0.5% (5 mg/ml) eye drops , solution, single -dose container tropicamide
What Tropikamid Bausch and Lomb is and what it is used for
Tropicamide Bausch & Lomb is used to dilate the pupil when examining the fundus.
Tropicamide is short-acting and the maximum effect occurs within 20–25 minutes and persists for 15–20 minutes, the maximum effect decaying rapidly. The pupil returns to normal size within 3–4 hours.
What you need to know before using Tropikamid Bausch and Lomb
Do not use Tropikamid Bausch and Lomb
- if you are allergic to tropicamide or any of the other ingredients of this medicine (listed in section 6).
- If you are at increased risk of high pressure in the eye because the anterior chamber of the eye is too shallow or the chamber angle where the eye’s fluid drains from the eye is too narrow
Other medicines and Tropicamide Bausch and Lomb
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The safety of use during pregnancy and breastfeeding is not clear, as modern documentation is lacking. Tropicamide Bausch & Lomb should therefore only be used during pregnancy if the treatment is necessary and then the lowest possible dose should be used.
It is unknown how much tropicamide passes into breast milk. Infants can be very sensitive to tropicamide contained in Tropikamid Bausch & Lomb. The product should therefore not be used during breastfeeding.
Driving ability and use of machinery
Tropicamide can affect the ability to drive or use machines. Tropicamide can affect visual acuity and cause temporary blurred vision. You should therefore not drive or use machinery until your vision returns to normal.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Tropikamid Bausch and Lomb
Tropicamide Bausch & Lomb is given by healthcare professionals.
The recommended dose is 2 drops 5 minutes apart. If necessary, give another 1 or 2 drops after 30 minutes.
If you have used too much Tropikamid Bausch and Lomb
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 users):
Flushing, fever, high heart rate, confusion, hallucinations, agitation, constipation, burning after the infusion, blurred vision, impaired near vision, and sensitivity to light.
Uncommon (may affect up to 1 in 100 users):
Allergy during prolonged use, difficulty urinating
Has been reported (occurring in an unknown number of users):
Acute increased pressure in the eye
How Tropikamid Bausch and Lomb should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 ºC. Do not freeze. Store in the original packaging. Light sensitive.
Use before the expiry date stated on the label on the box after Ex. Date. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tropicamide 5 mg/ml
- Other ingredients are sodium hydroxide/diluted hydrochloric acid and purified water
Appearance and package sizes of the medicine
Single-dose containers of soft plastic, 20 x 0.5 ml, separately packed in the outer casing.
BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24 – D24PPT3 – Ireland
Manufacturer
Laboratoire Chauvin SA
ZI Rapier
07200 Aubenas – France