For the fast and effective reduction of fever, including post immunisation pyrexia and the fast and effective relief of the symptoms of colds and influenza and mild to moderate pain, such as a sore throat, teething pain, toothache, earache, headache, minor aches and sprains

For oral administration. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4, Special warnings and precautions for use) For post immunization pyrexia: One 2.5ml dose followed by one further 2.5ml dose 6 hours later if necessary. No more than two 2.5ml doses in 24 hours. If the fever is not reduced

consult your doctor. For pain, fever and symptoms of cold and influenza: For children weighing 5kg or more: 20mg/kg bodyweight daily in divided doses. Using the spoon or dosing syringe device provided this can be achieved as follows: Infants 3 – 6 months weighing more than 5kg: One 2.5ml dose may be taken 3 times in 24 hours. Infants 6 - 12 months: One 2.5ml dose may be taken 3 to 4 times in 24 hours. Children 1 - 3 years: One 5ml dose may be taken 3 times in 24 hours. Children 4 - 6 years: 7.5ml (5ml + 2.5ml) may be taken 3 times in 24 hours. Children 7 - 9 years: Two 5ml doses may be taken 3 times in 24 hours. Children 10 – 12 years: Three 5ml doses may be taken 3 times in 24 hours. Doses should be given approximately every 6 to 8 hours, (or with a minimum of 4 hours between each dose if required). Not suitable for children under 3 months of age unless advised by your doctor. For short term use only. If the child's (aged over 6 months) symptoms persist for more than 3 days, consult a doctor. For children under 6 months: if the child's symptoms persist for more than 24 hours (3 doses), consult a doctor. If symptoms worsen, consult your doctor.

Hypersensitivity to ibuprofen or any of the excipients 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 anti-inflammatory drugs. 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 NSAIDs therapy Severe heart failure, renal failure or hepatic failure (see section 4.4, Special warnings and precautions for use). Last trimester of pregnancy (See section 4.6, Pregnancy and lactation).

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. Other NSAIDs: The use of Ibuprofen with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided (see section 4.5 Interaction with other medicinal products and other forms of interaction). SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (see section 4.8 Undesirable effects) Renal: Renal impairment as renal function may further deteriorate (See sections 4.3 Contraindications and 4.8 Undesirable effects) Hepatic: Hepatic dysfunction (See sections 4.3 Contraindications and 4.8 Undesirable effects) 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 edema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high SAPOFEN JR 100MG/5ML SUSPENSION 100ML 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. Impaired female fertility: 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. Gastrointestinal: 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). 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. 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 hemorrhage or perforation (see section 4.3 Contraindications), and in the elderly. 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 oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5 Interaction with other medicinal products and other forms of interaction). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8 Undesirable effects). 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. SAPOFEN JR 100MG/5ML SUSPENSION 100ML Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue 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 Ibuprofen in case of varicella (see section 4.8). Masking of symptoms of underlying infections Sapofen – Junior can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Sapofen – Junior is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen. This product contains maltitol liquid (E965): patients with rare hereditary problems of fructose intolerance should not take this medicine. The label will state: Read the enclosed leaflet before taking this product. Do not give this product if your baby or child: • Is under 3 months old • Has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding • Is allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers • Is taking other NSAID painkillers, or aspirin with a daily dose above 75 mg Speak to your doctor or pharmacist before giving this product if baby or child: • Has or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems. This product is intended for children aged between 3 months and 12 years. If you are an adult taking this product: Speak to a pharmacist or your doctor before taking if: SAPOFEN JR 100MG/5ML SUSPENSION 100ML • You are pregnant. • You are trying to get pregnant. • Are elderly. • Are a smoker. Do not exceed the stated dose. Keep out of the reach and sight of children. For short term use. If symptoms persist for more than 3 days, consult your doctor. For children under 6 months, if the symptoms persist for more than 24 hours (3 doses) consult your doctor.

Ibuprofen should be avoided 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 4.4 Special warnings and precautions for use). 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 Pharmacodynamic properties). Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (See section 4.4 Special warnings and precautions for use) Ibuprofen should be used with caution in combination with: Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. SAPOFEN JR 100MG/5ML SUSPENSION 100ML Patient should therefore always seek the advice of doctor or pharmacist before using ibuprofen with other medicines. in addition to those mentioned above the following medicines can interact with ibuprofen: •Diuretics (water tablets). •Cardiac glycosides, such as digoxin, used to treat heart conditions. •Lithium. •Zidovudine (an anti-viral drug). •Steroids (used in the treatment of inflammatory conditions). •Methotrexate (used to treat certain cancers). •Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down patient immune response). •Medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression. •Antibiotics called quinolones such as ciprofloxacin. •Aminoglycosides (a type of antibiotic). •Mifepristone. •Any other ibuprofen preparations, such as those you can buy without a prescription. •Any other anti-inflammatory pain killer, including aspirin. •Cholestyramine (a drug used to lower cholesterol). •Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes). •Voriconazole or fluconazole (types of anti-fungal drugs). •Gingko biloba herbal medicine.

Whilst no teratogenic effects have been demonstrated in animal studies, the use of this product 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 persistent 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 Special Warnings and Precautions for Use, regarding female fertility

None expected at recommended doses and duration of therapy.

The following frequencies are taken as a basis when evaluating undesirable effects: 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

 

Hypersensitivity reactions have been reported and these may consist of: (a) Non-specific allergic reactions and anaphylaxis (b) Respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea (c) Various skin reactions, e.g. pruritus, 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 shortterm use. In the treatment of chronic conditions, under long-term 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 and bronchospasm. Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Uncommon: abdominal pain, nausea, 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 Special warnings and precautions for use). Nervous System: Uncommon: Headache. Very rare: Aseptic meningitis – single cases have been reported very rarely. 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: SAPOFEN JR 100MG/5ML SUSPENSION 100ML Uncommon: Various skin rashes. Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic 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 Special warnings and precautions for use). Cardiovascular and Cerebrovascular: 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).

 

To report any side effect(s): The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-7662 SFDA Call Center: 19999 E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa

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.

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. Ibuprofen has been shown to have an onset of both analgesic and antipyretic action within 30 minutes. ATC Code, M01A E01 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.

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

There are no preclinical safety data of relevance to the consumer.

Polysorbate 80, Sucrose Granular, Sorbitol Solution 70% Non-Cryst, Glycerol, Sodium Benzoate, Disodium Edetate, Citric Acid Anhydrous, Avicel RC, Keltrol Xanthan Gum PF, Sunset Yellow, Orange Flavour Juicy, Pineapple Flavour, Sodium Citrate Anhydrous and Purified Water

Not applicable.

36 Months/3Years. In use shelf-life This medicine will be expired after 30 days from the first opening

Store below 30°C.

100ml &150ml Amber glass bottle with white child-resistant cap and tamper evident ring

No Special Disposal.