Waxsol Ear Drops Ducosate Sodium Bp 0.5% W/V
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PACKAGE LEAFLET: INFORMATION FOR THE USER
WAXSOL
4
EAR DROPS
Docusate Sodium BP 0.5% w/v
PICDA
Read all of this leaflet care-fully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet:
1. What WAXSOL is and what it is used for
2. Before you use WAXSOL
3. How to use WAXSOL
4. Possible side effects
5. How to store WAXSOL
6. Further information
1. What WAXSOL is and what it is used for
WAXSOL is used to help remove ear wax in adults, the elderly and children. The drops help to clear your ear canal if it is blocked with wax by softening it and breaking it up.
2. Before you use WAXSOL
Do not use WAXSOL
• if you have a perforated (burst) eardrum.
• if your ear is sore inside.
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
• If you are pregnant or thinking of becoming pregnant WAXSOL can be used.
• If you are breast-feeding WAXSOL can be used.
Driving and using Machines
WAXSOL should not affect your ability to drive or use machines.
3. How to use WAXSOL
Always use WAXSOL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to use the drops:
• Fill the dropper from the bottle.
• Tilt your head to one side.
• Gently drip WAXSOL into your blocked ear until it is full.
The best time to do this is before you go to bed.
Only use the drops for 2 nights at a time. If you feel that the drops are not working after this time, or the problem continues to exist, please contact your doctor or pharmacist.
If you use more WAXSOL than you should, this may seep from the ear. It is unlikely that you will notice any problems but if you do have any (such as skin irritation) you should tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, WAXSOL can cause side effects, although not everybody gets them.
• Some people may have an allergic reaction which may include reddness of the skin area and/or a rash.
• Rarely there is stinging or soreness, which does not last long. If it does continue, do not use the drops on the next night.
• Injuries or swelling of the ear canal may result in painful symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store WAXSOL
Keep all medicines out of the reach and sight of children. Store the bottle below 25°C.
Do not use WAXSOL after the expiry date which is printed or embossed on the carton and label as month/ year. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information What WAXSOL contains
The active substance is Docusate sodium. The liquid in the bottle contains 0.5% w/v docusate sodium.
The other ingredients are glycerin, water and a preservative called phenonip. What WAXSOL looks like and contents of the bottle
WAXSOL is a clear, colourless liquid and is available in 10 millilitre and 11 millilitre amber glass bottles which contain a special dropper.
Marketing Authorisation Holder
The Marketing Authorisation Holder is Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Take ley, Bishop’s Stort-ford, CM22 6PU. It is made by Norgine Pharma, 28100 Dreux Cedex, France.
Ear Care
Your ears normally look after themselves. Never put cotton buds or anything else inside your ear. You could hurt yourself. The ears make wax naturally. Sometimes it builds up and goes hard. When this happens you may become a bit deaf or have earache. You can use WAXSOL on its own or before the doctor or nurse washes out your ear. Never put anything in your ear to try and clear the wax yourself. This leaflet was last approved in November 2013.
56UK2061110-01
Studio Oberlander • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany
Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail: info@studio-oberiaender.de
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Geb ra uchsinformation |
3 n U D | ||
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Hersteller: |
MEDA Pharma GmbH & Co. KG |
Benutzte Farben: | |
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Produkt: |
WAXSOL Ear Drops Solution |
m |
Black |
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10 ml | |||
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Meda-Nr. |
56UK2061110-01 | ||
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Hersteiier-Nr. |
0120403106 | ||
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Land: United Kingdom | |||
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GroBe: |
157 x 105 mm |
Korrektur: 2. | |
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Text: |
8,0 pt / 8,5 pt |
Datum: 18. 11. 2013 | |
1113_GI_Waxsol_Drops_10ml_56UK2061110-01.indd 3 18.11.13 17:38