Patient Leaflet Updated 12-Jan-2021 | Aspire Pharma Ltd
Eylamdo 20mg/ml + 5mg/ml eye drops, solution
Package leaflet: Information for the user
eylamdo 20mg/ml + 5mg/ml Eye Drops, Solution
dorzolamide/timolol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Important information about the administration of this product
Eylamdo Eye Drops are contained within a novel multidose eye drop bottle, which allows for the solution not to contain any preservatives. Due to the design of the container, administration with these eye drops is not the same as standard eye drop bottles.
Please read the full instructions on the correct use of this product in Section 3 of the leaflet (‘‘How to use Eylamdo’’), before using these eye drops.
What is in this leaflet
1. What Eylamdo is and what it is used for
2. What you need to know before you use Eylamdo
3. How to use Eylamdo
4. Possible side effects
5. How to store Eylamdo
6. Contents of the pack and other information
1. What Eylamdo is and what it is used for
Eylamdo contains two medicines: dorzolamide and timolol.
These medicines lower pressure in the eye in different ways.
Eylamdo is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eye drop medicine used alone is not adequate.
Eylamdo eye drops solution is a sterile solution that does not contain a preservative.
2. What you need to know before you use Eylamdo
Do not use Eylamdo
If you are not sure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Eylamdo.
Tell your doctor about any medical or eye problems you have now or have had in the past, such as:
If you have a history of contact hypersensitivity to silver, you should not use this product as dispensed drops may contain traces of silver from the container closure.
Tell your doctor before you have an operation that you are using Eylamdo, as timolol may change effects of some medicines used during anaesthesia.
Also tell your doctor about any allergies or anaphylactic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing.
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 Eylamdo 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 Eylamdo is instilled into the eye, it may affect the entire body.
Eylamdo has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine.
Children and adolescents
There is limited experience with dorzolamide/timolol (preserved formulation) in infants and children.
Use in patients with liver impairment
Tell your doctor about any liver problems you have now or have suffered from in the past.
Other medicines and Eylamdo
Eylamdo 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, particularly:
Pregnancy and breast-feeding
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 using this medicine.
Use in pregnancy
You should not use Eylamdo if you are pregnant unless your doctor considers it necessary.
Use in breast-feeding
You should not use Eylamdo if you are breast-feeding. Timolol may get into your milk.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with Eylamdo, 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.
3. How to use Eylamdo
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The appropriate dose 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 Eylamdo 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 tip of the multi-dose container to touch the eye or areas around the eye. It could cause injury to your eye. The eye drops solution may 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 multi-dose container, keep the tip of the multi-dose container away from contact with any surface.
Instructions for use
Before instillation of the eye drops:
Instillation:
1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.
2. Tilt your head backwards and hold the bottle above your eye.
3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.
If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.
4. Blink a few times so that the drop spreads over the eye.
5. After using Eylamdo, press a finger into the corner of your eye, by the nose, for 2 minutes. This helps to stop Eylamdo getting into the rest of your body.
6. Repeat the instructions 2. – 5. to deliver a drop into the other eye also, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.
7. After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
8. At the end of the 28-day in-use shelf life of the medicine, there will be some Eylamdo left in the bottle. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 28 days after first opening the bottle.
If you use more Eylamdo than you should
If you put too many drops in your eye or swallow 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.
If you forget to use Eylamdo
It is important to use this medicine 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 use a double dose to make up for a forgotten dose.
If you stop using Eylamdo
If you want to stop using this medicine talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually carry on using the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop using Eylamdo without speaking to your doctor.
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 or breathing, hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
The following adverse reactions have been reported with dorzolamide/timolol or one of its components either during clinical trials or during post-marketing experience:
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)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
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)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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/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.
5. How to store Eylamdo
Keep this medicine out of the sight and reach of children.
Store below 30°C.
After first opening, the product may be stored for a maximum of 28 days.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month. Make sure the container is properly closed.
Do not use this medicine if you notice that the seal is broken the first time you use the container.
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 Eylamdo contains
What Eylamdo looks like and contents of the pack
Eylamdo eye drops solution is presented as a 5ml clear, colourless slightly viscous solution, in white opaque 11ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a white HDPE cap.
Pack sizes: 1, 2, 3, 4 or 6 bottles in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
and
or
This leaflet was last revised in 07/2020
1010368-P10.3
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
http://www.aspirepharma.co.uk
+44 (0)1730 231148