SOMINGATIM 15 MICROGRAMS/ML + 5 MG/ML Krople do oczu, roztwór w jednorazowym pojemniku

Treść ulotki

1. SOMINGATIM 15 micrograms/ml + 5 mg/ml
   1. What SOMINGATIM is and what it is used for
   2. What you need to know before using SOMINGATIM
   3. How to use SOMINGATIM
   4. Possible side effects
   5. How to store SOMINGATIM
   6. Contents of the pack and other information

SOMINGATIM 15 micrograms/ml + 5 mg/ml

Eye drops, solution in single-dose container
tafluprost/timolol

Read this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SOMINGATIM is and what it is used for

SOMINGATIM 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. SOMINGATIM is used when the pressure inside the eye is too
high.
SOMINGATIM 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 SOMINGATIM

Do not use SOMINGATIM

• 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 in the past breathing 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 heartbeat).

Warnings and precautions
Talk to your doctor or pharmacist before using SOMINGATIM.

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
• breathing problems, asthma or chronic obstructive lung 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 eye surgery.

Tell your doctor if you have

• kidney problems
• liver problems.

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

• SOMINGATIM may increase the length, thickness, color and/or number of eyelashes and may cause unusual hair growth on the eyelids.
• SOMINGATIM may cause darkening of the skin around the eyes. Remove any solution residue on the skin. This will limit the risk of skin darkening.
• SOMINGATIM may change the color of the iris (the colored part of the eye). If SOMINGATIM is applied to only one eye, the color of that treated eye may become irreversibly different from the other eye.
• SOMINGATIM may 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 SOMINGATIM
because timolol may alter the effect of some medicines used during anesthesia.

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

Other medicines and SOMINGATIM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
SOMINGATIM 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 lower 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
SOMINGATIM and applying the other medicine.

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

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

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

SOMINGATIM 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 accumulation during
treatment.

3. How to use SOMINGATIM

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 drop of SOMINGATIM 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 SOMINGATIM less effective.
Use SOMINGATIM in both eyes only if your doctor has prescribed it. Discard open containers
and any remaining product immediately after use.
For use as an eye drop only. Do not swallow.
Avoid contact of the single-dose container with the eye or surrounding area. This could
cause eye damage. The single-dose container may also become contaminated with bacteria capable
of causing eye infections that can cause serious eye injury and may even lead
to vision loss. To avoid contamination of the single-dose container, prevent the tip of the single-dose container from coming into contact with any surface.

Instructions for use:
When starting 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 appropriate space on the pouch.
Each time you use SOMINGATIM:

• 1. Wash your hands.
• 2. Remove the strip of containers from the pouch.
• 3. Detach a single-dose container from the strip.
• 4. Replace what remains of the strip in the pouch and fold the edge of the pouch to reclose it.
• 5. To open the container, remove the tab by twisting it. (Figure A).
• 6. Hold the container between your thumb and index finger. Make sure the tip of the container does not protrude more than 5 mm above your index finger. (Figure B).
• 7. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or rest on the bridge of your nose. Look up. With your other hand, pull down your lower eyelid. Be careful to avoid any part of the container touching your eye or the area around your eye. Gently press the container and let one drop fall into the space between your eyelid and your eye. (Figure C).
• 8. Close your eye and press with your finger on the inner corner of your eye for about two minutes. This will help prevent the eye drop from draining through the tear duct. (Figure D).
• 9. Remove any residual solution on the skin around your eye.

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

If your doctor has prescribed applying the eye drop 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 elapse between administering
SOMINGATIM and applying the other medicine.

If you use more SOMINGATIM 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 SOMINGATIMapply a single drop as soon as you remember, then
return to your normal dosing schedule. However, if the time of the next dose is close, skip the missed dose. Do not use a double dose to make up for a missed dose.

Do not stop using SOMINGATIM without consulting your doctor.If you stop
treatment with SOMINGATIM, the pressure inside your eye will return to increase. This may
cause permanent eye damage.
If you have any doubts about 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 everyone gets them.
In most cases, the side effects are not serious. It is usually possible to continue using the eye drops if
the effects are not serious. If something worries you, contact your doctor or pharmacist.

The following are known side effects associated with the use of SOMINGATIM:
Common 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. Feeling of a foreign body in the eye. Change in eyelash color. Sensitivity to light. Blurred
vision.

Uncommon side effects(may affect up to 1 in 100 people):
Nervous system disorders
Headache
Eye disorders
Eye dryness. 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 SOMINGATIM (tafluprost and timolol) and, therefore, may also occur with
the use of SOMINGATIM:
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 system 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
(sometimes due to stopping miotic therapy). Lowering of the upper eyelid. Double vision. Blurred vision
and detachment of the layer under the retina containing 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 disturbance. 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 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.
Systemic disorders
Muscle weakness/fatigue. Thirst.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. 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 SOMINGATIM

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.
Keep the sealed aluminium sachets in a refrigerator (2°C - 8°C). Do not open the sachet until
you are ready 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 SOMINGATIM 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, hydrochloric acid and/or sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of SOMINGATIM and contents of the pack
SOMINGATIM is a clear and colorless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 ml of solution. Each pouch contains 10 single-dose containers. SOMINGATIM is available in packs of 30 or 90 single-dose containers.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
More detailed information on this medicine is available on the AIFA website