Latanoprost/Timolol 50 Microgram/Ml + 5 Mg/Ml Eye Drops Solution
I I I
PACKAGE LEAFLET: INFORMATION FOR THE USER
Latanoprost/Timolol 50 microgram/ml + 5mg/ml eye drops, solution
777206WTH/2H
What is in this leaflet
1. What Latanoprost/Timolol is and what it is used for
2. What you need to know before you use Latanoprost/Timolol
3. How to use Latanoprost/Timolol
4. Possible side effects
5. How to store Latanoprost/Timolol
6. Contents of the pack and other information
1. WHAT LATANOPROST/ TIMOLOL IS AND WHAT IT IS USED FOR
The name of your medicine is Latanoprost/Timolol 50 microgram/ml + 5mg/ml Eye Drops, solution (referred to as Latanoprost/Timolol throughout this leaflet). Latanoprost/Timolol contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.
Latanoprost/Timolol is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within the eye, eventually affecting your eyesight. Your doctor will usually prescribe you Latanoprost/ Timolol when other medicines have not worked adequately.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
Latanoprost/Timolol can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age.
Do not use Latanoprost/Timolol if you
• are allergic to the active substances latanoprost or timolol, beta-blockers or any of the other ingredients of Latanoprost/Timolol 50 microgram/ml + 5mg/ml Eye Drops solution (listed in section 6).
• have now or have had in past severe breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).
• have serious heart problems or heart rhythm disorders.
• are pregnant or trying to become pregnant.
• are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Latanoprost/Timolol, if you have now or have had in the past:
• heart problems such as coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure, disturbances ofheart rate such as bradycardia (slow heart rate), Prinzmetal’s angina (chest pain occurs at rest). If taking Latanoprost/Timolol you should be monitored for signs of deterioration of these illnesses.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• poor blood circulation disease such as Raynaud’s disease or Raynaud’s syndrome (discolouration of fingertips in cold accompanied with pain).
• diabetes or low blood sugar levels (hypoglycaemia) as timolol may mask signs and symptoms oflow blood sugar.
• overactivity of the thyroid gland as timolol may mask signs and symptoms.
• any kind of eye surgery (including cataract surgery).
• eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision, dry eyes or cornea problems, problems with choroidea).
• take beta-blocking drugs (used for therapy of high blood pressure, rapid heart rate etc.).
• severe allergic reactions that would usually require hospital treatment.
• a viral infection of the eye caused by the herpes simplex virus (HSV).
• wear contact lenses. You can still use Latanoprost/Timolol but follow the instructions for contact lens wearers in section 3.
Tell your doctor before you have an operation that you use Latanoprost/ Timolol as timolol may change the effects of some medicines used during anaesthesia. Your doctor may want you to have extra checks on your heart and circulation if you use Latanoprost/Timolol.
Other medicines and Latanoprost/ Timolol
Latanoprost/Timolol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (or eye drops).
In particular, speak to your doctor or
pharmacist if you know that you are taking any of the following types of medicine:
• prostaglandins, prostaglandin analogues or prostaglandin derivates.
• beta-blockers.
• epinephrine.
• drugs used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrythmics (incl. amiodarone, quinidnine (used to treat heart conditions and some types of malaria), digitalis glycosides or parasympathomimetics.
• quinidine (used to treat heart conditions and some types of malaria).
• antidepressants (fluoxetine, paroxetine).
Using Latanoprost/Timolol with food, drink and alcohol
Normal meals, food or drink have no effect on when or how you should use Latanoprost/Timolol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Latanoprost/Timolol when you are pregnant unless your doctor considers it necessary. Do not use Latanoprost/Timolol when you are breast-feeding. Latanoprost/Timolol may get into your milk.
Neither latanoprost nor timolol have been found to have any effect on male or female fertility in animal studies.
Driving and using machines
When you use Latanoprost/Timolol your vision may become blurred for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.
Latanoprost/Timolol contains a preservative called benzalkonium chloride
This preservative may cause eye irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. See the instructions for contact lens wearers in section 3.
3. HOW TO USE LATANOPROST/ TIMOLOL
Always use Latanoprost/Timolol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dosage for adults (including the elderly) is one drop once a day in the affected eye(s).
Do not use Latanoprost/Timolol more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often. Use Latanoprost/Timolol as instructed by your doctor until your doctor tells you to stop.
Contact lens wearers
If you wear contact lenses, you should remove them before using Latanoprost/ Timolol. After using Latanoprost/ Timolol you should wait 15 minutes before putting your contact lenses back in.
Instructions for use
Follow the steps below to help you use Latanoprost/Timolol properly:
1. Wash your hands and sit or stand comfortably.
2. Unscrew the outer protective cap.
3. Use your finger to gently pull down the lower eyelid of your affected eye until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.
4. Place the tip of the bottle close to your eye. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
5. Squeeze the bottle gently so that only one drop goes into your eye and then release the lower eyelid.
6. After using Latanoprost/Timolol press a finger against the corner of the affected eye by the nose. Hold for 2 minutes whilst keeping the eye closed. This helps to stop
Latanoprost/Timolol getting into the rest of the body.
7. If you use drops in both eyes, repeat the steps for your other eye.
8. If a drop misses your eye, try again.
9. Put the cap back on the bottle.
If you use Latanoprost/Timolol with other eye drops
Wait at least 5 minutes between using Latanoprost/Timolol and using the other eye drops.
If you use more Latanoprost/Timolol than you should
If you put too many drops in your eye you may experience some minor irritation in your eye and your eyes may water and turn red. This should pass but if you are worried contact your doctor for advice.
If you swallow Latanoprost/Timolol
If you swallow Latanoprost/Timolol accidentally you should contact your doctor for advice. If you swallow a lot of Latanoprost/Timolol you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.
Read all of this leaflet carefully
before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you any have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.
Tell your doctor immediately that you have been using Latanoprost/Timolol if you notice changes in your heart rate or heart function. It is also possible that Latanoprost/Timolol might cause serious changes in the way your heart works.
If you forget to use Latanoprost/Timolol
Carry on with the usual dosage at the usua.l time. Do not take a double dose to make up to the dose you have forgotten. 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.
You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to a doctor or pharmacist. Do not stop using Latanoprost/ Timolol without speaking to your doctor.
Listed below are the known side effects of using Latanoprost/Timolol.
The most important side-effect is the possibility of a gradual, permanent change in your eye colour.
The following review covers side effects reported to date in terms of their frequency:
Very common
(may affect more than 1 in 10people):
• 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 take years to develop. The colour change may be permanent and may be more noticeable if you use Latanoprost/Timolol 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 Latanoprost/ Timolol treatment is stopped.
Common
(may affect up to 1 in 10people):
• Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye) and eye pain.
Uncommon
(may affect up to 1 in 100people):
• Headache.
• Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or disruption of the surface of the eye.
• Skin rashes or itching (pruritus).
Other side effects
Although not seen with Latanoprost/ Timolol, the following additional side effects have been seen with the medicines in Latanoprost/Timolol (latanoprost and timolol) and therefore might occur when you use Latanoprost/Timolol:
Like other medicines applied into eyes, Latanoprost/Timolol is absorbed into the blood. The timolol portion of this combination may cause similar side effects as seen with ‘intraveneous’ and/or ‘oral’ beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected.
Heart (cardiac) disorders:
• Worsening of angina.
• Awareness of heart rhythm (palpitations).
• Slow heart rate, Changes in heart rhythm.
• Chest pain.
• Swelling (oedema).
• Congestive heart failure - heart disease with shortness of breath and swelling of the feet and legs due to fluid build-up), heart block, heart attack, heartfailure.
Nervous system disorders:
• Dizziness.
• Fainting or feeling you may faint (syncope).
• Stroke.
• Reduced blood supply to the brain.
• Worsening of symptoms of myasthenia gravis (muscle disorder).
• Tingling or numbness in the skin.
• Headache.
Eye disorders:
• Changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening, changes to the direction of eyelash growth).
• Swelling around the eye.
• Swelling of the coloured part of the eye (iritis/uveitus).
• Swelling at the back of the eye (macular oedema).
• Dry eye.
• Inflammation/irritation of the surface of the eye (keratitis).
• Corneal erosion and swelling (damage to the front layer of the eyeball).
• Fluid filled cyst within the coloured part of the eye (iris cyst).
• Sensitivity to light (photophobia).
• Changes in lid and around eye resulting in deepening of the eyelid groove.
• Eye burning, stinging, itching, tearing, redness.
• Inflammation of conjunctiva and eye lids (blepharitis).
• Injury to the lining of the back of the eye (a condition known as retinal detachment, but only seen when used following some kinds of eye surgery).
• Decreased corneal sensitivity.
• Visual changes/disturbances, double or blurred vision.
• Drooping of the upper eyelid (making the eye stay half closed).
Ear disorders:
• Whistling/ringing in the ears (tinnitus).
Breathing (respiratory) disorders:
• Asthma, worsening of asthma.
• Shortness of breath, difficulty breathing.
• Sudden difficulty to breathe (bronchospasm).
• Cough.
Digestive system (gastrointestinal) disorders:
• Taste disturbances.
• Feeling sick (nausea).
• Indigestion.
• Diarrhoea.
• Dry mouth.
• Stomach-ache.
• Vomiting.
Skin disorders:
• Darkening of the skin around the eyes.
• Hair loss/baldness (alopecia).
• Skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
• Skin rash.
Muscle and skeletal disorders:
• Joint pain.
• Muscle pain (not caused by exercise).
Metabolism and nutrition disorders:
• Low blood glucose levels.
Infections and infestations:
• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Blood flow (vascular) disorders:
• Low blood pressure.
• Discolouration/coldness of the fingers and toes (Raynaud’s phenomenon) and coldness of the hands and feet.
General disorders:
• Muscle weakness/tiredness.
Immune system disorders:
• Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing.
• Hives or itchy rash.
• Localized and generalized rash.
• Itchiness.
• Severe sudden life-threatening allergic reaction (anaphylactic reaction).
Reproductive system and breast disorder:
• Sexual dysfunction.
• Decreased sex drive.
Psychiatric disorders:
• Difficulty sleeping (insomnia).
• Depression.
• Nightmares.
• Memory loss.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
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 the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LATANOPROST/ TIMOLOL
Keep this medicine out of the sight and reach of children.
Do not use Latanoprost/Timolol after the expiry date which is stated on the bottle and box after EXP. The expiry date refers to the last day of that month. Before Latanoprost/Timolol is first opened, it should be stored at 2 °C - 8 °C (in a refrigerator).
Once the bottle has been opened, Latanoprost/Timolol can be kept at room temperature (below 25 °C). You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle. Write down the date you open it.
Keep the bottle in the outer carton in order to protect the medicine from light.
Do not use Latanoprost/Timolol if you notice the bottle is damaged or eye drops don’t look right in some other way.
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 Latanoprost/Timolol 50 microgram/ml + 5mg/ml Eye Drops, solution contains
• The active substances are latanoprost and timolol maleate. 1 ml of Latanoprost/Timolol 50 microgram/ml + 5mg/ml Eye Drops, solution contains latanoprost 50 micrograms and timolol maleate 6.83 mg equivalent to 5 mg timolol.
• The other ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, benzalkonium chloride, hydrochloric acid, sodium hydroxide, water for injections.
What Latanoprost/Timolol 50 microgram/ml + 5mg/ml Eye Drops, solution looks like and contents of the pack
The solution is a clear colourless, odourless liquid. Each bottle contains 2.5 ml eye drop solution.
Pack sizes:
1 x 2.5 ml 6 x 2.5ml
3 x 2.5 ml 8 x 2.5 ml
4 x 2.5 ml 12 x 2.5 ml
Not all pack sizes may be marketed.
Marketing authorisation holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22,
00040 Pomezia (Roma), Italy
This leaflet was last revised in 05/2014.
‘Zentiva’ is a registered trademark.
© 2014 Zentiva.
777206WTH/2H
BACK
FRONT
CODE: 777206WTH/2H
DATE:19/05/2014
[ CLIENT: TUBILUX
[ PRODUCT: Leaflet Latanoprost/Timolol
[ MEASURE: 120 x 500 mm (120 x 27 mm)
fCOLOURS: MBS
[ EXTRA: Deca code XIXI Visual code 3-7- 11
[text SIZE: 9 pt
J
NOTE: Carta da 40 g/m2
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