Ibuprofen 200mg Soft capsules

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Ibuprofen
Available from:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
ATC code:
M01AE; M01AE01
INN (International Name):
Ibuprofen
Dosage:
200 milligram(s)
Pharmaceutical form:
Capsule, soft
Therapeutic area:
Propionic acid derivatives; ibuprofen
Authorization status:
Marketed
Authorization number:
PA0678/146/001
Authorization date:
2002-03-08

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Ibuprofen 200 mg Soft Capsules

1461_PIL_20_366

Package leaflet: Information for the user

Ibuprofen 200mg soft capsules

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

information for you.

This medicine is available without prescription, for you to treat a mild illness without a doctor’s help.

Nevertheless, you still need to use your medicine carefully to get the best results. Always take this medicine

exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet, you may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, or if any of the side effects get serious, please tell your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

You must see a doctor if your symptoms worsen or persist. See section 3

What is in this leaflet

What your medicine 200mg is and what it is used for

What you need to know before you take your medicine

How to take your medicine

Possible side effects

How to store your medicine

Contents of the pack and other information

1.

What your medicine is and what it is used for

Each liquid-filled soft capsule contains 200 mg of ibuprofen.

Ibuprofen belongs to a group of medicines called Non Steroidal Anti-inflammatory Drugs (NSAIDs) that work

by relieving pain and reducing inflammation, swelling and fever.

Your medicine is for the relief of mild to moderate pain including rheumatic and muscular pain, backache,

headache, dental pain, period pain, feverishness and the symptoms of colds and influenza

2.

What you need to know before you take your medicine

Please read the following information.

Do not give to children under 12 years of age, except on the advice of a doctor.

Do not take this medicine

if you:

are suffering from or have had two or more separate occurrences of stomach ulcers or bleeding.

have suffered in the past from stomach bleeding or perforation because of treatment with this medicine

or any other NSAID.

suffer from other bleeding conditions or blood disease.

are allergic to ibuprofen or any of the other ingredients of this product, aspirin/acetylsalicylic acid, or

other related painkillers.

suffer from severe liver, kidney or heart failure.

are in the last 3 months of pregnancy.

during chicken pox (varicella) it is advisable to avoid the use of ibuprofen.

Warnings and Precautions

Talk to your pharmacist or your doctor if you:

are asthmatic or suffer from hay fever.

are suffering from liver or kidney problems.

are suffering from autoimmune diseases including Systemic Lupus Erythematosus (SLE) – a condition

of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of

other organs.

are suffering from or have a history of gastro-intestinal disorders, such as ulcerative colitis or Crohn’s

Disease, because medicines such as ibuprofen may make these conditions worse.

are in the first 6 months of pregnancy.

are 12-18 years old as there is a risk of renal impairment. Therefore, ask a doctor before use if a child

or adolescent between 12-18 years of age has not been drinking fluids or has lost fluids due to continuous

vomiting or diarrhoea.

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 of 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.

Take special care with Ibuprofen 200 mg

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen 200 mg Capsules treatment.

You should stop taking Ibuprofen 200 mg Capsules 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.

Medicines such as Ibupreofen 200 mg Capsules may be associated with a small increased risk of heart attack

(“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not

exceed the recommended dose or duration of treatment. See section 3.

Other medicines and Ibuprofen 200 mg Soft Capsules

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

Do not use this medicine if you are taking aspirin/acetylsalicylic acid with a daily dose above 75 mg, or other

NSAID painkillers.

Talk to your doctor or pharmacist if you are taking:

medicines that are anti-coagulants (i.e. thin blood/prevent clotting, e.g. aspirin/acetylsalicylic acid,

warfarin, ticlopidine), diuretics (water tablets - increase the amount of urine you produce)

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

atenolol, angiotensin-II receptor antagonists such as losartan), or other medicines, as these may affect or

be affected by treatment with ibuprofen.

other medicines such as corticosteroids (used in the management of asthma and to treat skin diseases and

other conditions), anti-platelet agents (generally used to thin the blood to help prevent stroke or heart

problems), cardiac glycosides (used in patients with heart problems), selective serotonin reuptake

inhibitors (SSRIs) or lithium (used to treat depression), methotrexate (used in the treatment of some

cancers, and to treat psoriasis or rheumatoid arthritis), ciclosporin or tacrolimus (used in patients

receiving organ transplants, and to treat some skin disorders), zidovudine (used to treat HIV infection),

quinolone antibiotics (a class of antibiotics used to treat some infections), phenytoin (used in the treatment

of epilepsy), or antacids (used to treat indigestion).

Some other medicines may also affect or be affected by the treatment of Ibuprofen 200mg Soft Capsules.

You should therefore always seek the advice of a doctor or pharmacist before you take Ibuprofen 200mg

with other medicines.

Pregnancy and breastfeeding

Ibuprofen belongs to a group of medicines, NSAIDs, which may impair fertility in women. This effect is

reversible upon stopping the medicine. It is unlikely that ibuprofen, used occasionally, will affect your chances

of becoming pregnant, however tell your doctor before using this medicine if you have problems becoming

pregnant or are trying to become pregnant.

If you are in the first 6 months of pregnancy talk to your doctor before taking ibuprofen.

Do not take ibuprofen during the last 3 months of pregnancy,

Ibuprofen appears in breast milk in very low concentrations, but this is unlikely to adversely affect the breast-

fed infant.

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.

Important information about some of the ingredients of your medicine

Ibuprofen 200 mg Soft Capsules contain soya lecithin. If you are allergic to peanut or soya, do not use this

medicinal product.

Ibuprofen 200 Soft Capsules mg contains sorbitol (E 420).

Sorbitol is a source of fructose. If your doctor has told you (or your child)

have an intolerance to some sugars

or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a

person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine

3.

How to take your medicine

This product is intended for short term use only. You should only take the lowest dose for the shortest time

necessary to relieve your symptoms.

If you are aged between 12 and 18 years and the product is required for more than 3 days or if the symptoms

worsen, you should contact your doctor.

If you are 18 years or older, you should not take this medicine for longer than 10 days unless your doctor tells

you to. If symptoms persist or worsen consult your doctor.

The recommended dose for adults, older people and children and adolescents between 12-18 years of age: 1 or

2 capsules every 4 to 6 hours as required. The recommended interval between doses is approximately 6 to 8

hours, and you must leave at least 4 hours between doses. Do not take more than 6 capsules (1200 mg of

ibuprofen) in any 24 hour period. The capsules should be swallowed whole with water before or after food. Do

not give to children under 12 years of age.

If you take more capsules than you should

or if children have taken the medicine by accident always

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

Bring the remaining capsules with you to show the doctor. The symptoms can include nausea, stomach pain,

vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high

doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness

and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forget to take Ibuprofen 200mg Soft Capsules

Do not take a double dose to make up for a forgotten dose.

If you have questions regarding the use of your medicine, ask your doctor or pharmacist

4.

Possible side effects

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

The following side effects are very rare (less than 1 in 10,000 people) but if you experience any of these STOP

taking this medicine immediately and contact your doctor or pharmacist:

Stomach ulceration or perforation. Symptoms could include severe abdominal pain, vomiting blood (or

liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry

stools.

Inflammation of the brain lining (meningitis). Symptoms could include stiff neck, headache, feeling or

being sick, fever, or feeling disorientated.

Severe allergic reactions (could be life-threatening). Symptoms may include sudden signs of allergy such

as rash, itching or hives on the skin, fainting, low blood pressure, faster heart rate, swelling of the face,

tongue and throat, shortness of breath, wheezing or trouble breathing.

Asthma / worsening of asthma and other breathing difficulties.

Severe conditions of the skin that may affect the mouth and other parts of the body. This may progress to

a severe skin reaction which starts with painful red areas, then large blisters, and ends up with peeling of

layers of skin around the mouth, nose, eyes or genitals. This may be accompanied by fever and chills,

aching muscles and generally feeling unwell.

Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes.

Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial

infarction”) or stroke.

Other possible side effects

If any of the following side effects gets serious, or if you notice any side effect not listed in this leaflet, please

tell your doctor or pharmacist.

Less than 1 in 100 people may experience the following uncommon side effects:

Allergic reactions such as hives, skin rashes and itching (or Systemic Lupus Erythematosus - SLE).

Abdominal pain, indigestion, heartburn and feeling sick.

Headache or dizziness.

Less than 1 in 1,000 people may experience the following rare side effects:

Diarrhoea, wind, constipation or being sick.

Less than 1 in 10,000 people may experience the following very rare side effects:

Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth

ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose.

High blood pressure, heart failure or chest pain.

Nervousness, visual impairment ringing in the ears and dizziness.

Kidney problems. Symptoms could include swelling of the ankles.

Severe skin reactions. Symptoms could include blistering.

Blood in urine, or foamy appearance of urine.

Other very rare side effects with unknown frequency:

Worsening of symptoms of colitis and Crohn’s disease.

Skin becomes sensitive to light

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 Ibuprofen 200 mg if you develop these symptoms and seek medical

attention immediately. See also section 2.

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 HPRA Pharmacovigilance, Earlsfort Terrace,

Dublin

Tel:

+353

6764971;

Fax:

+353

6762517.

Website:

www.hpra.ie;

E-mail:

medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store your medicine

Do not use this medicine after the expiry date stated on the side of the carton. The expiry date refers to

the last day of the month.

Do not store your medicine above 25

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help to protect the environment

6.

Contents of the pack and other information

What your medicine contains

The active substance is ibuprofen. Each liquid-filled soft capsule contains 200mg of Ibuprofen.

The other ingredients are macrogol 600, potassium hydroxide, partially dehydrated sorbitol liquid (E 420)

gelatin, quinoline yellow (E104), patent blue (E131), purified water, white ink [titanium dioxide (E171),

propylene glycol, polyvinyl acetate phthalate, macrogol 400], phosal (soya lecithin, triglycerides (medium

chain), glyceryl stearate, oleic acid, ascorbyl palmitate).

What your medicine looks like and contents of the pack

Ibuprofen 200 mg Soft capsules are green translucent, oval, soft gelatin capsules printed ‘Advil’ on one side in

white ink.

The blister packs contain 6, 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 72, 80, 90, 96 or 100 capsules. (Not all

pack sizes may be marketed.)

The Marketing Authorisation Holder is:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12

Riverwalk, CityWest Business Campus, Dublin 24, Ireland.

The manufacturer is:

Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90 - 04011 Aprilia (LT),

Italy.

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

Ireland - Ibuprofen 200mg Soft Capsules

Netherlands – Advil Reliva Liquid-Caps, zachte capsules 200 mg

This leaflet was last revised in January 2021

Read the complete document

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Ibuprofen 200mg Soft capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains ibuprofen 200 mg.

Excipients : sorbitol (E 420), soya lecithin.

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Soft capsule

Green translucent, oval soft gelatin capsule printed ‘Advil’ on one side in white ink.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Ibuprofen is indicated for the relief of mild to moderate pain including rheumatic and muscular pain, backache, headache,

dental pain, dysmenorrhoea, feverishness and for the relief of symptoms of cold and influenza

4.2 Posology and method of administration

For oral administration and short-term use only.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).

For all indications:

Adults, older people and children and adolescents between 12-18 years of age.

If in children or adolescents between 12 -18 years of age, this medicinal product is required for more than 3 days, or if

symptoms worsen, a doctor should be consulted.

For adults aged 18 years or olderthe patient should consult a doctor if symptoms persist or worsen, or if the product is

required for more than 10 days.

1 or 2 capsules up to three times per day as required. The respective dosing interval should be chosen in line with the observed

symptoms and the maximum recommended daily dose. Doses should be given approximately every 6-8 hours, with a minimum

interval of 4 hours between each dose. A total dose of 1200 mg of ibuprofen (6 capsules) should not be exceeded in any 24

hour period. The capsules should be taken with water.

Not to be used for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the other ingredients in the product (see Section 4.4 Special Warnings and

Precautions.

Use in patients hypersensitive to aspirin or with bronchospasm, asthma, rhinitis, angioedema or urticaria associated with

non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofen should not be given to patients with active or history of recurrent peptic ulcer/haemorrhage (two or more distinct

episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation related to previous NSAID therapy.

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Cerebrovascular bleeding, other active bleeding, or haematological disease.

Severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV).

Last trimester of pregnancy (see section 4.6 Fertility, Pregnancy and Lactation).

4.4 Special warnings and precautions for use

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

symptoms (see gastrointestinal and cardiovascular risks below).

Older people:

Older people

have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation

which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease

and Ibuprofen 200 mg Soft Capsules should not be used where other NSAIDs have produced reactions.

Other NSAIDs:

The use of Ibuprofen 200 mg Soft Capsules with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should

be avoided (see section 4.5).

Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease:

Caution should be taken when ibuprofen is given to patients with SLE and autoimmune diseases – increased risk of aseptic

meningitis has been reported. (see section 4.8).

Renal, Cardiac and Hepatic:

Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate (see sections 4.3

and 4.8). The dose should be as low as possible and renal function should be monitored.

There is a risk of renal impairment in dehydrated children or adolescents between 12 -18 years of age.

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to 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.

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400mg/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 ofarterial 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

exercised

before

initiating

long-term

treatment

patients

with

risk

factors

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

ibuprofen (2400 mg/day) are required.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female

fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal:

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

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

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

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

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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.

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, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as aspirin (see section 4.5).

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

Dermatological:

Severe skin reactions

Severe 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 for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within

first

month

treatment.

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

ibuprofen-containing products. Ibuprofen 200 mg Soft Capsules should be discontinued at the first appearance of skin rash,

mucosal lesions or any other sign of hypersensitivity.

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 200 mg Soft Capsules in case of varicella.

Masking of symptoms of underlying infections

Ibuprofen 200 mg Soft Capsules can mask symptoms of infection, which may lead to delayed initiation of appropriate

treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired

pneumonia and bacterial complications to varicella. When Ibuprofen 200 mg Soft Capsules is administered for fever or pain

relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if

symptoms persist or worsen.

The pharmacological activity of ibuprofen may reduce fever and inflammation, thus diminishing their utility as diagnostic signs

in detecting underlying conditions.

Ibuprofen 200 mg Soft Capsules contain sorbitol E 420.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Ibuprofen 200 mg soft Capsules contain soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

4.5 Interaction with other medicinal products and other forms of interactions

Ibuprofen should be avoided in combination with:

Aspirin:

Concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased

adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin 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 aspirin cannot be

excluded.No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Other NSAIDs:

Ibuprofen should not be used with other pain relievers such as NSAIDs.

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4). When taking

anticoagulants it should be taken into account that long-term use of ibuprofen may increase the risk of bleeding.

Antihypertensives and diuretics: NSAIDs may diminish the effects of antihypertensives or thiazide diuretics. Diuretics can

increase the risk of nephrotoxicity of NSAIDs.

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Corticosteroids: When taking corticosteroids and ibuprofen concomitantly there is an increased risk of gastrointestinal

ulceration or bleeding. (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4)

Cardiac glycosides: Ibuprofen may increase serum digitalis concentrations. Serum digitalis concentrations should therefore be

monitored in patients with decreased renal function or congestive heart failure.

Lithium: Increases in serum lithium concentrations following administration of ibuprofen may be clinically significant.

Methotrexate: Concomitant administration of ibuprofen with moderate and high doses of methotrexate may lead to serious

and fatal methotrexate toxicity. Patients with reduced renal function may be at additional risk of toxicity from the combination

even when low doses of methotrexate (≤20 mg/week) are used.

Ciclosporin: Increased risk of nephrotoxicity.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased

risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone

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

Phenytoin: Ibuprofen may increase pharmacologically active free phenytoin. Patients taking ibuprofen for long-term use

should be monitored.

Antacids: Certain antacids may increase the gastrointestinal absorption of ibuprofen. This is considered to be of clinical

relevance particularly during long-term use of ibuprofen.

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, ibuprofen should not be given unless clearly necessary. If ibuprofen 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-hydroamniosis;

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

- 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, ibuprofen is contraindicated during the third trimester of pregnancy.

Lactation

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In limited studies, ibuprofen appears in breast milk in very low concentrations.Based upon the low level detected (0.0008% of

maternal dose), it is unlikely to affect the breast-fed infant adversely.

Fertility

See section 4.4 regarding female fertility.

4.7 Effects on ability to drive and use machines

No studies on the effect of ability to drive or use machines have been performed.

4.8 Undesirable effects

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the

treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

The adverse effects have been listed in order of decreasing frequency, using the following convention: 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:

Very rare:

Decreased haematocrit and haemoglobin levels.

Cardiac Disorders:

Not known:

Oedema, hypertension, angina pectoris and cardiac

failure, have been reported in association with NSAID

treatment.

Clinical studies suggest that use of ibuprofen,

particularly at a high dose (2400mg/day) may be

associated with a small increased risk of arterial

thrombotic events (for example myocardial infarction

or stroke) (see section 4.4).

Blood and Lymphatic System Disorders:

Very rare:

Haematopoietic disorders (anaemia, haemolytic

anaemia, aplastic anaemia, leucopenia,

thrombocytopenia, pancytopenia, agranulocytosis).

First signs are: fever, sore throat, superficial mouth

ulcers, influenza-like symptoms, severe exhaustion,

unexplained bleeding and bruising.

Nervous System Disorders:

Uncommon:

Headache, dizziness, cerebrovascular accident

Very rare:

Aseptic meningitis – single cases have been reported

very rarely.

Eye Disorders:

Very rare:

Visual impairment.

Ear and Labyrinth Disorders:

Very rare:

Tinnitus and vertigo.

Respiratory, Thoracic and Mediastinal Disorders:

Very rare:

Asthma, bronchospasm, dyspnoea and wheezing.

Gastrointestinal Disorders:

The most commonly-observed adverse events are

gastrointestinal in nature.

Uncommon:

Abdominal pain, abdominal distension, nausea and

dyspepsia.

Rare:

Diarrhoea, flatulence, constipation and vomiting.

Very rare:

Peptic ulcer, perforation or gastrointestinal

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haemorrhage, melaena, haematemesis, sometimes fatal,

particularly in the elderly, ulcerative stomatitis, gastritis,

mouth ulcer.

Not known:

Exacerbation of colitis and Crohn's disease (see section

4.4).

Renal and Urinary Disorders:

Very rare:

Acute renal failure, tubulointerstitial nephritis, nephritic

syndrome, papillary necrosis, especially in long-term

use, associated with increased serum urea and oedema;

haematuria and proteinuria.

Skin and Subcutaneous Tissue Disorders:

Uncommon:

Various skin rashes

Very rare:

Severe forms of skin reactions such as bullous reactions,

including Stevens-Johnson Syndrome, erythema

multiforme and toxic epidermal necrolysis can occur.

Not known:

Drug reaction with eosinophilia and systemic

symptoms (DRESS syndrome)

Acute generalised exanthematous pustulosis (AGEP)

Photosensitivity reactions.

Infections and Infestations:

Not known:

Meningitis, aseptic meningitis.

Vascular Disorders:

Very rare:

Hypertension.

General Disorders and Administration Site Conditions:

Very rare:

Oedema, swelling and peripheral oedema.

Immune System Disorders:

Uncommon:

Hypersensitivity reactions with urticaria and pruritis.

Very rare:

Severe hypersensitivity reactions. Symptoms could be:

facial, tongue and laryngeal swelling, dyspnoea,

tachycardia, hypotension (anaphylaxis, angioedema or

severe shock).

Not known:

Non-specific allergic reactions

Respiratory tract reactivity (e.g. asthma, aggravated

asthma and bronchospasm).

Various skin reactions including exfoliative and bullous

dermatoses (including epidermal necrolysis and

erythema multiforme).

In patients with existing auto-immune disorders (such

as systemic lupus erythematosus, mixed connective

tissue disease) during treatment with ibuprofen, single

cases of symptoms of aseptic meningitis, such as stiff

neck, headache, nausea, vomiting, fever or

disorientation have been observed (see section 4.4).

Hepatobiliary Disorders:

Very rare:

Liver disorders, hepatitis and jaundice.

Psychiatric Disorders:

Very rare:

Nervousness.

Reporting of suspected adverse reactions

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

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asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1

6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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, hypotension 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 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Propionic acid derivatives

ATC code: M01A E01

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In

humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet

aggregation.

Clinical evidence demonstrates that when 400 mg of ibuprofen are taken, pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when

they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400mg were taken

within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the

formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these

data to the clinical situation, (for) the possibility that regular, long-term use of ibuprofen may reduce cardioprotective effect of

low-dose aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see

section 4.5).

5.2 Pharmacokinetic properties

After oral administration, solubilized ibuprofen (as present in Liquigel Capsules) is quickly absorbed when administered under

fasting conditions. C

is achieved within 0.6 hours compared to conventional tablets (¾ – 1½ hours). When taken with food,

peak levels are observed after 1-2 hours.

Ibuprofen protein binding is approximately 99%. After an oral dose, ibuprofen is 75 – 85% excreted in the urine during the first

24 hours (mainly in the form of two metabolites), the remainder being eliminated in the faeces following excretion in bile.

Excretion is complete within 24 hours.

The half-life of ibuprofen in plasma is approximately 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3 Preclinical safety data

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Preclinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose

toxicity, genotoxicity and carcinogenic potential. No teratogenic effect has been demonstrated in animal experiments, however,

use of ibuprofen during pregnancy should, if possible, be avoided.

Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure,

indicating little relevance to clinical use.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol600, potassium hydroxide, sorbitol liquid, partially dehydrated, gelatin, quinoline yellow (E104), patent blue (E131),

purified water, soya lecithin, triglycerides (medium chain), glyceryl stearate, oleic acid, ascorbyl palmitate, Opacode White ink:

titanium dioxide (E171), propylene glycol, polyvinyl acetate phthalate, Macrogol400.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

The Liquigel Capsules are packed into blister strips in a cardboard box.

Pack A:

Blister: White opaque thermoformed unplasticised PVC (250 μm) / Polyethylene extrusion coating (30 μm) /PVdC (90 gsm) heat

sealed to the foil.

Foil: Hard temper aluminium foil (20 μm) / Heatseal lacquer (7 gsm)

Pack B:

Blister: White opaque thermoformed unplasticised PVC (250 μm) / PVdC coating (60 gsm) heat sealed to the foil.

Foil: Glassine (35 gsm) / Lamination adhesive / Aluminium foil (9 μm) / Heat seal lacquer (7 gsm).

A pack range will consist of packs of 6, 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 72, 80, 90, 96 and 100 Liquigel capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

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8 MARKETING AUTHORISATION NUMBER

PA0678/146/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 8

March 2002

Date of last renewal: 9

November 2009

10 DATE OF REVISION OF THE TEXT

March 2021

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