication to a maximum of 6 tablets (2400 mg) daily, taken in 3 or 4 divided doses.

Use in children and adolescents

Adolescents from 15 to 17 years of age:

The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily)in 3 to 4 divided doses. Your doctor will advise you accordingly.

The tablet should be swallowed with a glass of water, preferably after a meal.

Patients with sensitive stomach are recommended to take Ibuprofen during a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves.

Elderly

If you are elderly you will be more prone to side effects, especially bleeding ulceration and perforation in the digestive tract, which may be fatal. Your doctor will advise you accordingly.

Reduced kidney or liver function

If you suffer from reduced kidney or liver function, your doctor will advise you accordingly.

Ibuprofen 600 mg Tablets

Ibuprofen is contraindicated in children and adolescents younger than 15 years of age (See section 2).

The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not be greater than 800 mg of ibuprofen. The recommended dose is:

Rheumatic diseases

Adults:

The recommended dose is 1200 mg-1800 mg daily in divided doses. Lower doses may be prescribed by your doctor. Due to the nature and severity of your condition, the doctor may increase your medication to a maximum of 2400 mg daily, taken in 3 or 4 divided doses.

Use in children and adolescents

Adolescents from 15 to 17 years of age.

The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses. Your doctor will advise you accordingly. The tablet should be swallowed with a glass of water, preferably after a meal. Patients with sensitive stomach are recommended to take Ibuprofen during a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves.

Elderly

If you are elderly you will be more prone to side effects, especially bleeding, ulceration and perforation in the digestive tract, which may be fatal. Your doctor will advise you accordingly.

Reduced kidney or liver function

If you suffer from reduced kidney or liver function, your doctor will advise you accordingly.

If you take more Ibuprofen than you should

If you have taken more ibuprofen 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), or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion and shaky eye movement, and exacerbation of asthma in asthmatics. At high doses, drowsiness, excitation, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness and dizziness, blood in urine, low blood pressure, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported.

If you forget to take Ibuprofen

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.

4. possible side effects

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

With regard to the following side effects, it must be considered that they are largely dependent on the dose and that they vary from patient to patient.

The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.

The side effects are stated according to the frequency they occur. The following convention has been used:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people,

Uncommon: may affect up to 1 in 100 people,

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

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

Not known: frequency cannot be estimated from the available data

The following side effects are important and will require immediate action if you experience them. You should stop taking Ibuprofen and see your doctor immediately if the following symptoms occur:

Very common :

  • – heartburn, abdominal pain, indigestion

Common:

  • – black tarry stools or blood-stained vomit (digestive tract ulcer with bleeding)

Uncommon:

  • – visual distrubances

  • – hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low blood pressure)

  • – photosensitivity (increased sensitivity to sunlight)

Rare:

– vision loss

Very rare :

  • – swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing (angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock

  • – sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain

  • – a sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure

  • – severe rash with blisters on the skin especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson's syn­drome). This can get even more severe, the blisters get larger and spread out and parts of the skin may slough off (Lyell's syndrome). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle (necrotizing fasciitis)

Other possible side effects with Ibuprofen are:

Very common:

  • – Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation.

Common:

  • – Digestive tract ulcer with or without perforation. – Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn’s disease) and complications of diverticula of the large bowel (perforation or fistula)

  • – Microscopic bleeding from the intestine which may result in anemia

  • – Mouth ulcers and inflammation (ulcerative stomatitis)

  • – Headache, sleepiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability

Uncommon:

  • – Inflammation of the stomach lining (gastritis)

  • – Kidney problems including development of oedema, inflammation of the kidneys and kidney failure

  • – Runny nose

  • – Difficulty breathing (bronchospasm)

Rare:

  • – Depression, confusion, hallucinations

  • – Lupus erythematosus syndrome

  • – Increase of blood urea nitrogen, serum transaminases and alkaline phosphatase decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease of serum calcium and increase in serum uric acid values

  • – Damage of the kidney tissue

Very rare:

  • – Unpleasant awareness of heart beat, heart failure or heart attack

  • – Disorders of blood cell formation (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia)

The first symptoms or signs may include fever, sore throat, surface mouth ulcers, flulike symptoms, severe fatigue, nasal and skin bleeding)

  • – Ringing or buzzing in the ears

  • – Inflammation of the oesophagus or pancreas

  • – Narrowing of the bowel

  • – Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction, damage or failure

  • – liver damage especially in long-term use or liver failure

  • – Hair loss

  • – Inflammation of the brain membrane without bacterial infection (aseptic meningitis)

Not known:

  • – Tingling of the hands and feet

  • – Anxiety

  • – Impaired hearing

  • – General feeling of being unwell

  • – Inflammation of the optic nerve which may cause vision problems

  • – 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 localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalized 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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website:

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

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 carton after EXP. The expiry date refers to the last day of that month.

Ibuprofen Tablets should be stored below 25°C and protected from light.

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 contains

The active substance is Ibuprofen.

The other ingredients are: pregelatinised starch, maize starch, maize starch paste, magnesium stearate, colloidal anhydrous silica, hydroxypropyl methylcellulose, polyethylene glycol 6000, erythrosine (E127), titanium dioxide (E171) and dioctyl sodium. Ibuprofen tablets 200 mg also contain purified water.

What Ibuprofen looks like and contents of the pack

The tablets are available in three different strengths containing either 200 mg, 400 mg or 600 mg of Ibuprofen.

Ibuprofen Tablets 200 mg tablets are biconvex and pink in colour.

Ibuprofen Tablets 400 mg tablets are also biconvex and pink in colour.

Ibuprofen Tablets 600 mg tablets are capsule shaped and pink in colour.

Ibuprofen Tablets are available in securitainers of 100, 250, 500 and 1000 tablets.

Marketing Authorisation Holder

Polhampton Lane, Overton, 3 & 4 Quidhampton Business Unit, Hampshire., RG25 3ED, United Kingdom

Manufacturer responsible for release:

Waymade Plc,

Sovereign House,

Miles Gray Road, Basildon, Essex SS14 3FR.

This leaflet was last revised in 01/2021