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Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml eye drops, solution
LATANOPROST+TIMOLOL 50 micrograms/ml + 5 mg/ml eye drops, solution
latanoprost + timolol
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
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 your eye, eventually affecting your eyesight. Your doctor will usually prescribe you Latanoprost+Timolol when other medicines have not worked adequately.
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.
Talk to your doctor or pharmacist before using Latanoprost+Timolol if you have now or have had in the past:
Tell your doctor before you have an operation that you are using Latanoprost+Timolol as timolol may change effects of some medicines used during anaesthesia.
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.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Talk to your doctor or pharmacist if you know that you are taking any of the following types of medicine:
Normal meals, food or drink have no effect on when or how you should use Latanoprost+Timolol.
Pregnancy
Do not use Latanoprost+Timolol if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.
Breast-feeding
Do not use Latanoprost+Timolol if you are breast-feeding. Latanoprost+Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.
Fertility
Latanoprost and timolol have been found to have no effect on male or female fertility in animal studies.
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.
This medicine contains 0.2 milligrams of benzalkonium chloride in each millilitre. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
This medicine contains 6.3 mg phosphates in each ml of solution. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose 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.
Your doctor may want you to have extra checks on your heart and circulation of you use Latanoprost+Timolol.
If you wear contact lenses, you should remove them before using Latanoprost+Timolol. After using this product you should wait 15 minutes before putting your contact lenses back in.
Always wash your hands before applying eye drops.
Apply your eye drops in the following way:
1. Remove protective cap.
2. Tilt your head back and look at the ceiling.
3. Gently pull the lower eyelid down until there is a small pocket, as illustrated in figure 1.
4. Squeeze the upturned dropper bottle to release a drop into your eye.
5. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) as illustrated in figure 2 and hold for 2 minutes. This helps to stop Latanoprost+Timolol getting into the rest of the body.
Avoid touching the dropper tip against your eye or anything else.
Replace and tighten the cap straight after use.
Wait at least 5 minutes between using Latanoprost+Timolol and using the other eye drops.
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 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.
Carry on with the usual dosage at the usual time. Do not take a double dose to make up to the dose you have forgotten.
If you are unsure about anything talk to your doctor or pharmacist.
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’re 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. It is also possible that Latanoprost+Timolol might cause serious changes in the way your heart works. If you notice changes in your heart rate or heart function you should speak to a doctor and tell them you have been using Latanoprost+Timolol.
The following are known side effects of using Latanoprost+Timolol:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Like other medicines applied into eyes, latanoprost and timolol are absorbed into the blood.
This may cause similar side effects as seen with systemic beta-blocking agents. The incidence of side effects after using eye drops is lower than when medicines are, for example, taken by mouth or injected.
Although not seen with Latanoprost+Timolol, the following additional side effects have been seen with the medicines in Latanoprost+Timolol and therefore might occur when you use this product:
Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/ yellowcardor 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after EXP 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 opening the bottle it is not necessary to store it in a refrigerator but do not store it above 25°C. After opening do not use this bottle for more than 4 weeks. When you are not using Latanoprost+Timolol, keep the bottle in the outer carton, in order to protect from light.
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.
The active substances are latanoprost and timolol maleate. Each ml of solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol.
The other ingredients are:
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate (E339i)
Disodium phosphate anhydrous (E339ii)
Hydrochloric acid solution (E507)
Sodium hydroxide solution (E524)
Water for injections.
See section 2 “Latanoprost+Timolol contains benzalkonium chloride and phosphate buffers” for further information.
Latanoprost+Timolol is a clear, colourless solution contained in a LDPE bottle and dropper applicator, PP screw cap, tamper evident LDPE overcap.
Pack sizes:
1 bottle × 2.5 ml
3 bottles × 2.5 ml
6 bottles × 2.5 ml
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names
UK
Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml eye drops, solution
SWEDEN
Xatabloc 50 mikrogram/ml + 5 mg/ml ögondroppar, lösning
This leaflet was last revised in June 2023
D06019