Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tropicamide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2.What you need to know before you use this medicine 3.How to use this medicine 4.Possible side effects 5.How to store this medicine
this medicine Store below 25°C. Always use this medicine exactly as your doctor, pharmacist or nurse has told Store ampoules in the original pouch. Once open, the pouch should be used or you. Check with your doctor, pharmacist or nurse if you are not sure. discarded after 14 days. Do not freeze. The drops are for single use only and provided in single use units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion. The drops are for single use only and provided in single use units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion. The recommended dose is: Do not throw away any medicines via wastewater or household waste. Ask •The normal adult dose is 1 drop followed by a second drop after an interval your pharmacist how to throw away medicines you no longer use. These of 5 minutes. A further 1 drop may be instilled after 30 minutes, if required. measures will help to protect the environment. •The dose for children will be decided by the doctor or eye specialist. 1 What this medicine is and what it is used for 6 Contents of the pack and other information Method of administration Tropicamide contains a mydriatic and cycloplegic agent. It is used to enlarge What this medicine contains Make sure you follow these instructions carefully: the pupil of your eye and temporarily paralyse the lens. Your doctor or eye •The active ingredient is tropicamide. Each unit contains approximately 0.5ml 1.Wash your hands. specialist may use it to examine your eye. eye drops solution of tropicamide 1% w/v (5mg). 2.Use a mirror, this will help you to see what you are doing. • T he other ingredients are hydrochloric acid (for pH adjustment) and 3. C arefully dry your eyes using a tissue, and twist off the cap from the body 2 What you need to know before you use this medicine purified water. of the unit. Do not use this medicine: This medicine does not contain a preservative as it is a sterile single use unit. 4.Pull your lower eyelid down gently, and then carefully place 1 or 2 drops •if you are allergic to the active substance (tropicamide) or any of the other inside your lower eyelid. What this medicine looks like and contents of the pack ingredients (listed in section 6). 5.Close your eye and blink a few times to make sure your eye is covered by This medicine is a clear, colourless solution. Each aluminium pouch contains •if you have history of closed angle glaucoma with your eyes likely to develop the liquid. 5 low density polyethylene single-dose containers containing 0.5ml sudden increased internal pressure when the pupil is enlarged. 6.Close the eyelids. It is advisable to press gently on the inner corner of your of solution. eyelid for 3 minutes. This will help stop the solution draining into your Warnings and precautions Pack sizes: nose and throat. This is especially advisable in children, the elderly and Talk to your doctor, pharmacist or nurse before using tropicamide. 20 x 0.5ml (4 pouches with 5 single-dose containers) population at risk. Use of this product may cause: Marketing Authorisation Holder and Manufacturer 7. R epeat steps 4, 5 and 6 for the other eye, if necessary, then throw away the •Increase in the pressure of your eye. You should have your eye pressure unit, even if some solution remains. Marketing Authorisation Holder checked before initiation of therapy, especially in the elderly. If you use more Tropicamide than you should Aspire Pharma Limited, Unit 4, Rotherbrook Court Take special care Bedford Road, Petersfield, Hampshire, GU32 3QG, UK An overdose is very unlikely to occur. If you suddenly feel unwell after Ask yourself the following questions: receiving the drops, tell your doctor or eye specialist or contact your nearest Manufacturer •Is this product to be used in a small child? emergency department immediately. UNOLAB MANUFACTURING S.L •Are your eyes red or inflamed? Avenida Rita Levi Montalcini N°23 If the answer to any of these questions is yes, tell your doctor or eye specialist. 4 Possible side effects 28906 Getafe, Madrid, Spain Children Like all medicines, this medicine can cause side effects, although not Blind or partially sighted? Consult your doctor for advice as serious adverse reactions may occur with everybody gets them. Is this leaflet hard to see or read? the use of this product. The following side effects may occur: Call 01730 231148 to obtain the leaflet in a format suitable •temporary stinging and blurred vision. This will gradually wear off. Other medicines and Tropicamide •dry mouth. This is caused by the active substance being absorbed through This leaflet was last revised in Tell your doctor, pharmacist or nurse if you are using, have recently used or the tear duct and causing a common effect for this type of medicine. This January 2025 might use any other medicines. effect should wear off within a couple of hours. 1010648 – P1.7
30M013
directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects, you can help provide more information on the safety of this medicine.
this medicine
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the overwrap of each unit and on the carton after the letters "EXP". The expiry date refers to the last day of that month.
Pregnancy, breastfeeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Contact lenses Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off. Driving and using machines Some people find bright light (such as daylight) uncomfortable for a few hours after receiving Tropicamide. This may make it difficult for you to drive. As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.
If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. 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
Tropicamide 1% w/v eye drops, solution in single-dose container comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tropicamide 1% w/v eye drops, solution in single-dose container is tropicamide.
Medicines with the same active substance, strength and form include: Minims Tropicamide 0.5% w/v, Eye drops solution, Minims Tropicamide 1% w/v, Eye drops solution, Mydriacyl 1% eye drops, solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tropicamide 1% w/v eye drops, solution in single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
As a topical mydriatic and cycloplegic.
Posology
Adults (including the elderly):
1 drop followed by a second drop after an interval of 5 minutes. A further 1 drop may be instilled after 30 minutes, if required.
Paediatric population:
At the discretion of the physician.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Tropicamide is contraindicated in narrow angle glaucoma and in eyes where the filtration angle is narrow, as an acute attack of angle closure glaucoma may be precipitated.
Use with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
Care should be exercised in small children.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy.
None known.
There is no evidence as to the drug's safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. This product should only be used in pregnancy if considered essential by the physician.
Patient warning: Patients who receive a mydriatic may suffer from photophobia and this may impair their ability to drive under certain circumstances.
Transient stinging, dry mouth and blurred vision may occur following the use of this product.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Systemic effects from tropicamide are not expected. Should an overdose occur causing local effects, e.g. sustained mydriasis, pilocarpine or 0.25% w/v physostigmine should be applied.
Ask anything about Tropicamide 1% w/v eye drops, solution in single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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