Patient Information Leaflet for Otowell-DS Ear Spray (Docusate Sodium 5mg/ml)
Read this leaflet carefully before you start using Otowell-DS Ear Spray. Keep this leaflet as you may need to read it again. If you have further questions, ask your doctor or pharmacist, or refer to the contact details at the end of this leaflet.
What Otowell-DS is and what it is used for
Otowell-DS Ear Spray is a non-prescription medication designed to aid in the removal of ear wax. It contains Docusate Sodium, an effective surfactant that softens, loosens, and helps expel ear wax. This can relieve symptoms such as partial hearing loss, earache, and general discomfort associated with wax buildup. Regular use helps maintain ear hygiene and prevents wax accumulation.
What you need to know before you use Otowell-DS
Do not use Otowell-DS:
– If you have an allergy to Docusate Sodium or any other component of this product (a complete list of ingredients is provided in section 6).
– If your eardrum is perforated or if you suspect it might be.
– If there is an active or suspected infection in your ear.
– If you experience ear pain, irritation, or any discharge that does not resemble ear wax.
Warnings and precautions:
– Discuss with your healthcare provider if you have had ear surgery or any chronic ear conditions before using this product.
– Avoid contact with eyes; if contact occurs, rinse thoroughly with water.
– Otowell-DS should not be used in the presence of ear tubes (grommets).
Children and adolescents:
– Suitable for children aged 2 years and above under adult supervision. Use in children should be managed by an adult to ensure safety and efficacy.
Other medicines and Otowell-DS:
– Although interactions with other ear medicines are unlikely, please inform your healthcare provider about all types of medications you are using, including over-the-counter drugs and herbal products.
Pregnancy, breastfeeding, and fertility:
– There is limited data on the use of Otowell-DS during pregnancy and breastfeeding. It is advisable to consult your healthcare provider before using this product if you are pregnant, planning to become pregnant, or breastfeeding.
Driving and using machines:
– Otowell-DS typically does not impair your ability to drive or operate machinery. Nevertheless, if you experience temporary hearing disturbances after use, avoid performing potentially hazardous tasks such as driving or operating heavy machinery.
How to use Otowell-DS
Preparation and administration:
– Ensure your hands are clean and dry before use.
– Gently shake the bottle to mix the contents.
– To minimize discomfort, warm the bottle in your hands for several minutes before use.
– Tilt your head to one side and gently insert the nozzle tip into the upward-facing ear.
– Pump the spray as directed by the label or your healthcare provider, usually one to two sprays.
– Keep your head tilted for several minutes to allow the solution to soften the wax effectively.
– Repeat the procedure for the opposite ear if necessary.
Dosage:
– Adults and children over 12 years: 1 to 2 sprays into each ear, twice a day.
– Children 2 to 12 years: 1 spray into each ear, twice a day or as directed by a healthcare professional.
Duration of treatment:
– Use regularly for up to 4 days or until symptoms improve. Do not use for more than 4 consecutive days without medical advice.
Possible side effects
Most people do not experience side effects with Otowell-DS. However, side effects can occur which include:
– Temporary hearing loss.
– Tinnitus (ringing or buzzing in the ear).
– Mild to moderate ear irritation or discomfort.
– Allergic reactions, such as rash, itching, or redness around the ear.
Seek immediate medical help if you experience:
– Severe pain, swelling, or infection signs in the ear.
– Persistent or worsening symptoms despite treatment.
– Any sudden changes in hearing.
How to store Otowell-DS
– Keep the bottle tightly closed in order to protect from light and moisture.
– Do not store above 25°C (77°F).
– Keep out of reach and sight of children.
– Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
– Dispose of the product appropriately 6 months after opening or as per the expiry date, whichever is earlier.
Contents of the pack and other information
What Otowell-DS contains:
– The active ingredient is Docusate Sodium at a concentration of 5mg per ml.
– The other ingredients include glycerin, purified water, and preservatives to ensure product stability and prevent microbial growth.
What Otowell-DS looks like and contents of the pack:
– Otowell-DS is available in a 10 ml plastic bottle equipped with a spray pump designed for precise delivery.
Manufacturer:
– Able Pharma, City: Baddi, State: Himachal Pradesh, Country: India
Further Information:
– For further information, email ablepharma@gmail.com or visit www.ablepharma.com
This leaflet was last revised in [November 2024].
End of the Patient Information Leaflet for Otowell-DS Ear Spray.