What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00156/0069 .


Hypromellose 0.3% w/v Eye Drops (FAMAR)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hypromellose 0.3% w/v Eye Drops

Hypromellose

(Referred to as Hypromellose Eye Drops in this leaflet)

Read all of this leaflet carefully before you start using this medicine becasue 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.

What is in this leaflet:

1. What Hypromellose Eye Drops are and what they are used for
2. What you need to know b efore you use Hypromellose Eye Drops
3. How to use Hypromellose Eye Drops
4. Possible side effects
5. How to store Hypromellose Eye Drops
6. Contents of the pack and other information

1. What Hypromellose Eye Drops are and what they are used for

The active ingredient hypromellose belongs to a group of medicines known as eye lubricants (ocular lubricants).

Hypromellose Eye Drops are used to treat conditions where not enough tears are made to keep the eye lubricated and clean. Hypromellose Eye Drops lubricate the surface of the eye (including artificial eyes) in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production.

2. What you need to know before you use Hypromellose Eye Drops

Do not use Hypromellose Eye Drops if:

  • you are allergic (hypersensitive) to Hypromellose or any of the other ingredients of this medicine, which are listed in section 6 of this leaflet.
  • you are wearing soft contact lenses.

Warnings and precautions

Talk to your doctor or pharmacist before using Hypromellose

  • If you develop an eye infection during this treatment.
  • If you are wearing contact lenses.

Take special care with Hypromellose Eye Drops if:

  • your eye irritation persists or worsens,
  • you have a headache or eye pain,
  • your vision changes
  • you have permanently red eyes

If any of the above apply to you, stop using Hypromellose Eye Drops and contact your doctor immediately.

If you are unsure about taking this medicine or you have any questions, go and talk to your doctor first and follow the advice given.

Other medicines and Hypromellose Eye Drops

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

Hypromellose 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 clears before driving or using machines.

Important information about some of the ingredients of Hypromellose Eye Drops

This medicine contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.

Remove contact lenses before you use Hypromellose Eye Drops and wait at least 15 minutes before you put them back in.

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. How to use Hypromellose Eye Drops

Always use Hypromellose Eye Drops exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Soft contact lenses must not be worn during treatment with Hypromellose Eye Drops.

The recommended dose is one or two drops three times daily as needed, or as directed by your doctor.

Instructions for use

1. Before opening a new bottle of Hypromellose Eye Drops, please check that the safety strip on the bottom of the outer cap is unbroken.
2. Twist the outer cap to break the seal.
3. Wash your hands well before use.
4. Remove the outer cap. If you are putting in the drops yourself, you should use a mirror.
5. Tilt your head back and look up at the ceiling.
6. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye.
7. Hold the bottle between the thumb and middle finger of the other hand, turn the bottle upside down near to the eye, try not to touch the eye with the nozzle.
8. Apply enough pressure to the container to release one to two drops, as directed by your doctor.
9. Blink your eye a few times.
10. If you think that you have missed the eye, then insert another drop.
11. Repeat steps 5-10 for the other eye if you have been told to use Hypromellose Eye Drops in both eyes.
12. Replace the outer cap on the container, trying not to touch the applicator tip with anything, including the eye or your fingers.
13. Wash your hands

If you are unsure about how to use Hypromellose Eye Drops talk to your doctor or pharmacist.

How much to use

The usual dose is 1 or 2 drops placed in each eye three times daily, however this may vary depending on the amount of lubrication needed.

If there is no improvement see your doctor or pharmacist.

Hypromellose Eye Drops are for external use only.

If you use more Hypromellose Eye Drops than you should

It can be washed out of your eye with warm water. It will not cause you any harm. If you are worried then talk to your doctor or pharmacist.

Hypromellose Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any of this medicine, contact your doctor.

If you forget to take Hypromellose Eye Drops

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 Hypromellose Eye Drops

You should keep using Hypromellose Eye Drops for as long as your doctor has asked. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this.

4. Possible side effects

Like all medicines, Hypromellose Eye Drops can cause side effects, although not everybody gets them.

  • 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 Hypromellose Eye Drops 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 via 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.

5. How to store Hypromellose Eye Drops

Keep out of the sight and reach of children.

Make sure the container is properly closed after each use.

Store below 25°C.

Do not use Hypromellose Eye Drops after the expiry date which is printed on the label. The expiry date refers to the last day of that month.

Dispose of this medicine four weeks after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other Information

What Hypromellose Eye Drops contain

The active substance is hypromellose 0.3%w/v The other ingredients are purified water, sodium chloride, potassium chloride, borax, boric acid, benzalkonium chloride solution. It may also contain sodium hydroxide or hydrochloric acid.

What Hypromellose Eye Drops look like and contents of the pack

Hypromellose Eye Drops are a clear, colourless solution supplied in a plastic bottle with a dropper nozzle and a tamper proof cap. Each bottle contains 10ml of sterile solution.

Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
RM3 8UG
United Kingdom

Manufacturer

Farmigea S.p.A.
Via G.B. Oliva 6/8
56121 Pisa
Italy

Famar S.A.
Alimos Plant 63
AG Dmitriou Str.
Agiou Dmitriou 63
Alimos Attiki
17456
Greece

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Product licence numbers:

Hypromellose Eye Drops BPC 0.3%w/v

PL 0156/0069 HK 22087

This leaflet was last updated May 2018

MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

D04397