Sommingatim

Package leaflet: Information for the patient

SOMINGATIM 15 micrograms/ml + 5 mg/ml

Eye drops, solution in single-dose container
tafluprost/timolol
Please read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 associated with increased pressure inside the eye, which over time may damage 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 previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough)
• if you have a slow heart rate, 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 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
• overactivity of the thyroid gland, as timol0l may mask signs and symptoms of thyroid disease
• any type of allergies or anaphylactic reactions
• myasthenia gravis (a rare disease 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 SOMINGATIM may cause the following effects, some of which may be
permanent:

• SOMINGATIM may increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual growth of eyelid hair.
• SOMINGATIM may cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will help reduce 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 the treated eye may become permanently 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, inform your doctor that you are using SOMINGATIM,
as timolol may alter the effect of certain 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 lack of safety and efficacy data in this age group.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and SOMINGATIM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SOMINGATIM may alter the effect of other medicines, or its effect may be altered by 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 for treating diabetes
• quinidine (used to treat heart conditions and certain types of malaria)
• antidepressants known as fluoxetine and paroxetine.

If you are using other medicines in the eye, wait at least 5 minutes between the administration of
SOMINGATIM 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, breastfeeding and fertility
If you are of childbearing age, you must use effective contraception during treatment with SOMINGATIM. Do not use SOMINGATIM if you are pregnant. Do not use SOMINGATIM if you are breastfeeding.
Please consult your doctor.
Driving and using machines
The use of SOMINGATIM may be associated with side effects such as blurred vision, which
may affect your ability to drive or operate machinery. Wait until you feel well and your vision has cleared before driving or operating machinery.
SOMINGATIM 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, in very rare cases, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use SOMINGATIM

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 1 drop of SOMINGATIM in the eye or eyes, once daily.
Do not use more drops or use the medicine more frequently than prescribed by
your doctor. Doing so may make SOMINGATIM less effective.
Use SOMINGATIM in both eyes only if your doctor has specifically instructed you to do so. Immediately discard the single-dose container and any remaining product after use.
For ophthalmic use only. Do not swallow.
Avoid letting the single-dose container come into contact with the eye or surrounding area. This could cause eye injury. The single-dose container may also become contaminated with bacteria that can cause serious eye infections, potentially leading to permanent eye damage or even vision loss. To prevent 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.
Write the date of opening on the space provided on the pouch.

Each time you use SOMINGATIM:

1. Wash your hands.
2. Remove the strip of containers from the pouch.
3. Detach one single-dose container from the strip.
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 A).
6. Hold the container between your thumb and index finger. Make sure the tip of the container does not extend more than 5 mm beyond your index finger. (Figure B).
7. Tilt your head backward or lie down. Rest your hand on your forehead. Your index finger should align with your eyebrow or rest on the bridge of your nose. Look upward. With your other hand, gently pull down the lower eyelid. Be careful to avoid touching the eye or the surrounding area with any part of the container. Gently squeeze the container to release one drop into the space between the eyelid and the eye. (Figure C).
8. Close your eye and press gently with your 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 D).
9. Wipe away any excess solution remaining on 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 to 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 medicine.

If you are using other eye medications, wait at least 5 minutes between administering SOMINGATIM and the other medication.

If you use more SOMINGATIM than you should, you may experience dizziness, headache, heart-related symptoms, or breathing problems. If necessary, consult your doctor.

If SOMINGATIM is accidentally swallowed, consult your doctor immediately.

If you forget to use SOMINGATIM, 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 the missed one.

Do not stop using SOMINGATIM without first consulting your doctor. If you stop treatment with SOMINGATIM, the pressure inside your eye will rise again, which may cause permanent eye damage.

If you have any questions about how to use 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.
In most cases, side effects are not serious.
You can generally continue using the eye drops if the side effects are not severe. If you are concerned about anything, consult your doctor or pharmacist.
The following are the known side effects associated with the use of SOMINGATIM:
Common side effects (may affect up to 1 in 10 people):
Eye disorders
Itching of the eye. Eye irritation. Eye pain. Eye redness. Changes in the length, thickness, and number of eyelashes. Sensation of a foreign body in the eye. Change in eyelash colour. Light sensitivity. Blurred vision.
Uncommon 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 eye surface. 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 medicinal products
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 fine 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/macular cystoid edema (swelling of the retina inside the eye leading to worsening of vision).
Skin disorders
Unusual growth of fine hair on the eyelids.
Effects on the respiratory system
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 muscular 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, potentially 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 rhythm or heart rate. 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 disease). Difficulty breathing. Cough.
Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Taste disturbances. Abdominal pain. Vomiting.
Skin disorders
Hair loss. Skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis. Skin rash.
Musculoskeletal disorders
Muscle pain not due to physical exercise. Joint pain.
Reproductive system and breast disorders
Peyronie's disease (may cause curvature of the penis). Sexual dysfunction. Decreased libido.
General disorders
Muscle weakness/fatigue. Thirst.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 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
aluminum pouch, and on the outer carton after “Exp.”. The expiry date refers to the last day of that month.
Keep the sealed aluminum pouches 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, dispose of any opened single-dose containers and any remaining solution.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SOMINGATIM 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, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of SOMINGATIM and contents of the pack
SOMINGATIM is a clear, colourless liquid (solution) supplied in single-dose containers made of plastic, each containing 0.3 ml of solution. Each sachet 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 European Economic Area Member States under the following names:

More detailed information on this medicinal product is available on the AIFA website