Nuromol Pain Relief Tablets, Paracetamol and Ibuprofen, Pack Of 16, From The Makers Of Nurofen

Product Information

Antihypertensives: (ACE inhibitors and Angiotensin II Antagonists) and diuretics: NSAIDs may reduce the effects of these drugs. In some patients with compromised renal function (e.g dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDS. The final decision on whether to approve a change is made by the MHRA, on behalf of the UK Licensing Authority. 2. About Nuromol COX is involved in making substances in the body known as prostaglandins, in response to injury and in certain diseases and conditions. The prostaglandins cause pain, swelling and inflammation. Ibuprofen reduces inflammation and pain by reducing the production of these prostaglandins. Wider availability and awareness of this product could potentially make this a better option than codeine or dihydrocodeine containing P products for stronger pain relief before advice is needed from a healthcare professional, for stronger pain relief. Codeine or dihydrocodeine products are more liable to be misused and lead to addiction. 5. Further details on the application 5.1 Label and leaflet

Nuromol is not recommended for women who are trying to get pregnant because NSAIDs like ibuprofen can temporarily reduce female fertility.

Nuromol

There are no special handling requirements for Nuromol that would prevent its availability as a General Sales medicine. 4.4 Role of the pharmacist cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);

This would result in a person taking 400mg/day more of ibuprofen than currently authorised as P or GSL, resulting in a total ibuprofen daily intake of 1600mg. This is within prescribing limits of a maximum daily dose of 2400mg. Even at the conservative estimate of toxicity (100mg/kg) a 60kg adult would need to take 30 tablets at once to overdose. The risk of low body-weight adults (up to 50kg) using this product Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with Nuromol. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Common side effects Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.This evidence needs to focus on the risk to the public. This includes evidence on the possible abuse or misuse of the medicine. The evidence may include: 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 of 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. Use of this product should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg daily) with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200 mg daily) is associated with an increased risk of arterial thrombotic events.Paracetamol is readily absorbed from the gastrointestinal tract. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose-dependent. Plasma levels of paracetamol from this product are detected from 5 minutes with peak plasma concentrations occurring at 0.5-0.67 hours after ingestion on an empty stomach. When this product was taken with food peak paracetamol plasma levels were lower and delayed by a median of 55 minutes, but overall extent of absorption was equivalent. In children ingestion of more than 400 mg/kg of Ibuprofen may cause symptoms. In adults the dose response effect is less clear cut. The patient information leaflet and label are provided in Annex 2 and Annex 3. 5.2 Summary of Product Characteristics Nurofen Cold & Flu Relief 200mg/5mg Tablets, Nurofen Day & Night Cold & Flu 200mg/5mg Tablets, Contains ibuprofen & phenylephrine hydrochloride, For cold & flu relief. In patients suffering from, or with a history of, bronchial asthma or allergic disease NSAIDs have been reported to precipitate bronchospasm.