Ibuprofen 600mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Ibuprofen
Available from:
DE Pharmaceuticals
ATC code:
M01AE01
INN (International Name):
Ibuprofen
Dosage:
600mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10010100
Authorization number:
; PL 20416/0293

Title:

Ref:

Date:

Size (mm):

Modified:

Ibuprofen 600mg PIL

D-IBU

13/02/18

297(H) x 210(W)

03/12/19

Colours

(Printed)

Process

Black

Colours

(Non printed)

SPECIAL

Cutter

D A L K E I T H

L A B O R A T O R I E S

In this leaflet:

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

2. Before you take Ibuprofen Tablets

3. How to take Ibuprofen Tablets

4. Possible side effects

5. How to store Ibuprofen Tablets

6. Further information

Read all of this leaflet carefully before you start taking

this medicine.

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

This medicine is only for you. Do not give it to anyone else to

take. It may harm them, even if their symptoms are the same

as yours.

If you have any further questions, please ask your doctor or

pharmacist.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this

leaflet. See section 4.

Patient Information Leaflet

Ibuprofen 600 mg Tablets BP

This medicine will be called Ibuprofen Tablets in this leaflet.

D0001/2

1. What Ibuprofen Tablets are and what they are

used for

These tablets contain the active ingredient, ibuprofen. Ibuprofen

is a non-steroidal anti-inflammatory drug (NSAID) which relieves

pain and reduces inflammation.

Ibuprofen Tablets are used to relieve mild or moderate pain for

instance when you have:

Rheumatoid arthritis or osteoarthritis

Ankylosing spondylitis (where you get stiff and painful back

and hip joints)

Pain and swelling in and around other joints

An injury to the soft tissues such as sprains and strains.

2. Before you take Ibuprofen Tablets

Some people

must not

take these tablets. Do not take

these tablets if:

You know you are allergic to ibuprofen or to any of the other

ingredients (these are listed in section 6)

You have had allergic reactions (e.g. asthma, blocked or runny

nose, swelling of the face or throat or itching) when you have

taken aspirin or other NSAID painkillers e.g. naproxen

You have a peptic ulcer (ulcer in your stomach or duodenum)

or bleeding in your stomach, or have had two or more

episodes of peptic ulcers, stomach bleeding or perforation

You have had stomach bleeding or perforation ever caused by

taking NSAIDs

You have severe heart, liver or kidney problems

You have a condition which increases your tendency to bleeding

You are more than 6 months pregnant.

These tablets are not recommended for children.

There is a risk of renal impairment in dehydrated children and

adolescents.

You must be

especially careful

You have, or have ever had asthma as ibuprofen might bring

on an attack

You have a history of problems with your stomach or

intestines e.g. ulcerative colitis or Crohn’s disease

You have heart, liver or kidney problems

You have high blood pressure

You have systemic lupus erythematosus (SLE) or mixed

connective tissue disorder (an immune system disorder)

You are elderly as you may be more likely to suffer side

effects (see section 4).

If any of the conditions above apply to you, please discuss your

treatment with your doctor before taking this medicine.

Taking other medicines

Ibuprofen Tablets may affect or be affected by some other

medicines. For example:

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

clotting e.g. warfarin, acetylsalicylic acid/aspirin, ticlopidine)

Selective serotonin reuptake inhibitors (to treat depression

e.g. fluoxetine)

Diuretics (to increase urine output)

Medicines that reduce high blood pressure (ACE inhibitors

such as captopril, beta-blockers such as atenolol medicines,

angiotensin-II receptor antagonists such as losartan)

Drugs for heart disease e.g. digoxin

Lithium (to treat depression)

Methotrexate (used in cancer treatment)

Ciclosporin or tacrolimus (to prevent rejection in organ and

bone marrow transplants)

Mifepristone (used to terminate pregnancy)

Quinolone antibiotics (for infections)

Aminoglycosides (a type of antibiotic e.g. neomycin)

Zidovudine (to treat HIV infection)

Voriconazole or fluconazole (to treat fungal infections)

Colestyramine (used to lower cholesterol)

Sulfonylureas e.g. glibenclamide (to treat diabetes)

Ginko biloba (a herbal medicine). You may bleed more easily

if you are taking this with ibuprofen

Oral steroids (used in hormone replacement therapy and to

treat inflammation)

Aspirin or any other NSAID painkillers. If you take these at

the same time as ibuprofen you may increase the risk of

getting side effects.

Some other medicines may also affect or be affected by the

treatment of Ibuprofen Tablets. You should therefore always seek

the advice of your doctor or pharmacist before you use Ibuprofen

Tablets with other medicines.

Other special warnings

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

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.

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.

Driving and using machinery

Ibuprofen Tablets may make you feel dizzy, tired, drowsy or might

affect your vision. If you are affected you should not drive or

operate machinery.

Pregnancy and breastfeeding

Are you pregnant, or breast feeding? Check with your doctor

before taking ibuprofen.

3. How to take Ibuprofen Tablets

The tablets should be swallowed with a drink of water. They

should be taken with or after food to reduce the possibility of

side effects.

The doctor will decide what dose of tablets you need to take.

Always take the tablets exactly as the doctor has told you. The

dose will be on the pharmacist’s label. If you are not sure, ask

your doctor or pharmacist. Carry on taking them for as long as

you have been told unless you have any problems. In that case,

check with your doctor.

The usual dose is as follows:

Adults: Take 1 tablet initially, followed by 1 tablet every six hours if

necessary. Do not take more than 4 tablets in any 24 hour period.

Elderly: Your doctor may have told you to take a lower dose than

the usual adult dose stated above. Follow your doctor’s

instructions. Your doctor may want to do some tests after you

start taking these tablets to check you are not bleeding in your

stomach or intestines.

Not recommended for children.

If you take more tablets than you should

If you have taken more Ibuprofen Tablets 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. Take your tablets or the pack with you so

that the doctor knows what you have 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 a dose of Ibuprofen Tablets

If you have missed a dose, take it as soon as you remember and

then take your next dose after 6 hours. Do not take a double

dose to make up for the missed dose.

4. Possible side effects

Like all medicines Ibuprofen Tablets can cause side effects,

although not everybody gets them. There will be fewer side effects

if you take the lowest effective dose for the shortest time necessary.

Stop taking the tablets and seek immediate medical help

if you:

Pass blood in your faeces (stools/motions)

Pass black tarry stools

Vomit any blood or dark particles that look like coffee grounds.

These may be signs of a stomach ulcer or bleeding in your

stomach.

Stop taking the tablets and tell your doctor if you

experience:

Stomach pain or other abnormal stomach symptoms,

indigestion or heartburn

Allergic reactions which can include skin rash, itching,

bruising, painful red areas, flaking, peeling or blistering,

dizziness, difficulty in breathing, wheezing or shortness of

breath, swollen face, throat, lips, hands or fingers or sores

around the nose, mouth, ears, genitals or anus

Yellowing of your skin or whites of your eyes and/or pale

stools, dark urine, loss of appetite as these may be signs of

liver problems

Passing more or less urine than normal, difficult or painful

urination, cloudy or foamy urine, blood in urine, pain in the

back, fever, rash, swelling (particularly of the ankles), high

blood pressure, as these may be signs of kidney problems.

Effects reported vary rarely are:

Inflammation of the pancreas causing severe pain in the

abdomen and back

Stevens-Johnson syndrome (serious illness causing blistering

of the skin, mouth, eyes and genitals)

Toxic epidermal necrolysis (serious illness causing blistering of

the skin)

If you get any of these, stop taking the tablets and tell your

doctor as soon as possible.

Other effects which have been reported are:

High blood pressure, oedema (water retention), heart failure

(which can cause shortness of breath or swollen ankles)

Feeling or being sick, diarrhoea, constipation, flatulence (wind)

or sore mouth

Worsening of the symptoms of colitis and Crohn’s disease

Blood disorders including severe reduction in the number of

white or red blood cells which may cause pale skin, weakness

or breathlessness and increase the risk of bleeding or bruising

or make infections more likely

Frequency (not known): 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 if you develop these

symptoms and seek medical attention immediately. See also

section 2.

Increased sensitivity to sunlight, skin rashes. 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 cell)

Headache, feeling of dizziness or “spinning”, ringing in the

ears, impaired hearing, difficulty sleeping, tiredness,

drowsiness, confusion, anxiety, eyesight problems (such as

blurred, partial or complete loss of vision, change in colour

vison, blind spots, halos around lights), tingling or numbness

in the hands and feet, depression or hallucinations

Aseptic meningitis (especially in patients with auto-immune

disorders such as systemic lupus erythematosus and mixed

connective tissue disease). Symptoms include fever,

headache, stiff neck and back, feeling or being sick, skin rash,

eyes being very sensitive to bright light, disorientation and

muscle pain

Swelling and irritation inside the nose

Inflammation of the stomach lining. Symptoms include

stomach pain or discomfort, feeling or being sick, loss of

appetite, bad taste in the mouth, belching and indigestion

Medicines such as ibuprofen may be associated with a small

increased risk of heart attack (“myocardial infarction”) or stroke.

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: 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

Keep out of the sight and reach of children.

Blisters: Do not store above 25°C. Store in the original package

and in the outer carton to protect the tablets from light and

moisture.

Tablet containers: Do not store above 25°C. Store in the

original container and keep the container tightly closed, in order

to protect the tablets from light and moisture.

Do not use the tablets after the expiry date shown on the carton

or label.

If your doctor tells you to stop taking the tablets, please take any

left over back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each coated tablet contains 600 mg of the active ingredient,

ibuprofen. The other ingredients are maize starch, microcrystalline

cellulose, croscarmellose sodium, povidone, colloidal anhydrous

silica, alginic acid, sodium laurilsulfate, sodium starch glycollate,

magnesium stearate, hydroxypropylcellulose,

hydroxypropylmethylcellulose, polyethylene glycol, erythrosine

(E127) and titanium dioxide (E171).

What the medicine looks like

The tablets are oblong, pink and film coated.

They are supplied to your pharmacist in containers of 50, 84, 100,

250 or 500 tablets. Not all pack sizes may be available.

Product licence holder and manufacturer

The product licence holder is Dalkeith Laboratories Ltd., 2 Park

Street, Woburn, Bedfordshire, MK17 9PG, UK.

Manufactured by RxFarma Ltd., Colonial Way, Watford, Herts,

WD24 4YR, UK.

Product Licence Number: PL 17496/0019

Date of revision: November 2019

If you would like the leaflet in a different format, please contact

the licence holder at the above address.

Continued, please turn over.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ibuprofen Tablets B.P. 600 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Ibuprofen 600 mg

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Pink capsule shaped, biconvex 22 x 10 mm, film coated tablets marked with “ FIL/

I600” on one side and decorative scoreline on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Ibuprofen is indicated for its analgesic and anti-inflammatory effect in rheumatoid

arthritis (including juvenile rheumatoid arthritis or Still’s disease) ankylosing

spondylitis, osteoarthritis and other non-rheumatoid arthropathies.

In non-articular rheumatoid conditions, ibuprofen is indicated in periarticular

conditions e.g. frozen shoulder, bursitis, tendinitis, tenosynovitis and low back pain.

Ibuprofen can be used in soft-tissue injuries, e.g. sprains and strains.

It is also indicated for the relief of mild to moderate pain, e.g. dental and post-

operative pain and dysmenorrhoea.

It is also indicated for the relief of migraine.

4.2

Posology and method of administration

For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for

the shortest duration necessary to control symptoms (see section 4.4).

Adults:

Initial dosage is 1800 mg daily in divided doses. Some patients can be

maintained on

600 -1800 mg daily. In severe or acute conditions it may be advantageous to

increase the dosage provided that the total daily dosage does not exceed

2400 mg in divided doses.

Elderly:

The elderly are at increased risk of the serious consequences of adverse

reactions. If an NSAID is considered necessary, the lowest effective dose

should be used and for the shortest possible duration. The patient should be

monitored regularly for GI bleeding during NSAID therapy.

Children:

Ibuprofen BP 600 mg tablets are not suitable for children.

Undesirable effects may be minimised by using the lowest effective dose for

the shortest duration necessary to control symptoms (see section 4.4).

Do not break the tablet in half.

4.3

Contraindications

Hypersensitivity to any of the constituents.

NSAIDs are contraindicated in patients who have previously shown

hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in

response to ibuprofen, aspirin or other NSAIDs.

Severe hepatic and renal failure and Severe heart failure (NYHA Class IV)

(See section 4.4 Special warnings and precautions for use).

Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).

Active or previous peptic ulcer.

History of upper gastrointestinal bleeding or perforation, related to previous

NSAIDs therapy.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific

inhibitors (See section 4.5 Interactions).

4.4

Special warnings and precautions for use

All patients:

Undesirable effects may be minimised by using the lowest effective dose for the

shortest duration necessary to control symptoms (see section 4.2, and GI and

cardiovascular risks below).

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs especially

gastrointestinal bleeding and perforation which may be fatal (see section 4.2

Posology and method of administration).

Respiratory disorders

Caution is required if administered to patients suffering from, or with a previous

history of, bronchial asthma since NSAIDs have been reported to precipitate

bronchospasm in such patients. The possibility of cross-sensitivity with aspirin and

other NSAIDs should be borne in mind.

Systemic lupus erythematous and mixed connective tissue disease – increased

risk of aseptic meningitis (see section 4.8 Undesirable effects).

Chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease)

– as these conditions may be exacerbated (see section 4.8 Undesirable effects).

There is limited evidence that drugs which impair cyclo-oxygenase/

prostaglandin synthesis may cause impairment of female fertility by an effect

on ovulation. This is reversible upon withdrawal of treatment.

Cardiovascular, renal and hepatic impairment

administration

NSAID

cause

dose

dependent

reduction

prostaglandin formation and precipitate renal failure. Patients at greatest risk of this

reaction

those

with

impaired

renal

function,

cardiac

impairment,

liver

dysfunction, those taking diuretics and the elderly. Renal function should be

monitored in these patients (see also section 4.3).

“There is a risk of renal impairment in dehydrated children

and adolescents.”

For POM:

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of

hypertension and/or mild to moderate congestive heart failure as fluid retention and

oedema have been reported in association with NSAID therapy.

For OTC:

Caution

(discussion

with

doctor

pharmacist)

required

prior

starting

treatment in patients with a history of hypertension and/or heart failure as fluid

retention, hypertension and oedema have been reported in association with NSAID

therapy.

Cardiovascular and cerebrovascular effects

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400

mg/day) may be associated with a small increased risk of arterial thrombotic events

(for example myocardial infarction or stroke). Overall, epidemiological studies do

not suggest that low dose ibuprofen (e.g.

1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II- III),

established

ischaemic

heart

disease,

peripheral

arterial

disease,

and/or

cerebrovascular

disease

should

only

treated

with

ibuprofen

after

careful

consideration and high doses (2400 mg/day) should be avoided.

Careful

consideration

should

also

exercised

before

initiating

long-term

treatment of patients with risk factors for cardiovascular events (e.g. hypertension,

hyperlipidaemia,

diabetes

mellitus,

smoking),

particularly

high

doses

ibuprofen (2400 mg/day) are required.

Severe skin reactions

Serious

skin

reactions,

some

them

fatal,

including

exfoliative

dermatitis,

Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported

rarely in association with the use of NSAIDSs (see section 4.8). Patients appear to

be at highest risk of these reactions early in the course of therapy, the onset of the

reaction occurring in the majority of cases within the first month of treatment.

Acute generalised exanthematous pustulosis (AGEP) has been reported in relation

to ibuprofen-containing products. Ibuprofen should be discontinued, at the first

appearance of signs and symptoms of severe skin reactions, such as skin rash,

mucosal lesions, or any other sign of hypersensitivity.

4.5

Interaction with other medicinal products and other forms of interaction

Acetylsalicylic acid

Concomitant

administration

ibuprofen

acetylsalicylic

acid

generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect

of low dose acetylsalicylic acid on platelet aggregation when they are dosed

concomitantly. Although there are uncertainties regarding extrapolation of

these data to the clinical situation, the possibility that regular, long-term use of

ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic

acid cannot be excluded. No clinically relevant effect is considered to be likely

for occasional ibuprofen use (see section 5.1).

Antihypertensives: Reduced anti-hypertensive effect.

Diuretics:

Reduced

diuretic

effect.

Diuretics

increase

risk

nephrotoxicity of NSAIDs. NSAIDs may increase risk of hyperkalaemia with

potassium-sparing diuretics and may also antagonise thiazides, and reduce

anti-hypertensive effect of furosemide.

Cardiac Glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and

increase plasma cardiac glycoside levels.

Lithium: Decreased elimination of lithium.

Methotrexate: Decreased elimination of methotrexate.

Cyclosporin: Increased risk of nephrotoxicity

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone

administration as NSAIDs can reduce the effects of mifepristone.

Corticosteroids:

Increased

risk

bleeding

(see

section

Special

warnings and precautions for use)

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as

warfarin (sse section 4.4 Special warnings and precautions for use).

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk

of convulsions associated with quinolone antobiotics. Patients taking NSAIDS

and quinolones may have an increased risk of developing convulsions.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given

with tacrolimus.

Phenytoin Sodium: Phenytoin concentration and toxicity have been increased

by Ibuprofen.

Zidovudine: There is evidence of an increased risk of haemarthroses and

haematoma in HIV (+) haemophiliacs receiving concurrent treatment with

zidovudine and ibuprofen.

Experimental data suggest that ibuprofen may inhibit the effect of low dose

aspirin on platelet aggregation when they are dosed concomitantly. However,

the limitations of these data and the uncertainties regarding extrapolation of

ex-vivo data to the clinical situation imply that no firm conclusions can be

made for regular ibuprofen use, and no clinically relevant effect is considered

to be likely for occasional ibuprofen use (see section 5.1).

4.6

Pregnancy and lactation

Pregnancy:

Congenital abnormalities have been reported in association with NSAID

administration in man; however, these are low in frequency and do not appear to

follow any discernable pattern. In view of the known effects of NSAIDs on the foetal

cardiovascular system (risk of closure of ductus arteriosus), use in the last trimester of

pregnancy is contraindicated. The onset of labour may be delayed and the duration

increased with an increased bleeding tendency in both mother and child (see section

4.3 Contraindications). NSAIDs should not be used in the first two trimesters of

pregnancy or labour unless the potential benefit to the patient outweighs the potential

risk to the foetus.

Lactation:

In limited studies so far available, NSAIDs can appear in the breast milk in very low

concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

See section 4.4 Special warnings and precautions for use regarding female fertility.

4.7

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are

possible after taking NSAIDs. If affected, patients should not drive or operate

machinery.

4.8

Undesirable effects

Gastrointestinal:

The most commonly observed adverse effects are gastrointestinal in nature. Peptic

and duodenal ulcers, perforation or GI bleeding, sometimes fatal, particularly in the

elderly, may occur (see section 4.4 Special warnings and precautions for use).

Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain,

melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s

disease

(see

section

4.4)

have

been

reported

following

administration.

Less

frequently, gastritis has been observed.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs.

These may consist of:

Non-specific allergic reactions and anaphylaxis

Respiratory tract reactivity comprising asthma, aggravated asthma,

bronchospasm or dyspnoea

Assorted skin reactions, including rashes of various types, pruritis,

urticaria, purpurea, angiodema and, more rarely, exfoliative and

bullous

dermatoses

(including

epidermal

necrolysis,

erythema

multiforme).

Cardiovascular

Oedema has been reported in association with NSAID treatment. Fluid retention

may rarely precipitate congestive heart failure in elderly patients.

Other adverse events reported less commonly include:

Renal

Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome

and renal failure. Haematuria.

Hepatic

Abnormal liver function, hepatitis and jaundice.

Neurological and special senses

Visual disturbances, optic neuritis, headaches, parasthesia, rarely reports of aseptic

meningitis (especially in patients with existing auto-immune disorders, such as

systemic lupus erythematosus, mixed connective tissue disease) with symptoms

such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section

4.4),

depression,

nervousness,

confusion,

hallucinations,

tinnitus,

vertigo,

dizziness, malaise, insomnia, fatigue and drowsiness.

Very rarely toxic amblyopia has occurred; on cessation of treatment recovery

occurred.

Haematological

Thrombocytopenia,

neutropenia,

agranulocytosis,

aplastic

anaemia

and haemolytic anaemia.

Dermatological

Photosensitivity.

Skin and subcutaneous tissue disorders

Not known: Acute generalised exanthematous pustulosis (AGEP)

Oedema, hypertension, and cardiac failure, have been reported in association with

NSAID treatment.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400

mg/day) may be associated with a small increased risk of arterial thrombotic events

(for example myocardial infarction or stroke) (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the

medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9

Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the

dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will

develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea.

Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious

poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness,

occasionally excitation and disorientation or coma. Occasionally patients develop

convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin

time / INR may be prolonged, probably due to interference with the actions of

circulating clotting factors. Acute renal failure and liver damage may occur.

Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a

clear airway and monitoring of cardiac and vital signs until stable. Consider oral

administration of activated charcoal if the patient presents within 1 hour of ingestion

of a potentially toxic amount. If frequent or prolonged, convulsions should be treated

with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products,

nonsteroids, propionic acid derivatives. ATC code: MO1AE

Ibuprofen is a phenylpropionic acid derivative which has analgesic, anti-

inflammatory and anti-pyretic actions.

Experimental data suggest that ibuprofen may competitively inhibit the effect

of low dose acetylsalicylic acid on platelet aggregation when they are dosed

concomitantly. Some pharmacodynamic studies show that when single doses

of ibuprofen 400 mg were taken within 8 h before or within 30 min after

immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of

acetylsalicylic acid on the formation of thromboxane or platelet aggregation

occurred. Although there are uncertainties regarding extrapolation of these

data to the clinical situation, the possibility that regular, long-term use of

ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic

acid cannot be excluded. No clinically relevant effect is considered to be likely

for occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties

Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma concentrations

occur about 1 to 2 hours after ingestion. Ibuprofen is extensively bound to plasma

proteins and has a half-life of about 2 hours. The excretion of Ibuprofen is rapid and

complete.

5.3

Preclinical safety data

Ibuprofen has been used in general medicine over a long period exceeding 20 years.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Cores: Pregelatinised starch, maize starch, maize starch as a 22% paste, Aerosil,

magnesium stearate

Coating: hypromellose, macrogol 6000, erythrosine lake FD & C Red No.3 E127,

titanium dioxide E171, dioctyl sodium sulphosuccinate

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Three years when packed in tablets containers.

Three years when packed in blister packs.

6.4

Special precautions for storage

Do not store above 25°C. Store in the original container/outer carton

6.5

Nature and contents of container

Tablet container:

Pack sizes: 12, 21, 24, 28, 48, 56, 84, 96, 100, 250, 500 and 1000

Packaging composition: high density polyethylene.

Blister packs

Pack sizes: 12, 21, 24, 28, 48, 56 , 84, 96, 100

Packaging composition: rigid white PVC and 20

m aluminium foil.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Public Assessment Report

UKPAR

Ibuprofen 600mg tablets

(ibuprofen)

UK Licence Number: PL 00037/0675

Abbott Laboratories Limited

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

2

LAY SUMMARY

Ibuprofen 600mg tablets

(ibuprofen)

This is a summary of the Public Assessment Report (PAR) for Ibuprofen 600mg

tablets (PL 00037/0675). This medicinal product will be referred to as Ibuprofen

Tablets in the remainder of the report for ease of reading.

This summary explains how Ibuprofen Tablets was assessed and its authorisation

recommended, as well as their conditions of use. It is not intended to provide practical

advice on how to use these products.

For practical information about using Ibuprofen Tablets, patients should read the

Patient Information Leaflet (PIL) available on the Medicines and Healthcare products

Regulatory Agency (MHRA) website

or contact their doctor or pharmacist.

What are Ibuprofen Tablets and what are they used for?

This medicine is the same as Brufen 600 mg Tablets (PL 46302/0009) which has

already been authorised. The company (Mylan Products Limited) that makes Brufen

600 mg Tablets (PL 46302/0009) has used its scientific data as a basis for the grant of

an identical licence for Ibuprofen Tablets (informed consent).

Ibuprofen Tablets can be used to relieve pain and inflammation in conditions such as

osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s

disease), arthritis of the spine, ankylosing spondylitis, swollen joints, frozen shoulder,

bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.

Ibuprofen Tablets can also be used to treat other painful conditions such as toothache,

pain after operations, period pain and headache, including migraine.

How do Ibuprofen Tablets work?

Ibuprofen (the active substance in this medicine) belongs to a group of medicines

called anti-inflammatory pain killers. It can be used to relieve pain and inflammation.

How are Ibuprofen Tablets used?

The pharmaceutical form of Ibuprofen 600 mg Tablets is a tablet, this medicine taken

by mouth (orally).

The patient should always take this medicine exactly as his/her doctor has advised.

The patient should check with his/her doctor or pharmacist if unsure.

Ibuprofen Tablets are taken with or after food, with a glass of water. Ibuprofen

Tablets should be swallowed whole and not chewed, broken, crushed or sucked to

help prevent discomfort in the mouth or irritation in the throat.

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

3

Ibuprofen is

NOT

suitable for children under 12 years of age.

Please read section 3 of the package leaflet for detailed information on dosing

recommendations, the route of administration and the duration of treatment.

How have Ibuprofen Tablets been studied?

Ibuprofen Tablets (PL 00037/0675) are considered identical to previously authorised

Brufen 600 mg Tablets (PL 46302/0009) (Mylan Products Limited), with

the same

benefits and risks. No new studies have been provided for

Ibuprofen Tablets (PL

00037/0675). but reference is made to the studies for Brufen 600 mg Tablets (PL

46302/0009).

What are the possible side effects of Ibuprofen Tablets?

Like all medicines, these medicines can cause side effects, although not everybody

gets them.

The application for Ibuprofen Tablets is considered to be identical to the previously

authorised application for Brufen 600 mg Tablets (Mylan Products Limited) (PL

46302/0009) with the same benefits and risks.

For a full list of all the side effects reported with Ibuprofen Tablets see section 4 of

the patient information leaflet (PIL), available on the Medicines and Healthcare

products Regulatory Agency (MHRA) website.

For the full list of restrictions, see the patient information leaflet (PIL).

Why are Ibuprofen Tablets approved?

No new or unexpected safety concerns arose from these applications. The MHRA,

therefore, considered that the benefits of Ibuprofen Tablets outweigh their risks; and

the grant of a marketing authorisation was recommended.

What measures are being taken to ensure the safe and effective use of Ibuprofen

Tablets?

A Risk Management Plan (RMP) has been developed to ensure that Ibuprofen Tablets

are used as safely as possible. Based on this plan, safety information has been

included in the Summary of Product Characteristics (SmPC) and the patient

information leaflet (PIL) for Ibuprofen Tablets, including the appropriate precautions

to be followed by patients.

Known side-effects are continuously monitored. Furthermore, new safety signals

reported by patients and healthcare professionals will be monitored and reviewed

continuously, as well.

Other information about Ibuprofen Tablets

The UK granted marketing authorisations for Ibuprofen 600mg tablets on 04 October

2017. The full PAR for Ibuprofen Tablets follows this summary. For more

information about treatment with Ibuprofen Tablets, read the patient information

leaflet (PIL) or the patient should contact their doctor or pharmacist. This summary

was last updated in December 2017.

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

4

Ibuprofen 600mg tablets

PL 00037/0675

TABLE OF CONTENTS

INTRODUCTION

QUALITY ASPECTS

NON-CLINICAL ASPECTS

IV CLINICAL ASPECTS

User consultation

VI Overall conclusion, benefit/risk assessment and

recommendation

Table of content of the PAR update

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

5

I

INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the MHRA considered

that the application for Ibuprofen 600mg tablets (PL 00037/0675). could be

approved. This product is a Prescription-Only Medicine (legal status POM) indicated

for:

Its analgesic and anti-inflammatory effects in the treatment of rheumatoid

arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing

spondylitis, osteoarthritis and other non-rheumatoid (seronegative)

arthropathies.

In the treatment of non-articular rheumatic conditions, Ibuprofen is indicated

in periarticular conditions such as frozen shoulder (capsulitis), bursitis,

tendinitis, tenosynovitis and low back pain; Ibuprofen can also be used in soft

tissue injuries such as sprains and strains.

Ibuprofen is also indicated for its analgesic effect in the relief of mild to

moderate pain such as dysmenorrhoea, dental and post-operative pain and for

symptomatic relief of headache, including migraine headache.

This application was made under Article 10c of Directive 2001/83/EC, as amended,

claiming to be identical to the cross-reference product Brufen 600 mg Tablets (PL

46302/0009).

Ibuprofen 600mg tablets

The Applicant makes reference to a national marketing authorisation granted to Mylan

Products Limited for Brufen 600 mg Tablets (PL 43900/0009) which was transferred

to this marketing authorisation holder on 20 March 2015 by change of ownership.

Prior to this, the product has undergone multiple changes of ownership, including

registration to BGP Products Limited (PL 43900/0009) Abbott Laboratories Limited

(PL 00037/0335) from 05 March 2002, Knoll Limited from 25 July 1995 and Knoll

Pharma Limited from 01 April 1993.

No new non-clinical or clinical studies were conducted, which is acceptable given that

the application is for a product which is identical to a product that has been granted a

marketing authorisation in the UK.

The proposed manufacturing sites are consistent with those registered for the cross-

reference product and evidence of Good Manufacturing Practice (GMP) compliance

has been provided.

A satisfactory summary of the pharmacovigilance system and risk management plan

has been provided with these applications.

A National Marketing Authorisation was granted in the UK on 04 October 2017.

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

6

II

QUALITY ASPECTS

LICENCE NO(S):

PL 00037/0675

PROPRIETARY NAMES:

Ibuprofen 600mg tablets

ACTIVE(S):

ibuprofen

COMPANY NAME:

Abbott Laboratories Limited

E.C. ARTICLE:

Article 10c of Directive 2001/83/EC, as amended

LEGAL STATUS:

Prescription-Only Medicine (legal status POM)

II.1

INTRODUCTION

This is a simple, informed consent application for Ibuprofen 600mg tablets, submitted

under Article 10c of Directive 2001/83/EC, as amended.

II.2.

Medicinal Product Name

The following product name is proposed: Ibuprofen 600mg tablets. The product has

been named in line with current requirements.

Strength, pharmaceutical form, route of administration, container and pack sizes

Ibuprofen 600mg tablets contain 600mg of the active substance ibuprofen.

The route of administration is oral.

Ibuprofen 600mg tablets:

The finished products are packaged in transparent polyvinyl chloride (PVC) /

aluminium foil blisters. The blisters are packed into cartons containing 60 or 100

tablets.

Blister packs comprising of transparent PVC film / polyvinylidene chloride (PVDC) /

aluminium foil. The blisters are packed into cartons containing pack size 60 or 100

tablets.

Not all pack sizes may be marketed, however, the marketing authorisation holder has

agreed to provide mock-ups of any pack size to the relevant regulatory authorities

before marketing.

The proposed shelf-life is 3 years with the storage conditions, ‘Do not store above

25°C, store in the original package’. The proposed packaging and shelf-life are

consistent with the details registered for the cross-reference product.

Legal status

On approval, this product will be available as a prescription-only medicine (POM).

Marketing authorisation holder/Contact Persons/Company

Abbott Laboratories Limited, Abbott House, Vanwall Business Park, Vanwall Road,

Maidenhead, Berkshire, SL6 4XE, UK

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

7

Manufacturers

The proposed manufacturing sites are consistent with those registered for the

cross-reference products and evidence of Good Manufacturing Practice (GMP)

compliance has been provided.

Qualitative and quantitative composition

The composition is consistent with the details registered for the cross-reference

product.

Manufacturing process

The proposed manufacturing process is consistent with the details registered for the

cross-reference product.

Finished product/shelf-life specification

The proposed finished product specification is in line with the details registered for

the cross-reference product.

Drug substance specification

The proposed drug substance specification is consistent with the details registered for

the cross-reference products.

TSE Compliance

None of the excipients contain materials of animal or human origin.

No genetically modified organisms (GMO) have been used in the preparation of these

products.

Expert Report

The applicant has included expert reports in Module 2 of these applications. Signed

declarations and copies of the experts’ CVs are enclosed in Module 1.4 for the

quality, non-clinical and clinical experts. All are considered to have sufficient

experience for their responsibilities.

Product Name and Appearance

See section ‘II.3. Medicinal Product Name’ for details of the proposed product name.

The appearance of the product is identical to the cross-reference product.

Summary of Product Characteristics (SmPC)

The proposed SmPC are consistent with the details registered for the cross-reference

product.

II.3

Discussion on chemical, pharmaceutical and biological aspects

The grant of a marketing authorisation is recommended.

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

8

III

NON-CLINICAL ASPECTS

Introduction

No new non-clinical data have been supplied with the application and none are

required for an application of this type.

Ecotoxicity/Environmental Risk Assessment (ERA)

Since this product will be used in substitution for other products that are currently on

the market, no increase in environmental exposure is anticipated. An Environmental

Risk Assessment (ERA) is, therefore, not deemed necessary.

Discussion on the non-clinical aspects

The grant of a marketing authorisation is recommended.

IV

CLINICAL ASPECTS

Introduction

No new clinical data have been supplied with this application and none are required

for an application of this type.

The SmPC and PIL are consistent with those of the cross-reference product.

The Marketing Authorisation Holder (MAH) has provided details of a suitable

pharmacovigilance system that fulfils the requirements and provides adequate

evidence that they have the services of a qualified person responsible for

pharmacovigilance, and have the necessary means for the notification of any adverse

reaction suspected of occurring either in the Community or in a third country.

The Qualified Person (QP) responsible for pharmacovigilance is stated and their

Curriculum Vitae (CV) is included.

Risk Management Plan (RMP)

The Marketing Authorisation Holder (MAH) has submitted a Risk Management Plan

(RMP), in accordance with the requirements of Directive 2001/83/EC, as amended,

describing the pharmacovigilance activities and interventions designed to identify,

characterise, prevent or minimise risks relating to the use of this product. A summary

of safety concerns, as approved in the RMP, is listed below:

Routine pharmacovigilance and routine risk minimisation are proposed for all safety

concerns.

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

9

Discussion on the clinical aspects

The grant of a marketing authorisation is recommended.

V

User consultation

The company makes reference to a user consultation with target patient groups on the

essentially identical patient information leaflet (PIL) for Brufen 600 mg Tablets. This

is acceptable.

VI

Overall conclusion, benefit/risk assessment and recommendation

The quality of the product is acceptable, and no new non-clinical or clinical concerns

have been identified. The applicant's product is identical to their respective reference

product. Extensive clinical experience with ibuprofen is considered to have

demonstrated the therapeutic value of the compound. The benefit-risk assessment is,

therefore, considered to be positive.

In accordance with Directive 2010/84/EU, the current approved UK versions of the

SmPC and PIL for this product are available on the Medicines and Healthcare

products Regulatory Agency (MHRA) website.

The current approved labels for Ibuprofen 600mg tablets are presented on the

following pages:

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

10

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

11

UKPAR Ibuprofen 600mg tablets & Ibuprofen 800mg PR tabletsIbuprofen 600mg tablets

PL 00037/0675-676

12

Table of content of the PAR update

Steps taken after the initial procedure with an influence on the Public Assessment

Report (Type II variations, PSURs, commitments)

Date submitted

Application

type

Scope

Outcome

Similar products

Search alerts related to this product

View documents history

Share this information