Summary of medicine characteristics - IBUCAPS IBUPROFEN 200 MG SOFT GELATIN CAPSULES, GALPHARM IBUPROFEN 200 MG SOFT CAPSULES, OPTIPHARMA IBUPROFEN 200 MG SOFT CAPSULES, IBUPROFEN 200 MG LIQUID CAPSULES, PARAMED IBUPROFEN 200 MG LIQUID CAPSULES, ESSENTIAL WAITROSE IBUPROFEN 200 MG LIQUID
1 NAME OF THE MEDICINAL PRODUCT
Ibucaps Ibuprofen 200 mg Soft Gelatin Capsules
Ibuprofen 200 mg Liquid Capsules
Paramed Ibuprofen 200 mg Liquid Capsules
Galpharm Ibuprofen 200 mg Soft Capsules
Essential Waitrose Ibuprofen 200 mg Liquid Capsules
OptiPharma Ibuprofen 200 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 200 mg ibuprofen.
Excipient(s) with known effect
Every capsule contains 55.63 mg of sorbitol and 0.05 mg of Ponceau 4R (E124).
The capsules may contain trace amounts of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Oval pink capsules printed with “I200” in white
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
Method of administration
For oral administration and short-term use only. Do not chew.
Posology
Adults, the elderly and children over 12 years:
Undesirable effects may be minimised by using the lowest effective dose for the shortest
duration necessary to control symptoms (see section 4.4).
The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Take one or two capsules (200 mg – 400 mg), up to three times a day as required (maximum dose 400 mg).
Leave at least four hours between doses and do not take more than 6 capsules (1200 mg) in any 24 hour period.
Paediatric population
Children under 12 years:
Not recommended.
4.3 Contraindications
Hypersensitivity to ibuprofen, peanuts or soya or to any of the excipients listed in section 6.1.
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.
Renal failure or hepatic failure (see section 4.4).
Severe heart failure (NYHA Class IV).
Last trimester of pregnancy (see section 4.6).
4.4 Special warnings and precautions for use
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).
The elderly have an increased frequency of adverse reactions to NSAIDs, especially GI 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 cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).
Renal impairment:
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8).
There is a risk of renal impairment in dehydrated adolescents.
Hepatic impairment:
Hepatic dysfunction (see sections 4.3 and 4.8).
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 oedema have been reported in association with NSAID therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) 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. < 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
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).
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 NSAIDs doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), 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).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
Severe skin reactions:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported 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. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reaction, such as rash, mucosal lesions, or any other sign of hypersensitivity.
Ponceau 4R (E124) contained as excipient in the product may cause allergic reactions.
Masking of symptoms of underlying infections:
Ibucaps 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 Ibucaps is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
General considerations:
This medicine contains 55.63 mg of sorbitol in each capsule. Patients with rare hereditary problems of fructose intolerance should not take this medicine because of the presence of sorbitol.
Ibucaps contains lecithin originating from soya oil. Patients who are allergic to peanut or soya should not use this medicinal product.
This medicine contains Ponceau 4R (E124). It may cause allergic reactions.
The label will include:
Read the enclosed leaflet before taking this product.
Do not take if you
– have (or have had two or more episodes of) 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 before taking this product if you
– have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
– are a smoker
– are in the first 6 months of pregnancy If symptoms persist or worsen, consult your doctor.
4.5 Interaction with other medicinal products and other forms of interactionIbuprofen should be avoided in combination with:
– Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
– Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).
– 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. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
– Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
– Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
– Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
– Lithium: There is evidence for potential increases in plasma levels of lithium.
– Methotrexate: There is a potential for an increase in plasma methotrexate.
– Ciclosporin: Increased risk of nephrotoxicity.
– Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
– Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
– Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
– Quinolone antibiotics: 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.
4.6 Fertility, pregnancy and lactation
Pregnancy
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen 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).
Breastfeeding
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
Fertility
See section 4,4 regarding female fertility.
4.7 Effects on ability to drive and use machines
Ibucaps has no or negligible influence on the ability to drive and use machines.
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. 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 short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
The side-effects are listed below per system/organ class and frequency.
Adverse reactions have been ranked under headings of frequency using the following convention: 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).
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).
| System organ class | Side effect | Frequency |
| Blood and lymphatic system disorders | 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 | Very rare |
| Immune system disorders | Hypersensitivity reactions consisting of1 : | |
| Urticaria and pruritus | Uncommon | |
| Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). | Very rare | |
| Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. | Not known |
| Nervous system disorders | Headache | Uncommon |
| Aseptic meningitis2 | Very rare | |
| Cardiac disorders | Cardiac failure and oedema | Not known |
| Vascular disorders | Hypertension | Not known |
| Gastrointestinal disorders | Abdominal pain, nausea and dyspepsia. | Uncommon |
| Diarrhoea, flatulence, constipation and vomiting. | Rare | |
| Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. | Very rare | |
| Exacerbation of colitis and Crohn’s disease (see section 4.4). | Not known | |
| Hepatobiliary disorders | Liver disorders. | Very rare |
| Skin and subcutaneous tissue disorders | Various skin rashes | Uncommon |
| Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur. | Very rare | |
| Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalised exanthematous pustulosis (AGEP). Photosensitivity reactions. | Not known | |
| Renal and urinary disorders | Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. | Very rare |
| Renal insufficiency | Not Known | |
| Investigations | Decreased haemoglobin levels | Very rare |
Description of Selected Adverse Reactions
1 Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or © assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
2 The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug
intake, and disappearance of symptoms after drug discontinuation). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseIn 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. In serious poisoning metabolic acidosis may occur.
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
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non steroids; propionic acid derivatives, ATC code: M01AE01
Mechanism of action
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 competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 hours before or within 30 minutes after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
5.2 Pharmacokinetic properties
Absorption
Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body.
Distribution
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.
Elimination
The half-life of ibuprofen is about 2 hours. The excretion is rapid and complete via the kidneys.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.
5.3 Preclinical safety data
5.3 Preclinical safety dataThere are no preclinical safety data of relevance additional to that contained elsewhere in the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule contents
Macrogol 600
Potassium hydroxide
Purified water
Capsule shell
Gelatin
Sorbitol
Purified water
Ponceau 4R (E124)
Capsule printing ink
Purified water
Titanium dioxide
Propylene glycol
Isopropyl alcohol
HPMC 2910/Hypromellose 3cP
Processing Aids
Medium Chain Triglycerides
Isopropyl alcohol
Lecithin
6.2 Incompatibilities
Not applicable
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
A blister pack consisting of opaque, white 250 micron polyvinyl chloride (PVC)/30 micron polyethylene, coated with 90 g/m2 polyvinylidene chloride (PVDC), heat sealed to 20 micron aluminium foil. The blisters are packed into cardboard cartons.
Package size(s): 4, 10 or 16 capsules per carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDERPatheon Softgels B.V. (trading as Banner Pharmacaps Europe)
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
PL 14338/0001