NUROFEN PLUS

Israel - English - Ministry of Health

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Active ingredient:
CODEINE AS HEMIHYDRATE; IBUPROFEN
Available from:
RECKITT BENCKISER (NEAR EAST) LTD
ATC code:
M01AE51
Pharmaceutical form:
TABLETS
Composition:
IBUPROFEN 200 MG; CODEINE AS HEMIHYDRATE 10 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD, UK
Therapeutic group:
IBUPROFEN, COMBINATIONS
Therapeutic area:
IBUPROFEN, COMBINATIONS
Therapeutic indications:
For short term use for the relief of acute (short lasting) moderate pain, such as rheumatic pain (arthritis), muscular pain, backaches, neuralgia, migraine, headache, dental pain and menstrual pain.
Authorization number:
132 54 31026 00
Authorization date:
2015-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

NUROFEN PLUS Tab 25. 12. 2005, RH

"

ע עבקנ הז ןולע טמרופ

"

רשואו קדבנ ונכותו תואירבה דרשמ י

."

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.”

NUROFEN

PLUS

TABLETS

Composition

Each tablet contains:

Active Ingredient

Ibuprofen

Codeine phosphate hemihydrate 12.8 mg

(equivalent to codeine 10 mg)

Other Ingredients

Cellulose, microcrystalline, sodium starch glycollate (

from potato starch

), starch

pregelatinised (

from maize, potato, or rice starch

), hypromellose (hydroxypropylmethyl

cellulose), titanium dioxide (E 171), talc

Pharmacological Particulars

Pharmacodynamic Properties

Ibuprofen is an analgesic which acts peripherally, inhibiting prostaglandin synthesis

and the action of chemical mediators of pain. Codeine is a narcotic analgesic acting

on central opiate receptors, although its pharmacological effects are thought to be

due largely to its biotransformation to morphine.

The combination of a well tolerated peripheral analgesic with a centrally acting

analgesic provides optimum pain relief with a lower potential for producing side-

effects.

Pharmacokinetic Properties

The elimination half-life of both ibuprofen and codeine is approximately three hours,

and both drugs are given three to fours times daily. The combination of the two

drugs is therefore appropriate from a pharmacokinetic viewpoint; the tablet exhibits

normal release characteristics for both active substances.

Indications

For the relief of pain in such conditions as: rheumatic and muscular pain, backache,

neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms

of colds and influenza.

Contraindications

Known hypersensitivity to the drug or to any ingredient of the preparation.

Patients with a history of, or existing peptic ulceration.

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

Previous allergic reaction to any other pain reliever / fever reducer:

Because

potential

cross-sensitivity

other

NSAIDs

(prescription

nonprescription) , ibuprofen should not be used in patients in whom aspirin or other

NSAIDs

have

induced

symptoms

asthma,

rhinitis,

urticaria,

nasal

polyps,

angioedema,

bronchospasm

other

symptoms

allergic

reactions

(anaphylactoid reactions have occurred in such patients).

Patients

recently

about

have

heart

surgery

(see

also

Precautions

Hypersensitivity to codeine, respiratory depression, chronic constipation.

NUROFEN PLUS Tab 25. 12. 2005, RH Page 2 of 6

Warnings

Long- term use of ibuprofen may increase the risk of heart attack or stroke.

Ibuprofen may cause a severe allergic reaction, especially in people allergic to

aspirin.

This product contains a nonsteroidal anti- inflammatory drug (NSAID), which may

cause stomach bleeding. The chance is higher if the patient is: over 60, has had

stomach ulcers or bleeding problems, takes a blood thinning (anticoagulant) or

steroid drug, takes other drugs containing an NSAID ( aspirin, ibuprofen , naproxen

or others), has 3 or more alcoholic drinks every day while using this product. Longer

duration of use and higher dosages are also risk factors.

Ibuprofen should be administered under close supervision to patients with a history

upper

gastrointestinal

tract

disease.

symptoms

persist,

worsen,

symptoms develop, the physician should be referred to.

Nurofen Plus tablets should be used with caution in those with hypotension and/ or

hypothyroidism. The tablets should be used with caution in patients with raised

intracranial pressure or head injury.

Use in Pregnancy

Administration of ibuprofen is not recommended during pregnancy.

The onset of labor may be delayed and duration of labor increased, therefore it is

recommended not to use ibuprofen during the last 3 months of pregnancy.

Based on animal studies and limited clinical experience there is no evidence to

suggest foetal abnormalities associated with the use of codeine. However, the

product should be avoided during pregnancy.

Use in Breastfeeding

Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect

the breastfed infant adversely.

Codeine is excreted in breast milk.

Use in Pediatrics

This product is not to be used in children under 12 years of age.

Adverse Reactions

Adverse Reactions Attributed to Ibuprofen

Gastrointestinal

Epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting,

indigestion, constipation, abdominal cramps or pain, fullness of gastrointestinal tract,

dyspepsia, gastrointestinal bleeding, peptic ulceration,.

Central Nervous System

Dizziness, severe headache, nervousness, convulsions, pain in the spinal column.

Dermatological

Rash (including maculopapular type), pruritus, photosensitivity, skin peeling.

Rarely exfoliative dermatitis and epidermal necrolysis have been reported with

ibuprofen.

Special Senses

Hearing disturbance.

Metabolic/Endocrine

Decreased appetite.

Cardiovascular

Edema,

fluid

retention

(generally

responds

drug

discontinuation,

Precautions).

NUROFEN PLUS Tab 25. 12. 2005, RH Page 3 of 6

Hematological

Neutropenia,

agranulocytosis,

aplastic

anemia,

hemolytic

anemia,

thrombocytopenia, decreased hemoglobin and hematocrit.

Allergic

Fever.

Bronchospasm may be precipitated in patients with a history of aspirin-sensitive

asthma

Other Hypersensitivity Reactions:

Rarely hypersensitivity reactions with cutaneous eruptions, urticaria and pruritus,

as well as attacks of asthma, with or without drop in blood pressure, have been

observed. In single cases, severe hypersensitivity reactions, manifesting as facial

edema,

swelling

tongue,

swelling

larynx,

dyspnea,

tachycardia,

hypotension

severe

shock

have

been

reported.

these

symptoms

occur,

immediate medical attention is necessary.

In single cases, serious forms of skin reactions such as erythema multiforme can

occur.

In patients with existing auto-immune disorders (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.

Other

Stiffness, sudden decrease in the amount of urine, black stools.

Renal papillary necrosis which can lead to renal failure.

Adverse Reactions Attributed to Codeine

Side

effects

codeine

include

constipation,

respiratory

depression,

cough

suppression, nausea and drowsiness

Precautions

Note

Patients sensitive to one of the non-steroidal anti-inflammatory agents (NSAIDs)

may be sensitive to any of the other NSAIDs also.

Blurred and/or diminished vision, scotomata, and changes in color vision have

been reported. If a patient develops such complaints while receiving ibuprofen, the

drug should be discontinued and the patient should have an ophthalmological

examination which includes central visual fields and color vision testing.

As with other NSAIDs, patients should be cautioned about engaging in activities

requiring mental alertness and motor coordination, such as driving a car.

Physicians

should

consulted

patients

taking

ibuprofen

exhibit

signs

symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye

symptoms, skin rash, weight gain, or edema.

Fluid retention and edema have been reported in association with ibuprofen.

Therefore, the drug should be used with caution in patients with a history of cardiac

decompensation or hypertension.

Since ibuprofen is eliminated primarily by the kidneys, patients with significantly

impaired renal function should be closely monitored, and a reduction in dosage

should be anticipated to avoid drug accumulation.

Ibuprofen should be used with caution in individuals with intrinsic coagulation

defects, and those on anticoagulant therapy.

Caution should be exercised when this product is administered to asthma sufferers

since bronchospasm may be precipitated in patients suffering from, or with a

previous history of bronchial asthma or allergic disease.

The elderly are at increased risk of the consequence of adverse reactions.

NUROFEN PLUS Tab 25. 12. 2005, RH Page 4 of 6

Undesirable effects may be minimised by using the minimum effective dose for the

shortest possible duration.

Monitoring of blood urea nitrogen (BUN), serum creatinine concentrations and/or

serum potassium concentrations may be required at periodic intervals during therapy,

especially in patients with documented hepatic or renal function impairment.

The same monitoring may also be required in patients known or suspected to be at

risk for renal function impairment, patients taking diuretics concurrently, and in

patients in whom signs of possible renal toxicity occur, such as substantial increases

in blood pressure, fluid retention, or rapid weight gain.

In order to avoid exacerbation of disease or adrenal insufficiency, patients who

have been on prolonged corticosteroid therapy should have their therapy reduced

slowly, rather than discontinued abruptly, when ibuprofen is added to the treatment

regimen.

As with other non-steroidal anti-inflammatory agents, borderline elevations of one

or more liver tests may occur in up to 15% of patients. These abnormalities may

progress, remain essentially unchanged, or be transient with continued therapy.

Because serious gastrointestinal tract ulcerations and bleeding can occur without

warning symptoms, physicians should follow chronically treated patients for the signs

and symptoms of ulcerations and bleeding and should inform them (in case of

children, the child

s parent/guardian) of importance of this follow-up.

Patients with symptoms and/or signs suggesting liver dysfunction, or in whom an

abnormal

liver

test

occurred,

should

evaluated

evidence

development of more severe hepatic reactions while on therapy with ibuprofen.

Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been

reported

with

ibuprofen

with

other

non-steroidal

anti-inflammatory

agents.

Although such reactions are rare, if abnormal liver tests persist or worsen, or clinical

signs

symptoms

consistent

with

liver

disease

develop,

systemic

manifestations

occur

(e.g.,

eosinophilia,

rash,

etc.),

ibuprofen

should

discontinued.

cross-study

comparisons

with

doses

ranging

from

1200-3200

daily

several

weeks,

slight

dose-response

decrease

hemoglobin/hematocrit

noted.

Aseptic meningitis with fever and coma has been observed on rare occasions in

patients on ibuprofen therapy. Although it is probably more likely to occur in patients

with systemic lupus erythematosus and related connective tissue diseases, it has

been reported in patients who do not have an underlying chronic disease. If signs or

symptoms of meningitis develop in a patient on ibuprofen, the possibility of its being

related to ibuprofen should be considered.

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.

Patients Who Require Surgery (Including Dental Surgery)

Caution is recommended in patients who require surgery. Most of the Nonsteroidal

anti-inflammatory agents inhibit platelet aggregation and may prolong bleeding time,

which may increase intra-and postoperative bleeding. Consideration should therefore

be given to discontinuing NSAIDs treatment for an appropriate length of time prior to

elective surgery, depending on the potency and duration of effect of the individual

agent on platelet aggregability.

In case of patients requiring dental surgery, nonsteroidal anti-inflammatory agents

cause

soreness,

irritation,

ulceration

oral

mucosa.

Most

nonsteroidal

anti-inflammatory

agents

rarely

cause

leukopenia

and/or

thrombocytopenia, which may result in an increased incidence of microbial infection,

delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs,

dental work should be deferred until blood counts return to normal, and patients

should be instructed in proper oral hygiene.

NUROFEN PLUS Tab 25. 12. 2005, RH Page 5 of 6

Drug Interactions

Ibuprofen/Coumarin-Type Anticoagulants:

Because bleeding has been reported when

ibuprofen and other non-steroidal anti-inflammatory agents have been administered

to patients on coumarin-type anticoagulants, physicians should exercise caution

when administering ibuprofen to patients on anticoagulants.

Ibuprofen/Aspirin/Non-Steroidal

Anti-Inflammatory Agents (NSAIDs):

Animal studies

have demonstrated that aspirin administered with NSAIDs causes a decrease in

blood levels and activity of non-aspirin drugs. Since concomitant use offers no

therapeutic advantage, such combinations should be avoided.

Ibuprofen/Methotrexate

:

Animal

studies

indicate

that

ibuprofen,

well

other

NSAIDs, may enhance the toxicity of methotrexate. Caution should be used if

ibuprofen is administered concomitantly with methotrexate.

Ibuprofen/Beta-Blockers

: As with other nonsteroidal anti-inflammatory agents , the

antihypertensive effect of beta-blockers may be reduced.

Ibuprofen/Furosemide/Thiazides

:

Clinical studies, as well as random observations,

have shown that ibuprofen can reduce the natriuretic effect of furosemide and

thiazides in some patients. During concomitant therapy with ibuprofen, patients

should be observed closely for signs of renal failure, as well as to assure diuretic

efficacy.

Ibuprofen/Lithium:

Ibuprofen may produce an elevation of plasma lithium levels and a

reduction in renal lithium clearance. Therefore, when ibuprofen and lithium are

administered concurrently, subjects should be observed carefully for signs of lithium

toxicity.

Ibuprofen/Alcohol:

Concomitant use of non-steroidal anti-inflammatory agents with

alcohol may increase the risk of gastrointestinal side effects, including ulceration or

hemorrhage.

Ibuprofen/Probenecid:

Probenecid may decrease excretion and increase the serum

concentration of NSAIDs, possibly enhancing effectiveness and/or increasing the

potential for toxicity of these agents. A decrease in dosage of the NSAIDs may be

considered necessary.

Ibuprofen/Zidovudine

: There is evidence of prolonged bleeding time in patients

receiving concurrent treatment with zidovudine and ibuprofen.

Codeine/Monoamine Oxidase (MAO) Inhibitors

: Codeine interacts with monoamine

oxidase inhibitors.

Dosage and Administration

Notes

This product should be taken with or after food.

The tablets should not to be used for more than 10 days for the treatment of pain,

or for more than 3 days for the treatment of fever, unless instructed by the physician.

The smallest effective dose should be used.

In primary dysmenorrhea, Nurofen Plus Tablets should be taken immediately

following the onset of pain.

Recommended dosage:

Adults:

One or two tablets every four to six hours.

Children under 12 years:

Not recommended.

Elderly:

No special dosage modifications are required for elderly patients, unless renal or

hepatic function is impaired, in which case dosage should be assessed individually.

Do not take more than 6 tablets in 24 hours.

NUROFEN PLUS Tab 25. 12. 2005, RH Page 6 of 6

Overdosage

Overuse of this product, defined as consumption of quantities in excess of the

recommended dose, or consumption for a prolonged period, may lead to physical or

psychological dependency. Symptoms of restlessness and irritability may result when

treatment is stopped.

For Ibuprofen

Manifestations

Symptoms include nausea, headache, vomiting, dizziness, drowsiness, nystagmus,

blurred vision, tinnitus, and, rarely, hypotension, metabolic acidosis, renal failure,

and, loss of consciousness. Large overdoses are generally well tolerated when no

other drugs are involved.

Treatment

No special antidote is available.

Patients should be treated symptomatically as required. Use supportive care where

appropriate. Within one hour of ingestion, activated charcoal or gastric lavage

followed by activated charcoal if the dose is greater than 400 mg/kg, can be used.

For Codeine

Manifestations

Nausea and vomiting are prominent features of codeine overdose. Respiratory

depression, excitability, convulsions, hypotension and loss of consciousness may

occur with large codeine overdose.

Treatment

The stomach should be emptied. If severe CNS depression has occurred, artificial

respiration, oxygen and parenteral naloxone may be needed. Imbalance in electrolyte

levels should be considered

Storage

Store in a dry place below 25oC.

Presentation

Bottles of 100 and 200 tablets.

Blisters of 6, 12, 24, 60, and 72 tablets.

Manufacturer

Boots Healthcare International

Nottingham, England

Importer

Abic Marketing Ltd

P.O.Box 8077, Netanya.

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