1. NAME OF THE MEDICINAL PRODUCT

Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of Solution Contains:
Tropicamide USP…………………..1% w/v

  1. PHARMACEUTICAL FORM

Single-use, sterile eye drops.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

As a topical mydriatic and cycloplegic.

4.2 Posology and method of administration

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.

Children:

At the discretion of the physician.

4.3 Contraindications

Do not use in patients with a known hypersensitivity to tropicamide.

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.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

Patient warning: Patients who receive a mydriatic may suffer from photophobia and this may impair their ability to drive under certain circumstances.

4.8 Undesirable effects

Transient stinging, dry mouth and blurred vision may occur following the use of this product.

4.9 Overdose

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.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Tropicamide is a parasympatholytic agent, which acts by blocking the action of the parasympathetic nervous system. As acetylcholine is the neuro-humoral transmitter at the receptor site of the parasympathetic nervous system, tropicamide competes with acetylcholine for uptake at the receptor sites, thereby blocking its action. The results are mydriasis, due to unopposed action of the dilator pupillae, and cycloplegia.

5.2 Pharmacokinetic properties

No data on the pharmacokinetics of topical tropicamide are available.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium hydroxide, Hydrochloric acid, Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

15 months.

6.4 Special precautions for storage

Store below 25°C. Do not freeze. Protect from light.

6.5 Nature and contents of container

A sealed, conical shaped container fitted with a twist and pull-off cap. Each   unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.

6.6 Special precautions for disposal and other handling

Each   unit should be discarded after a single use.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

TROPICAMIDE
OPHTHALMIC SOLUTION USP
1% W/V
TAJ PHARMA

PATIENT INFORMATION LEAFLET

Tropicamide

Read all this leaflet carefully before you start using your medicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Remember this medicine is for you. Do not give it to someone else.

IN THIS LEAFLET:

  1. What Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma Tropicamide  Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma  are and what they are used for
  2. Before you use your Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma
  3. How to use your Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma
  4. Possible side effects
  5. How to store your Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma
  6. Further information

    1. WHAT TROPICAMIDE OPHTHALMIC SOLUTION USP 1% W/V TAJ PHARMA ARE AND WHAT THEY ARE USED FOR

Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma Tropicamide contains a mydriatic and cycloplegic agent. It is used to enlarge the pupil of your eye and temporarily paralyse the lens. Your doctor or eye specialist may use it to examine your eye.

  1. BEFORE YOU USE YOUR TROPICAMIDE OPHTHALMIC SOLUTION USP 1% W/V TAJ PHARMA

Do not use these drops if

  • you are allergic to the active substance (tropicamide) or any of the other ingredients (refer to the end of this leaflet).
  • you have history of closed angle glaucoma with your eyes likely to develop sudden increased internal pressure when the pupil is enlarged

Consult your doctor for advice; use of this product may cause:

  • Increase in the pressure of your eye. You should have your eye pressure checked before initiation of therapy, especially in elderly.

Take special care

Ask yourself the following questions:

  • Is this product to be used in a small child?
  • Are your eyes red or inflamed?

If the answer to any of these questions is yes, tell your doctor or eye specialist.

If you are pregnant, may be pregnant, or are breastfeeding

Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.

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 Ophthalmic Solution USP 1% w/v Taj Pharma Tropicamide. This may make it difficult for you to drive.

As with all  Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma , your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.

  1. HOW TO USE YOUR TROPICAMIDE OPHTHALMIC SOLUTION USP 1% W/V TAJ PHARMA

The drops are for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately.

Discard any unused portion.

Dosage

  • The normal adult dose is 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.
  • The dose for children will be decided by the doctor or eye specialist.

Method of administration

Make sure you follow these instructions carefully:

  1. Wash your hands.
    2. Use a mirror, this will help you to see what you are doing.
    3. Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit.
    4. Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid.
    5. Close your eye and blink a few times to make sure your eye is covered by the liquid.
    6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk.
    7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains.

If you use more Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma Tropicamide than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately.

  1. POSSIBLE SIDE EFFECTS

The following side effects may occur:

  • temporary stinging and blurred vision. This will gradually wear off.
  • dry mouth. This is caused by the active substance being absorbed through the tear duct and causing a common effect for this type of medicine. This effect should wear off within a couple of hours.

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 or pharmacist.

  1. HOW TO STORE YOUR TROPICAMIDE OPHTHALMIC SOLUTION USP 1% W/V TAJ PHARMA

Keep out of the reach and sight of children.

Do not use the  Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma  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.

Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light.

The drops are for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion.

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.

  1. FURTHER INFORMATION

What do your  Tropicamide Ophthalmic Solution USP 1% w/v Taj Pharma  contain

Each ml of Solution Contains:
Tropicamide USP…………………..1% w/v

The other ingredients are sodium hydroxide and hydrochloric acid (for pH adjustment) and purified water.

This medicine does not contain a preservative as it is a sterile single use unit.

Contents of the pack

Each carton contains 20 units.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com