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LATANOPROST 0.005% W/V EYE DROPS SOLUTION, MEDIZOL 0.005% W/V EYE DROPS SOLUTION - patient leaflet, side effects, dosage

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Patient leaflet - LATANOPROST 0.005% W/V EYE DROPS SOLUTION, MEDIZOL 0.005% W/V EYE DROPS SOLUTION

MEDIZOL® 0.005% w/v

Eye Drops, Solution

Latanoprost

Medicom Healthcare


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you or for your child only. Do not pass it on to others. It may harm them, even if their symptoms of illness are the same as yours.
  • If you or your child get any side effects, talk to your doctor or the doctor treating your child or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Medizol is and what it is used for

  • 2. What you need to know before you use Medizol

  • 3. How to use Medizol

  • 4. Possible side effects

  • 5. How to store Medizol

  • 6. Contents of the pack and other information.

1.what medizol is and what it is used for

Medizol belongs to a group of medicines known as prostaglandin analogues. It lowers the pressure within your eye by increasing the natural flow of fluid from inside the eye into the blood stream.

Medizol is used to treat adults with open angle glaucoma and ocular hypertension. These conditions are linked with an increase in the pressure within your eye. If they are not treated they may affect your eyesight.

Medizol is also used to treat increased eye pressure and glaucoma in ail ages of children and babies.

2.what you need to know before you use medizol

Medizol can be used in adults (including the elderly) and in children from birth to 18 years of age. Medizol has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use Medizol

  • – if you are allergic (hypersensitive) to latanoprost or any of the other ingredients of Medizol (listed in section 6)

Warning and precautions Take special care with Medizol: Talk to your doctor or the doctor treating your child or your pharmacist before you apply Medizol or before you give this medicine to your child if you think any of the following apply to you or your child:

  • If you or your child are about to have or have had eye surgery (including cataract surgery)
  • If you or your child suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision)
  • If you or your child suffer from dry eyes
  • If you or your child have severe asthma or the asthma is not well controlled
  • Ifyouoryour child wear contact lenses. You can still use Medizol, but follow the instruction for contact lens wearers in Section 3
  • If you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).

Other medicines and Medizol Tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines (including eye drops). Use of more than one prostaglandin-related eye drop is not recommended. There have been reports of raised pressure in the eye when two prostaglandin analogues are used together.

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 for advice. Do not use Medizol when you are pregnant or breast-feeding.

Driving and using machines

As with other eyedrops, if your vision is blurred when you first put your drops in, wait until this wears off before you drive or operate machinery.

Medizol contains Benzalkonium chloride

Medizol contains a preservative called benzalkonium chloride.

This preservative may cause eye irritation or disruption to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. If you or your child wear contact lenses, they should be removed before using Medizol. See the instructions for contact lens wearers in Section 3.

3. how to use medizol

Always use Medizol exactly as your doctor or the doctor treating your child has told you until they tell you to stop. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults (including elderly) and children is one drop once a day in the affected eye(s). The best time to do this is in the evening.

Do not use Medizol more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Contact lens wearers

If you or your child wear contact lenses, you should remove these before using Medizol. After using Medizol you should wait 15 minutes before putting the contact lenses back into the eyes.

Using with other eye drops:

If you have to use other eye drops you should wait for at least five minutes before using them.

How to use Medizol.

Follow the steps below to help you use Medizol properly:

  • 1. Wash your hands and sit or stand comfortably.

  • 2. Unscrew the protective cap (which should be retained).

  • 3. Use your finger to gently pull down the lower eyelid of your affected eye.

  • 4. Place the tip of the bottle close to, but not touching your eye.

  • 5. Squeeze the bottle gently so that only one drop goes into your eye and then release the lower eyelid.

  • 6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.

  • 7. Repeat in your other eye if your doctor has told you to do tnis.

  • 8. Put the cap back on the bottle.

If you use more Medizol than you should

If you put too many drops in your eye, you may feel some slight irritation in the eye and the eyes may water and turn red. If you are worried, contact your doctor for advice.

Contact your doctor as soon as possible if you oryour child swallows Medizol accidentally.

If you forget to use Medizol

If you forget to apply your drops at the usuaRime, just skip that dose. Do not apply a double dose to make up for the missed dose. Instead, just wait until the next time you are supposed to apply it, and then apply your normal dose.

If you stop using Medizol

You should speak to your doctor or the doctor treating your child if you want to stop using Medizol.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following are known side effects of using Medizol:

Very common (may affect more than 1 in 10 people):

  • A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may develop gradually although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Medizol in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Medizol treatment is stopped.
  • Redness of the eye
  • Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye). If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week). You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
  • A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly in people of Japanese origin. These changes involve an increase of the colour (darkening), length, thickness and number of your eye lashes and other hair near the eye.

Common (may affect up to 1 in 10 people):

  • Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):

  • Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
  • Skin rash.
  • Chest pain (angina), awareness of heart rhythm (palpitations).
  • Asthma, shortness of breath (dyspnoea).
  • Chest pain.
  • Headache, dizziness.
  • Muscle pain, joint pain

Rare (may affect up to 1 in 1,000 people):

  • Inflammation of the iris (iritis), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema), misdirected eyelashes or an extra row of eyelashes, scarring of the surface of the eye, fluid filled area within the coloured part of the eye (iris cyst).
  • Skin reactions on the eyelids, darkening of the skin of the eyelids
  • Worsening of asthma
  • Severe itching of the skin
  • Developing a viral infection of the eye caused by herpes simplex virus (HSV)

What Medizol looks like and contents of the pack

Medizol is a clear colourless solution in a dropper polyethylene container of 5 ml with tamper evident polyethylene screw cap.

Each bottle contains 2.5 ml eye drops solution corresponding to approximately 80 drops of solution.

Pack sizes: 1 × 2.5 ml

3 × 2.5ml

Not all packaging sizes may be marketed.

Marketing Authorisation Holder

MEDICOM HEALTHCARE LTD.

Lynton House, 7–12 Tavistock Square, Kings Cross, London, WC1H9LT, U.K.

Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071 Pomezia (RM)

ITALY

PL 18956/0021

This leaflet was last revised in

June 2019

Very rare (may affect up to 1 in 10,000 people):

  • Worsening of angina in patients who also have heart disease, sunken eye appearance (eye sulcus deepening).

5. how to store medizol

Keep this medicine out of the sight and reach of children.

Do not use Medizol after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month.

Store the unopened bottle in a refrigerator (2°C – 8°C). After first opening the bottle: do not store above 25°C and use within 4 weeks.

Keep the bottle in the outer carton in order to protect from light.

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

6. contents of the pack and other information

What Medizol contains

The active substance is latanoprost 0.005% w/v (50 micrograms in one ml).

The other ingredients are: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate, anhydrous disodium phosphate, water for injections.

9-LTPOM-11-GB-PV5

Sources: Original (products.mhra.gov.uk)