SOLUBLE DENTOGEN IBUPROFEN EFFERVESCENT TABLETS 200MG

Active substance: IBUPROFEN

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Soluble Dentogen Ibuprofen Effervescent Tablets 200mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200mg
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Effervescent tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of toothache pain and pain swelling following minor oral surgery.

4.2

Posology and method of administration
For oral administration and short-term use only.
Adults, the elderly and children over 12 years
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms. The patient should consult a doctor or dentist if symptoms persist or
worsen, or if the product is required for more than 10 days.
Initial dose - One or two tablets to be taken. The initial dose may be followed by
further doses of one or two tablets every four hours. Leave at least four hours
between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.
To be taken preferably after food.

Children
Not suitable for children under 12 years.
Directions
The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve
more quickly in warm water, or if stirred.

4.3

Contraindications
Hypersensitivity to ibuprofen or any of the constituents in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma,
rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs.
Active or previous peptic ulcer.
History of upper gastrointestinal bleeding or perforation, related to previous
NSAIDs therapy.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors
(See section 4.5 Interactions).
Severe hepatic failure, renal failure or heart failure (See section 4.4, Special
warnings and precautions for use).
Last trimester of pregnancy (See section 4.6 Pregnancy and lactation).
Severe heart failure.
Each tablet contains 661mg or 28.8 mmol of Na+. This should be taken into
account when prescribing for patients on a sodium restricted diet.

4.4

Special warnings and precautions for use
Bronchospasm may be precipitated in patients suffering from or with a previous
history of bronchial asthma or allergic disease.
Undesirable effects may be minimised by using the minimum effective dose for the
shortest possible duration.
The elderly are at increased risk of the serious consequences of adverse reactions.
Systemic lupus erythematosus and mixed connective tissue disease increased risk of
aseptic meningitis (see section 4.8 Undesirable effects).

Chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease) – as
these conditions may be exacerbated (See section 4.8 Undesirable effects).
Hypertension and/or cardiac impairment as renal function may deteriorate and/or
fluid retention occur.
Renal impairment as renal function may further deteriorate (See section 4.3
Contraindications and Section 4.8 Undesirable effects).
Hepatic dysfunction (See section 4.3 Contraindications and Section 4.8 Undesirable
effects).
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.
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.
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 gastrotoxicity or bleeding, such as corticosteroids, or
anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section
4.5 Interactions).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment
should be withdrawn.
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.
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see GI and cardiovascular risks
below).
Cardiovascular and cerebrovascular effects
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at
high doses (2400mg daily) and in long-term treatment 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.
1200mg daily) is associated with an increased risk of myocardial infarction.



The label will include:
Read the enclosed leaflet before taking this product.
Do not take if you • have or have ever had a stomach ulcer, perforation or bleeding.
• are allergic to ibuprofen or any other ingredient of the product, aspirin or other
related painkillers.
• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg.
• are in the last 3 months of pregnancy.

Speak to a pharmacist or your doctor or dentist before taking this product if you
• have asthma, liver, heart, kidney or bowel problems.
• are in the first 6 months of pregnancy.
If symptoms persist or worsen, consult your dentist or doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. However, the limitations of
these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical
situation imply that no firm conclusions can be made for regular ibuprofen use, and
no clinically relevant effect is considered to be likely for occasional ibuprofen use
(see section 5.1).
Ibuprofen should not be used in combination with: Aspirin: Unless low-dose aspirin
(not above 75mg daily) has been advised by a doctor, as this may increase the risk of
adverse reactions (See section 4.3 Contraindications).
Other NSAIDs: As these may increase the risk of adverse effects (See section 4.3
Contraindications).
Ibuprofen should be used with caution in combination with: Anticoagulants: NSAIDs
may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).
Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs.
Corticosteroids: May increase the risk of adverse reactions in the adverse reactions in
the gastrointestinal tract (See section 4.4 Special warnings).
Lithium: There is evidence for potential increases in plasma levels of lithium.
Methotrexate: There is a potential for an increase in plasma methotrexate.
Zidovudine: There is evidence of an increased risk of haemarthroses and
haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine
and ibuprofen.

4.6

Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use
of Soluble Dentogen Ibuprofen Effervescent Tablets should, if possible, be avoided
during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature
closure of the foetal ductus arteriosus with possible persistant pulmonary
hypertension. The onset of labour may be delayed and the duration increased with an
increased bleeding tendency in both mother and child (See section 4.3
Contraindications).
In limited studies, ibuprofen appears in the breast milk in very low concentration and
is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7

Effects on ability to drive and use machines
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
Hypersensitivity reactions have been reported and these may consist of:
(a) Non-specific allergic reactions and anaphylaxis.
(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm,
dyspnoea
(c) Various skin reactions, e.g. pruritis, urticaria, angioedema and more rarely
exfoliative and bullous dermatoses (including epidermal necrolysis and erythema
multiforme).
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 longterm treatment, additional adverse effects may occur.
Hypersensitivity reactions: Uncommon: Hypersensitivity reactions with urticaria and
pruritus.
Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and
laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or
severe shock).
Exacerbation of asthma or bronchospasm.
Gastrointestinal: Uncommon: abdominal pain, nausea, and dyspepsia. Rare:
diarrhoea, flatulence, constipation and vomiting.Very rare: peptic ulcer, perforation or
gastrointestinal haemorrhage,sometimes fatal, particularly in the elderly.
Exacerbation of ulcerative colitis and Crohn’s disease (See section 4.4).
Nervous system:
Uncommon: Headache.
Renal: Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
Hepatic: Very rare: liver disorders.
Haematological: Very rare: Haematopoietic disorders (anaemia, leucopenia,
thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat,
superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding
and bruising.

Skin:
Uncommon: Various skin rashes.
Very rare: Severe forms of skin reactions such as erythema multiforme and epidermal
necrolysis can occur.
Immune System: 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).
Oedema, hypertension, and cardiac failure, have been reported in association with
NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at
high doses 2400mg daily) and in long-term treatment may be associated with a small
increased risk of arterial thrombotic events (for example myocardial infarction or
stroke) (see section 4.4).

4.9

Overdose
In children, ingestion of more than 400 mg/kg may cause symptoms. In adults the
dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms
Most patients who have ingested clinically important amounts of NSAIDs will
develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea.
Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious
poisoning , toxicity is seen in the central nervous system, manifesting as drowsiness,
occasionally excitation and disorientation or coma. Occasionally patients develop
convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin
time/INR may be prolonged, probably due to interference with the actions of
circulating clotting factors. Acute renal failure and liver damage may occur.
Exacerbation of asthma is possible in asthmatics.
Management
Management should be symptomatic and supportive and include the maintenance of a
clear airway and monitoring of cardiac and vital signs until stable. Consider oral
administration of activated charcoal if the patient presents within 1 hour of ingestion
of a potentially toxic amount. If frequent or prolonged, convulsions should be treated
with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. In one study, when a single
dose of ibuprofen 400mg was 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. However, the limitations
of these data and the uncertainties regarding extrapolation of ex vivo data to the
clinical situation imply that no firm conclusions can be made for regular ibuprofen
use, and no clinically relevant effect is considered to be likely for occasional
ibuprofen use.

5.2

Pharmacokinetic properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed
throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on
an empty stomach. When taken with food peak levels are observed after 1 to 2 hours.
These times may vary with different dosage forms.
The half-life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium bicarbonate
Sodium carbonate (anhydrous)
Sodium cyclamate
Sodium saccharin
Citric acid anhydrous

Docusate sodium
Polyethylene glycol powder 6000
Povidone
Orange mint flavour 611160E
IMS

6.2

Incompatibilities
None stated.

6.3

Shelf life
24 months unopened.

6.4

Special precautions for storage
Store in a cool dry place.

6.5

Nature and contents of container
Strip pack using PPFM laminate, constructed of: 40gsm MGBK paper / 12gsm LDPE
/ 8µ aluminium foil / 23gsm LDPE. Strips are packed into a carton containing either
10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER

Ayrton Saunders Limited,
North Way,
Walworth Industrial Estate,
Andover,
SP10 5AZ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0090

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/01/91 / 29/01/99

10

DATE OF REVISION OF THE TEXT
17/02/2009

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)