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EXTRA STRENGTH IBUPROFEN CAPLETS 400MG

Active substance(s): IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Extra Strength Ibuprofen Caplets 400 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 400 mg

3

PHARMACEUTICAL FORM
Tablets
White, sugar coated, capsule shaped tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Rheumatic or muscular pain, pain of non-serious arthritic conditions, backache,
neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms
of cold and influenza

4.2

Posology and method of administration
For oral administration
To be taken preferably with or after food.
For short-term use only.
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms. The patient should consult a doctor if symptoms persist or worsen, or if
the product is required for more than ten days.

Adults, the elderly and children over 12 years
400 mg, up to three times a day as required.
Leave at least four hours between doses and do not take more than 1200 mg in any 24
hour period.
Do not give to children under 12 years of age.

4.3.

Contraindications
Ibuprofen should not be administered to patients with bleeding disorders.
Hypersensitivity to ibuprofen or any of the excipients in the product.
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in
response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs.
Severe hepatic, renal and cardiac failure (See section 4.4 – Special warnings
and precautions for use).
During the last trimester of pregnancy (See section 4.6 – Pregnancy and
lactation).
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’s
therapy.
High doses of non-steroidal anti-inflammatory drugs are contraindicated with
concomitant mifamurtide (See section 4.5 - Interactions with other medicinal
products and other forms of interaction).

4.4.

Special warnings and precautions for use
In all patients:
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.2, and GI
and cardiovascular risks below).
Other NSAIDs: The use of this ibuprofen product with concomitant NSAIDs
including cyclo-oxygenase-2 specific inhibitors should be avoided (See section
4.5 Interactions).

Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs,
especially gastrointestinal bleeding and perforation which may be fatal (See
section 4.2 Posology and administration).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a
previous history of, bronchial asthma or allergic disorders, since NSAIDs have
been reported to precipitate bronchospasm in such patients.
Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. Patients at greatest risk
of this reaction are those with impaired renal function, cardiac impairment,
liver dysfunction, those taking diuretics and the elderly. The dose should be
kept as low as possible and renal function should be monitored in these
patients. Hepatic impairment is also associated with an increased risk of
gastro-intestinal bleeding. (See also Section 4.3 – Contraindications).
Caution in patients with a history of renal or hepatic impairment, as fluid
retention and oedema have been reported in association with NSAID therapy.
Sodium and water retention may occur and renal function may deteriorate.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of
hypertension and/or mild to moderate congestive heart failure as fluid
retention and oedema have been reported in association with NSAID therapy.
Although 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), non-selective NSAIDs are also
associated with a small increased risk of thrombotic events even when used
short-term in those with no cardiovascular risk factors. Overall,
epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200mg
daily) is associated with an increased risk of myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure, established
ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular
disease should only be treated with ibuprofen after careful consideration.
Similar consideration should be made before initiating longer-term treatment
of patients with risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking).
Gastrointestinal bleeding, ulceration and perforation:
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.

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), in the elderly, and in
patients who smoke. 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 corticosteroids,
or anticoagulants such as warfarin, selective serotonin re-uptake inhibitors 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.
NSAIDs 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 – Undesirable effects) and because of the
potential for gastrointestinal bleeding.
Systemic as well as local effects of NSAIDs contribute to gastrointestinal
damage; taking oral formulations with milk or food, or using enteric-coated
formulations, or changing the route of administration may only partially
reduce symptoms such as dyspepsia.
Skin and subcutaneous tissue disorders:
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 for 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. Ibuprofen should be discontinued at the first
appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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 (See
section 4.8 – Undesirable effects).
Infections:
NSAIDs should be used with caution in patients with infections, as symptoms
such as fever, pain and inflammation may be masked.
Varicella (chickenpox) can be at the origin of serious cutaneous and soft tissue
infectious complications. To date, the contributing role of NSAIDs in the
worsening of varicella infections cannot be ruled out. Ibuprofen should be

used with caution in patients, particularly children, with varicella infection,
particularly if there is a possibility of secondary infection.
Female fertility:
The use of ibuprofen may impair female fertility and is not recommended in
women attempting to conceive. The reduction in female fertility is reversible
on stopping
treatment.In women who have difficulties conceiving or who are undergoing
investigation of infertility, withdrawal of ibuprofen should be considered.
Patients with hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
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 three months of pregnancy
Speak to a pharmacist or your doctor before taking this product if you
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, liver, heart, kidney or bowel problems
• are pregnant or trying to get pregnant
• are elderly
• are a smoker.
If symptoms persist consult your doctor.
Do not exceed the stated dose. Keep out of the reach and sight of children.

4.5

Interactions with other medicinal products and other forms of interaction
Care should be taken in patients treated with any of the following drugs as
interactions have been reported in some patients.
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant
use of two or more NSAIDs, including aspirin (unless low-dose aspirin, not above
75mg daily, has been advised by a doctor) as this may increase the risk of
gastrointestinal side effects and toxicity including ulceration or haemorrhage (See
section 4.4 Special Warnings and Precautions).
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).

Alcohol: Increased risk of gastro-intestinal bleeding or ulceration in susceptible
patients.
Antibacterials: Increased risk of nephrotoxicity with concomitant administration of
ibuprofen and aminoglycosides. 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.
Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin
and heparin (See section 4.4 – Special warnings and precautions for use).
Antidepressants: Selective serotonin re-uptake inhibitors (SSRIs) may increase the risk
of gastro-intestinal bleeding and ulceration.
Antidiabetics: May enhance the hypoglycaemic effects of sulphonylureas.
Antiepileptics: May enhance the effects of phenytoin by inhibiting its metabolism.
Antihypertensives: Reduced antihypertensive effect of antihypertensives, including
ACE inhibitors, angiotensin-II antagonists, beta-blockers and vasodilators; increased
monitoring of the effectiveness of antihypertensive therapy may be necessary.
Increased risk of nephrotoxicity, renal impairment and hyperkalaemia with ACE
inhibitors and of renal impairment and hyperkalaemia with angiotensin-II antagonists.
Antiplatelet drugs: Increased risk of bleeding with clopidogrel and ticlopidine.
Antivirals: Increased risk of haematological toxicity with zidovudine. There is evidence
of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs
receiving concurrent treatment with zidovudine and ibuprofen.
Ritonavir may increase plasma concentrations of ibuprofen.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Ciclosporin: Increased risk of nephrotoxicity.
Corticosteroids: Increased risk of gastro-intestinal ulceration and gastro-intestinal
bleeding. (See section 4.4 – Special warnings and precautions for use)
Diuretics: Reduced diuretic and antihypertensive effects. Possibility of hyperkalaemia
with potassium-sparing diuretics. Diuretics can increase the risk of nephrotoxicity of
NSAIDs.
Lithium: Decreased elimination of lithium.
Methotrexate: Decreased elimination of methotrexate.
Mifamurtide: High doses of non-steroidal anti-inflammatory drugs (NSAIDs) are
contraindicated with concomitant mifamurtide (see section 4.3 - Contraindications),
as it has been demonstrated in vitro that high-dose NSAIDs (cyclooxygenase
inhibitors) can block the macrophage activating effect of liposomal mifamurtide.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.

Muscle Relaxants: Reduced excretion of baclofen (increased risk of toxicity).
Penicillamine: Possible increased risk of nephrotoxicity when NSAIDs are given with
penicillamine.
Pentoxyfylline: May increase risk of gastrointestinal bleeding; avoid concomitant use.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus.

4.6.

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 preand 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 oligohydroamniosis;
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
In the limited studies so far available, NSAIDs can appear in breast milk in
very low concentrations. NSAIDs should, if possible, be avoided when
breastfeeding.

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

4.7

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

4.8.

Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency
(number of patients expected to experience the reaction), using the following categories: 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: aseptic meningitis
Blood and lymphatic system disorders
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.
Not known: Neutropenia. Prolonged bleeding time, aplastic anaemia and haemolytic
anaemia. Eosinophilia.
Immune system disorders

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).
Not known: Other hypersensitivity reactions have been reported and these may
consist of:
(a) non-specific allergic reactions or fever
(b) respiratory tract reactivity, e.g. rhinitis, asthma, aggravated asthma,
bronchospasm or dyspnoea.
(c) various skin reactions e.g. purpura, angioedema and more rarely exfoliative and
bullous dermatoses (including epidermal necrolysis and erythema multiforme).
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed
connective tissues) 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).
Metabolism and nutrition disorders
Not known: Hyponatraemia or hyperkalaemia.
Psychiatric disorders
Not known: Depression, nervousness, insomnia, confusion, hallucinations
Nervous system disorders

Uncommon: Headache
Not known: Paraesthesia, dizziness and drowsiness.
Eye disorders
Not known: Visual disturbances. Optic neuritis.
Ear and labyrinth disorders
Not known: Tinnitus, vertigo
Cardiac disorders

Not known: Oedema has been reported in association with NSAID treatment.
NSAIDs may induce or aggravate hypertension. Fluid retention may precipitate
congestive heart failure.
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) (see
section 4.4).
Vascular disorders
Not known: Vasculitis.
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 stroke) (see section 4.4).
Respiratory, thoracic and mediastinal disorders

Not known: Pulmonary eosinophilia. Exacerbation of asthma and bronchospasm (see
Hypersensitivity for other respiratory reactions).
Gastrointestinal disorders

The most commonly observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, nausea and dyspepsia.
Rare: diarrhoea, flatulence, constipation and vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal particularly in the elderly. Ulcerative stomatitis,
gastritis. Exacerbation of ulcerative colitis and Crohn’s disease (See section 4.4).
Not known: Pancreatitis.
Hepatobiliary disorders

Not known: Abnormal liver function, hepatitis and jaundice.
Skin and subcutaneous tissue disorders

Uncommon: Various skin rashes
Very rare: Bullous reactions including Steven’s Johnson syndrome, erythema
multiforme and toxic epidermal necrolysis.
Not known: Photosensitivity, lichen planus and pseudoporphyria have also been
reported in patients receiving ibuprofen (see Hypersensitivity for other skin
reactions).
Renal and urinary disorders

Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema. Papillary necrosis associated with
NSAIDs can lead to renal failure.
Not known: Acute renal failure with pre-existing renal impairment. Interstitial
fibrosis associated with NSAIDs can lead to renal failure. Nephrotoxicity in various
forms, including interstitial nephritis, nephrotic syndrome and renal failure. Acute
flank pain. Haematuria.

General disorders and administration site conditions
Not known: Malaise, fatigue

4.8.

Overdose
In children ingestion of more than 400mg/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. Dizziness, tinnitus, fainting, 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 one hour of ingestion of a potentially toxic amount.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially
toxic amounts. Frequent or prolonged convulsions should be treated with
intravenous diazepam or lorazepam. Give bronchodilators for asthma.
Other measures may be indicated by the patient’s clinical condition.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ibuprofen is a phenylpropionic acid derivative which has analgesic anti-inflammatory
and antipyretic actions.
Many possible mechanisms for the action of NSAIDS have been postulated.
However, ibuprofen in common with other NSAIDS probably achieves its antiinflammatory effect through inhibition of prostoglandin synthesis at the site of the
lesion, thereby preventing the sensitizing of tissue to other pain producing mediators

(e.g. histamine, 5-hydroxytryptamine and bradykinin). Most NSAIDS delay normal
platelet aggregation by inhibiting thromboxane A2 production.
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 400 mg was taken within 8 hours before or within 30 minutes after
immediate release aspirin dosing (81 mg), 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.
About 1% is excreted in urine as unchanged ibuprofen and about 14% as conjugated
ibuprofen.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on
an empty stomach. When taken with food, peak levels are observed after one to two
hours. These times may vary with different dosage forms.
Ibuprofen is extensively bound to plasma proteins and has a half life of about two
hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data
The only consistent pathological effect of repeated ibuprofen dose studies in
experimental animals was ulceration of the gastrointestinal tract. No evidence of
carcinogenicity has been seen in rats. Reproduction studies on white rabbits in the
early part of pregnancy showed no treatment related abnormalities, similar
satisfactory results were obtained with mice and rats. Cultures of lymphocytes from
rheumatic patients taking ibuprofen showed no significant increase in chromosome
aberrations.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Colloidal anhydrous silica
Starch (potato)
Povidone
Microcrystalline cellulose
Alginic acid
Magnesium stearate
Sodium lauryl sulphate
Sodium starch glycollate
Croscarmellose sodium
Coating Materials
PVAP sealcote (contains polyvinyl acetate phthalate & stearic acid)
Purified talc
Sucrose
Calcium carbonate
Acacia
Titanium dioxide (E171)
Carnauba wax

6.2

Incompatibilities
None stated except as in ‘interactions with other medicaments’.

6.3

Shelf life
Three years from date of manufacture.

SUMMARY OF PRODUCT CHARACTERISTICS

6.4

Special precautions for storage
Do not store above 25°C. Store the blister in the outer carton in order to
protect from light and moisture.

6.5

Nature and contents of container
Blister Pack
Tablets are packed individually in pre-moulded PVC film and sealed with
aluminium foil.
Pack sizes available in blister packs: 8, 12, 16, 24, 32, 48, 56, 64, 72, 84 and
96.
(Pharmacy)
A.
Aluminium Foil
Coated hard tempered foil, gauge 20 microns
B.
Rigid PVC Film
Characteristics:
Standard Vacuum Forming
Polyvinyl Chloride Film
Gauge:
250pm (micron)
Colour:
Opaque white

6.6

Special precautions for disposal
Return any left over tablets to the Pharmacist.

7

MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd,
Ash Road North,
Wrexham,
LL13 9UF,
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 29831/0308

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/10/2006

10

DATE OF REVISION OF THE TEXT
18/03/2013

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)

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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.

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