Package leaflet: Information for the user. LUXFEN, <[2 mg/ml eye drops, solution]> Active substance: brimonidine tartrate

Transcription

1 Package leaflet: Information for the user LUXFEN, <[2 mg/ml eye drops, solution]> Active substance: brimonidine tartrate 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 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. What is in this leaflet 1. What LUXFEN, <[2 mg/ml eye drops, solution]> is and what it is used for 2. What you need to know before you use LUXFEN, <[2 mg/ml eye drops, solution]> 3. How to use LUXFEN, <[2 mg/ml eye drops, solution]> 4. Possible side effects 5. How to store LUXFEN, <[2 mg/ml eye drops, solution]> 6. Contents of the pack and other information 1. What LUXFEN, <[2 mg/ml eye drops, solution]> is and what it is used for LUXFEN, <[2 mg/ml eye drops, solution]> is a medicine for reducing intra-ocular pressure (pressure within the eye) in patients with open-angle glaucoma or ocular hypertension (high fluid pressure in the eye). Brimonidine tartrate 2 mg/ml eye drops solution may be used alone or in combination with other medicines to reduce intra-ocular pressure. 2. What you need to know before you use LUXFEN, <[2 mg/ml eye drops, solution]> Do not use LUXFEN, <[2 mg/ml eye drops, solution]>: - If you are allergic (hypersensitive) to brimonidine tartrate or to any of the ingredients of LUXFEN, <[2 mg/ml eye drops, solution]>, - If you are being treated with a medicine classified as a monoamine oxidase inhibitor (MAO inhibitor), - If you are being treated with certain antidepressant medicines (such as tricyclic antidepressants or mianserin). - You must inform your doctor if you are taking any antidepressant medicines. - In the case of newborn babies and infants (from birth until 2 years). Warnings and precautions - If you suffer from severe or unstable and untreated heart disease, - If you suffer from depression, - If you suffer from a disorder of reduced blood supply to the brain (cerebral insufficiency) or to the heart (heart failure), - If you suffer from a fall in blood pressure which causes vertigo and dizziness when you sit up or stand up after lying down (orthostatic hypotension),

2 - If you suffer from a constriction of the blood vessels, principally of the hands and arms (Raynaud s disease), or a chronic inflammatory vascular disease with an obstruction of the blood vessels as a result of clotting (thrombangitis obliterans), - If you have liver or kidney problems. Consult your doctor if any of these circumstances apply to you! Brimonidine is not recommended for use in children (from 2 12 years). Other medicines and LUXFEN, <[2 mg/ml eye drops, solution]> Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Substances that affect the central nervous system (CNS): the effect of substances that affect the central nervous system (alcohol, barbiturates, opiates, sedatives or anaesthetics) may be increased by LUXFEN, <[2 mg/ml eye drops, solution]>. Medicines that treat disorder of the nervous system (chlorpromazine, methylphenidate), antihypertensive medication (reserpine): caution is recommended in the case of patients treated with medicines that can affect the absorption and metabolism of adrenaline, noradrenaline and other so-called biogenic amines in the blood. Antihypertensive agents, heart drugs: a slight fall in blood pressure is detected in some patients after administration of LUXFEN, <[2 mg/ml eye drops, solution]>. Caution should be exercised if LUXFEN, <[2 mg/ml eye drops, solution]> is used at the same time as antihypertensive agents and/or heart drugs from the group of digitalis glycosides. Adrenoreceptor agonists or antagonists: Caution should be exercised when a systemically administered medicine is first given at the same time, or there is a change in the dose (regardless of the method of administration) which may cause interactions with α-adrenoreceptor agonists or can affect their action, such as adrenoreceptor agonists or antagonists (isoprenaline or prazosin) for example. Pregnancy and breast-feeding Studies have not yet been conducted to determine whether it is safe to use brimonidine eye drops, solution during pregnancy. LUXFEN, <[2 mg/ml eye drops, solution]> should therefore be used with caution during pregnancy, and only if the expected benefit to the mother outweighs the possible risk to the foetus. It is not known whether brimonidine passes into human breast milk. LUXFEN, <[2 mg/ml eye drops, solution]> should therefore not be used in breast-feeding mothers. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines LUXFEN, <[2 mg/ml eye drops, solution]> can cause tiredness and / or drowsiness. This can affect the ability to drive or use machines safely. LUXFEN, <[2 mg/ml eye drops, solution]> can cause blurred vision and / or abnormal vision. This can affect your ability to drive or use machines safely, particularly in the dark and under poor lighting conditions. You should wait until these symptoms have cleared before driving or using machinery. LUXFEN, <[2 mg/ml eye drops, solution]> contains benzalkonium chloride. This may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses. 3. How to use LUXFEN, <[2 mg/ml eye drops, solution]>

3 Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is very important to use LUXFEN, <[2 mg/ml eye drops, solution]> for the period of time prescribed by your doctor. If you have the impression that the effect of LUXFEN, <[2 mg/ml eye drops, solution]> is too strong or too weak, talk to your doctor. Unless your doctor has instructed otherwise, the usual dose is one drop in the affected eye/eyes twice daily approximately 12 hours apart. Instructions for use Brimonidine is for use as eye drops only. Do not swallow. Always wash your hands before applying eye drops. Apply your eye drops in the following way: 1. Tilt your head back and look at the ceiling. 2. Gently pull the lower eyelid down until there is a small pocket. 3. Squeeze the upturned dropper bottle to release a drop into your eye. Immediately after applying each drop, you should close your eye and press your fingertip against the inside corner of the closed eye (near the nose) for 1 minute. This helps to reduce the absorption of Brimonidine into your body. If you are using more than one eye medicine, the products should be applied at an interval of at least 5 15 minutes. Use in children Brimonidine eye drops must not be used in new-born babies and infants (from birth until 2 years). Brimonidine is not recommended for use in children (from 2 12 years). If you use more LUXFEN, <[2 mg/ml eye drops, solution]> than you should There is no experience in adults of an overdosage with brimonidine eye drops, which is unlikely when given as eye drops. A few cases of overdose have been reported in newborn children. Symptoms include sleepiness, floppiness, low body temperature and breathing difficulties. If any of these occur, contact your doctor immediately. In the case of an adult who had unintentionally taken an oral dose of about 10 drops of brimonidine eye drops moderate hypotension was observed several hours after taking. This was followed by a steep increase in blood pressure about 8 hours after taking. If you suspect an overdose contact your doctor or a duty doctor. Bring the packaging of the medicine with you so that the doctor can be aware of the active substance that has been taken. If you forget to use LUXFEN, <[2 mg/ml eye drops, solution]> If you forget to apply LUXFEN, <[2 mg/ml eye drops, solution]>, apply the forgotten dose instead as soon as you realise this. If however you do not remember the forgotten dose until shortly before the time for the next dose, omit the forgotten dose and continue with the next application at the usual time. Do not use more drops to make up for a forgotten dose. If you are in any doubt, ask your doctor or pharmacist. Do not change the prescribed dose yourself. If you stop using LUXFEN, <[2 mg/ml eye drops, solution]> Do not interrupt or stop treatment with LUXFEN, <[2 mg/ml eye drops, solution]> without having talked to your doctor! 4. Possible side effects

4 Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. The most commonly occurring side effects (in 22 to 25% of patients) are dry mouth, red eyes and burning and itchy eyes. These side effects are usually temporary and rarely serious enough to require treatment with LUXFEN, <[2 mg/ml eye drops, solution]> to be stopped. Allergic reactions in the eyes occurred in 12.7% of patients during clinical trials. These occurred in most cases after three to nine months. In the event of allergic reactions, treatment with LUXFEN, <[2 mg/ml eye drops, solution]> should be stopped. An analysis of the side effects was based on the following incidence rate: Very common: affects more than 1 user in 10 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Rare: affects 1 to 10 users in 10,000 Very rare: affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data During treatment with LUXFEN, <[2 mg/ml eye drops, solution]> the following side effects were observed Topical side effects: Very common: - Eye irritation (eye redness, burning, stinging, a feeling of something in the eye, itching, follicles or white spots on the see-through layer which covers the surface of the eye), - Blurred vision, - An allergic reaction in the eye. Common: Topical irritation (red and swollen eyelids, inflamed eyelids, conjunctival oedema and discharge, eye pain and runny eyes), hypersensitivity to light, superficial damage or colouration of the cornea, dry eyes, conjunctival blisters, abnormal vision, conjunctivitis. Very rare: Iritis, contraction of the pupils. Unknown frequency: - Itching of eyelids, iridocyclitis (inflammation of the iris and inner muscles behind iris). Systemic side effects: Very common: Headache, dry mouth, tiredness/drowsiness. Common: Symptoms in the upper airways, vertigo, gastro-intestinal pain, weakness, altered taste. Uncommon: Pounding heart beat / irregular heart rate (including slow or fast heart rate), general allergic reactions, depression, dry nose. Rare: Dyspnoea.

5 Very rare: Fainting, hypertension, hypotension, sleeplessness. Unknown frequency: - - Skin reactions including redness, face swelling, itching, rash and widening of blood vessels. 5. How to store LUXFEN, <[2 mg/ml eye drops, solution]> Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the bottle. The expiry date refers to the last day of that month. Once opened, LUXFEN, <[2 mg/ml eye drops, solution]> may be stored for a maximum of 28 days. 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 LUXFEN, <[2 mg/ml eye drops, solution]> contains - The active substance is brimonidine tartrate. 1 ml solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. - The other ingredients are: benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, and sodium hydroxide and hydrochloric acid for ph adjustment. What LUXFEN, <[2 mg/ml eye drops, solution]> looks like and contents of the pack LUXFEN, <[2 mg/ml eye drops, solution]> is a clear, slightly greenish-yellow solution. The eye drops solution is available in 5 ml or 10 ml bottle with a dropper tip in packs of 1, 3 or 6. Not all pack sizes may be marketed. Marketing Authorisation Holder [To be completed nationally] Manufacturer Pharma Stulln GmbH Werksstraße Stulln Germany or SANITAS, AB Veiverių str. 134B, LT Kaunas Lithuania This medicinal product is authorised in the Member States of the EEA under the following names: Denmark: Bulgaria: Czech Republic: Hungary: LUXFEN, 2mg/ml Øjendråber, opløsning LUXFEN, 2mg/ml Капки за очи, разтвор LUXFEN, 2mg/ml Oční kapky, roztok LUXFEN, 2mg/ml Oldatos szemcsepp

6 Latvia: Lithuania: Poland: Slovak Republic: LUXFEN, 2mg/ml Acu pilieni, šķīdums LUXFEN 2mg/ml akių lašai, tirpalas LUXFEN LUXFEN, 2mg/ml Očná roztoková instilácia This leaflet was last revised in {MM/YYYY}