Taflodim

Patient Information Leaflet

Taflodim 15 micrograms/ml + 5 mg/ml

Eye drops, solution in single-dose container
Tafluprost/Timolol
Generic medicine
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Taflodim is and what it is used for

What type of medicine is this and how does it work?
Taflodim eye drops contains tafluprost and timolol. Tafluprost belongs to a group of medicines
called prostaglandin analogues and timolol belongs to a group of medicines called beta-
blockers. Tafluprost and timolol work together to reduce the pressure inside the eye.
Taflodim is used when the pressure inside the eye is too high.
What is this medicine used for?
Taflodim is used to treat a type of glaucoma called open-angle glaucoma, as well as a condition known as ocular hypertension in adults. Both of these conditions are associated with increased pressure inside the eye and, over time, may impair vision.

2. What you need to know before using Taflodim

Do not use Taflodim

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Taflodim.
Tell your doctor before using this medicine if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure
• heart rate disorders such as a slow heartbeat
• respiratory problems, asthma, or chronic obstructive lung disease
• a disease characterized by poor blood circulation (e.g., Raynaud’s disease or Raynaud’s syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels
• overactive thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• any type of allergies or anaphylactic reactions
• myasthenia gravis (a rare condition causing muscle weakness)
• other eye diseases; for example, corneal disease (the transparent tissue covering the front part of the eye) or a condition requiring eye surgery.

Tell your doctor if you have

• kidney problems
• liver problems.

Please note that Taflodim may cause the following effects, some of which may be permanent.
Taflodim may:

• increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual growth of fine hair on the eyelids.
• cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will help reduce the risk of skin darkening.
• change the colour of the iris (the coloured part of the eye). If Taflodim is applied to only one eye, the treated eye may become permanently a different colour compared to the other eye.
• cause growth of hair in areas where the solution repeatedly comes into contact with the skin surface.

Before undergoing surgery, inform your doctor that you are using Taflodim, as
timolol may alter the effect of certain medicines used during anaesthesia.
Children and adolescents
The use of Taflodim is not recommended in children and adolescents under 18 years of age due to
lack of safety and efficacy data in this age group.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may
lead to a positive anti-doping test.
Other medicines and Taflodim
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Taflodim may alter the effect of other medicines, or its effect may be altered
by the use of other medicines.
In particular, inform your doctor if you are using or plan to use:

• other eye drops for the treatment of glaucoma
• medicines to reduce blood pressure
• medicines for the heart
• medicines to treat diabetes
• quinidine (used to treat heart conditions and certain types of malaria)
• antidepressants known as fluoxetine and paroxetine.

If you are using other eye medications, wait at least 5 minutes between the administration of
Taflodim and the application of the other medicine.
Contact lenses
Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting them.
Pregnancy, breast-feeding and fertility
If you are of childbearing age, you must use effective contraception during treatment with Taflodim. Do
not use Taflodim if you are pregnant. Do not use Taflodim if you are breast-feeding. Ask your doctor for advice.
Driving and using machines
The use of Taflodim may be associated with adverse effects such as blurred vision, which may
affect your ability to drive or operate machinery. Wait until you feel well and your vision is clear before driving or operating machinery.
Taflodim contains phosphate buffer
This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.3 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
very rarely cause cloudy corneal spots due to calcium deposits during treatment.

3. How to use Taflodim

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of Taflodim in the eye or eyes, once daily. Do not
apply more drops or use the medicine more frequently than prescribed by your
doctor. Doing so may reduce the effectiveness of Taflodim.
Use Taflodim in both eyes only if specifically instructed by your doctor. Immediately discard any opened containers and any unused solution after use.
For ophthalmic use only. Do not swallow.
Avoid letting the tip of the single-dose container come into contact with the eye or surrounding areas. This could cause eye injury, and the single-dose container may become contaminated with bacteria that can lead to serious eye infections, potentially resulting in vision loss. To avoid contamination of the single-dose container, ensure the tip does not touch any surface.

Instructions for use:
When opening a new pouch:
Do not use the single-dose container if the pouch is damaged. Open the pouch along the dotted line.
Record the date of opening in the designated space on the pouch.

Each time you use Taflodim:

1. Wash your hands.
2. Remove the strip of containers from the pouch.
3. Detach one single-dose container from the strip (Figure 1).
4. Return the remaining strip to the pouch and fold the edge of the pouch to close it.
5. To open the container, remove the tab by rotating it (Figure 2).
6. Hold the container between your thumb and index finger. Ensure the tip of the container does not extend more than 5 mm beyond the index finger (Figure 3).
7. Tilt your head backward or lie down. Rest your hand on your forehead. The index finger should be aligned with the eyebrow or rest on the bridge of the nose. Look upward. With the other hand, pull the lower eyelid downward. Be careful to avoid any part of the container touching the eye or the area around it. Gently squeeze the container to release one drop into the space between the eyelid and the eye (Figure 3).
8. Close the eye and press gently with a finger on the inner corner of the eye for about two minutes. This helps prevent the eye drops from draining through the tear duct (Figure 4).
9. Wipe away any excess solution from the skin around the eye.

If the drop does not enter the eye, repeat the procedure.
If your doctor has instructed you to apply the eye drops in both eyes, repeat steps 7 to 9 for the other eye.
One single-dose container contains enough solution for both eyes. After use, immediately discard the opened container and any remaining solution.
If you are using other eye medications, wait at least 5 minutes between administering Taflodim and applying the other medication.
If you use more Taflodim than prescribed, you may experience dizziness, headache, cardiac symptoms, or breathing difficulties. If necessary, consult your doctor.
If Taflodim is accidentally swallowed, consult your doctor.
If you forget to use Taflodim, apply one drop as soon as you remember, then continue with your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
Do not stop using Taflodim without first consulting your doctor. If you stop treatment with Taflodim, the pressure inside the eye will rise again, which may cause permanent eye damage.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In most cases, side effects are not serious.
You can usually continue using the eye drops if the side effects are not severe. If you are concerned about anything, speak to your doctor or pharmacist.

The following are known side effects associated with the use of Taflodim:

Common side effects
The following side effects may affect up to 1 in 10 people:

Eye disorders
Itchy eyes. Eye irritation. Eye pain. Eye redness. Changes in the length, thickness, and number of eyelashes. Feeling of a foreign body in the eye. Change in eyelash colour. Light sensitivity. Blurred vision.

Uncommon side effects
The following side effects may affect up to 1 in 100 people:

Nervous system disorders
Headache

Eye disorders
Dry eyes. Redness of the eyelids. Small, pinpoint areas of inflammation on the surface of the eye. Increased tear production. Swollen eyelids. Tired eyes. Inflammation of the eyelids. Inflammation inside the eye. Eye discomfort. Eye allergy. Eye inflammation. Abnormal eye sensitivity.

The following additional side effects have been observed during the use of the medicines contained in Taflodim (tafluprost and timolol) and therefore may also occur with the use of Taflodim:

The following side effects have been observed with tafluprost:

Eye disorders
Reduced ability of the eye to see details. Change in iris colour (sometimes permanent). Change in skin colour around the eyes. Swelling of the superficial membranes of the eye. Eye discharge. Pigmentation of the superficial membranes of the eye. Follicles on the superficial membranes of the eye. Sunken eye. Iritis/uveitis (inflammation of the coloured part of the eye). Macular edema/cystoid macular edema (swelling of the retina inside the eye leading to worsening vision).

Skin disorders
Unusual growth of eyelashes.

Respiratory effects
Worsening of asthma, shortness of breath.

The following side effects have been observed with timolol:

Immune system disorders
Allergic reactions, including swelling of the subcutaneous tissues, urticaria, and skin rash. Sudden onset of a severe, life-threatening allergic reaction. Itching.

Metabolism and nutrition disorders
Low blood sugar levels.

Psychiatric disorders
Depression. Difficulty sleeping. Nightmares. Memory loss. Nervousness. Hallucination.

Nervous system disorders
Dizziness. Fainting. Unusual sensations (such as pins and needles). Worsening of signs and symptoms of myasthenia gravis (a muscle disorder). Stroke. Reduced blood supply to the brain.

Eye disorders
Corneal inflammation. Reduced corneal sensitivity. Visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy). Drooping of the upper eyelid. Double vision. Blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery, possibly leading to visual disturbances. Corneal erosion.

Ear disorders
Tinnitus (perception of a high-pitched sound in the ears).

Cardiac disorders
Slow heartbeat. Chest pain. Palpitations. Edema (fluid accumulation). Changes in heart rate or rhythm. Congestive heart failure (a heart condition characterized by shortness of breath and swelling of feet and legs due to fluid accumulation). A type of heart rhythm disorder. Heart attack. Heart failure.

Vascular disorders
Low blood pressure. Limping. Raynaud's phenomenon, cold hands and feet.

Respiratory disorders
Narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease). Difficulty breathing. Cough.

Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Taste disturbances. Abdominal pain. Vomiting.

Skin disorders
Hair loss. Scaly, silvery rash (psoriasiform rash) or worsening of psoriasis. Rash.

Musculoskeletal disorders
Muscle pain not due to physical exertion. Joint pain.

Reproductive and breast disorders
Peyronie's disease (may cause curvature of the penis). Sexual dysfunction. Decreased libido.

General disorders
Muscle weakness/tiredness. Thirst.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Taflodim

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 single-dose container, on the
aluminum pouch, and on the outer carton after “Exp.”. The expiry date refers to the last day of that month.
Store the aluminum pouches unopened in the refrigerator (2°C - 8°C). Do not open the pouch until it is time to start using the eye drops, as unused containers contained in an opened pouch must be discarded 28 days after the first opening of the pouch.

After opening the aluminum pouch:

• Store the single-dose containers in the original aluminum pouch to protect the medicine from light.
• Do not store at temperatures above 25°C.
• Discard all unused single-dose containers 28 days after the first opening of the aluminum pouch.
• Immediately after use, discard any opened single-dose containers and any remaining solution.

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 Taflodim contains

• The active substances are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
• The other components are glycerol, disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Taflodim and package contents
Taflodim is a clear, colourless liquid (solution) supplied in plastic single-dose containers,
each containing 0.3 ml of solution. Each pouch contains 5 single-dose containers.
Taflodim is available in packs of 30 or 90 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)