ТАФЛОДИМ 15 МКГ/МЛ + 5 МГ/МЛ Капли для глаз, раствор в контейнере однократного использования

Содержание инструкции

1. Taflodim 15 micrograms/ml + 5 mg/ml
   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

Taflodim 15 micrograms/ml + 5 mg/ml

Eye drops, solution in single-dose container
Tafluprost/Timolol
Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 contain 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 conditions are linked to an increase
in pressure inside the eye and, over time, can 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 had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough)
• if you have a slowed heartbeat, 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 had in the past:

• coronary heart disease (symptoms may include chest pain or a feeling of tightness in the chest, shortness of breath or a feeling of suffocation), heart failure, low blood pressure
• heart rate disorders such as a slowed heartbeat
• respiratory problems, asthma or chronic obstructive pulmonary disease
• 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
• hyperthyroidism as timolol may mask the signs and symptoms of thyroid disease
• allergies or anaphylactic reactions of any kind
• myasthenia gravis (a rare disease that causes muscle weakness)
• other eye diseases; for example, corneal disease (the transparent tissue that covers the front of the eye) or a disease that requires ophthalmic surgery.

Tell your doctor if you have

• kidney problems
• liver problems.

Keep in mind thatTaflodim may have the following effects, some of which may be permanent,
Taflodim may::

• increase the length, thickness, color and/or number of eyelashes and may cause unusual hair growth on the eyelids.
• cause darkening of the skin around the eyes. Remove any solution residue on the skin. This will limit the risk of skin darkening.
• change the color of the iris (the colored part of the eye). If Taflodim is applied to only one eye, the color of that treated eye may become irreversibly different from the other eye.
• cause hair growth in areas where the solution repeatedly comes into contact with the skin surface.

Before undergoing surgery, tell your doctor that you are using Taflodim because the
timolol may alter the effect of some medicines used during anesthesia.

Children and adolescents
The use of Taflodim is not recommended in children and adolescents under 18 years of age due to
lack of data on safety and efficacy in this age group.
For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in positive anti-doping tests.

Other medicines and Taflodim
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Taflodim may change the effect of other medicines or its effect may be changed
by taking other medicines.
In particular, tell 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 some types of malaria)
• antidepressants known as fluoxetine and paroxetine.

If you apply other medicines to the eye,allow at least 5 minutes to pass between administering
Taflodim and applying the other medicine.

Contact lenses
Remove contact lenses before using the eye drops and wait at least 15 minutes before putting them back in.

Pregnancy, breastfeeding and fertility
If you are of childbearing potential, you should use effective contraceptive measures during treatment with Taflodim. Do not use
Taflodim if you are pregnant. Do not use Taflodim if you are breastfeeding. Ask your doctor for advice.

Driving and using machines
The use of Taflodim may be associated with undesirable effects, such as blurred vision, which may
affect the ability to drive and/or use machines. Wait until you feel well and your
vision returns to normal before driving or using machines.

Taflodim contains phosphate buffer
This medicine contains approximately 0.04 mg of phosphates in each drop equivalent to 1.3 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause
in very rare cases opaque spots on the cornea due to calcium buildup during treatment.

3. How to use Taflodim

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of Taflodim in the eye or eyes, once a day. Do not
apply a greater number of drops and do not use the medicine more often than prescribed by your doctor.
This may make Taflodim less effective.
Use Taflodim in both eyes only if your doctor has prescribed it. Discard opened containers and any
remaining product immediately after use.
For use as an eye drop only. Do not swallow.
Avoid contact of the tip of the single-dose container with the eye or the surrounding area. This
could cause eye damage, and the single-dose container could become contaminated with
bacteria capable of causing eye infections, causing serious damage to the eyes, even loss of
vision. To avoid contamination of the single-dose container, ensure that the
tip of the single-dose container does not come into contact with any surface.

Instructions for use:
When you start a new pouch:
Do not use the single-dose container if the pouch is broken. Open the pouch along the dotted line.
Record the date of opening the pouch 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 a single-dose container from the strip (Figure 1).
• 4. Replace what remains of the strip in 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. Make sure that the tip of the container does not protrude more than 5 mm above the index finger. (Figure 3).
• 7. Tilt your head back or lie down. Place your hand on your forehead. The index finger should be aligned

with the eyebrow or rest on the bridge of your nose. Look up. With the other hand, pull
the lower eyelid down. Be careful to avoid any part of the
container touching the eye or the area around the eye. Gently press the container and let
a drop fall into the space between the eyelid and the eye. (Figure 3)

• 8. Close your eye and press with your finger on the inner corner of the eye for about two minutes. This will help prevent the eye drops from draining through the tear duct. (Figure 4).
• 9. Remove any residual solution on the skin around the eye.

If the drop does not enter the eye, repeat the operation.

If your doctor has prescribed you to apply the eye drops to both eyes, repeat steps 7 to 9
for the other eye.
A single-dose container contains a sufficient dose for both eyes. After use, immediately discard the open container with any remaining medicine.

If you apply other medicines to the eye, allow at least 5 minutes to pass between administering
Taflodim and applying the other medicine.

If you use more Taflodim than you shouldyou may feel dizzy or experience headache, cardiac symptoms
or breathing problems. If necessary, ask your doctor for advice.

If the medicine is accidentally ingestedask your doctor for advice.

If you forget to use Taflodimapply a single drop as soon as you remember, then return
to your normal dosing times. However, if the time of the next dose is already near,
skip the missed dose. Do not use a double dose to make up for the missed dose.

Do not stop using Taflodim without consulting your doctor.If you stop treatment with
Taflodim, the pressure inside the eye will return to increase. This can cause permanent
eye damage.
If you have any doubts about using 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 to use the eye drops if the effects are not serious. If something worries you, 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
Eye itching. Eye irritation. Eye pain. Eye redness. Changes in the length, thickness and number of eyelashes. Foreign body sensation in the eye.
Change in eyelash color. 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 eye. Redness of the eyelids. Small pinpoint areas of inflammation on the surface of the eye. Increased tearing. 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 the color of the iris (sometimes permanent). Change in the color of the skin 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 colored part of the eye). Macular edema/cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision).
Skin disorders
Unusual growth of fluff on the eyelids.
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 tissues under the skin, hives and rash. Sudden onset of a life-threatening severe 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). Increased signs and symptoms of myasthenia gravis (a muscle disease). Stroke. Reduced blood supply to the brain.
Eye disorders
Corneal inflammation. Reduced corneal sensitivity. Visual disturbances including changes in refraction (due in some cases to discontinuation of miotic therapy). Drooping of the upper eyelid. Double vision. Blurred vision and detachment of the layer beneath the retina containing the blood vessels following filtering surgery, with possible resulting visual disturbances.
Corneal erosion.
Ear disorders
Tinnitus (perception of a ringing sound in the ears).
Cardiac disorders
Slowed heartbeat. Chest pain. Palpitations. Edema (fluid retention). Changes in the rhythm or rate of the heartbeat. Congestive heart failure (a heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation). A type of heart rhythm disorder. Heart attack. Heart failure.
Vascular disorders
Low blood pressure. Claudication. Raynaud's phenomenon, cold hands and feet.
Respiratory disorders
Narrowing of the airways in the lungs (mainly in patients with pre-existing disease).
Difficulty breathing. Cough.
Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Altered taste. Abdominal pain. Vomiting.
Skin disorders
Hair loss. Scaly, silvery-white skin rash (psoriasiform rash) or worsening of psoriasis. Rash.
Musculoskeletal disorders
Muscle pain not due to exercise. Joint pain.
Reproductive system and breast disorders
Peyronie's disease (can cause curvature of the penis). Sexual dysfunction. Decreased libido.
System disorders
Muscle weakness/fatigue. Thirst.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 sachet
and on the carton after “Exp.”. The expiry date refers to the last day of that month.
Store the sealed aluminium sachets in a refrigerator (2°C - 8°C). Do not open the sachet until
it is time to start using the eye drops, as any unused containers contained in an
opened sachet must be discarded 28 days after the first opening of the sachet.
After opening the aluminium sachet:

• Store the single-dose containers in the original aluminium sachet to protect the medicine from light.
• Do not store at a temperature above 25°C.
• Dispose of all unused single-dose containers after 28 days from the date of the first opening of the aluminium sachet.
• Dispose of opened single-dose containers and any remaining solution immediately after use.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Taflodim contains

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

Description of the appearance of Taflodim and contents of the pack
Taflodim is a clear and colorless 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 authorisation holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)