Nurofen
Doctors:
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We believe that you will find it beneficial to periodically receive various details about our products. For this reason we are supplying you with material, so as to specifically update you on the new analgesic, NUROFEN. NUROFEN is an analgesic, antipyretic, anti-inflammatory, with ibuprofen (200 mg) as the active compound.
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With regards to the important factor of safety, we are happy to inform you that the first large-scale investigation which explicitly judged the three most commonly used, first choice, analgesics (paracetamol, aspirin and ibuprofen), at their approved dosage for use without a doctor's prescription, indicated that: The overall tolerance of ibuprofen was equal to that of paracetamol and higher than that of aspirin.1
The study was carried out in France, where 1108 doctors and 8677 patients participated over a one-year period.
The high effectiveness in combination with the low incidence of unwanted effects makes ibuprofen an efficacious antipyretic with rapid onset activity2 and the analgesic of choice when it comes to primary dysmenorrhoea.3
In addition, ibuprofen is an anti-inflammatory analgesic which effectively defuses dental pain.4, 5
NUROFEN - LITERATURE
1. Moore, N., Van Ganse, E., Le Parc, J. M. et al., The Pain Study: Paracetamol, Aspirin and Ibuprofen New Tolerability Study, Clin. Drug. Invest., 1999; 18 (2):89-98
2. Welker, Y. et. al., Multicentric, GP-based study of the antipyretic activity and the tolerance of ibuprofen in the treatment of febrile syndromes in adults, Med. Mal. Infect., 1998; 28:1-6
3. Morrison, J. C. et. al., Analgesic Efficacy of Ibuprofen for Treatment of Primary Dysmenorrhoea, Southern Med. J., 1980; 73:999-1002
4. Cooper, S. A. et. al., Ibuprofen and Acetaminophen in the Relief of Acute Pain: A Randomized Double -Blind, Placebo - Controlled Study, J. Clin. Pharmacol., 1989; 29:1026-1030
5. Cooper S.A. Five Studies on Ibuprofen for Postsurgical Dental Pain. Am. J Med 1984;77{Ja}:70-7
NUROFEN - SYNOPSIS OF THE PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE PHARMACEUTICAL DRUG Nurofen Καψάκια
2. QUALITATIVE & QUANTITATIVE COMPOSITION Ibuprofen 200mg. (See 6.1. for constituents)
3. PHARMACEUTICAL FORM Soft capsule. Red, oval, semi-transparent soft capsule with a printed recognition label.
4. CLINICAL DATA
4.1 Therapeutic signs: Relief from mild to moderate pain symptoms such as headaches, dental pain and dysmenorrhoea. Fever.
4.2 Dosage and administration: Taken orally. The capsule is swallowed whole and taken with a glass of water without chewing. It is not suitable for children under 12 years of age. Adults and children over the age of 12: The initial dose is 1-2 capsules and if required, 1-2 capsules every 4-6 hours thereafter. Do not exceed more than 6 capsules in any 24 hours. Elderly: There is no stipulation of a specific dosage modification. Patients with sensitive stomachs are recommended to take Nurofen capsules with their food. If the symptoms persist or worsen after short-term use, the patient must consult his doctor.
4.3 Contra-Indications:
- Patients with known hypersensitivity to ibuprofen or to whichever other constituent of the pharmaceutical product.
- Patients with a history of bronchospasm, asthma, rhinitis or allergic rash that is related to aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs).
- Patients with active peptic ulcers or a history thereof, or those with haemorrhaging gastrointestinal systems.
- Patients with severe liver failure, kidney failure or uncontrollable heart disorder.
- During the last three months of pregnancy (see 4.6)
4.4 Special warnings and precautions for use: Care is required with patients suffering from:
- systematic eruptive lupus as well as with patients who suffer from connective tissue malady (see entry 4.8)
- gastrointestinal complaints and chronic intestinal inflammatory conditions (ulcerous colitis, Crohn? disease)
- hypertension and / or heart disorders
- kidney disorders
- liver disorder
- hereditary fructose intolerance (owing to sorbitol content)
- Bronchospasms can be triggered in patients suffering from bronchial asthma or allergic illnesses or those with a history of the above disorders.
4.5 Interaction with other drugs or other forms of interactions: Ibuprofen (as with other NSAIDs.) must be taken with caution, when used in combination with:
- Aspirin or other NSAIDs and glucocorticoids. These can increase the dangers of adverse effects regarding the gastrointestinal system.
- Anti-hypertensives and diuretics, as NSAIDs can reduce the activity of these drugs.
- Anti-coagulants. There are limited signs indicating that the activity of the orally taken anti-coagulants is increased.
- Lithium. There are indications for increased plasma lithium levels.
- Methotrexate. There are indications for increased plasma methotrexate levels.
- Zidovudine. There are indications of increased danger of bleeding of joint and haematoma in HIV positive haemophilic patients who are concurrently treated with zidovudine and ibuprofen.ταυτόχρονα ζιδοβουδίνη και ιβουπροφαίνη.
4.6 Pregnancy and lactation: There is not enough adequate information concerning the safety of ibuprofen used by humans. Since the effect of the inhibitive action on prostaglandin biosynthesis is not clear, it is recommended that the use of ibuprofen be avoided during the first six months of pregnancy. The use of ibuprofen in the last three months of pregnancy is not recommended. Due to the activity mechanism, there is a possibility of initiating contraction failure of the uterus, premature convergence of the arterial pore of the embryo and high pulmonary pressure in the new-born, increased affinity of haemorrhaging by the mother and child as well as edema development in the mother. Ibuprofen and its metabolites appear in very low concentrations in breast milk (0.0008% of the mother's dose). No negative effects on the infant are known and consequently, termination of breast-feeding is not required during short-term therapy, at the recommended dosage, for minor to mediocre pain and fever.
4.7 Effects on driving ability use of machinery: Protection for short-term use is not required with Nurofen?capsules.
4.8 Undesirable effects: The following side effects concern those who used ibuprofen for short-term therapy for minor to mediocre pains and fever. With long-term use or when used for the therapy of other diseases, other side effects could emerge.
Occasional: Gastrointestinal disturbances such as dyspepsia, bellyache, and nausea.
Rare: Diarrhoea, bloating, constipation and vomiting.
Very rare: Gastrointestinal ulcers, sometimes with haemorrhaging and perforation.
Nervous system
Occasional: Headache.
Kidneys:
Very rare: Reduction in urine excretion and edema of the kidney papillary may be observed, as well as acute kidney failure. Papillary necrosis has been reported, particularly in long-term use with increased concentrations of urea in the blood.
Liver:
Very rare: Liver disorders with long-term use.
Blood:
Very rare: Blood disorders (anaemia, leukopenia, thrombocytopenia etc). The first signs are: fever, sore throat, surface stomach ulcer, flue symptoms, extreme exhaustion, nosebleeds and dermal bleeding.
Skin:
Very rare: Can cause serious types of skin reactions such as erythema multiforme.
Immune system:
Very rare: In patients with autoimmune diseases (systematic eruptive lupus, connective tissue maladies), the following have been observed during therapy with ibuprofen: in isolated cases, the appearance of symptoms aseptic meningitis such as stiffness of the neck, headaches, nausea, vomiting, fever or orientation disorder.
Hypersensitivity reactions:
Occasional: Hypersensitivity reactions with rash.
Very rare: Serious hypersensitivity reactions. Symptoms can include: edema of the face, the tongue and the larynx, breathlessness, tachycardia, hypotension, heavy shock. Aggravated asthma.
4.9 4.9 Overdose:
Overdose symptoms: The symptoms evident on overdose include nausea, vomiting, belly ache, headaches, dizziness, drowsiness, sleepiness, dimmed vision, hearing disturbances and rarely hypotension, metabolic acidity, kidney failure and loss of consciousness.
Overdose Treatment: There is no specific antidote. Symptomatic therapy should be applied to patients wherever necessary. Wherever appropriate, exercise supportive therapy. Within one hour of taking the medication, activated charcoal can be used or stomach pumping together with activated charcoal if the dose is higher than 400 mg per kg of weight.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties:
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) which has been proven effective through common inflammation control experiments by the inhibition of prostaglandin biosynthesis. In humans, ibuprofen decreases the inflammatory pain, edema and fever. Furthermore, ibuprofen temporarily inhibits the agglutination of blood platelets. The clinical effectiveness of ibuprofen has been shown for pain such as headaches, dental pain, dysmenorrhea and fever, as well as for patients with aches and fever which arise with the common cold and flue and finally, for sore throat, myalgia or soft corpuscles trauma and lumbago.
5.2 Pharmacokinetic properties:
Nurofen capsules contain 200 mg of ibuprofen, dissolved in a hydrophilic solvent, and encapsulated in a gelatine covering. On ingestion, the gelatine cover is broken down by the gastric liquids thus liberating the dissolved ibuprofen which can be immediately absorbed. Ibuprofen absorption by the gastrointestinal system is adequate. A large percentage of the absorbed ibuprofen combines with plasma proteins and is dispersed in the articular fluid. The average maximum concentration of the Nurofen capsule content in the plasma is attained about 70 minutes after ingestion. When taken with food, the maximum intensity in the plasma may be delayed. Ibuprofen is metabolised by the liver and forms two major metabolites. It is excreted by the kidneys either in its original form, or as its two major metabolites, together with negligible amounts of unmetabolised ibuprofen. Excretion by the kidneys is both rapid and complete. Elimination half-life is approximately two hours. No special differences in the pharmacokinetic profile have been observed in the elderly.
5.3 Preclinical Safety Data:
Ibuprofen toxicity in animals was found to be lacerations and ulcers in the gastrointestinal system. Ibuprofen did not indicate mutagenic action in vitro and was not carcinogenic to rats or mice. Experimental studies showed that ibuprofen passes through the placenta, whilst no teratogenic effects have been demonstrated.
6. Pharmaceutical data
6.1 List of excipients: Macrogol 600, alpha-tocopherol macrogol succinate (tocoferoslan), povidone. Capsule covering: gelatin, maltitol liquid, sorbitol 76% solution, Ponceau 4R (E124), Label ink: Opacode white (titanium dioxide [E171], shellac), purified water.
6.2 Incompatibilities: None.
6.3 'Use-by' Date: Two years.
6.4 Specific storage conditions: Keep contents in the original box.
6.5 Nature and contents of container: The capsules are produced in blister push through packs in clear opaque 250 μm, PVC/60 gsm, PVdC plastic tray, heat-sealed in 20 Fm aluminium. The blister packs are available in paper boxes. Available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 and 48 capsules. Not all these options shall circulate in Greece.
6.6 Directions for use / handling: None.
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