Duelym

Package leaflet: Information for the user

Duelym 0,1 mg/g + 1 mg/g ophthalmic gel in single-dose container

bimatoprost/timolol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Duelym is and what it is used for
2. What you need to know before using Duelym
3. How to use Duelym
4. Possible side effects
5. How to store Duelym
6. Contents of the pack and other information

1. What Duelym is and what it is used for

Duelym contains two active substances, bimatoprost and timolol, which reduce intraocular pressure.
Bimatoprost belongs to a class of medicines called prostamides, an analogue of prostaglandins.
Timolol belongs to a class of medicines called beta-blockers.
Duelym ophthalmic gel is used to reduce elevated intraocular pressure in adults. Your doctor prescribes
this medicine when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.
The eye contains a clear, watery fluid that nourishes its interior. This fluid is constantly drained from the eye and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, pressure inside the eye increases.
Elevated intraocular pressure, if not reduced, can lead to a condition called glaucoma and may eventually cause vision damage. Duelym works by reducing the production of fluid and increasing the amount of fluid that is drained. This reduces pressure inside the eye.

2. What you should know before using Duelym

Do not use Duelym

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• if you have or have previously had respiratory disorders such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or long-lasting cough), or other types of breathing problems.
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).

Warnings and precautions
Talk to your doctor or pharmacist before using Duelym.
Before using this medicine, inform your doctor if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disorders, including slow heartbeat
• peripheral arterial circulation disorders (such as Raynaud's disease or Raynaud's syndrome)
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• in diabetes, timolol may mask signs and symptoms of low blood sugar levels
• timol combust may mask signs and symptoms of overactive thyroid gland
• any severe allergic reaction
• liver or kidney problems
• eye surface disorders
• separation of one of the layers of the eyeball after eye surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye leading to worsening vision), for example cataract surgery
• viral infection or inflammation of the eyes.

Inform your doctor before undergoing surgery that you are taking Duelym, as timolol may alter the effects of certain medicines used during anesthesia.
During treatment, Duelym may cause loss of fat around the eye, which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightening of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (inferior scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using Duelym, these changes may resolve. Duelym may also cause darkening and lengthening of eyelashes, and may darken the eyelids. The color of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated.
Duelym may cause growth of hair in areas in contact with the skin surface.

Children and adolescents
Duelym has not been studied in children under 18 years of age and therefore should not be used in patients under 18 years of age.

Other medicines and Duelym
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Duelym may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Inform your doctor if you are using or plan to use:

• medicines to lower blood pressure or to treat heart conditions and certain types of malaria (quinidine), heart medicines,
• medicines to treat diabetes,
• medicines used to treat urinary difficulties, lack of normal intestinal muscle movements, and Alzheimer's disease (parasympathomimetics),
• antidepressants known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Duelym during pregnancy unless your doctor considers it necessary.
Do not use Duelym while breastfeeding. Timolol may be excreted in breast milk.
Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines
When using Duelym, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.

3. How to use Duelym

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one drop once daily, in the evening (preferably) or in the morning, in each eye to be treated, at the same time every day.
If you are using Duelym together with another ophthalmic medicine, the other medicine should be administered at least 15 minutes before Duelym. Duelym should be used last. If you are using another ophthalmic ointment or gel,
consult your doctor.
Contact lens wearers
If you wear contact lenses, you must remove them before using Duelym. After using Duelym, wait 15 minutes before reinserting your contact lenses.
Instructions for use
This medicine is intended for ocular administration.
Follow these instructions to use the eye drops:

1. Wash your hands and sit or lie down comfortably.
2. Open the pouch containing the 10 single-dose containers.
3. Detach the individual container from the strip.

4. Twist the top part of the single-dose container as shown. Do not touch the tip after opening the container.

5. Gently pull down the lower eyelid of the affected eye using a finger.
6. Tilt your head backward and look at the ceiling.
7. Bring the opening of the single-dose container close to the eye, but without touching it.
8. Gently squeeze the single-dose container so that only one drop falls into the eye, then release the lower eyelid.

9. Wipe away any excess liquid running down the cheek. If a drop does not enter the eye, try again.
10. After using Duelym, press a finger into the corner of the eye near the nose (Figure 10) for 2 minutes. This helps prevent timolol from being absorbed into the rest of the body.

11. Repeat the procedure in the other eye if instructed by your doctor. Each single-dose container contains sufficient solution for both eyes.
12. Dispose of the single-dose container after use. Do not store it for reuse. Since sterility cannot be maintained after opening the single-dose container (ophthalmic gel without preservative), if not used immediately, it may become contaminated. A new container must be opened before each use.
13. Store the unused single-dose containers in the pouch. Unopened containers should be used within 1 month after opening the pouch.

If you use more Duelym than you should
Using more Duelym than recommended is unlikely to cause serious harm. Take the next dose at your usual time. If you are concerned, speak with your doctor or pharmacist.
If you forget to use Duelym
If you forget to use Duelym, continue with your usual dose at the scheduled time. Do not use a double dose to make up for a forgotten dose.
If you stop using Duelym
To work properly, Duelym must be used every day. If you stop using Duelym, your intraocular pressure may increase; therefore, talk to your doctor before stopping this treatment.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Generally, you may continue instilling the eye drops unless the side effects are severe. If you are concerned,
consult your doctor or pharmacist. Do not stop using Duelym without first discussing it with your doctor.

The following side effects have been reported with Duelym:

Very common side effects
These may affect more than 1 in 10 people
Eye-related

• Redness

Common side effects
These may affect 1 in 10 people
Eye-related

• Dry eye
• Eye irritation
• Foreign body sensation in the eye
• Itching of the eyes

Uncommon side effects
These may affect 1 in 100 people
Eye-related

• Small interruptions of the eye surface, with or without inflammation
• Darkening of the eyelids
• Inflammation of the eyelids
• Cysts in the eyelid
• Redness and itching of the eyelids
• Increased tear production
• Eye pain
• Crusty eyelids
• Eyelash elongation
• Redness and discomfort in the eyes
• Impaired vision
• Eyelid discomfort
• Numbness, tingling, pins and needles sensation in the eye
• Swelling of the eyes
• Difficulty seeing clearly

Skin-related

• Itching

General body-related

• Hot flushes
• Cold hands and feet
• Dizziness
• Headache
• Sensations of numbness, tingling, pins and needles
• Facial pain

Other side effects
Additional side effects have been observed in patients using eye drops containing timolol or bimatoprost and may therefore also occur with Duelym. As with other medicines applied to the eye, Duelym (bimatoprost and timolol) is absorbed into the bloodstream. This may cause side effects similar to those seen with beta-blocking agents administered intravenously and/or orally.
The incidence of side effects after topical ophthalmic administration is lower than when medicines are taken orally or injected.
The listed side effects include reactions observed with bimatoprost, timololo, and the class of beta-blockers used to treat eye disorders:

• Generalized allergic reactions, including subcutaneous swelling, hives, localized and generalized skin rash, itching, severe and sudden allergic reactions that may be life-threatening
• Low blood glucose levels
• Sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations
• Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder)
• Corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightness of the skin around the eye (dermatochalasis), and exposure of the lower white part of the eye (inferior scleral show), increased iris pigmentation (darker eye colour), eyelash loss, light sensitivity, darker eyelashes, eyelid swelling, itching, red and dry skin on the eyelids
• Slowed heart rate, chest pain, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), cardiac arrhythmia, heart attack, heart failure
• Low blood pressure, Raynaud's phenomenon (severe narrowing of blood vessels due to cold)
• Airway constriction (mainly in patients with pre-existing conditions), breathing difficulties, cough
• Hair loss, skin rashes with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting
• Muscle pain not caused by physical exercise
• Sexual dysfunction, decreased libido
• Muscle weakness / fatigue

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duelym

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, sachet, and single-dose container after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
After first opening of the sachet: use the single-dose containers within 1 month.
To help you remember, write the date of first opening on the sachet.
Keep unused single-dose containers in the opened sachet to protect them from light.
After first opening of the single-dose container: use the single-dose container immediately and discard it after use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Duelym contains
The active substances are bimatoprost and timolol. Each gram of ophthalmic gel contains 0.1 milligrams of
bimatoprost and 1.37 milligrams of timolol maleate, equivalent to 1 milligram of timolol.
The other components are sorbitol, carbomer, lysine monohydrate, macrogol, sodium acetate trihydrate, water for
injections.

Description of the appearance of Duelym and the contents of the package
Duelym is an opalescent, colourless ophthalmic gel in single-dose containers. It is supplied in single-dose
containers packed in sachets of 10 units.
Each single-dose container contains 0.3 g of product.
A package contains 10, 30 (3 x 10) or 90 (9 x 10) single-dose containers.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Laboratoires THEA
Zone Industrielle du Brézet
12 rue Louis Blériot
63100 Clermont-Ferrand
France

Manufacturer
LABORATOIRE UNITHER
1 rue de l’Arquerie
50200 Coutances
France
Or
Laboratoires THEA
Zone Industrielle du Brézet
12 rue Louis Blériot
63100 Clermont-Ferrand
France

This medicinal product is authorized in the European Economic Area Member States under the following
names:
This leaflet was last approved on:
More detailed information on this medicinal product is available on the website of the European Medicines Agency
https://www.aifa.gov.it/