Ibuprofen Liquid Capsules

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Ibuprofen 400 mg
Available from:
Neo Pharma Limited
INN (International Name):
Ibuprofen 400 mg
Dosage:
400 mg
Pharmaceutical form:
Liquid filled capsule
Composition:
Active: Ibuprofen 400 mg Excipient: Gelatin Medium chain triglyceride (miglyol 812N) Macrogol 600 Opacode black NS-78-17821 Potassium hydroxide Sorbitol
Prescription type:
Restricted
Manufactured by:
Strides Shasun Limited
Therapeutic indications:
Temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, neuralgia, sore throat, tennis elbow and colds and flu. Reduces fever.
Product summary:
Package - Contents - Shelf Life: Blister pack, White opaque PVC/PE/PVDC film - 6 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 10 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 12 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 20 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 24 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 40 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 48 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, White opaque PVC/PE/PVDC film - 50 capsules - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-10042b
Authorization date:
2016-09-30

Read the complete document

Ibuprofen Liquid Capsules

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New Zealand Data Sheet

IBUPROFEN LIQUID CAPSULES

Neo Health

Ibuprofen liquid capsules 400mg

1 PRODUCT NAME

Ibuprofen 400mg Liquid capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains Ibuprofen 400 mg.

For full list of excipients, see section 6.1

3.PHARMACEUTICAL FORM

Capsule, soft

Natural transparent, oval shaped, soft gelatin capsule containing clear colourless liquid.

imprinted with L 160 in Black edible ink.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

This medical product is indicated in adults and children & adolescents 12 years of age and over

for the symptomatic treatment of mild to moderate pain and/or inflammation associated with

headache, migraine, tension headache, muscular pain, dental pain, period pain, sinus pain, back

pain, arthritis pain, cold and flu symptoms.

4.2 Dosage and administration

For oral use and short-term use only. Capsules should not be chewed.

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

possible duration necessary to control symptoms (see section 4.4)

Adults and children & adolescents 12 years of age and over. Initial dose, one capsule with

water. Then, if necessary, one capsule every six hours. Do not exceed six capsules (2400 mg)

in any 24-hour period.

If in children and adolescents between 12 and 18 years this medicinal product is required

for 3 days, or if symptoms worsen a doctor should be consulted.

If in adults the product is required for more than 3 days in the case of fever and 4 days for

treatment of pain, or if the symptoms worsen the patient is advised to consult a doctor.

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It is recommended that patients with a sensitive stomach take Ibuprofen with food.

If taken shortly after eating, the onset of action of Ibuprofen may be delayed. If this happens

do not take more Ibuprofen than recommended within section 4.2 (posology) or until the

correct re-dosing interval has passed.

Special patient groups

Elderly:

No special dose adjustment is required. Because of the possible undesirable-effect profile

(see section 4.4), the elderly should be monitored particularly carefully.

Renal insufficiency:

No dose reduction is required in patients with mild to moderate impairment to renal

function (patients with severe renal insufficiency, see section 4.3).

Hepatic insufficiency (see section 5.2):

No dose reduction is required in patients with mild to moderate impairment to hepatic

function (patients with severe hepatic dysfunction, see section 4.3).

Children and adolescents:

For use in children and adolescents, see section 4.3.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the other excipients listed in

section 6.1.

In patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma,

rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid

(ASA) or other non-steroidal anti-inflammatory drugs (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).

Patients with severe hepatic failure, severe renal failure, or severe heart failure

(NYHA Class IV). See also section 4.4.

In patients with cerebrovascular or other active bleeding.

In patients with bleeding diathesis or coagulation disorders.

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In patients with unclarified blood-formation disturbances.

In patients with severe dehydration (caused by vomiting, diarrhoea or insufficient

fluid intake).

During the last trimester of pregnancy (see Section 4.6).

Adolescents weighing less than 40 kg or children under 12 years of age.

4.4 Special warnings and precautions for use

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

possible duration necessary to control symptoms (see gastrointestinal (GI) and

cardiovascular risks below).

Caution is required in patients with certain conditions, which may be made worse:

systemic lupus erythematosus and mixed connective tissue disease – increased

risk of aseptic meningitis (see section 4.8).

congenital disorder of porphyrin metabolism (e.g. acute intermittent

porphyria).

gastrointestinal disorders and chronic inflammatory intestinal disease

(ulcerative colitis, Crohn’s disease) (see section 4.8).

hypertension and/or cardiac impairment (see section 4.3 and 4.8).

renal impairment as renal function may deteriorate (see sections 4.3 and 4.8).

hepatic dysfunction (see sections 4.3 and 4.8).

directly after major surgery.

in patients who show allergic reactions to other substances, as they are also at

a higher risk of hypersensitivity reactions when using Ibuprofen

in patients who suffer from hayfever, nasal poyps, chronic obstructive

respiratory disorders, or have a history of allergic disease, as an increased risk

exists for them of allergic reactions occurring. These may present as asthma

attacks (so-called analgesics asthma). Quincke’s oedema or urticaria.

Gastrointestinal (GI) safety

The use with concomitant NSAID’s, including cyclo-oxygenase-2 specific inhibitors,

increases risk of adverse reactions (see section 4.5) and should be avoided.

Elderly:

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

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

Gastrointestinal (GI) bleeding, ulceration or perforation:

Gastrointestinal (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 GI events.

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

be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses and

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 drugs likely to increase gastrointestinal risk (see below

and section 4.5). Patients with a history of GI toxicity, particularly the 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 (SSRI’s) or anti-platelet agents such as aspirin (See

section 4.5).

NSAID’s should be given with care to patients with a history of gastrointestinal disease

(ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (see section

4.8).

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

Ibuprofen 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 tissues 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 Nurofen in case of varicella.

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 the use of ibuprofen, particularly at high doses (2400 mg daily)

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 daily) is associated with an increased risk of arterial thrombotic

events.

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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 for

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.

Other notes

Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very

rarely. At the first signs of a hypersensitivity reaction after taking/administering Ibuprofen

therapy must be stopped. Medically required measures, in line with the symptoms, must be

initiated by specialist personnel.

Ibuprofen, the active substance of Ibuprofen Liquid Capsules may temporarily inhibit the

blood-platelet function (thrombocyte aggregation). Therefore, it is recommended to monitor

patients with coagulation disturbances carefully.

In prolonged administration of Ibuprofen regular checking of the liver values, the kidney

function, as well as of the blood count, is required.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is

experienced

suspected,

medical

advice

should

obtained

treatment

should

discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in

patients who have frequent or daily headaches despite (or because of) the regular use of

headache medications.

The habitual intake of painkillers, particularly the combination of several painkillers, may lead

to permanent renal damage with the risk of renal failure (analgesic nephropathy). This risk

may be increased by salt loss and dehydration.

Through concomitant consumption of alcohol, active substance-related undesirable effects,

particularly those that concern the gastrointestinal tract or the central nervous system, may be

increased on use of NSAID’s.

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis

may cause impairment of female fertility by an effect on ovulation. This is reversible on

withdrawal of treatment (see section 4.6).

There is a risk of renal impairment in dehydrated adolescents.

The medicinal product contains sorbitol. Patients with rare hereditary problems of fructose

intolerance should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Acetylsalicylic acid (low dose):

Concomitant administration of ibuprofen and acetylsalicylic acid is not generally

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recommended because of the potential of increased adverse effects.

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

acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although

there are uncertainties regarding extrapolation of these data to the clinical situation, the

possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of

low- dose acetylsalicylic acid cannot be excluded. No clinical relevant effect is considered to

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

Other NSAIDs, including cyclooxygenase-2 selective inhibitors:

The concomitant administration of several NSAIDs may increase the risk of gastrointestinal

ulcers and bleeding due to a synergistic effect. The concomitant use of ibuprofen with other

NSAIDs should therefore be avoided (see section 4.4).

Digoxin, phenytoin, lithium:

The concomitant use of Ibuprofen with digoxin, phenytoin or lithium preparations may

increase serum levels of these medicinal products. A check of serum-lithium, serum-

digoxin and serum-phenytoin levels is not as a rule required on correct use (maximum over

4 days).

Corticosteroids:

Corticosteriods

as these may increase

risk

adverse

reactions,

especially

gastrointestinal tract (gastrointestinal ulceration or bleeding) (see Section 4.3).

Anti-platelet

agents

selective

serotonin

reuptake

inhibitors

(SSRIs):

Increased risk of gastrointestinal bleeding. (See section 4.4).

Anticoagulants:

NSAIDs may enhance the effect of anti-coagulants, such as warfarin (see section 4.4).

Probenecid and sulfinpyrazone:

Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of

ibuprofen.

Diuretics, ACE inhibitors, betareceptor-blocker and angiotensin-II antagonists:

NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients

with compromised renal function (e.g. dehydrated patients or elderly patients with compromised

renal function) the co-administration of an ACE inhibitor, betareceptor-blocker or angiotensin-II

antagonist and agents that inhibit cyclo- oxygenase may result in further deterioration of renal

function, including possible acute renal failure, which is usually reversible. Therefore, the

combination should be administered with caution, especially in the elderly. Patients should be

adequately hydrated and consideration should be given to monitoring of renal function after

initiation of concomitant therapy, and periodically thereafter.

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Potassium sparing diuretics:

The concomitant administration of Ibuprofen and potassium-sparing diuretics may lead to

hyperkalaemia (check of serum potassium is recommended).

Methotrexate:

administration

Ibuprofen

within

hours

before

after

administration

methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic

effect.

Ciclosporin:

risk

kidney-damaging

effect

ciclosporin

increased

through

concomitant administration of certain nonsteroidal antiinflammatory drugs. This effect

also cannot be ruled out for a combination of ciclosporin with ibuprofen.

Tacrolimus:

risk

nephrotoxicity

increased

if the two

medicinal

products

are administered

concomitantly

Zidovudine:

There is evidence of an increased risk of haemarthroses and haematoma in HIV (+)

haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Increased

risk

haematological

toxicity

when

NSAIDs

given

with

zidovudine.

Sulfonylureas:

Clinical investigations have shown interactions between nonsteroidal anti- inflammatory

drugs and antidiabetics (sulphonylureas). Although interactions between ibuprofen and

sulphonylureas have not been described to date, a check of blood-glucose values is

recommended as a precaution on concomitant intake.

Quinolone antibiotics:

Animal data indicate that NSAID’s can increase the risk of convulsions associated with

quinolone antibiotics. Patients taking NSAID’s and quinolones may have an increased risk

of developing convulsions.

Mifepristone:

NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs

can reduce the effect of mifepristone.

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4.6 Fertility, Pregnancy and lactation

Pregnancy:

Inhibition

prostaglandin

synthesis

adversely

affect

pregnancy

and/or

embryo/foetal

development.

Data

from

epidemiological

studies

raise

concern

about

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

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:

Ibuprofen and its metabolites can pass in low concentrations into the breast milk. No harmful

effects to infants are known to date, so for short-term treatment with the recommended dose

for pain and fever interruption of breast-feeding would generally not be necessary.

Fertility:

The use of ibuprofen may affect female fertility. This effect is reversible on withdrawal of

treatment.

Therefore

ibuprofen

recommended

women

having

difficulties becoming pregnant (see

section 4.4.).

4.7 Effects on ability to drive and use machines

Patients who experience dizziness, drowsiness, vertigo or visual disturbances while they are

taking ibuprofen, should avoid driving or using machinery. Single administration or short

term use of ibuprofen does not usually warrant the adoption of any special precautions. This

applies to a greater extent in combination with alcohol.

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4.8 Undesirable effects

The list of the following undesirable effects comprises all undesirable effects that have become

known under treatment with ibuprofen, also those under high-dose long- term therapy in

rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the

short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and

a maximum of 1800 mg for suppositories.

With the following adverse drug reactions, it must be accounted for that they are

predominantly dose-dependent and vary interindividually.

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

5.4).

Nausea,

vomiting,

diarrhoea,

flatulence,

constipation,

dyspepsia,

abdominal

pain,

melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see

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

observed. Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose

range and the duration of use.

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

treatment.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may

associated

with

small

increased

risk

arterial

thrombotic

events

(for

example

myocardial infarction or stroke) (see section 4.4).

Hypersensitivity reactions have been reported and these may consist of:

non-specific allergic reactions and anaphylaxis

respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm,

dyspnoea

various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely

exfoliative and bullous dermatoses (including epidermal necrolysis and erythema

multiforme)

The patient is to be instructed to inform a doctor at once and to stop taking ibuprofen if they

experience any of the above.

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Please note that within each frequency grouping, undesirable effects are presented in order of

decreasing seriousness.

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)

Infections and infestations:

Very rare: Exacerbation of infection-related inflammations (e.g. development of necrotising

fasciitis) coinciding with the use of nonsteroidal anti-inflammatory drugs has been described.

This

possibly

associated

with

mechanism

action

nonsteroidal

anti-

inflammatory drugs.

If signs of an infection occur or get worse during use of Ibuprofen, the patient is therefore

recommended to go to a doctor without delay. It is to be investigated whether there is

an indication for an anti-infective/antibiotic therapy.

The symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or

consciousness clouding have been observed under ibuprofen. Patients with autoimmune

disorders (SLE, mixed connective-tissue disease) appear to be predisposed.

Blood and Lymphatic System Disorders:

Very

rare:

Disturbances

blood

formation

(anaemia,

leukopenia,

thrombocytopenia,

pancytopenia, agranuloctosis). The first signs may be fever, sore throat, superficial wounds in

the mouth, influenza-like complaints, severe lassitude, nosebleeds and skin bleeding. In such

cases the patient should be advised to discontinue the medicine immediately, to avoid any self-

medication with analgesics or antipyretics and to consult a physician.

The blood count should be checked regularly in long-term therapy

Immune system disorders (Hypersensitivity):

Uncommon: Hypersensitivity reactions with urticaria and pruritus, as well as asthma attacks

(possibly with drop in blood pressure).

Very rare: severe general hypersensitivity reactions. Symptoms could be: facial, tongue

and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or

severe shock). Exacerbation of asthma and bronchospasm.

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Psychiatric disorders:

Very rare: Psychotic reactions, depression

Nervous System Disorders:

Uncommon: Central nervous disturbances such as headache, dizziness, sleeplessness,

agitation, irritability or tiredness

Eye disorders:

Uncommon: Visual disturbances

Ear and labyrinth disorders:

Rare: Tinnitus

Cardiac Disorders:

Very rare: palpitations, heart failure, myocardial infarction

Vascular disorders

Very rare: Arterial hypertension

Gastrointestinal Disorders:

Common: Gastro-intestinal complaints such as dyspepsia, pyrosis, abdominal pain, nausea,

vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may

cause anaemia in exceptional cases

Uncommon: Gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative

stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4), gastritis

Very

rare:

Oesophagitis,

pancreatitis,

formation

intestinal

diaphragm-like

strictures. The patient is to be instructed to withdraw the medicinal product and to go

doctor

immediately

severe

pain

upper

abdomen

melaena

haematemesis occurs.

Hepatobiliary Disorders:

Very rare: Hepatic dysfunction, hepatic damage, particularly in long-term therapy, hepatic

failure, acute hepatitis

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Skin and Subcutaneous Tissue Disorders

Very rare: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal

necrolysis, alopecia. In exceptional cases, severe skin infections and soft- tissue

complications may occur during a varicella infection (see also "Infections and infestations").

Not known:

Acute generalised exanthematous pustulosis (AGEP)

Drug reaction with eosinophilia and systemic symptoms (DRESS)

Renal and Urinary Disorders

Rare: Kidney-tissue damage (papillary necrosis) and elevated uric acid concentrations in the

blood may also occur rarely

Very rare: Formation of oedemas, particularly in patients with arterial hypertension or renal

insufficiency, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal

insufficiency. Renal function should therefore be checked regularly.

4.9 Overdose

In adolescents and adults the dose response effect is not 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 dizziness, drowsiness, occasionally excitation and

disorientation or coma. Occasionally patients develop convulsions. In serious poisoning

metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due

to interference with the actions of circulating clotting factors. Acute renal failure and liver

damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

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

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

activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic

amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or

lorazepam. Give bronchodilators for asthma.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic

group:

Anti-inflammatory

antirheumatic

products,

non-steroids;

propionic acid derivative.

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ATC Code: M01A E01

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that in the conventional animal-

experiment inflammation models has proven to be effective via prostaglandin- synthesis

inhibition. In humans, ibuprofen reduces inflammatory-related pain, swellings and fever.

Furthermore, ibuprofen reversibly inhibits ADP – and collagen – induced platelet aggregation

Experimental data suggests that ibuprofen may competitively inhibit the effect of low dose

acetylsalicylic

acid

platelet

aggregation

when

they

dosed

concomitantly.

Some

pharmacodynamics studies show that when single doses of ibuprofen 400mg were taken within

8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a

decreased

effect

acetylsalicylic

acid

formation

thromboxane

platelet

aggregation occurred. Although there are uncertainties regarding extrapolation of these data to

the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the

cardioprotective effect of low- dose acetylsalicylic acid cannot be excluded. No clinically

relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

5.2 Pharmacokinetic properties

oral

administration,

ibuprofen

partly

absorbed

stomach

then

completely in the small intestine.

Following

hepatic

metabolism

(hydroxylation,

carboxylation,

conjugation),

pharmacologically inactive metabolites are completely eliminated, mainly renally (90 %),

but also with the bile. The elimination half-life in healthy individuals and those with liver

and kidney diseases is 1.8 - 3.5 hours. Plasma-protein binding is about 99 %.

Peak plasma levels following oral administration of a normal-release pharmaceutical form

(tablet) are reached after 1 - 2 hours. Ibuprofen is absorbed rapidly from the gastrointestinal

tract following oral administration. In a pharmacokinetic study (R07- 1009), the time to peak

plasma

levels

(median

Tmax)

fasted

state,

normal-

release

pharmaceutical

form

ibuprofen acid tablets was 90 min compared with 40 min for Ibuprofen Capsules, soft.

Ibuprofen is detected in the plasma for more than 8 hours after administration of Ibuprofen.

5.3 Preclinical safety data

The subchronic and chronic toxicity of ibuprofen in animal experiments was observed

principally as lesions and ulcerations in the gastro-intestinal tract.

In vitro

in vivo

studies

gave no clinically relevant evidence of a mutagenic potential of ibuprofen. In studies in rats

and mice no evidence of carcinogenic effects of ibuprofen was found. Ibuprofen led to

inhibition of ovulation in rabbits as well as disturbance of implantation in various animal

species (rabbit, rat, mouse). Experimental studies have demonstrated that ibuprofen crosses

the placenta, for maternally toxic doses, an increased incidence of malformations (e.g.

ventricular septal defects) was observed. In animal studies it has been observed that the use

of NSAIDs, known to inhibit prostaglandin synthesis, may increase the incidence of dystocia

and delayed parturition.

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Pg. 14

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Fill

Polyethylene glycol-600

Potassium hydroxide

Purified water

Miscellaneous:

Polyethylene Glycol 600

Miglyol 812N

Gelatin Mass:

Gelatin 160 Bloom

Sorbitol Liquid, Partially dehydrated (polysorb 85/70/00)

Ink:

OPACODE WB Black NS-78-17821)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 25°C. Store in the original package to protect from moisture and light

6.5 Nature and contents of container

Blister, white opaque PVC/PE/ PVDC aluminium. Each blister tray contains 6, 10, 12, 20,

24, 30, 40, 48 or 50 capsules, soft. The blisters are packed in a cardboard carton. Not all pack

sizes may be marketed.

Ibuprofen Liquid Capsules

Pg. 15

6.6 Special precautions for disposal and other handling

No special requirements.

7 MEDICINE SCHEDULE

Restricted.

8 SPONSOR

Neo Pharma Limited,

Auckland, New Zealand

9 DATE OF FIRST APPROVAL

29/06/2017

10 DATE OF REVISION OF TEXT

03/11/2020

SUMMARY TABLE OF CHANGES

Section

changed

Summary of new information

The format of the datasheet is changed to new SPC style.

4.4

To include :Acute generalised exanthematous pustulosis (AEGP)

has been reported in relation to ibuprofen containing products.

4.8

To include:

Acute generalised exanthematous pustulosis (AEGP)

Drug reaction with eosinophilia and systemic symptoms (DRESS)

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