Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml eye drops, solution

• 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 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, please tell your doctor or pharmacist. See section 4.

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

• if you are allergic (hypersensitive) to latanoprost or timolol, beta-blockers, or any of the other ingredients of Latanoprost+Timolol (listed in section 6
• if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/ or long-standing cough)
• if you have serious heart problems or heart rhythm disorders

Talk to your doctor or pharmacist before using Latanoprost+Timolol if you have now or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure (hypotension)
• disturbances of heart rate such as slow heart beat (bradycardia)
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar
• overactivity of the thyroid gland as timolol may mask signs and symptoms
• you are about to have any kind of eye surgery (including cataract surgery) or have had any kind of eye surgery in the past
• you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• you know that you suffer from dry eyes
• you wear contact lenses. You can still use Latanoprost+Timolol but follow the instructions for contact lens wearers in Section 3
• you know that you suffer from angina (particularly a type known as Prinzmetal angina)
• you know that you suffer from severe allergic reactions that would usually require hospital treatment
• you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).

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:

• Prostaglandins, prostaglandin analogues or prostaglandin derivates
• Beta-blockers
• Epinephrine
• Drugs used to treat high blood pressure such as calcium channel blockers, guanethidine
• Antiarrhythmics (medications that normalise the heart rhythm)
• Digitalis glycosides (used to treat heart failure)
• Parasympathomimetic agents (e.g. for the treatment of high blood pressure)
• Quinidine (used to treat heart conditions and some types of malaria)
• Antidepressants known as fluoxetine and paroxetine.

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.

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 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:

• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
• 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, (angioedema) hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction (anaphylactic reaction).
• Low blood glucose levels (hypoglycaemia).
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache.
• Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
• Darkening of the skin around the eyes, 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/uveitis), scarring of the surface of the eye.
• Whistling/ringing in the ears (tinnitus).
• Angina, worsening of angina in patients who already have heart disease.
• Slow heart rate, chest pain, palpitations (awareness of heart rhythm), oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm disorder, heart attack, heart failure
• Low blood pressure, poor blood circulation which makes the fingers and toes numb and pale, cold hands and feet (Raynaud’s phenomenon).
• Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, shortness of breath, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness
• Sexual dysfunction, decreased libido.

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.

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