Cerumol Extra Virgin Olive Oil Ear Drops, 10ml, Gentle, Natural Formulation, Helps to Relieve Symptoms of Ear Wax, Softens Earwax, Dropper Included

Product Information

Some drugs may have Authority Required (Streamlined) status which does not require an explicit approval from Medicare, instead the doctor can use the Authority code found in the published Schedule for a given drug/indication. In addition to the pre‐specified information about study characteristics and aspects of methodology relevant to risk of bias (see below), we extracted the following summary statistics for each study and each outcome:

Only one study compared using drops with an active ingredient to not using drops at all. The drops may help increase the proportion of ears cleared of wax from 1 in 20 (if you do nothing) to about 1 in 5 (if you use drops). We found sufficient data to conduct meta‐analyses for five comparison pairs, including a prespecified subgroup analysis within our first comparison pair. if any of the side effects get serious or you notice any other side effects not mentioned in this leaflet.if there is anything else wrong with your ear - such as pain, swelling, discharge, infection or tinnitus (ringing sounds in We extracted the following key characteristics of each study: study design, setting, sample size, population, definition of outcomes and how these were collected. We collected baseline information on prognostic factors or effect modifiers, including duration of symptoms. We also extracted information on the rationale for and aims of wax clearance treatment.

Some PBS medications are restricted and require prior approval from Medicare before a doctor is able to prescribe them on the PBS. This prior approval to prescribe grants the doctor the Authority to prescribe the desired medicine and have it funded under the PBS. For the key outcomes presented in the 'Summary of findings' table, we also expressed the results as absolute numbers, based on the pooled results and compared to the assumed risk. We also planned to calculate the number needed to treat to benefit (NNTB) using the pooled results. The assumed baseline risk will usually be either (a) the median of the risks of the control groups in the included studies (this being used to represent a 'medium‐risk population') or, alternatively, (b) the average risk of the control groups in the included studies, this being the 'study population' ( Handbook 2011). If a large number of studies were available, and if it was appropriate, we also planned to present additional data based on the assumed baseline risk in (c) a low‐risk population and (d) a high‐risk population. Build up of ear wax is common. It can be uncomfortable for the patient and can cause hearing problems. Ear drops have been studied as a potential tool to soften the wax, preventing the need for further treatment such as syringing. This review looks at which treatment (oil‐ and water‐based drops or sprays) can help resolve wax build up.

Too much earwax for comfort? We recommend the best ear wax removers to unblock your ears quickly and safely

USAGE ADVICE Please read all the enclosed information leaflet carefully before use. It contains important information about this product. To gently soften and remove ear wax. For external use only. This liquid treatment comes with a handy rubber squeeze bottle (basically a syringe) which makes the drops easy to administer without causing a mess. You can use the bottle to keep your ears clean with warm water once the treatment has cleared out your excess ear wax. Users report that it only takes around three or four days of twice-daily treatment to clear their ears. Wash and dry hands before use. Tilt head sideways with the affected ear facing upwards. Avoid touching the ear with the dropper. Using the dropper, place 5 drops of oil into the ear, then gently massage around the outside of the ear. Never insert the dropper or any solid object into the ear. Allow a few minutes for the drops to reach the eardrum by keeping the head tilted then use a tissue to wipe away any surplus product that runs from the ear. Repeat in the other ear if required. Use the drops twice a day for three days.

Some people naturally create more ear wax, which causes them to accumulate it more frequently. Excessive ear wax can also form in people who regularly wear earplugs, headphones, or cotton buds in their ears. Interventions: warm tap water instilled into the ear as a softening agent 15 minutes before syringing versus syringing alone Cerumol contains refined arachis oil which lubricates the ear wax and chlorobutanol hemihydrate, an antibacterial agent, which is used to loosen the ear wax. Warning or Restrictions This review includes 10 studies comparing the effects of ear drops for the removal of ear wax. The drops were of a variety of different types: oil‐based treatments, water‐based treatments and others, and the studies looked at both active comparators such as saline or water alone and no treatment. Any side effects or discomfort brought on by the study medicine were noted in detail. There was no discernible difference between the two groups in these parameters; both treatments were demonstrated to be successful in softening ear wax and being well tolerated.

PHARMACIST ONLY MEDICINE

Interventions: 5% dioctyl sodium sulphosuccinate in a maize oil base (Dioctyl‐medo ear drops) + syringing versus maize oil + syringing Oil Based Products: lubricate and softens and loosens the wax (not considered a true cerumenolytic because it doesn’t break down the wax) Very rarely, an unpleasant taste has been reported. Stop using the ear drops immediately if this happens and tell your doctor.

Burton MJ, Doree C (2009). Eardrops for the removal of earwax (review). The Cochrane Collaboration. Issue 1: 1 – 33. DOI: 10.1002/14651858.CD004326.pub2 Some ear wax remover liquids come in spray form, which you may find easier to administer than drops. Some also come with special syringe-style applicators to help get the solution safely into your ear and deliver a measured amount with each squirt.

S8 PRESCRIPTION

Seven studies reported on our second primary outcome (adverse events: discomfort, irritation or pain) ( Jaffe 1978; Keane 1995; Lyndon 1992; Meehan 2002; Oron 2011; Singer 2000; Whatley 2003). Of these, two studies (141 participants; 176 ears) contributed quantitative data and were included in the meta‐analysis ( Jaffe 1978; Lyndon 1992). The remaining five studies were summarised in our narrative synthesis. Comment: all participants were accounted for. One patient did not complete follow‐up, but no reasons were provided. Authority to prescribe an Authority medicine is granted for specific indications and/or for certain patient circumstances. Authority may be obtained by telephone to Medicare Australia (known as "phone approval") or in writing from an authorised delegate of the Minister for Health. Adults, the elderly and children over 1 year: Tilt head sideways with the affected ear facing upwards. Avoid touching the ear with the dropper. Using the dropper, place 2-3 drops of the oil at room temperature into the ear, then gently massage around the outside of the ear. Never insert the dropper or any solid object into the ear. Allow a few minutes for the drops to reach the eardrum by keeping the head tilted and repeat in the other ear if required. Plug the ear lightly with cotton wool if necessary to prevent leakage. Use the drops twice a day for up to seven days. Yes - there are no known harmful effects when this medicine is used by pregnant or breastfeeding mothers.