Consumer medicine information

Minims Tropicamide

Tropicamide

BRAND INFORMATION

Brand name

Minims Tropicamide Eye Drops

Active ingredient

Tropicamide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Tropicamide.

What is in this leaflet

This leaflet answers some common questions about Minims Tropicamide, including how to use the eye drops.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Tropicamide against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Minims Tropicamide is used for

Minims Tropicamide belongs to a class of medicines called antimuscarinic agents. It is used to enlarge the pupil of the eye and to temporarily paralyse the lens so that your doctor can examine your eye. It is usually used at the beginning of an eye examination.

Ask your doctor if you have any questions about why this medicine has been prescribed to you. Your doctor may have prescribed it for another reason.

Before you use Minims Tropicamide

When you must not use it

Do not use Minims Tropicamide if you have an allergy to:

  • any medicine containing tropicamide
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not use Minims Tropicamide if you have narrow angle glaucoma (high pressure in the eye). Tropicamide can increase the pressure in the eye.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • glaucoma (high pressure in the eye)
  • fast heartbeat or any heart condition or had heart surgery.

Tell your doctor if you are pregnant or are breast-feeding. Your doctor will discuss with you the risks and benefits involved.

Tell your doctor if you wear contact lenses. You should not wear contact lenses while using this medicine.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Tropicamide.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Tropicamide may interfere with each other. In particular if you are using other eye drops.

These medicines may be affected by Minims Tropicamide or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while using this medicine.

How to use Minims Tropicamide

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor for help.

How much to use

Use Minims Tropicamide only when prescribed by your doctor. Your doctor will tell you how often to use the eye drops and how many drops to use each time.

The usual dose is one drop instilled into the eye followed by a second drop after an interval of 5 minutes. If necessary, a further one drop may be instilled after 30 minutes.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing contact lenses, remove them before putting the drops in your eye.

Your doctor will normally instil the drops into your eyes for you. If you are instilling your own drops, then follow these steps to use the eye drops.

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch/pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release one or two drops into the pouch/pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.
  11. Repeat steps 4-10 for the other eye if needed.
  12. Throw away any eye drops left in the container.
  13. Wait 15 minutes before replacing your contact lenses.

If you use too much (overdose)

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of Tropicamide. If you think that an infant or young child may have swallowed any or all of the contents of the container of Minims Tropicamide, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

While you are using Minims Tropicamide

Things you must do

If you have any irritation, pain, swelling, excessive tear production or light-sensitivity occur while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes.

Stop using the eye drops and contact your doctor if these symptoms persist.

If you are to have or have had eye surgery tell your doctor. Your doctor may advise you to stop your treatment with Minims Tropicamide.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if you think they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Minims Tropicamide affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause transient blurred vision at the time of application and sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Tropicamide.

This medicine helps most people but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • blurred vision and/or problems seeing clearly
  • local irritation or stinging or feeling of having something in the eye
  • discomfort in the eye(s) due to sensitivity to light. This may also involve some discolouration of the front of the eye.

The above list includes the more common side effects of your medicine.

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • thirst, dryness of the mouth
  • rash or flushing
  • increased sweating
  • behavioural changes. These are more common in children.
  • drowsiness and sedation
  • slow, fast or irregular heart beat
  • constipation
  • nausea or vomiting.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Tropicamide

Storage

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining containers.

Product description

What it looks like

Minims Tropicamide comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Tropicamide contains 0.5%w/v or 1.0%w/v of Tropicamide as the active ingredient.

It also contains:

  • Water - Purified
  • Sodium hydroxide
  • Hydrochloric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Tropicamide is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Tropicamide 0.5%
AUST R 32288

Minims Tropicamide 1.0%
AUST R 32289

In New Zealand Minims Tropicamide is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation

This leaflet was prepared in February 2018

Published by MIMS May 2018

BRAND INFORMATION

Brand name

Minims Tropicamide Eye Drops

Active ingredient

Tropicamide

Schedule

S4

 

1 Name of Medicine

Tropicamide.

2 Qualitative and Quantitative Composition

Minims Tropicamide Eye Drops contain tropicamide 0.5% and 1% w/v. No preservatives are contained in the formulation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A single-use eye drops, solution.
Minims Tropicamide are clear, colourless sterile ophthalmic solution. No preservatives are contained in the formulation.

4 Clinical Particulars

4.1 Therapeutic Indications

Minims Tropicamide Eye Drops is one of the antimuscarinics used to produce mydriasis and cycloplegia.

4.2 Dose and Method of Administration

Adults (including the elderly).

To produce mydriasis, 1 or 2 drops of a 0.5% solution are instilled 15 to 20 minutes before examination of the eye.
To produce cycloplegia, 1 or 2 drops of a 1% solution are required, repeated after 5 minutes. A further drop may be necessary to prolong the effect after 20 to 30 minutes.
Systemic absorption can be minimised by pressure on the tear duct immediately after application.

4.3 Contraindications

Hypersensitivity to tropicamide or any other component listed in the formulation.
Narrow angle glaucoma.

4.4 Special Warnings and Precautions for Use

Identified precautions.

For topical ophthalmic use only. Not for injection.
Tropicamide should not be used in patients with a narrow angle glaucoma since it may raise intraocular pressure and precipitate an acute attack.
As with other antimuscarinic agents, tropicamide should be used with caution in conditions characterised by tachycardia, such as thyrotoxicosis, heart failure and in cardiac surgery where it may further accelerate the heart rate. Care is required in patients with acute myocardial infarction as ischaemia and infarction may be made worse.
Tropicamide may significantly increase intraocular pressure.
Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of tropicamide eye drops and wait at least 15 minutes before reinsertion.

Use in the elderly.

In the elderly and others where increased ocular pressure may be encountered, mydriatics and cycloplegics should be used with caution.

Paediatric use.

Tropicamide has been reported to be inadequate for cycloplegia in children. Avoid use in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effects of antimuscarinic agents such as tropicamide may be enhanced by the concomitant administration of other drugs with antimuscarinic properties. Prolonged mydriatic and cycloplegic effects of tropicamide were reported with preinstillation of procaine.

Other drugs interactions.

Drug interactions have been reported with co-administration of an anticholinergic agent cisapride counteracting gastromotility inducement; procainamide coadministered with tropicamide may result in additive antivagal effects on the anterioventricular nodal conduction.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies in animals have not been conducted to evaluate these effects.
(Category B2)
Animal reproduction studies have not been conducted with tropicamide. It is not known whether tropicamide can cause foetal harm when administered to pregnant women or can affect reproductive capacity.
 It is not known whether this drug is excreted in human milk.

4.7 Effects on Ability to Drive and Use Machines

This preparation may cause transient blurring of vision on application. Patients should be advised not to drive or operate hazardous machinery until vision is clear. Patients may experience sensitivity to light and should protect their eyes from bright illumination during dilation.

4.8 Adverse Effects (Undesirable Effects)

Body.

Anaphylaxis.

CVS.

Transient bradycardia followed by tachycardia, with palpitations and arrhythmias.

CNS.

Drowsiness and sedation, inability to concentrate and fatigue, psychotic reactions and behavioural disturbances, more common in children than adults.

Resp.

Dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, bronchospasm.

GIT.

Difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Occasionally, vomiting may occur.

Skin.

Rash erythematous and pruritus. Flushing and dryness of the skin, increased sweating.

Ocular.

Photophobia with or without corneal staining, significant increases in intraocular pressure, corneal irritation, smarting eyes, severe oedema of the eyelids and rhinitis. Dilation of pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia.

Paediatric population.

Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children. Psychotic reactions, behavioural disturbances and cardio-respiratory collapse have been reported with this class of drug, especially in children.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
As Minims Tropicamide are single dose units of 0.5 mL overdose is unlikely to occur.
Should overdosage occur causing local effects, e.g. sustained mydriasis, physostigmine 0.25% w/v should be applied.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Minims Tropicamide is a topical antimuscarinic ophthalmic preparation that blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
Tropicamide has an action similar to atropine but its cycloplegic and mydriatic effects have a more rapid onset and a shorter duration of effect. Tropicamide has the quickest recovery time of all the antimuscarinics.
Mydriasis is produced within 20 to 40 minutes of instillation and usually lasts for about 6 hours; cycloplegia is maximal within about 30 minutes and is short lasting with complete recovery of accommodation normally within 6 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium hydroxide, hydrochloric acid and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.) Protect from light.

6.5 Nature and Contents of Container

Minims Tropicamide Eye Drops are supplied as a clear colourless sterile eye drops in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units. Each unit contains approximately 0.5 mL.
Minims Tropicamide Eye Drops are available in two strengths 0.5% (5 mg/mL) and 1% (10 mg/mL).

6.6 Special Precautions for Disposal

Each Minims unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: N-ethyl-N-(4-pyridylmethyl) tropamide.
Molecular formula: C17H20N2O2.
Molecular weight: 284.4.

CAS number.

1508-75-4.
Tropicamide is a white or almost white, crystalline powder, slightly soluble in water, freely soluble in ethanol and in methylene chloride.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes