JOKATH 40 МКГ/МЛ + 5 МГ/МЛ Капли для глаз, раствор

Содержание инструкции

1. Jokath 40 micrograms/mL + 5 mg/mL eye drops, solution
   1. What is Jokath and what is it used for
   2. What you need to know before using Jokath
   3. How to use Jokath
   4. Possible side effects
   5. How to store Jokath
   6. Contents of the pack and other information

Jokath 40 micrograms/mL + 5 mg/mL eye drops, solution

travoprost/timolol
Medicinal product
equivalent

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

1. What is Jokath and what is it used for

Jokath eye drops solution is a combination of two active substances (travoprost and timolol).
Travoprost is a prostaglandin analogue whose mechanism of action consists
in increasing fluid outflow, reducing pressure in the eye. Timolol is a beta-
blocker whose mechanism of action consists in reducing the production of fluid inside
the eye. The two active substances act simultaneously in order to reduce pressure
inside the eye.
Jokath eye drops are used for the treatment of elevated intraocular pressure in
adults, including the elderly. Such pressure levels can lead to a condition
called glaucoma.
Jokath eye drops solution is a sterile solution that does not contain a preservative

2. What you need to know before using Jokath

Do not use Jokath

• if you are allergic to travoprost, timolol or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any prostaglandin or beta-blocker.
• if you have or have had in the past problems with your airways such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough) or other types of respiratory problems.
• in case of severe hay fever.
• in case of slowed heartbeat, heart failure or irregular heartbeat (irregular heartbeat).
• in case of clouding of the ocular surface.

Ask your doctor if you are subject to any of these conditions.

Warnings and precautions
Before using Jokath, tell your doctor or pharmacist if you suffer from, or have suffered in
the past from:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
• changes in heart rate such as slow heartbeat.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• disease with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes (as timolol may mask the signs and symptoms of low blood sugar)
• hyperactivity of the thyroid gland (as timolol may mask signs and symptoms of a thyroid disease)
• myasthenia gravis (chronic muscle weakness)
• cataract surgery.
• episodes of eye inflammation.

Tell your doctor before undergoing surgery that you are taking Jokath because the
timolol may alter the effect of some medicines used during anesthesia.
If a severe allergic reaction (skin rash, redness and itching
in the eye) occurs during the use of Jokath, whatever the cause, the treatment with
adrenaline may not be as effective. It is therefore important
to inform your doctor that you are using Jokath when you need to receive any
other treatment.
Jokath may change the color of your iris (the colored part of the eye). This
change may be permanent.
Jokath may increase the length, thickness, color and/or number of your eyelashes and may
cause unusual hair growth on your eyelids.
Travoprost may be as sorb through the skin, therefore it should not be used by
pregnant women or those planning to become pregnant. If any medicine comes into
contact with the skin, wash immediately.

Children
Jokath should not be used in children and adolescents under the age of 18 years.

Other medicines and Jokath
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
Jokath may influence or be influenced by other medicines that you are taking,
including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or
intend to use

• medicines to reduce blood pressure,
• medicines for the heart including quinidine (used to treat heart problems and some types of malaria)
• medicines for the treatment of diabetes or the antidepressants fluoxetine and paroxetine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before using this
medicine.
Do not use Jokath in case of pregnancy, unless your doctor considers it necessary. If
there is a possibility of becoming pregnant, while using this medicine you should adopt
adequate contraception. Do not use Jokath if you are breastfeeding. This medicine may be
excreted in breast milk.

Driving and using machines
You may notice blurred vision for a while after using Jokath.
Jokath may also cause hallucinations, dizziness, nervousness or fatigue in some
patients.
Do not drive or use machines until any of these symptoms have disappeared.

Jokath contains macrogolglycerol hydroxystearate 40 and propylene glycol
This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin
reactions.
This medicine contains 7.5 mg of propylene glycol in each ml of solution. Propylene glycol may cause skin irritation.

3. How to use Jokath

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is
One drop in the affected eye(s) once a day in the morning or evening.
Take the dose every day at the same time.
Use Jokath in both eyes only as prescribed by your doctor. Use the medicine for the period of time recommended by your doctor.
Jokath can only be used as an eye drop.

Instructions for use

1a 1b	Remove the bottle (figure 1a) from the cardboard box and c write the date of opening on the cardboard box and on the bottle in the appropriate space. a Take the bottle and a mirror. Wash your hands. m Remove the cap (figure 1b). r a F l e d a n a
2	i Hold the bottle upside down with your thumb on the shoulder of the bottle and your other fingers on the bottom. Before the first use, pump the bottle repeatedly, about 10 times, until the first drop appears (figure 2). t I
z n e g 3	a i Tilt your head back. Lower the eyelid with a clean finger until there is a "pocket" between the eyelid and the eye. The drop will go here (figure 3). Bring the tip of the bottle close to the eye. Use the mirror if it helps.

4 5

Do not touch the eye or eyelid, the surrounding areas or other surfaces with the dropper. This could infect the drops. c Gently press on the bottom of the bottle to release one drop of medicine at a time (figure 4). a If a drop misses the eye, try again. After using the medicine, press a finger in the corner m of the eye, near the nose for 2 minutes (figure 5). This helps to stop the medicine from entering the rest of the body. r a F l e d

If you are using drops in both eyes, repeat the same steps for the other eye. n Close the bottle cap tightly immediately after use. a Use only one bottle of medicine at a time. Do not open the cap until you need to use the bottle. i The bottle must be discarded 28 days after first opening, to prevent infection and use a new bottle.

If you use more Jokath than you should
If you take more Jokath than you should ,rinse it away with lukewarm water. Do not
take any more drops until the time scheduled for the next dose.

If you forget to use Jokath
If you forget to take Jokath, continue treatment with the next scheduled dose.
Do not use a double dose to make up for a missed dose. The dose
should not exceed one drop per day per affected eye(s).

If you stop using Jokath
If you stop taking Jokath without talking to your doctor, the pressure
in your eye will be uncontrolled, which may lead to loss of vision.
If you are using other eye drops, leave at least 5 minutes between instilling Jokath and
the other eye drops.
If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes
after using the eye drops before putting the lenses back in.
If you have any doubts about using 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.
You can generally continue to take the drops unless the effects experienced are serious.
If you are worried, consult your doctor or pharmacist. Do not stop using
Jokath without talking to your doctor.

Very common

(may affect more than 1 in 10 people

)
Effects
in the eye
Eye redness

Common

(may affect up to 1 in 10 people

)
Effects
in the eye
inflammation of the eye surface with damage to the surface, eye pain, blurred vision, abnormal vision, dry eye, itchy eyes, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging pain).

Uncommon

(may affect up to 1 in 100 people

)
Effects
in the eye
inflammation of the eye surface, inflammation of the eyelids, swollen conjunctiva, increased eyelash growth, inflammation of the iris, eye inflammation, sensitivity to light, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, redness of the eyelid, change of
eyelid color, darkening of the skin (around the eyes).
General undesirable effects
allergic reaction to the active ingredient, dizziness, headache, increase or decrease in
blood pressure, shortness of breath, excessive hair growth, runny nose,
skin inflammation and itching, decreased heart rate.

Rare undesirable effects

(may affect up to 1 in 1000 people

)
Effects in the eye
thinning of the eye surface, inflammation of the eyelid glands,
rupture of blood vessels in the eye, formation of crusts on the eyelid, abnormal positioning
of the eyelashes, abnormal eyelash growth.
General undesirable effects
nervousness, irregular heartbeat, hair loss, voice disturbances, difficulty
breathing, cough, sore throat, hives, abnormal liver blood tests,
alteration of skin color, darkening of the skin, thirst, fatigue, discomfort
inside the nose, colored urine, pain in hands and feet.

Not known

(frequency cannot be estimated from available data

)
Effects in the eye
lowering of the eyelid (the eye remains half-closed), sunken eyes (the eyes
appear more recessed), changes in the color of the iris (colored part of the eye).
General undesirable effects
skin rash, heart failure, chest pain, stroke, fainting, depression,
asthma, increased heart rate, sensation of numbness or
tingling, palpitations, swelling of the lower limbs, unpleasant taste.

In addition:
Jokath is a combination of 2 active ingredients. Like other medicines administered to the
eyes, travoprost and timolol (a beta-blocker) are absorbed into the blood. This can
cause side effects similar to those observed when beta-blocker medicines are
administered orally or by injection. The incidence of side effects after
administration to the eyes is lower than after oral or
injection administration.
The side effects listed below include reactions observed with the class of
beta-blockers used to treat eye conditions or reactions observed with travoprost alone.
Effects in the eye: inflammation of the eyelid, inflammation of the cornea, detachment of the
layer under the retina containing blood vessels following filtering surgery which can
cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage
to the front layer of the eyeball), double vision, eye discharge, swelling around
the eye, itchy eyelids, outward rotation of the eyelid with redness,
irritation and excessive tearing, blurred vision (sign of lens opacification), swelling of a part of the eye (uvea), eczema of the eyelids, vision with
halo, decreased eye sensitivity, pigmentation inside the eye, dilated pupils,
change in eyelash color, change in eyelash texture,
abnormal visual field.
General undesirable effects

Ear and labyrinth disorders:dizziness with a sensation of rotation, ringing in the
ears.

Heart and circulation: slowed heart rate, palpitations, edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs
due to fluid buildup), a type of heart rhythm disorder, heart attack,
low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced blood supply
to the brain.

Respiratory: constriction of the airways in the lungs (mainly in patients with
pre-existing disease), runny or stuffy nose, sneezing (due to allergy), difficulty
breathing, nosebleeds, dry nose.

Nervous system and systemic disorders: difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional discomfort).

Gastrointestinal: taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain,
vomiting and constipation.

Allergy: increased allergy symptoms, generalized allergic reactions including
swelling under the skin that can occur in areas such as the face and limbs and which
can obstruct the airways causing difficulty swallowing or breathing, localized and generalized
skin rash, itching, severe, life-threatening unexpected allergic reactions.

Skin: skin rash with a silvery-white appearance (psoriasiform rash) or
worsening of psoriasis, skin flaking, abnormal texture of hair or
hair, skin inflammation with itchy rash and
redness, change in hair color, loss of eyelashes, itching, abnormal hair growth,
redness of the skin.

Muscular: increased signs and symptoms of myasthenia gravis (muscle disease),
unusual sensations such as pins and needles, muscle weakness/lassitude, muscle pain
not caused by exercise, joint pain.

Reproductive system: sexual dysfunction, decreased libido.

Metabolism: low blood sugar levels, increased prostate cancer marker.

Reporting of side effects
If you get any side effects, 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 Jokath

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
outer packaging and on the vial after “Exp.”. The expiry date refers to
the last day of that month.
Do not use the medicine if you notice that the vial has been broken or damaged before opening.
This medicine does not require any particular storage conditions.

It is necessary to throw away the vial 28 days after first opening, to prevent infections and
use a new vial. Note the date on which you opened the vial in the space on the label and
on the vial’s box.
Do not dispose of any medicine in the 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 Jokath contains
The active ingredients are travoprost and timolol. Each mL of solution contains 40
micrograms of travoprost and 5 mg of timolol (as timolol maleate).
The other ingredients are Mannitol (E421), Boric acid, sodium hydroxide (for pH adjustment),
Macrogolglycerol hydroxystearate (nominal value 40), Propylene glycol (E1520),
sodium chloride and purified water.

Description of the appearance of Jokath and contents of the pack
Jokath eye drops, solution is presented as a 2.5 mL transparent,
colourless and practically particle-free aqueous solution, packaged in a cardboard box inside
a 5 mL white multi-dose container (PP) with pump (PP, HDPE, LDPE) and cylinder and
press-fit cap (HDPE).
The product is available in the following pack sizes:
Cartons containing 1 or 3 bottles
Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
DK Jokath (40 micrograms/mL+ 5 mg/mL)
IT Jokath
AT Jokath 40 Micrograms /mL + 5 mg/ml Eye drops, solution
DE Jokath 40 Micrograms/mL + 5 mg/ mL Eye drops, solution

Marketing Authorisation Holder and
manufacturer:
Marketing Authorisation Holder
Pharmathen SA
6 Dervenakion Str, Pallini, 153 51, Greece
Manufacturer
JADRAN - GALENSKI LABORATORIJ d.d., Svilno 20, Rijeka 51000, Croatia
Pharmathen SA - 6, Dervenakion str. Pallini Attiki – 15351, Greece