Hydroxy Propyl Methyl Cellulose Ophthalmic Solution 2%/3% in Prefilled Syringes Taj Pharma
- Name of the medicinal product
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution 2%/3% in Prefilled Syringes Taj Pharma
- Qualitative and quantitative composition
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution 2% / 3% in Prefilled Syringes
For the full list of excipients, see section 6.1
- Pharmaceutical form
Eye drops, Solution in prefilled syringe.
Clear to slightly opalescent colourless, slightly viscous solution.
- Clinical particulars
4.1 Therapeutic indications
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is used as artificial tears to prevent damage to the cornea in patients with keratoconjunctivitis sicca accompanying rheumatoid arthritis, xerophthalmias or keratitis or during gonioscopy procedures. It is also used to moisten hard contact lenses and to lubricate artificial eyes.
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution provides immediate relief of dry eye conditions (including dry eye conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres eg air-conditioning, central heating, wind and sun)
4.2 Posology and method of administration
The recommended dosage for adults, children and elderly is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician.
Administration: For ocular use only.
4.3 Contraindications
Hypersensitivity to active substance, Hydroxy Propyl Methyl Cellulose Opthalmic Solution or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
May cause transient mild stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, patients should discontinue use and consult a physician or pharmacist (see section 4.8).
In order to preserve the sterility, the dropper should not be allowed to touch any part of the eye or any other surface. (Label warning: Do not touch any part of the eye with the dropper). The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.
Remove contact lenses prior to application and wait at least 15 minutes before reinserting. Benzalkonium chloride is known to discolour soft contact lenses.
4.5 Interaction with other medicinal products and other forms of interaction
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution prolongs the contact time of topically applied drugs commonly used in ophthalmology.
4.6 Fertility, pregnancy and lactation
Fertility
Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility. Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is a pharmacologically inert compound and it would not be expected to have any effect on fertility.
Pregnancy
There are no or limited amount of data from the use of ophthalmic Hypromellose in pregnant women. Systemic exposure to Hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.
Lactation
It is unknown whether topical Hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding women to Hypromellose is negligible. In addition to this, Hypromellose is pharmacologically inert.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
The following adverse reactions have been reported following administration of Hydroxy Propyl Methyl Cellulose Ophthalmic Solution.
Frequency cannot be estimated from the available data:
Eye disorder:
- transient mild stinging or vision blurred,
- eye pain,
- foreign body sensation in eyes,
- eye irritation,
- ocular hyperaemia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 at www.mhra.gov.uk/yellowcard.
4.9 Overdose
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one Prefilled Syringe
- Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:
Ophthalmologicals: other ophthalmologicals
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methylcellulose are that mucilages of hypromellose have greater clarity and fewer undispersed fibres are usually present. It prolongs the action of medicated eye drops and is used as artificial tears to prevent damage to the cornea in dry eye syndromes.
5.2 Pharmacokinetic properties
Not applicable to topical (ophthalmic) preparations.
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is an inert substance. It has no pharmacological activity and not absorbed systemically. Hence, the pharmacokinetic properties have not been studied.
5.3 Preclinical safety data
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity or to have any effect on reproductive processes.
Similarly no specific local ocular toxicity or irritation studies have been conducted; however no adverse effects are anticipated. Indeed, hypromellose ophthalmic solution is used as a control in some ophthalmic drugs studies because of the acknowledged low level of toxicity.
- Pharmaceutical particulars
6.1 List of excipients
Sodium chloride
Potassium chloride
Borax
Boric acid
Benzalkonium chloride solution
Purified water
Sodium hydroxide solution (for pH adjustment)
Hydrochloric acid ( for pH adjustment)
6.2 Incompatibilities
Not known
6.3 Shelf life
Unopened: 24 months
After first opening: 1 month
6.4 Special precautions for storage
Protect from light.
Do not store above 25°C
A slight haziness which may develop in the unopened product is normal and does not adversely affect the product.
Discard after four weeks of opening.
6.5 Nature and contents of container
Pack Type
Prefilled Syringe with polystyrene spiked cap.
6.6 Special precautions for disposal and other handling
Do not touch dropper tip to any surface as this may contaminate the contents.
If the drop of medication is not retained in the eye upon dosing for any reason, instill another drop.
- 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
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution 2%/3% in Prefilled Syringes Taj Pharma
Hydroxy Propyl Methyl Cellulose Opthalmic Solution 2%/ 3% w/v
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.
- Your medicine, Hydroxy Propyl Methyl Cellulose Opthalmic Solution Eye Drops BP will be referred to as Hydroxy Propyl Methyl Cellulose Opthalmic Solution in this leaflet.
What is in this leaflet
- What Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is and what it is used for
2. What you need to know before you use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
3. How to use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
4. Possible side effects
5. How to store Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
6. Contents of the pack and other information - What Hydroxy Propyl Methyl Cellulose Ophthalmic Solution is and what it is used for
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution, is an artificial tear used to relieve dry eye conditions (eg. conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres eg. air-conditioning, central heating, wind and sun). It is also used to moisten hard contact lenses and to lubricate artificial eyes.
- What you need to know before you use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
Do not use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
- If you are allergic to Hydroxy Propyl Methyl Cellulose Ophthalmic Solution or any other ingredient of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
- If you develop an eye infection during this treatment.
- If you are wearing contact lenses.
Other medicines and Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Please tell your doctor or pharmacist if you are applying any other type of eye drops or eye ointment before you start to use this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution may cause a temporary blurring of vision immediately after using the drops. Do not drive or operate machines if you experience any visual disturbance after using the product. Wait until this clear before driving or using machines.
Hydroxy Propyl Methyl Cellulose Ophthalmic Solution contains benzalkonium chloride
The eye drops contain benzalkonium chloride as preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting. The preservative is known to discolour soft contact lenses.
- How to use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one or two drops three times daily as needed, or as directed by your doctor.
If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drops.
Instructions for use
- First wash your hands
- Avoid touching any part of the eye (or any other surface) with the tip of the Prefilled Syringe
- This product contains benzalkonium chloride and should not be used if soft contact lenses are being worn. However if you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting
- These drops are supplied as a sealed Prefilled Syringe with a cap. When using the Prefilled Syringe for the first time, use it carefully.
- Tilt your head back and look at the ceiling
- Pull the lower eyelid gently downwards
- Hold the Prefilled Syringe upside down above the eye and gently deliver with the Prefilled Syringe to release a drop into your eye
- Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute
- Repeat for the other eye if necessary
- Replace and tighten the cap immediately after use
Be careful not to touch the tip of the Prefilled Syringe on your eye or on any other surface.
Eye solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately.
If you use more Hydroxy Propyl Methyl Cellulose Ophthalmic Solution than you should, it can be washed out of your eye with warm water.
If you forget to use Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not take a double dose to make up for a forgotten dose.
If you stop using Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
You should speak to your doctor or pharmacist, if you want to stop taking Hydroxy Propyl Methyl Cellulose Ophthalmic Solution.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:
- vision blurred
- eye pain
- foreign body sensation in eyes
- eye irritation
- redness of eye
These effects should wear off after a short time. If these effects persist or get worse, or you notice any side effects not listed in this leaflet stop using Hydroxy Propyl Methyl Cellulose Ophthalmic Solution and talk to your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. By reporting side effects you can help provide more information on the safety of this medicine.
- How to store Hydroxy Propyl Methyl Cellulose Ophthalmic Solution
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 Prefilled Syringe after Expiry Dt. The expiry date refers to the last day of the month.
Do not store above 25°C.
Protect from light. A harmless slight haziness may develop in the unopened Prefilled Syringe.
Discard the Prefilled Syringe after opening, even if there is solution remaining.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
- Contents of the pack and other information
What Hydroxy Propyl Methyl Cellulose Opthalmic Solution contains
The active substance is Hydroxy Propyl Methyl Cellulose Opthalmic Solution.
The other ingredients are Sodium Chloride, Potassium Chloride, Borax, Boric Acid, Benzalkonium Chloride Solution (as preservative) 0.01% w/v, Sodium Hydroxide Solution, Hydrochloric Acid and Purified Water.
What Hydroxy Propyl Methyl Cellulose Ophthalmic Solution looks like and contents of the pack
Hydroxy Propyl Methyl Cellulose Opthalmic Solution Eye Drops is a clear colourless, slightly viscous solution
Each Prefilled Syringe contains 10 ml of solution.
- 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
