Dorzolamide/Timolol 20Mg/Ml + 5Mg/Ml Eye Drops, Solution

Package leaflet: Information for the user Dorzolamide/Timolol 20mg/ml + 5mg/ml Eye Drops, Solution

Read all of this leaflet carefully before Before surgery and anaesthesia (even at the you start using this medicine because it dentist), tell your doctor or dentist that you are contains important information for you. using Dorzolamide/Timolol eye drops, as this medicine may change effects of some medicines - Keep this leaflet. You may need to read it used during anaesthesia and there may be a again. sudden fall in blood pressure associated with the - If you have any further questions, ask your anaesthetic. doctor or pharmacist. - This medicine has been prescribed for you Children and adolescents only. Do not pass it on to others. It may harm There is limited experience with Dorzolamide/ them, even if their signs of illness are the Timolol eye drops in infants and children. same as yours. Use in elderly - If you get any side effects, talk to your doctor In studies with Dorzolamide/Timolol eye or pharmacist. This includes any possible side drops, the effects of Dorzolamide/Timolol eye effects not listed in this leaflet. See section 4. drops were similar in both elderly and younger - The full name of this medicine is patients. Dorzolamide/Timolol 20mg/ml + 5mg/ml Other medicines and Dorzolamide/ Eye Drops, Solution but within the leaflet it Timolol eye drops will be referred to as Dorzolamide/Timolol Dorzolamide/Timolol eye drops can affect or eye drops. be affected by other medicines you are using, including other eye drops for the treatment of What is in this leaflet: glaucoma. 1 What Dorzolamide/Timolol eye Tell your doctor or pharmacist if you are taking, drops are and what they are used for have recently taken or might take any other medicines. This is particularly important if any of 2 What you need to know before you the following apply to you: use Dorzolamide/Timolol eye drops • You are taking antihypertensive medicines 3 which are used to lower high blood pressure How to use Dorzolamide/Timolol eye or medicines to treat heart disease such as drops calcium channel blockers and ß-blockers or 4 Possible side effects digoxin 5 • You are taking medicines to treat a disturbed or How to store Dorzolamide/Timolol uneven heartbeat such as quinidine or digoxin eye drops • You are using another eyedrop that contains a 6 Contents of the pack and other ß-blocker • You are taking another carbonic anhydrase information inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye 1 drops, or by some other method What Dorzolamide/Timolol eye • You are taking quinidine (used to treat heart drops are and what they are used for conditions and some types of malaria) Dorzolamide/Timolol eye drops are a • You are taking monoamine oxidase inhibitors combination of two medicines: dorzolamide and (MAOIs) or selective serotonin reuptake timolol. inhibitors (SSRIs) (such as fluoxetine and • Dorzolamide belongs to a group of medicines paroxetine) both of which are used to treat called “carbonic anhydrase inhibitors”. depression or another illness • Timolol belongs to a group of medicines called • You are taking a parasympathomimetic “beta blockers.” medicine which may have been prescribed to help you pass urine. Parasympathomimetics Dorzolamide/Timolol eye drops are prescribed are also a particular type of medicine which to lower raised pressure within the eye in the are sometimes used to help restore normal treatment of glaucoma when beta-blocker eye movements through the bowel drops used alone are not adequate. • You are taking narcotics such as morphine used to treat moderate to severe pain or if you are taking large doses of aspirin. Although there is 2 What you need to know before you no evidence that dorzolamide hydrochloride use Dorzolamide/Timolol eye drops interacts with aspirin, some other medicines which are related to dorzolamide hydrochloride Do not use Dorzolamide/Timolol eye and which are taken by mouth, have been drops if you: known to interact with aspirin • are allergic to dorzolamide or timolol, beta • You are taking medicines to treat diabetes or blockers or any of the other ingredients of this high blood sugar medicine (listed in section 6) • You are taking epinephrine (adrenaline). • have now or have had in the past respiratory Pregnancy and breast-feeding problems such as asthma, severe chronic If you are pregnant or breast-feeding, think you obstructive lung disease (severe lung disease may be pregnant or are planning to have a baby, which may cause wheeziness, difficulty in ask your doctor or pharmacist for advice before breathing and/or long-standing cough) using this medicine. • have severe kidney problems, or a prior Do not use Dorzolamide/Timolol eye drops if history of kidney stones you are pregnant unless your doctor considers it • have a disturbance in the pH (acid/alkali necessary. balance) of your blood Do not use Dorzolamide/Timolol eye drops if you • have certain heart problems, including are breast-feeding. Timolol may get into your certain heart rhythm disturbances producing milk. an abnormally slow heart rate or severe heart failure. Driving and using machines Dorzolamide/Timolol eye drops may cause side If you think any of these apply to you, do not use effects such as blurred vision in some patients. Dorzolamide/Timolol eye drops until you have Do not drive or use any tools or machines until consulted your doctor. the symptoms have cleared. Warnings and precautions Talk to your doctor or pharmacist before using Dorzolamide/Timolol eye drops contain Dorzolamide/Timolol eye drops. benzalkonium chloride Before you use this medicine, tell your doctor if Benzalkonium chloride may be absorbed by soft you have now or have had in the past: contact lenses and may change the colour of the • coronary heart disease (symptoms can include contact lenses. You should remove contact lenses chest pain or tightness, breathlessness or before using this medicine and put them back 15 choking), Prinzmental’s angina (chest pain minutes afterwards. while resting), heart failure, low blood pressure. Benzalkonium chloride may also cause eye • disturbances of heart rate such as slow heart irritation, especially if you have dry eyes or beat. disorders of the cornea (the clear layer at the • breathing problems, asthma or chronic front of the eye). If you feel abnormal eye obstructive pulmonary disease. sensation, stinging or pain in the eye after using • poor blood circulation disease (such as this medicine, talk to your doctor. Raynaud’s disease or Raynaud’s syndrome). • diabetes as Dorzolamide/Timolol eye drops may mask signs and symptoms of low blood 3 How to use Dorzolamide/Timolol eye sugar. drops • overactivity of the thyroid gland as Dorzolamide/Timolol eye drops may mask Always use this medicine exactly as your signs and symptoms. doctor has told you. Check with your doctor or • liver problems, if you have muscle weakness pharmacist if you are not sure. or have been diagnosed as having myasthenia gravis. The appropriate dosage and duration of • any allergies to a medicine you have taken. treatment will be established by your doctor. If you develop conjunctivitis (redness and The recommended dose is one drop in the irritation of the eyes), swelling of the eye or affected eye(s) two times a day, for example in eyelids, skin rash or itching in and around the the morning and in the evening. eye contact your doctor immediately. Such symptoms may be due to an allergic reaction or If you use Dorzolamide/Timolol eye drops with may be a side effect of Dorzolamide/Timolol eye another eye drop, leave at least 10 minutes drops (See section 4). between putting in Dorzolamide/Timolol eye drops and the other medicine. Tell your doctor if you develop an eye infection, Do not change the dosage of the drug without receive an eye injury, have eye surgery, develop consulting your doctor. If you must stop other reactions or worsening of symptoms. treatment, contact your doctor immediately. If you wear soft contact lenses, it is important Do not allow the tip of the container to touch that your lenses are removed before using your eye or areas around your eye. It may your eye drops and not put back into your eyes become contaminated with bacteria that can until 15 minutes after using your eye drops as cause eye infections leading to serious damage the preservative benzalkonium chloride may of the eye, even loss of vision. To avoid possible possibly discolour the contact lenses. contamination of the container, keep the tip of the container away from contact with any continued top of next column surface. BBBA7158 continued over page

Dorzolamide / Timolol 2% / 0.5% Eye drops 1x5ml PIL - UK

approved for print/date Item number: BBBA7158 Colours Non Printing Colours 1. Black 1. Originator: G. Worth Dimensions: 148x420 Origination Date: 23/12/2019 Min Body Text Size: 8pt 2. 2. Revision Date: 10/01/2019 Supplier: IL/Pharmathen 3. 3. Revised By: G. Worth 4. 5. Proof Round 23/12/2019 Technical Date sent: 6. 5 Approval Date received: 23/12/2019 [email protected]

Cartons and label leaflets only (labels only when specified) GTIN 13 (Belgium & Slovenia): German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 6 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.12.2019 In order to secure correct dosage - the dropper Rare (may affect up to 1 in 1,000 people): tip should not be enlarged. Systemic lupus erythematosus (an immune disease which may cause an inflammation of Instructions for use: internal organs), tingling or numbness of the It is recommended that you wash your hands hands or feet, trouble sleeping, nightmares, before putting in your eye drops. memory loss, weakening of the muscles, It may be easier to apply your eye drops in front decreased sex drive, stroke, temporary short of a mirror. sightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment following filtration surgery), drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in your ear, low blood pressure, irregular heartbeat, chest pain, palpitations (a quicker and/or irregular heartbeat), oedema (fluid build up), heart attack, congestive heart failure (heart disease with shortness of breath and swelling of the feet and 1. Before using the medication for the first time, legs due to fluid build up), reduced blood flow to be sure that the tamper-proof seal on the the brain, swelling or coldness of your hands and bottle neck is unbroken. A gap between the feet and reduced circulation in your arms and bottle and the cap is normal for an unopened legs, leg cramps and/or leg pain when walking bottle. (claudication), shortness of breath, feeling out 2. Take off the cap of the bottle. of breath, runny or stuffed nose, nose bleed, 3. Tilt your head back and gently pull your lower difficulty in breathing, cough, throat irritation, eyelid down to form a small pocket between dry mouth, diarrhoea, contact dermatitis, your eyelid and your eye (see picture 1). hair loss, psoriasis or worsening of psoriasis, 4. Invert the bottle, and squeeze it until a single Peyronie’s disease (which may cause a curvature drop is dispensed into the eye as directed by of the penis), weakness/tiredness, allergic type your doctor. Do not touch your eye or eyelid reactions such as rash, hives, itching, in rare cases with the dropper tip (see picture 1). possible swelling of the lips, eyes and mouth, 5. After using Dorzolamide/Timolol eye drops, wheezing, cerebral ischaemia (not enough blood press a finger into the corner of your eye, by flow to the brain). the nose for 2 minutes (see picture 2). This helps to stop timolol getting into the rest of Not known (frequency cannot be estimated the body. from the available data): 6. Repeat steps 3 to 5 with the other eye if Low blood glucose levels, heart failure, a type instructed to do so by your doctor. of heart rhythm disorder, stomach pain and 7. Put the cap back on and close the bottle vomiting, muscle pain not caused by exercise, straight after you have used it. sexual dysfunction and decreased libido. Shortness of breath, foreign body sensation in If you use more Dorzolamide/Timolol eye the eye (feeling that there is something in your drops than you should eye), dysgeusia (distortion of the sense of taste), It is important to keep to the dose your doctor hallucination, forceful heartbeat that may be has prescribed. If you put too many drops in rapid or irregular (palpitations). your eye or swallow any of the contents of the If any of the side effects gets serious, or if you bottle, you may feel unwell, for example you may notice any side effects not listed in this leaflet, become light-headed, have difficulty breathing, please tell your doctor or pharmacist, particularly or feel that your heart rate has slowed. If you feel if you experience any changes/visual disturbance any of the above effects you should seek medical when using Dorzolamide/Timolol eye drops after attention immediately. eye surgery. If you forget to use Dorzolamide/Timolol Reporting of side effects eye drops If you get any side effects, talk to your doctor, It is important to use Dorzolamide/Timolol eye pharmacist or nurse. This includes any possible drops as prescribed by your doctor. side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card If you miss a dose, apply it as soon as possible. Scheme at: www.mhra.gov.uk/yellowcard or However, if it is almost time for the next dose, search for MHRA Yellow Card in the Google Play skip the missed dose and go back to your regular or Apple App Store. dosing schedule. By reporting side effects you can help provide Do not use a double dose to make up for a more information on the safety of this medicine. forgotten dose. If you stop using Dorzolamide/Timolol 5 How to store Dorzolamide/Timolol eye drops If you want to stop using this medicine talk to eye drops your doctor first. Keep this medicine out of the sight and reach of If you have any further questions on the use of children. this medicine, ask your doctor or pharmacist. Do not use this medicine after the expiry date which is stated on the bottle label and the carton 4 after EXP. The expiry date refers to the last day of Possible side effects that month. Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicinal product does not require any special temperature storage conditions. You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk Dorzolamide/Timolol eye drops should be used to a doctor or pharmacist. Do not stop using within 28 days after the bottle is first opened. Dorzolamide/Timolol without speaking to your Therefore, you must throw away the bottle 4 doctor. weeks after you first opened it, even if some solution is left. To help you remember, write If you experience any of the following serious down the date that you opened it in the space on side effects, stop using this medicine and tell the carton. your doctor immediately or go to the nearest hospital accident and emergency department: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to • Generalised allergic reactions including throw away medicines you no longer use. These swelling beneath the skin that can occur in measures will help protect the environment. areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, 6 Contents of the pack and other localised and generalised rash, itchiness, severe information sudden life-threatening allergic reaction. • Serious illness with severe peeling and swelling What Dorzolamide/Timolol eye drops of the skin, blistering of the skin, mouth, eyes, contain genitals and fever. Skin rash with pink-red • The active substances are Dorzolamide and blotches especially on palms of hands or soles Timolol. Each ml contains 20mg dorzolamide of feet which may blister. (as 22.26mg of dorzolamide hydrochloride) and 5mg timolol (as 6.83mg of timolol maleate). Like other medicines applied into eyes, • The other ingredients are Mannitol (E421), Dorzolamide/Timolol eye drops are absorbed Hydroxy Ethyl Cellulose, Benzalkonium into the blood. This may cause similar side Chloride (as a preservative), Sodium Citrate effects as seen with ‘intraveneous’ and/or ‘oral’ (E331), Sodium Hydroxide (E524) for pH beta-blocking agents. Incidence of side effects adjustment and Water for injection. after topical ophthalmic administration is lower than when medicines are, for example, taken by What Dorzolamide/Timolol eye drops mouth or injected. look like and contents of the pack The following side effects may be seen with Your medicine is in the form of a sterile, clear, Dorzolamide/Timolol eye drops or one of its slightly viscous, colourless aqueous eye drop components: solution. Very common (may affect more than 1 in 10 Dorzolamide/Timolol eye drops are presented in people): a white opaque medium density polyethylene Burning and stinging of the eyes, unusual taste bottle with a sealed low density polyethylene dropper tip and a high density polyethylene cap Common (may affect up to 1 in 10 people): with tamper proof seal, containing 5ml of the Redness in and around the eye(s), watering or ophthalmic solution. itching of the eye(s), and effects on the surface of the eye(s), swelling and/or irritation in and Pack size: 1 bottle of 5ml around the eye(s), feeling of having something Marketing Authorisation Holder in the eye (corneal erosion), decreased corneal Accord, Barnstaple, EX32 8NS, UK sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, Manufacturer blurred vision, headache, sinusitis (feeling of Famar S.A., Plant A tension or fullness in the nose), feeling sick, also 63 Agiou Dimitriou Street called nausea, and fatigue. 174 56 Alimos Greece Uncommon (may affect up to 1 in 100 people): Dizziness, depression, inflammation of the iris, This leaflet was last revised in January 2020. blurred vision (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye), slow heartbeat, fainting, laboured breathing, indigestion, and kidney stones (often marked by a sudden onset of excruciating, cramping pain in their low back and/or side, groin, or abdomen). continued top of next column BBBA7158

Dorzolamide / Timolol 2% / 0.5% Eye drops 1x5ml PIL - UK