Patient Leaflet Updated 06-Apr-2021 | Santen UK Limited
COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container
COSOPT® Preservative-Free 20 mg/ml + 5 mg/ml eye drops, solution in single-dose container
(dorzolamide / timolol)
1. What COSOPT Preservative-Free is and what it is used for
2. What you need to know before you use COSOPT Preservative-Free
3. How to use COSOPT Preservative-Free
4. Possible side effects
5. How to store COSOPT Preservative-Free
6. Contents of the pack and other information
COSOPT Preservative-Free contains two medicines: dorzolamide and timolol.
These medicines lower pressure in the eye in different ways.
COSOPT Preservative-Free is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate.
If you are not sure whether you should use this medicine, contact your doctor or pharmacist.
Talk to your doctor before using COSOPT Preservative-Free
Tell your doctor about any medical or eye problems you have now or have had in the past,
Tell your doctor before you have an operation that you are using COSOPT Preservative-Free as timolol may change effects of some medicines used during anaesthesia.
Also tell your doctor about any allergies or anaphylactic reactions.
Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia gravis.
If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately.
If you suspect that COSOPT Preservative-Free is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine and contact your doctor immediately.
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or develop a reaction including new or worsening symptoms.
When COSOPT Preservative-Free is instilled into the eye it may affect the entire body.
COSOPT Preservative-Free has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine.
There is limited experience with COSOPT (preserved formulation) in infants and children.
In studies with COSOPT (preserved formulation), the effects of COSOPT (preserved formulation) were similar in both elderly and younger patients.
Tell your doctor about any liver problems you now have or have suffered from in the past.
COSOPT Preservative-Free 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 using, have recently used or might use any other medicines. This is particularly important if you are;
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
Do not use COSOPT Preservative-Free if you are pregnant unless your doctor considers it necessary.
Use in breast-feeding
Do not use COSOPT Preservative-Free if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.
No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with COSOPT Preservative-Free, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The appropriate dosage and duration of treatment will be established by your doctor.
The recommended dose is one drop in the affected eye(s) in the morning and in the evening.
If you are using COSOPT Preservative-Free with another eye drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of the medicine without consulting your doctor.
If you have difficulty administering your eye drops, seek the assistance of a family member or carer.
Do not allow the single dose container to touch the eye or areas around the eye. It could cause injury to your eye. It may also become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the single dose container, wash your hands before using this medicine and keep the tip of the single dose container away from contact with any surface. A new single dose container should be opened immediately prior to each use; there is enough solution in each container for both eyes if your doctor has told you to use the drops in both eyes
Discard the opened container with any remaining contents immediately after use.
Open the foil sachet which contains the individual single dose containers. Write the date of first opening on the sachet.
Every time you use COSOPT Preservative-Free
1. Wash your hands
2. Take the strip of containers from the sachet
3. Detach one single dose container from the strip .
4. Put the remaining strip back in the pouch and fold the edge to close the pouch.
5. To open the container, twist off the tab. (Picture A)
6. Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger. (Picture B)
7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye (Picture C). Do not blink while applying the drop to your eye. Each single dose container contains enough solution for both eyes.
8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body (Picture D).
9. Wipe off any excess solution from the skin around the eye.
If your doctor has told you to use drops in both eyes, repeat steps 7 to 9 for your other eye.
After putting the drop into the eye(s), throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution.
Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor.
If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.
Santen would like to find out what you think about the dropper and how you were able to put the drops into your eyes. If you would like to provide us with any feedback please use the following free phone line to call and you will be asked some short questions.
Tel: 08450754863
If you put too many drops in your eye or swallow any of the contents of the container, among other effects, you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your doctor immediately.
It is important to take COSOPT Preservative-Free as prescribed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.
Do not take a double dose to make up for the forgotten dose.
If you want to stop using this medicine talk to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you experience any of the following side effects, stop using this medicine and seek immediate medical advice as these could be signs of a reaction to the medicine.
Generalised allergic reactions including swelling beneath the skin can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing, shortness of breath , hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
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 COSOPT Preservative-Free without speaking to your doctor.
The following adverse reactions have been reported with COSOPT Preservative-Free or one of its components either during clinical trials or during post-marketing experience:
Very common (may affect more than 1 in 10 people):
Burning and stinging of the eyes, taste perversion.
Common (may affect up to 1 in 10 people):
Redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realizing of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness to the nose), nausea, weakness/tiredness and fatigue.
Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, shortness of breath, indigestion, and kidney stones.
Rare (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, temporary short sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances, drooping of the eyelids (making the eye stay half closed), 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, changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), cerebral ischaemia (reduced blood supply to the brain), chest pain, forceful heartbeat that may be rapid or irregular (palpitations), heart attack, Raynaud's phenomenon, swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, respiratory failure, rhinitis, nose bleed, constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery coloured appearance (psoriasiform rash), Peyronie’s disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Stevens Johnsons syndrome, toxic epidermal necrolysis).
Like other medicines applied into your eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with 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. Listed additional side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
Not known (frequency cannot be estimated from the available data):
Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucination and foreign body sensation in eye (feeling that there is something in your eye).
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 at: www.mhra.gov.uk/yellowcard or 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 the unopened sachets of COSOPT Preservative-Free after the expiry date shown by the six digits following EX (or EXP) on the foil package. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original foil sachet in order to protect from light.
You can use COSOPT Preservative-Free 15 days after first opening the sachet.
Discard any unused single dose containers after this time.
Discard the opened single dose container with any remaining solution immediately after first use.
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.
COSOPT Preservative-Free is a clear, colourless to nearly colourless slightly viscous solution. Each foil sachet contains 15 or 10 low density polyethylene single dose containers containing 0.2 ml of solution.
Pack sizes:
30 x 0.2 ml (2 sachets with 15 single dose containers or 3 sachets with 10 single-dose containers)
60 x 0.2 ml (4 sachets with 15 single dose containers or 6 sachets with 10 single-dose containers)
120 x 0.2 ml (8 sachets with 15 single dose containers or 12 sachets with 10 single-dose containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder UK:
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names
Cosopt Finland, France, Lithuania, Portugal, Sweden
Cosopt brez konzervansa Slovenia
Cosopt Conserveermiddelvrij Netherlands
Cosopt fără conservant Romania
Cosopt Free Slovakia
Cosopt Free bez konzervačních přísad Czech Republic
Cosopt monodose Italy
Cosopt PF Bulgaria, Latvia, Poland, Spain
Cosopt PF “Χωρίς συντηρητικό” Greece
Cosopt Preservative-free Ireland, United Kingdom
Cosopt-S Germany
Cosopt sine Austria
Cosopt Ukonserveret Denmark
Cosopt Unit Dose Belgium, Luxemburg
Cosopt Uno Hungary
This leaflet was last revised in February 2021.
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT COSOPT PRESERVATIVE-FREE, INCREASED EYE PRESSURE OR GLAUCOMA?
This leaflet gives the most important information about COSOPT Preservative-Free. If you have any questions after you have read it, ask your doctor or pharmacist, who can give you more information
Further information about glaucoma is available from:
Registered Charity number 274681.
Alternatively, if you or someone you know has problems with their vision, and you require further advice or information, please phone the Royal National Institute for the Blind (RNIB) Helpline on 0303 123 9999.
(The IGA and RNIB are independent UK charities and are not associated with Santen Oy.)
ZZ
cosopt-sd-uk-APPR 20210313 [Fareva 099]
Salisbury Hall, St Albans, AL2 1BU, UK
0345 075 4863
+44 (0)1727 615 110
