OLATALIN 20 mg /Ml + 5 Mg/Ml Глазные Капли, Раствор

Содержание инструкции

1. Olatalin 20 mg/ml + 5 mg/ml eye drops, solution
   1. What is Olatalin and what is it used for
   2. What you need to know before using Olatalin
   3. How to use Olatalin
   4. Possible side effects
   5. How to store Olatalin
   6. Package contents and other information

Olatalin 20 mg/ml + 5 mg/ml eye drops, solution

dorzolamide/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 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Olatalin and what is it used for

Olatalin contains two active ingredients: dorzolamide and timolol. Olatalin is available as a
sterile, preservative-free eye drop.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". Together, these medicines lower the pressure inside the eye in different ways.

Olatalin is prescribed to lower the pressure inside the eye in the treatment of glaucoma
when beta-blocker eye drops used alone are not sufficient.

2. What you need to know before using Olatalin

Do not use Olatalin

• if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had in the past respiratory problems such as asthma or severe chronic obstructive bronchitis (a severe lung condition that can cause wheezing, difficulty breathing and/or long-lasting cough),
• if you have a slowing of the heart rate, heart failure or heart rhythm disorders (irregular heartbeat),
• if you suffer from severe kidney problems or have a history of kidney stones,
• if you have an excess of acidity in the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis).

If you are not sure whether you should use Olatalin, contact your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Olatalin.
Tell your doctor about any medical or eye problems you currently have or have had in the
past, especially if you have:

• coronary heart disease (symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure,
• respiratory rhythm disorders such as a slowed heartbeat,
• respiratory problems, asthma or chronic obstructive pulmonary disease,
• poor blood circulation (such as Raynaud's disease or syndrome),
• diabetes because timolol can mask the signs and symptoms of hypoglycemia,
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms,
• any allergies or anaphylactic reactions,
• muscle weakness or a diagnosis of myasthenia gravis.

Before undergoing surgery, inform your doctor that you are using Olatalin because timolol can
alter the effect of some medicines used during anesthesia.
Contact your doctor if during treatment with Olatalin:

• you develop eye irritation or any new eye problem such as redness or swelling of the eyelids, contact your doctor immediately.
• you suspect that Olatalin is causing an allergic or hypersensitivity reaction (e.g. skin rash, severe skin reaction, or redness and itching of the eye), stop the medicine and contact your doctor immediately.
• you develop an eye infection, suffer an eye injury, undergo eye surgery or develop a reaction including new symptoms or a worsening of existing ones.

Olatalin has not been studied in patients who wear contact lenses. If you wear soft contact
lenses, you should consult your doctor before using Olatalin.
Children
Experience with dorzolamide and timolol in the preservative-containing formulation in newborns and children
is limited.
Elderly
In studies with dorzolamide and timolol in preservative-containing formulation, the effects were similar in
both elderly and younger patients.
Use in patients with hepatic impairment
Tell your doctor about any liver problems you currently have or have suffered in the past.

Other medicines and Olatalin
Olatalin can influence or be influenced by other medicines you are taking, including other
eye drops for the treatment of glaucoma. Tell your doctor if you are taking or intend to take
medicines to lower blood pressure, medicines for the heart or medicines for the treatment of
diabetes.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. This is particularly
important if:

• you are taking medicines to lower blood pressure or medicines for the treatment of heart disease and for the treatment of altered or accelerated heartbeat (such as calcium antagonists, beta-blockers or digoxin),
• you are using another eye drop containing a beta-blocker,
• you are taking another carbonic anhydrase inhibitor, for example acetazolamide,
• you are taking monoamine oxidase inhibitors (MAO) - medicines used to treat depression or other diseases of the nervous system,
• you are taking a parasympathomimetic drug, which may have been prescribed to help you urinate. Parasympathomimetics are a particular type of drug sometimes used to restore normal bowel movements.
• you are taking opioids such as morphine for the treatment of moderate to severe pain,
• you are taking medicines to treat diabetes,
• you are taking medicines to treat depression, called fluoxetine and paroxetine,
• you are taking a sulfonamide drug - used e.g. for the treatment of infections,
• you are taking quinidine (used to treat heart problems and some types of malaria).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy
Do not use Olatalin during pregnancy.
Use during breastfeeding
Do not use Olatalin if you are breastfeeding. Timolol can pass into breast milk.

Driving and using machines
Studies have not been conducted on the effects on the ability to drive vehicles or operate machinery.
Olatalin can cause side effects such as blurred vision that may impair your ability
to drive vehicles or operate machinery.
Wait to drive or operate machinery until you feel well or your vision is clear. It is
your responsibility to assess whether you are able to drive motor vehicles or perform work that requires
greater attention. One of the factors that can affect your abilities regarding these aspects is
the use of medicines due to their effects and/or side effects. The description of these effects and
side effects can be found in other paragraphs. Therefore, read all the information contained in
this leaflet. If you are not sure, consult your doctor, pharmacist or nurse.

3. How to use Olatalin

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will determine the appropriate dosage and duration of treatment.
The recommended dose is one drop in the affected eye(s) in the morning and evening.
If you are using Olatalin with another eye drop, the drops must be instilled at least 10 minutes
apart from each other. Eye ointments should be administered last.
Do not change the dosage of the medicine without first consulting your doctor.
Avoid contact between the tip of the bottle and your eye or the surrounding area. Contamination with bacteria may occur, which can cause eye infections resulting in damage to the
eye, up to and including loss of vision. To prevent any type of contamination of the bottle,
wash your hands before using this medicine and make sure that the tip of the bottle does not come into
contact with any surface.

Before instilling the eye drops:

• When you use the medicine for the first time, before dispensing a drop into your eye, you should first practice using the dropper by gently pressing it to dispense a drop into the air, away from your eye.
• When you are confident that you can dispense one drop at a time, choose the most comfortable position for instilling the drops (you can sit, lie on your back, or stand in front of a mirror).

Instructions for use:

• 1. Wash your hands thoroughly before using this medicine.
• 2. If the packaging or bottle is damaged, the medicine should not be used.
• 3. When using the medicine for the first time, the cap must be unscrewed after making sure that the safety seal is intact. You should feel slight resistance until this tamper-evident seal breaks (see figure 1).

Figure 1

• 4. If the tamper-evident seal is loose, it should be discarded as it could fall into the eye and cause injury.
• 5. Tilt your head back and gently pull down your lower eyelid, forming a pocket between the eyelid and your eye (see figure 2). Avoid contact between the tip of the bottle and your eye, eyelid, or fingers to prevent contamination of the solution.

Figure 2

• 6. One drop should be instilled into the pocket by gently pressing the bottle. Gently press the bottle in the center and let a drop fall into your eye. There may be a few seconds delay between when you press the bottle and the drop comes out (see figure 3). Do not press too hard if you are unsure how to administer the medicine, ask your doctor, pharmacist or nurse.

Figure 3
7 Close your eye and press with your finger on the inner corner of your eye for about two minutes (see

figure 4). This helps prevent the medicine from passing into the rest of your body.

Figure 4

• 8. Repeat steps 5, 6, and 7 in your other eye if your doctor has told you to do so.
• 9. After use and before re-capping the bottle, it should be turned upside down once without touching the tip of the dropper, to remove any residual liquid on the tip. This is necessary to ensure the dispensing of subsequent drops. After instillation, the cap of the bottle must be screwed on (see figure 5).

Figure 5
If a drop does not reach your eye, you should try again.

If you use more Olatalin than you should
If you put too many drops in your eye or ingest the contents of the bottle, you may experience dizziness, difficulty breathing, or a slowing of your heart rate. Contact your doctor immediately.

If you forget to use Olatalin
It is important to use Olatalin according to your doctor's prescription.
If you forget a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop using Olatalin
If you want to stop taking this medicine, ask your doctor first.
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 everybody gets them.

Serious side effects:
If you experience any of the following side effects, stop taking this medicine
and seek immediate medical attention or go to the nearest emergency room.
Rare (may affect up to 1 in 1000 people):
chest pain, edema (fluid retention), 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 accumulation), cardiac arrest, heart block,
low blood pressure, cerebral ischemia (reduced blood supply to the
brain), stroke.
shortness of breath, respiratory failure, constriction of the pulmonary airways
signs and symptoms of systemic allergic reactions, including angioedema, urticaria, itching,
skin rash, anaphylaxis
severe skin reactions, including subcutaneous swelling.
Other side effects:
You can generally continue using the drops, unless the effects are serious. If you are concerned, talk
to a doctor or pharmacist. Do not stop using Olatalin without first talking to your doctor.
The following adverse reactions have been reported with dorzolamide and timolol or with either one:

Very common (may affect more than 1 in 10 people):
Burning and irritation of the eyes, altered taste.

Common (may affect up to 1 in 10 people):
Effects on the eyes: redness inside and around the eye/eyes, tearing or itching
of the eye/eyes, corneal erosion (damage to the surface of the eyeball), swelling and/or
irritation inside and around the eye/eyes, foreign body sensation in the eye,
decreased corneal sensitivity (inability to realize you have something
in the eye), eye pain, dry eyes, blurred vision.
General side effects: headache, sinusitis (feeling of pressure or fullness in the nose),
nausea weakness/fatigue, tiredness.

Uncommon (may affect up to 1 in 100 people):
Effects on the eye: inflammation of the iris, visual disturbances including refractive changes
(sometimes due to discontinuation of miotic therapy).
General side effects: dizziness, depression, slowed heartbeat,
fainting, shortness of breath, indigestion, kidney stones.

Rare (may affect up to 1 in 1000 people):
Effects on the eye: temporary myopia, which may resolve upon discontinuation of treatment,
retinal detachment of the layer beneath the retina containing blood vessels following filtering surgery
which can cause visual disturbances, drooping of the eyelid (eye remains half-closed),
double vision, crusting of the eyelids, corneal swelling (with symptoms of
visual disturbances), low eye pressure.
General side effects:

• strong heartbeat that may be fast or irregular (palpitations),
• Raynaud's phenomenon, swelling or coldness in the hands and feet and reduced circulation in the arms and legs, leg cramps and/or leg pain when walking (claudication),
• cough, throat irritation, dry mouth,
• insomnia, nightmares, memory loss,
• tingling or numbness in the hands or feet, and increased signs and symptoms of myasthenia gravis (muscle disorder),
• decreased sexual desire,
• Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs),
• tinnitus, rhinitis, nosebleeds,
• diarrhea,
• contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash),
• Peyronie's disease (which can cause a curvature of the penis),
• allergic-type reactions such as rash, urticaria, itching, in rare cases possible swelling of lips, eyes and mouth, wheezing.

Frequency not known (frequency cannot be estimated from the available data):
General side effects: hallucination, increased heart rate, increased blood
pressure.
Effects on the eye: foreign body sensation in the eye (feeling that something
is in the eye).
As with other ophthalmic medications, timolol is absorbed into the bloodstream.
This can cause side effects similar to those observed with oral beta-blockers. Fewer side effects are observed after topical application to the eyes compared to when medications
are taken, for example, orally or by injection. Additional side effects listed
include reactions observed within the class of beta-blockers when used for the
treatment of eye conditions.

Not known:
General side effects: low blood sugar levels, abdominal pain, vomiting, muscle pain
not caused by exercise, sexual dysfunction.

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 to
adverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Olatalin

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 pack and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening, store at a temperature below 30°C.
Vial of 5 ml
Discard 60 days after first opening of the vial, even if some solution remains.
Vial of 10 ml
Discard 90 days after first opening of the vial, even if some solution remains.
To help you remember the date of first opening, write the date on the pack.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olatalin contains

• The active ingredients are dorzolamide and timolol. Each ml contains dorzolamide hydrochloride equivalent to 20 mg of dorzolamide and timolol maleate equivalent to 5 mg of timolol. Each drop (approximately 35 µl) contains 0.70 mg of dorzolamide and 0.18 mg of timolol.
• The other ingredients are: hydroxyethylcellulose, mannitol (E421), sodium citrate (E331), sodium hydroxide (E524) (for pH adjustment) and purified water.

Description of the appearance of Olatalin and package contents
Olatalin is a clear, colorless, slightly viscous solution.
This medicine is available in white LDPE bottles with a multi-dose dropper applicator in
HDPE with a silicone valve and a tamper-evident HDPE screw cap and the cardboard
box.
Package size: 1 bottle x 5 ml, 3 bottles x 5 ml, 1 bottle x 10 ml
Not all pack sizes may be marketed.

Marketing authorization holder
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
Italy

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa
Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Member State Name of the medicinal product
Austria Tidimaz 20 mg/ml+5 mg/ml Eye drops, solution
Czech Republic Dorzolamide/Timolol Polpharma
Denmark Tidimaz
Finland Tidimaz
France Olatalin 20 mg/mL + 5 mg/mL, eye drops solution
Ireland Tidimaz 20 mg/ml + 5 mg/ml eye drops, solution
Italy Olatalin
Norway Tidimaz
Portugal Olatalin
Sweden Tidimaz