Buplex Rx 200 mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Ibuprofen
Available from:
Actavis Group PTC ehf
ATC code:
M01AE; M01AE01
INN (International Name):
Ibuprofen
Dosage:
200 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Propionic acid derivatives; ibuprofen
Authorization status:
Marketed
Authorization number:
PA1380/088/001
Authorization date:
2009-07-03

Package leaflet: Information for the patient

Buplex Rx 200 mg film-coated tablets

Ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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.

What is in this leaflet:

What Buplex Rx is and what it is used for

What you need to know before you take Buplex Rx

How to take Buplex Rx

Possible side effects

How to store Buplex Rx

Contents of the pack and other information

1.

What Buplex Rx is and what it is used for

Buplex Rx belongs to a group of medicines called NSAID (non-steroidal anti-inflammatory drugs)

which work by reducing pain, inflammation and fever.

Buplex Rx is used to provide relief from mild to moderate pain such as headache, including migraine

headache, dental pain, period pain and fever.

If you are over 12 years of age your doctor may also prescribe this or higher doses for the treatment of

rheumatoid arthritis, osteoarthritis, or other inflammatory or painful joint conditions, as well as for

inflammatory and painful conditions of soft tissues such as muscles.

2.

What you need to know before you take Buplex Rx

Do not take Buplex Rx:

if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section

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 or

other drugs for pain and inflammation (NSAIDs).

if you have suffered from an ulcer or bleeding in the stomach or small intestine (duodenum)

related to previous use of drugs for pain and inflammation (NSAIDs)

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 suffer from severe liver, kidney or heart problems (including coronary heart disease)

if you are in the last 3 months of pregnancy

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 Buplex Rx 200 mg film-coated tablets to children younger than 6 years.

Warnings and precautions

Talk to your doctor before taking Buplex Rx

if you have Systemic Lupus erythematosus (SLE) or other autoimmune diseases

if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)

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

if you have disturbances in the formation of blood cells

if you have problems with normal blood clotting mechanism

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

if you suffer from circulation problems in the arteries of your arms or legs

if you have liver, kidney, heart problems or high blood pressure

if you have just had major surgery

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 Buplex Rx”, below).

Skin reactions

Serious skin reactions have been reported in association with ibuprofen treatment. You should stop

taking Buplex Rx 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.

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 Buplex Rx 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.

Other precautions

During long-term, high-dose use of pain killers headache may occur which should not be treated with

high doses of this medicine.

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.

During chicken pox (varicella) it is advisable to avoid the use of Buplex Rx.

Buplex Rx 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

Do not use in children younger than 6 years.

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

Other medicines and Buplex Rx

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

medicines.

The side effects of Buplex Rx may be increased if certain medicines are taken at the same time. On

the other hand, Buplex Rx may increase or decrease the effect of other medicines or increase their side

effects when taken at the same time.

Buplex Rx may affect or be affected by some other medicines. For example:

other NSAIDs

medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid,

warfarin, heparin, ticlopidine)

platelet aggregation inhibitors (against clotting) such as clopidogrel

methotrexate (used to treat cancer and auto-immune diseases)

digoxin (for treatment of various heart conditions)

phenytoin (used in prevention of the occurrence of epileptic seizures)

lithium (used to treat depression and mania)

diuretics (water tablets), including potassium-sparing diuretics

medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such

as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

cholestyramine (used in the treatment of high cholesterol)

aminoglycosides (medicines against certain types of bacteria)

SSRIs (medicines against depression) such as paroxetine, sertraline, citalopram

moclobemide (RIMA – a medicine to treat depressive illness or social phobia)

ciclosporin, tacrolimus (for immuno-suppression after organ transplant)

zidovudine or ritanovir (used to treat patients with HIV)

mifepristone

probenecid or sulfinpyrazone (for treating gout)

quinolone antibiotics

sulphonylureas (to treat type 2 diabetes)

corticosteroids (used against inflammations)

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)

Some other medicines may also affect or be affected by the treatment of Buplex Rx. You should

therefore always seek the advice of your doctor or pharmacist before you use Buplex Rx with other

medicines.

Buplex Rx with food and drink

You should swallow Buplex Rx with a glass of water during or after a meal.

Avoid alcohol since it may enhance the side effects of Buplex Rx, especially those affecting the

stomach, intestines or brain.

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 drive a car or operate

machinery may be impaired in individual cases. This effect is potentiated by simultaneous

consumption of alcohol.

Buplex Rx contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say

essentially ‘sodium-free’.

3.

How to take Buplex Rx

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

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

necessary to control symptoms.

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 (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 4 to 6 hours.

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

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 usual dose is 2-3 tablets 3 times a day. 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.

Adolescents over 12 years of age (>40 kg):

The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily in 3 to 4 divided

doses.

The tablet should be swallowed with a glass of water during or after a meal. For the ease of

swallowing or adjusting of doses the tablets can be divided in equal doses.

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

should be consulted.

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. 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 Buplex Rx than you should

If you have taken more Buplex Rx than you should, or if a child has taken this medicine by accident,

always contact a doctor or your nearest hospital to get an opinion of the risk and advice on action to be

taken.

The symptoms of overdose can include nausea, stomach pain, diarrhoea, vomiting (may be blood

streaked), headache, ringing in the ears, confusion and shaky eye movement. Bleeding from the

stomach or intestines may also occur.

At high doses and in more serious cases of overdose, drowsiness, chest pain, palpitations, loss of

consciousness, excitation, disorientation, coma, convulsions (mainly in children), weakness, dizziness,

cramps (especially in children), blurred vision and eye problems, kidney failure, blood in urine, liver

damage, low blood pressure, cold body feeling, breathing problems, bluish discolouration of lips,

tongue and fingers, and increased bleeding tendency have been reported. Worsening of asthma in

asthmatics can also occur.

If you forget to take Buplex Rx

If you forget to take a dose, take it as soon as you can, except if there is less than four hours remaining

until the time for the next dose.

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.

Undesirable effects are more likely with higher doses and longer duration of treatment.

Medicines such as Buplex Rx may be associated with a small increased risk of heart attack

(myocardial infarction) 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 Buplex Rx and see your doctor immediately if the following symptoms occur:

Common:

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

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

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

Not known:

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 generalised exanthematous pustulosis). Stop using Buplex Rx if you develop these

symptoms and seek medical attention immediately. See also section 2.

You should stop taking the medicine and contact your doctor as soon as possible if you develop the

following side effects:

Very common:

heartburn, abdominal pain, indigestion

Uncommon:

blurred vision or other eye problems such as sensitivity to light

hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low blood

pressure)

photosensitivity (increased sensitivity to sunlight)

Rare:

vision loss

Very rare:

sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water

retention and weight gain

Other possible side effects with Buplex Rx 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

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

Uncommon:

Inflammation of the stomach lining

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 and other liver enzymes, 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

Very rare:

Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure

Disorders of blood cell formation (with symptoms like: fever, sore throat, surface mouth ulcers,

flu-like 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

Damage of the kidney tissue

Hair loss

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

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

Buplex Rx may cause a reduction in the number of white blood cells and your resistance to infection

may be decreased. If you experience an infection with symptoms such as fever and serious

deterioration of your general condition, or fever with local infection symptoms such as sore

throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will

be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform

your doctor about your medicine.

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 HPRA Pharmacovigilance

Website: www.hpra.ie.

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

5.

How to store Buplex Rx

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 packs after EXP. The expiry date

refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Buplex Rx contains

The active substance is ibuprofen. Each film-coated tablet contains 200 mg ibuprofen.

The other ingredients are:

Tablet core: cellulose, microcrystalline, silica, colloidal anhydrous, hydroxypropylcellulose,

sodium laurylsulfate, croscarmellose sodium, talc

Film coating (Opadry (white) 06B28499): hypromellose, macrogol 400, titanium dioxide

(E171).

What Buplex Rx looks like and contents of the pack

Film-coated tablets.

White, oval, biconvex film-coated tablets with a score on one face.

Pack sizes:

Blisters: 6, 10, 12, 20, 24, 30, 50, 60, 90, 100 and 250 film-coated tablets.

Tablet containers: 10, 20, 30, 50, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78,

220 Hafnarfjordur, Iceland

Manufacturer

<Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon

EX32 8NS, United Kingdom>

<or>

<Balkanpharma – Dupnitsa AD

3, Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria>

<or>

<Balkanpharma – Razgrad AD,

68 Aprilsko vastanie Blvd.,

Razgrad 7200,

Bulgaria>

This medicinal product is authorised in the Member States of the EEA under the following

names:

Malta: Ibuprofen Actavis 200 mg;

Iceland: Íbúfen;

Ireland: Buplex Rx 200 mg Film-coated tablets;

Sweden: Ibuprofen Actavis 200 mg filmdragerade tabletter.

This leaflet was last revised in November 2019

Health Products Regulatory Authority

15 January 2020

CRN009K0H

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Buplex Rx 200 mg film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film‑coated tablet contains 200 mg ibuprofen.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film‑coated tablet.

White, oval, biconvex film‑coated tablets with a score on one face.

The tablet can be divided into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Mild to moderate pain, such as headache including migraine headache, dental pain.

Primary dysmenorrhoea.

Fever.

Rheumatic conditions such as arthritic diseases (e.g. rheumatoid arthritis including juvenile rheumatoid arthritis), degenerative

arthritic conditions (e.g. osteoarthritis), non-articular rheumatic conditions, other muscular and joint disorders, and soft tissue

injuries.

4.2 Posology and method of administration

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

symptoms (see section 4.4).

If a child or adolescent requires this medicinal product for more than 3 days, or if symptoms worsen, a doctor should be

consulted.

The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not

exceed 800 mg of ibuprofen.

The tablet should be swallowed with a glass of water during or after a meal.

Mild to moderate pain and fever

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

200‑400 mg given as a single dose or 3‑4 times a day with an interval of 4 to 6 hours. The dosage in migraine headache

should be: 400 mg given as a single dose, if necessary 400 mg with intervals of 4 to 6 hours.

The maximum daily dose should not exceed 1200 mg.

Children 6‑12 years (>20 kg):

Children 6‑9 years (20‑29 kg): 200 mg 1‑3 times a day with intervals of 4 to 6 hours as required.

The maximum daily dose should not exceed 600 mg.

Children 10‑12 years (30‑40 kg): 200 mg 1‑4 times a day with intervals of 4 to 6 hours as required.

The maximum daily dose should not exceed 800 mg.

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15 January 2020

CRN009K0H

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Primary dysmenorrhoea

Adults and adolescents over 12 years of age:

200‑ 400 mg 1‑3 times a day, with an interval of 4‑6 hours, as needed. The maximum daily dose should not exceed 1200 mg.

Rheumatic diseases

Adults:

The usual dose is 400‑600 mg 3 times a day. Maintenance doses of 600 mg‑1200 mg daily may be effective in some patients.

In acute and severe conditions the dose may be increased to a maximum of 2400 mg in 3 or 4 divided doses.

Adolescents over 12 years of age (>40 kg):

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

Elderly

NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased

risk of potentially fatal gastrointestinal haemorrhage, ulceration or perforation (see section 4.4). If treatment is considered

necessary, the lowest dose for the shortest duration necessary to control symptoms should be used. Treatment should be

reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Impaired renal function

In patients with mild or moderate reduction of renal function, the dose should be kept as low as possible for the shortest

duration necessary to control symptoms and renal function monitored. (For patients with severe renal failure see section 4.3).

Impaired liver function

In patients with mild or moderate reduction of liver function the dose should be kept as low as possible for the shortest

duration necessary to control symptoms and renal function monitored. (For patients with severe liver failure see section 4.3).

4.3 Contraindications

Buplex Rx is contraindicated in patients with:

hypersensitivity to the active substance or to any of the excipients listed in section 6.1

previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic

acid or other NSAIDs

history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy

active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or

bleeding)

severe hepatic or severe renal insufficiency

severe heart failure (NYHA Class IV) or coronary heart disease

last trimester of pregnancy (see section 4.6)

significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

cerebrovascular or other active bleeding

dishaematopoiesis of unknown origin

Buplex Rx 200mg film-coated tablets is contraindicated in children younger than 6 years of age.

4.4 Special warnings and precautions for use

The use of Buplex Rx with concomitant NSAIDs including cyclooxygenase‑2 selective inhibitors should be avoided.

Asthmatic patients are to seek their doctor's advice before using ibuprofen (see below).

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). Patients treated with NSAIDs long term should undergo

regular medical supervision to monitor for adverse events.

Buplex Rx should only be administered under strict consideration of the benefit-risk ratio in the following conditions:

Systemic Lupus Erythematosus (SLE) or other autoimmune diseases.

Congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria)

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15 January 2020

CRN009K0H

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The first and second trimester of pregnancy

Lactation

Special care has to be taken in the following cases:

Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)

Cardiac insufficiency and hypertension

Reduced renal function

Hepatic dysfunction

Disturbed haematopoiesis

Blood coagulation defects

Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial

asthma

Immediately after major surgical interventions

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with

or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer,

particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should

commence treatment on the lowest dose available.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these

patients, and also for patients requiring concomitant low-dose acetylsalicylic acid, or other medicinal products likely to increase

gastrointestinal risk. (See below and section 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI

bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or

bleeding, such as oral corticosteroids, anticoagulants such as warfarin or heparin, selective serotonin-reuptake inhibitors or

anti-platelet agents such as acetylsalicylic acid (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Buplex Rx, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as

their condition may be exacerbated. (See section 4.8).

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).

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, hypertension and oedema have been reported in association with NSAID therapy.

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 be treated with ibuprofen after careful consideration and high

doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for

cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen

(2400 mg/day) are required.

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Severe skin reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal

necrolysis, have been reported very rarely in association with the use of NSAIDs (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. /…/ should be discontinued at the first appearance of skin rash, mucosal lesions, or any other

sign of hypersensitivity.

Renal effect

Ibuprofen may cause the retention of sodium, potassium and fluid in patients who have not previously suffered from renal

disorders because of its effect on renal perfusion. This may cause oedema or even lead to cardiac insufficiency or hypertension

in predisposed patients.

As with other NSAIDs, the prolonged administration of ibuprofen to animals has resulted in renal papillary necrosis and other

pathological renal changes. In humans, there have been reports of acute interstitial nephritis with haematuria, proteinuria and

occasionally nephrotic syndrome. Cases of renal toxicity have also been observed in patients in whom prostaglandins play a

compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAIDs may cause a

dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal

decompensation. Patients at greatest risk of suffering this reaction are those with renal dysfunction, heart failure, hepatic

dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID treatment is generally followed

by recovery to the pre-treatment state.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of

aseptic meningitis.

Aseptic meningitis

Symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.

Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to

occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients

who do not have an underlying chronic disease.

Other precautions

Bronchospasm, urticaria or angioedema may be precipitated in patients suffering from or with a previous history of bronchial

asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases.

Ibuprofen may mask the signs or symptoms of an infection (fever, pain and swelling).

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infectious complications. To date, the

contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of

ibuprofen in case of varicella.

During the long‑term, high‑dose use of analgesics headaches may occur which should not be treated with elevated doses of

the medicinal product.

In general the habitual intake of analgesics, particularly the combination use of different analgesic substances, may cause

permanent renal damage and a risk of renal failure (analgesics nephropathy).

Ibuprofen may temporarily inhibit platelet aggregation and prolong the bleeding time. Therefore, patients with coagulation

defects or on anticoagulant therapy should be observed carefully.

In case of long‑term treatment with ibuprofen a periodical monitoring of hepatic and renal function as well as the blood count

is necessary, especially in high risk patients.

Consumption of alcohol should be avoided since it may intensify side effects of NSAIDs, especially if affecting the

gastrointestinal tract or the central nervous system.

Patients on ibuprofen should report to their doctor signs or symptoms of gastro-intestinal ulceration or bleeding, blurred

vision or other eye symptoms, skin rash, weight gain or oedema.

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Paediatric population

There is a risk of renal impairment in dehydrated children and adolescents.

Excipient

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interactions

Concomitant use of ibuprofen and the following substances should be avoided:

Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of

the potential of increased adverse events.

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).

Other NSAIDs: As a result of synergistic effects, the concurrent use of several NSAIDs can increase the risk of gastrointestinal

ulcers and haemorrhage. Co‑administration of ibuprofen with other NSAIDs should therefore be avoided (see section 4.4).

Anti-coagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin or heparin (see section 4.4). In case of

simultaneous treatment, monitoring of the coagulation state is recommended.

Ticlopidine: NSAIDs should not be combined with ticlopidine due to a risk of an additive effect in the inhibition of the platelet

function.

Methotrexate: NSAID inhibits the tubular secretion of methotrexate and certain metabolic interactions can occur resulting in

decreased clearance of methotrexate. The administration of Buplex Rx within 24 hours before or after the administration of

methotrexate can lead to an elevated concentration of methotrexate and an increase in its toxic effects. Therefore, concomitant

use of NSAIDs and high doses of methotrexate should be avoided. Also, the potential risk of interactions in low dose treatment

with methotrexate should be considered, especially in patients with impaired renal function. In combined treatment, renal

function should be monitored.

Ibuprofen (like other NSAIDs) should be taken only with caution in combination with the following substances:

Moclobemide: Enhances the effect of ibuprofen.

Phenytoin, lithium: Co‑administration of Buplex Rx with phenytoin or lithium preparations can increase the serum level of

these medicinal products. Checking the serum lithium level is necessary and it is recommended to check the serum phenytoin

levels.

Cardiac glycosides (e.g digoxin): NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma levels of cardiac

glycosides. Monitoring of serum digoxin is recommended.

Diurectis and antihypertensives: Diuretics and ACE-inhibitors can increase the nephrotoxicity of NSAIDs.NSAIDs can reduce the

effect of diuretics and antihypertensives, including ACE-inhibitors and beta-blockers. In patients with reduced kidney function

(e.g. dehydrated patients or elderly patients with reduced kidney function), the concomitant use of an ACE inhibitor and

angiotensin II antagonist with a cyclooxygenase-inhibiting medicinal product can lead to further impairment of kidney function

and through to acute renal failure. This is usually reversible. Such combination should therefore only be used with caution,

especially in elderly patients. The patients have to be instructed to drink sufficient liquid and periodic monitoring of the kidney

values should be considered for the time immediately after the start of the combination therapy.

The concomitant administration of Buplex Rx and potassium‑sparing diuretics or ACE-inhibitors can result in hyperkalaemia.

Careful monitoring of potassium levels is necessary.

Captopril: Experimental studies indicate that ibuprofen counteracts the effect of captopril of increased sodium excretion.

Aminoglycosides: NSAIDs can slow down the elimination of aminoglycosides and increase their toxicity.

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Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).

Ciclosporin: The risk of kidney damage by ciclosporine is increased by the concomitant administration of certain NSAIDs. This

effect cannot be ruled out for the combination of ciclosporin and ibuprofen, either.

Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen results in prolonged and reduced (25%) absorption

of ibuprofen. The medicinal products should be administered with at least one hour interval.

Tacrolimus: Elevated risk of nephrotoxicity.

Zidovudine: There is evidence of an increased risk of haemarthrosis and haematoma in HIV positive haemophilia patients

receiving concurrent treatment with zidovudine and ibuprofen. There may be an increased risk of haematotoxicity during

concomitant use of zidovudine and NSAIDs. Blood counts 1‑ 2 weeks after starting use together are recommended.

Ritonavir: May increase the plasma concentrations of NSAIDs.

Mifepristone: If NSAIDs are used within 8‑12 days after mifepristone administration they can reduce the effect of mifepristone.

Probenecid or sulfinpyrazone: May cause a delay in the elimination of ibuprofen. The uricosuric action of these substances is

decreased.

Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Sulphonylureas: NSAIDs can increase the hypoglycemic effect of sulphonylureas. In the case of simultaneous treatment,

monitoring of blood glucose levels is recommended.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-platelet aggregation agents (e.g. clopidogrel): Increase the risk of gastrointestinal bleeding (see section 4.4).

Alcohol, bisphosphonates and oxpentifylline (pentoxyflline): May potentiate the GI side-effects and the risk of bleeding and

ulceration.

Baclofen: Elevated baclofen toxicity.

4.6 Fertility, pregnancy and lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from

epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a

prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less

than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-

implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including

cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, Buplex Rx should not be given unless clearly necessary. If Buplex Rx is used

by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and

duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

renal dysfunction, which may progress to renal failure with oligo-hydramniosis;

the mother and the neonate, at the end of pregnancy to:

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possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently Buplex Rx is contraindicated during the last trimester of pregnancy.

Lactation

Ibuprofen is excreted in breast milk, but with therapeutic doses during short term treatment the risk for influence on infant

seems unlikely. If, however, longer treatment is prescribed, early weaning should be considered.

Fertility

The use of ibuprofen may impair fertility and is not recommended in women attempting to conceive. In women who have

difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered.

4.7 Effects on ability to drive and use machines

Ibuprofen generally has no adverse effects on the ability to drive and use 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 drive a car or operate machinery may be impaired in individual cases. This effect is potentiated by

simultaneous consumption of alcohol.

4.8 Undesirable effects

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding,

sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation,

dyspepsia, abdominal pain, melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn's disease (see

section 4.4) have been reported following administration. Less frequently, gastritis has been observed.

Undesirable effects are mostly dose-dependent. Especially the risk for the occurrence of gastrointestinal bleedings depends on

the dosage range and duration of the treatment. Other known risk factors, see section 4.4.

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).

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

The undesirable effects are less frequent when the maximum daily dose is 1200 mg.

Assessment of adverse reactions is normally based on the following occurrence frequency:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

Investigations

Rare: increase of blood urea nitrogen, serum transaminases and alkaline phosphatase, decrease in haemoglobin and

haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decrease of serum calcium, increase in serum

uric acid

Cardiac disorders

Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary oedema, oedema,

Blood and lymphatic system disorders

Very rare: haematopoietic disorders (anaemia, leucopoenia, thrombocytopenia, pancytopenia, agranulocytosis). The first

symptoms or signs may include: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin

bleeding

Not known: neutropenia

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Nervous system disorders

Common: headache, somnolence, vertigo, fatigue, agitation, dizziness, insomnia, irritability

Not known: optic neuritis, paraesthesia, aseptic meningitis

Eye disorders

Uncommon: visual disturbances

Rare: toxic amblyopia

Ear and labyrinth disorders

Very rare: tinnitus

Not known: hearing impaired

Respiratory, thoracic and mediastinal disorders

Uncommon: rhinitis, bronchospasm

Gastrointestinal disorders

Very common: gastrointestinal disorders, such as heartburn, dyspepsia, abdominal pain and nausea, vomiting, flatulence,

diarrhoea, constipation

Common: gastrointestinal ulcers, sometimes with bleeding and perforation (see section 4.4), occult blood loss which may lead

to anaemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of

colonic diverticula (perforation, fistula)

Uncommon: gastritis

Very rare: oesophagitis, pancreatitis, intestinal strictures

Renal and urinary disorders

Uncommon: development of oedema especially in patients with arterial hypertension or renal insufficiency, nephrotic

syndrome, interstitial nephritis which can be associated with renal failure

Very rare: renal papillary necrosis in long‑term use (see section 4.4)

Skin and subcutaneous tissue disorders

Uncommon: photosensitivity

Very rare: severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including

Stevens‑Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotising fascitis

Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous

pustulosis (AGEP)

Vascular disorder

Very rare: hypertension

Immune system disorders

Uncommon: hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes

with hypotension)

Rare: lupus erythematosus syndrome

Very rare: severe hypersensitivity reactions. The symptoms may include: facial oedema, swelling of the tongue, internal

laryngeal swelling with constriction of the airways, dyspnoea, tachycardia, fall of blood pressure to the point of life-threatening

shock

Hepatobiliary disorders

Very rare: liver dysfunction, liver damage, especially in long‑term use, liver failure, acute hepatitis, jaundice

Psychiatric disorders

Rare: depression, confusion, hallucinations

Not known: anxiety

General disorders and administration site conditions

Not known: malaise

Reporting of suspected adverse reactions

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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 HPRA Pharmacovigilance Website: www.hpra.ie.

4.9 Overdose

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, dizziness, vertigo and gastrointestinal bleeding may also occur. 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. Children may also develop myoclonic cramps. In serious

poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to the actions of

circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur.

Exacerbation of asthma is possible in asthmatics.

Treatment

Treatment should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac

and vital signs until stable. Gastric emptying or oral administration of activated charcoal is indicated if the patient presents

within one hour of ingestion of more than 400 mg per kg of body weight. If Buplex Rx has already been absorbed, alkaline

substances should be administered to promote the excretion of the acid ibuprofen in the urine. If frequent or prolonged,

convulsions should be treated with intravenous diazepam or lorazepam. Bronchodilators should be given for asthma. No

specific antidote is available.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids; propionic acid derivatives. ATC code:

M01AE01

Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity. Animal models for pain and

inflammation indicate that ibuprofen effectively inhibits the synthesis of prostaglandins. In humans, ibuprofen reduces pain

possibly caused by inflammation or connected with it, swelling and fever. Ibuprofen exerts an inhibitory effect on prostaglandin

synthesis by inhibiting the activity of cyclo-oxygenase. In addition ibuprofen has an inhibitory effect on ADP (adenosine

diphosphate) or collagen-stimulated platelet aggregation.

Experimental data suggest that ibuprofen may competitvely 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).

Ibuprofen inhibits prostaglandin synthesis in the uterus, thereby reducing intrauterine rest and active pressure, the periodic

uterine contractions and the amount of prostaglandins released into the circulation. These changes are assumed to explain the

alleviation of menstrual pain. Ibuprofen inhibits renal prostaglandin synthesis which can lead to renal insufficiency, fluid

retention and heart failure in risk patients (see section 4.3).

Prostaglandins are connected with ovulation and the use of medicinal products inhibiting prostaglandin synthesis may

therefore affect the fertility of women (see section 4.4, 4.6 and 5.3).

5.2 Pharmacokinetic properties

Absorption

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1‑2 hours after

administration.

Distribution

Ibuprofen is rapidly distributed throughout the whole body. The plasma protein binding is approximately 99%.

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Biotransformation

Ibuprofen is metabolised in the liver (hydroxylation, carboxylation).

Elimination

The elimination half-life is approximately 2.5 hours in healthy individuals. Pharmacologically inactive metabolites are mainly

excreted (90%) by the kidneys but also in bile.

5.3 Preclinical safety data

As a well established and widely used product, the pre-clinical safety of ibuprofen is well documented.

Ibuprofen's subchronic and chronic toxicity was mainly shown by animal tests as gastric tract damage and ulcers.

The vitro and in vivo tests have not shown any clinically significant signs about ibuprofen's mutagenicity. Furthermore no

carcinogenic effects have been observed in mice and rats.

Ibuprofen inhibits ovulation in rabbits and impairs implantation in various animal species (rabbit, rat, and mouse). In

reproduction tests undertaken with rats and rabbits, ibuprofen passed across the placenta. When using doses toxic to the

mother, malformations occur more frequently (i.e. ventricular septum defects).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Cellulose, microcrystalline

Silica, colloidal anhydrous

Hydroxypropylcellulose

Sodium laurylsulfate

Croscarmellose sodium

Talc

Film coating (Opadry (white) 06B28499)

Hypromellose

Macrogol 400

Titanium dioxide (E171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Opaque PVC/Aluminium blister packs.

Clear PVC/Aluminium blister packs.

Tablet containers (HDPE) with polypropylene caps.

Pack sizes:

Blisters: 6, 10, 12, 20, 24, 30, 50, 60, 90, 100 and 250 film‑coated tablets.

Tablet containers: 10, 20, 30, 50, 100 and 250 film‑coated tablets.

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Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

8 MARKETING AUTHORISATION NUMBER

PA1380/088/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 3

July 2009

Date of last renewal: 22

March 2014

10 DATE OF REVISION OF THE TEXT

January 2020

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