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

Содержание инструкции

1. Dorzolamide and Timolol Mylan Generics 20 mg/ml + 5 mg/ml eye drops
   1. What is Dorzolamide and Timolol Mylan Generics and what it is used for
   2. What you need to know before using Dorzolamide and Timololo Mylan Generics
   3. How to use Dorzolamide and Timololo Mylan Generics
   4. Possible side effects
   5. How to store Dorzolamide and Timololo Mylan Generics
   6. Contents of the pack and other information

Dorzolamide and Timolol Mylan Generics 20 mg/ml + 5 mg/ml eye drops

dorzolamide and timolol

Generic medicine

Read this leaflet carefully before you start using this medicineas 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 because 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 Dorzolamide and Timolol Mylan Generics is and what it is used for
• 2. What you need to know before you use Dorzolamide and Timolol Mylan Generics
• 3. How to use Dorzolamide and Timolol Mylan Generics
• 4. Possible side effects
• 5. How to store Dorzolamide and Timolol Mylan Generics 6 Contents of the pack and other information.

1. What is Dorzolamide and Timolol Mylan Generics and what it is used for

Dorzolamide and Timolol Mylan Generics is a combination of two medicines: dorzolamide
and timolol.

• Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”
• Timolol belongs to a group of medicines called “beta blockers”.

Dorzolamide and Timolol Mylan Generics is used to reduce increased intraocular pressure
in the treatment of glaucoma, when the use of a beta blocker eye drop used alone is not
adequate.

2. What you need to know before using Dorzolamide and Timololo Mylan Generics

Do not use Dorzolamide and Timololo Mylan Generics:

• if you are allergic to dorzolamide, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had breathing problems, such as asthma, or severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that causes wheezing, difficulty breathing and/or persistent cough);
• if you have certain heart problems, including some heart rhythm disorders that produce an abnormally slow heartbeat or severe heart failure;
• if you have severe kidney problems or have had kidney stones in the past
• if you have an excess of acidity in the blood caused by an accumulation of chlorine in the blood (hyperchloremic acidosis). If you think any of these apply to you, do not use Dorzolamide and Timololo Mylan Generics until you have consulted a doctor.

Warnings and precautions
Before using Dorzolamide and Timololo Mylan Generics, tell your doctor or pharmacist if
you suffer from:

• coronary heart disease (heart disease caused by poor blood circulation in the blood vessels of the heart), Prinzmetal's angina (chest pain at rest), heart failure, low blood pressure.
• other heart problems including some types of heart rhythm disorders such as slow heartbeat or severe heart failure
• any other lung or respiratory problem
• poor blood circulation, such as Raynaud's disease or Raynaud's syndrome.
• diabetes or hypoglycemia (low blood sugar levels) as timolol can mask the signs and symptoms of hypoglycemia
• hyperactivity of the thyroid gland as timolol can mask its signs and symptoms.
• if you have or have had liver problems, if you have muscle weakness or if you have been diagnosed with “myasthenia gravis”

During treatment
If you have a history of heart problems, your doctor may want to monitor your pulse rate and other signs of these problems while you are using Dorzolamide and Timololo Mylan
Generics.
Contact your doctor immediately if you develop conjunctivitis (redness and irritation
of the eye/s) swelling of the eyes or eyelids, rash or itching inside and around
the eye. These symptoms may be due to an allergic reaction or may be
an undesirable effect of Dorzolamide and Timololo Mylan Generics (see section 4
“Possible side effects”).
Tell your doctor if you develop an eye infection, suffer an eye injury, undergo
eye surgery, develop other reactions or worsening of symptoms.
If you wear soft contact lenses, it is important to remove the lenses before using the eye drops and
do not put them back in your eyes until 15 minutes have passed after using the eye drops,
as the preservative, benzalkonium chloride can discolor contact lenses.
Before surgery, tell your doctor that you are using Dorzolamide and Timololo Mylan
Generics, as it may cause a sudden drop in blood pressure associated
with anesthesia and timolol may change the effects of some medicines used during
anesthesia.
For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in a positive doping test.

Children and adolescents
There is limited experience with the use of Dorzolamide and Timololo Mylan Generics in infants,
children and adolescents.

Elderly patients
In clinical studies with Dorzolamide and Timololo Mylan Generics, the effects of Dorzolamide and
Timololo Mylan Generics observed in elderly patients and in younger patients were similar.

Other medicines and Dorzolamide and Timololo Mylan Generics
Dorzolamide and Timololo Mylan Generics can affect or be affected 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 take other medicines to lower blood pressure, medicines
for the heart or medicines for diabetes. Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other medicines, even those without
prescription.
This is particularly important if any of the following applies to you:

• you are taking antihypertensive medicines that are used to lower high blood pressure such as guanethidine or clonidine or medicines used to treat heart problems, such as calcium channel blockers and beta-blockers or digoxin.
• you are taking medicines to treat a heart disorder or irregularity of the heartbeat such as amiodarone, quinidine (used to treat some heart conditions and some types of malaria) or digoxin (used to treat heart disorders)
• you are using another eye drop that contains a beta-blocker such as timolol
• you are taking another carbonic anhydrase inhibitor such as acetazolamide. You can take this type of medicine by mouth, as an eye drop or via another route of administration.
• you are taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and paroxetine, both used to treat depression or another illness.
• you are taking a parasympathomimetic medicine such as bethanechol which may have been prescribed to you to facilitate urination. Parasympathomimetics are also a particular type of medicine sometimes used to help normalize bowel movements.
• you are taking high doses of aspirin. Although it is not known that dorzolamide hydrochloride interacts with aspirin, some other medicines related to dorzolamide hydrochloride and that are taken orally are known to interact with aspirin.
• you are taking medicines to treat diabetes or high blood sugar levels.
• you are taking adrenaline (epinephrine).

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.
Do not use Dorzolamide and Timololo Mylan Generics if you are pregnant unless your doctor
considers it necessary.
Do not use Dorzolamide and Timololo Mylan Generics if you are breastfeeding. Timolol can pass into
breast milk.
Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines
Dorzolamide and Timololo Mylan Generics can cause side effects such as blurred vision
in some patients. Do not drive or use tools or machines until the signs have disappeared.

Dorzolamide and Timololo Mylan Generics contains benzalkonium chloride.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changing their color. Remove the contact lenses before using this medicine and
wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you feel
an abnormal sensation in the eye, burning or pain after using this medicine, talk
to your doctor.

3. How to use Dorzolamide and Timololo Mylan Generics

Always use Dorzolamide and Timololo Mylan Generics exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be established by your doctor.
The recommended dose is one drop in the affected eye/s twice a day, for example in the
morning and evening.
If you are using another eye drop, Dorzolamide and Timololo Mylan Generics and the other agent must
be administered at least 10 minutes apart.
Do not change the dosage of this medicine without consulting your doctor. If you need to stop
treatment, contact your doctor immediately.
The tip of the dropper must not come into contact with the eye or with the areas surrounding
the eye. It may become contaminated with bacteria, which can cause eye infections that can lead to serious eye damage, including vision loss.
To avoid possible contamination of the dropper, keep the tip of the dropper away
from contact with any surface.
In order to ensure correct dosage – the tip of the dropper must not be widened.

Instructions for use
It is recommended to always wash your hands before applying the eye drops.
It may be easier to apply the eye drops in front of a mirror.

• 1. Before using the medicine for the first time, make sure that the safety seal located on the neck of the bottle is intact. A space between the bottle and the cap is normal for a bottle that has not yet been opened.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and gently pull down your lower eyelid, to form a small pocket between your eyelid and your eye.
• 4. Turn the bottle upside down, and press until a single drop has been introduced into the eye as prescribed by your doctor. DO NOT ALLOW THE TIP OF THE DROPPER TO COME INTO CONTACT WITHTHE EYE OR THE EYELID.
• 5. Repeat steps 3 and 4 for the other eye if your doctor has prescribed treatment for both eyes.
• 6. Replace the cap and close the bottle in an upright position after use.

After using Dorzolamide and Timololo Mylan Generics, press a finger into the corner
of your eye, near your nose (as shown in the figure above) for 2 minutes. This helps to
prevent timolol from spreading throughout the body.

If you use more Dorzolamide and Timololo Mylan Generics than you should
It is important to respect the dose prescribed by your doctor. If you instill too many drops
into your eye or if the contents of the bottle are ingested, you may feel unwell, for example you may have
a headache or feel tired, experience a feeling of emptiness in your head or dizziness, have
difficulty breathing, wheezing or feel that your heartbeat is slowed down. If you experience
any of the above effects, you should immediately seek medical attention.

If you forget to use Dorzolamide and Timololo Mylan Generics
It is important to use Dorzolamide and Timololo Mylan Generics as prescribed by your doctor.
If you forget a dose, apply the forgotten dose as soon as possible. However, if it is almost
time for the next dose, skip the forgotten dose and continue with the next dose at the scheduled time.
Do not use a double dose to make up for the forgotten dose.

If you stop using Dorzolamide and Timololo Mylan Generics
If you want to stop using the medicine, talk to 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 everyone will experience them.
Like other medicines that are applied directly to the eyes, Dorzolamide and Timolol
Mylan Generics is absorbed into the bloodstream. This can cause side effects similar to
those seen when using beta-blocker medications intravenously and/or orally.
The incidence of side effects after topical ophthalmic administration is lower
compared to when the drugs are taken, for example, orally or by injection. The
side effects listed include reactions observed within the class of beta-
blockers used for the treatment of eye disorders.
You are usually able to continue using the eye drops unless the side effects are
severe. If you have any doubts, contact your doctor or pharmacist. Do not stop using Dorzolamide and
Timolol Mylan Generics without talking to your doctor.

Stop using Dorzolamide and Timolol Mylan Generics and contact your doctor immediately or go to the nearest hospital emergency room if any of the
following side effects occur:
Common(may affect up to 1 in 10 people)

• swelling, tearing or redness of the eyes with eye pain and blurred vision, sometimes with sensitivity to light or the feeling of having something in your eye (keratitis).

Uncommon(may affect up to 1 in 100 people)

• inflammation of the iris (colored part of the eye) causing eye redness, eye pain and sensitivity to light (iridocyclitis) Rare(may affect up to 1 in 1,000 people)
• severe allergic reactions such as skin rash, hives, itching, swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing
• stroke or reduced blood supply to the brain (may experience collapse or notice numbness or weakness of the arms and legs, difficulty swallowing, slurred or altered speech or loss of speech)
• heart failure or congestive heart failure (heart condition with shortness of breath and swelling of the feet and hands due to fluid buildup)
• a type of heart rhythm disturbance (known as heart block) that alters the heart rate and can cause fainting, dizziness, fatigue, shortness of breath and chest pain
• heart attack (may experience sudden chest pain that radiates to the neck/jaw or an arm with shortness of breath and a cold, clammy feeling)
• fluid buildup under the retina following filtering surgery for glaucoma, which can cause visual disturbances
• serious lung or breathing problems (which can cause bluish discoloration of the lips or nails, confusion, loss of consciousness, fainting, fatigue, irregular heartbeat, rapid or labored breathing)
• systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs) with symptoms such as joint pain (similar to rheumatoid arthritis), fever, changes in blood tests (blood count) and rash
• severe skin reactions causing painful widespread redness of the skin, large blisters, detachment of the skin in sheets, bleeding of the lips, eyes, genitals or mouth, accompanied by fever (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Other possible side effects observed with dorzolamide and timolol used in
combination
Very common(may affect more than 1 in 10 people):

• burning and irritation to the eyes,
• taste alteration.

Common(may affect up to 1 in 10 people):

• damage to the surface of the eye, causing eye pain, redness inside and around the eye/eyes, a feeling of having something in the eye (corneal erosion)
• sinusitis (feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing pain, fever, nasal congestion and loss of smell).
• blurred vision, itching, tearing or redness of the eye

Uncommon(may affect up to 1 in 100 people):

• kidney stones (often signaled by a sudden onset of severe, cramping pain in the lower back and/or side, groin, or abdomen).

Rare(may affect up to 1 in 1,000 people):

• runny or congested nose
• itchy skin rash that occurs when a substance comes into contact with the skin (contact dermatitis)
• wheezing or shortness of breath

Not known(frequency cannot be estimated from the available data)

• depression
• sleep disturbances, nightmares
• dizziness
• weakness/fatigue
• tingling or numbness of the hands or feet
• ringing in the ears
• headache
• irregular heartbeat
• chest pain
• palpitations (faster or irregular heartbeat)
• slow heartbeat
• fluid retention (edema)
• low blood pressure
• fainting
• cold and swollen hands or feet and reduced circulation in the arms and legs
• nosebleeds
• cough
• nausea
• dry mouth
• indigestion
• hair loss
• skin rash that appears whitish or silvery (psoriasiform rash) or worsening of a skin condition with thickened, red patches of skin, often with silvery scales (psoriasis)
• curvature of the penis that can cause pain during erection (Peyronie's disease)
• eye irritation or swelling, dry eyes, double vision, irritation or crusting of the eyelids
• Foreign body sensation (feeling that something is in the eye).

The following side effects have been observed in addition to or more frequently with
dorzolamide, timolol or other beta-blockers for ophthalmic use when used
alone
Common (may affect up to 1 in 10 people ):

• headache
• decreased corneal sensitivity (may not be aware of having something in the eye and not feel any pain)
• eye pain, dry eye
• swelling/inflammation of the eyelids
• nausea
• unusual tiredness or weakness.

Uncommon (may affect up to 1 in 100 people ):

• depression
• dizziness
• slowed heartbeat
• shortness of breath
• indigestion
• fainting

Rare(may affect up to 1 in 1,000 people):

• insomnia (sleep disturbances), nightmares,
• memory loss,
• tingling or numbness of the hands or feet
• increased, in people who already suffer from it, signs and symptoms of myasthenia gravis (muscle disease that causes drooping eyelids, double vision, difficulty speaking and swallowing, and in some cases muscle weakness of the arms and legs),
• ringing in the ears
• irregular heartbeat
• chest pain,
• palpitations (faster and/or irregular heartbeat)
• low blood pressure
• swollen or cold hands and feet and reduced circulation in the arms and legs
• leg cramps and/or leg pain when walking (claudication)
• cough, sore throat
• diarrhea
• dry mouth
• hair loss or baldness
• skin rash with whitish or silvery formations (psoriasiform rash) or worsening of a skin condition with thickened, red patches of skin, often with silvery scales (psoriasis)
• curvature of the penis that can cause pain during erection (Peyronie's disease)
• decreased libido
• temporary nearsightedness that should resolve when treatment is stopped
• low eye pressure
• drooping eyelid (ptosis)
• nosebleeds
• fluid retention (edema)

Not known(frequency cannot be estimated from the available data) :

• low blood glucose levels, which can be observed with a blood test (hypoglycemia)
• abdominal pain, vomiting
• itching
• muscle pain, tenderness or weakness, not caused by exercise (myalgia)
• sexual problems, such as inability to achieve or maintain an erection.
• seeing, hearing or feeling things that are not there (hallucinations).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dorzolamide and Timololo Mylan Generics

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 label of the bottle and
on the packaging after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions. Store
in the original packaging to protect the medicine from light and humidity.
Dorzolamide and Timololo Mylan Generics must be used within 28 days after the first
opening of the bottle. Also, you must throw away the bottle after 4 weeks from the first opening,
even if some of the solution remains. To help you remember, write the date of opening the bottle
in the appropriate space on the packaging.
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 Dorzolamide and Timololo Mylan Generics contains
The active ingredients are dorzolamide and timolol.

• Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of Timololo (as timolol maleate)
• the other ingredients are: mannitol, hydroxyethylcellulose, benzalkonium chloride (as preservative) (see section 2 Dorzolamide and Timololo Mylan Generics contains the preservative benzalkonium chloride), sodium citrate, sodium hydroxide, water for injections.

Description of the appearance of Dorzolamide and Timololo Mylan Generics and contents of the
pack
Dorzolamide and Timololo Mylan Generics is a sterile, clear, colorless aqueous
solution, slightly viscous.
Dorzolamide and Timololo Mylan Generics is contained in a white opaque bottle made of
medium density polyethylene with a dropper applicator sealed with low density polyethylene and
a high density polyethylene screw cap with a tamper-evident seal, containing 5 ml of eye
solution.
Packs: 1, 3 or 6 bottles of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer responsible for batch release:
PHARMATHEN S.A., Dervenakion 6, Pallini 15351, Attiki, Greece
FAMAR S.A., Plant A, 63 Agiou Dimitriou Street, 174 56 Alimos, Athens, Greece
Mylan S.A.S
117 allée des Parcs, 69 800 Saint Priest
France

This medicinal product is authorised in the Member States of the EU with the following names.
Austria Dorzolamide + Timolol Arcana 20 mg/ml + 5 mg/ml - Eye drops
Belgium Tensoc Mylan 20 mg/ml + 5 mg/ml eye drops, solution
Denmark Tirzopt
France Dorzolamide/Timolol Mylan 20 mg/ml + 5 mg/ml, eye drops solution
Germany Dorzolamid dura plus 20 mg/ml + 5 mg/ml eye drops
Iceland Tirzopt
Italy Dorzolamide e Timololo Mylan Generics
Netherlands Dorzolamide/Timolol Mylan 20/5 mg/ml, eye drops, solution
Portugal Timolol + Dorzolamida Mylan
United Kingdom Dorzolamide/Timolol 20 mg/ml +5 mg/ml eye drops
Czech Republic Dorzogen Combi
Romania Gloptic 20 mg/5 mg/ml eye drops, solution
Slovenia Zortam 20 mg/5 mg in 1 ml eye drops, solution
Spain Dorzolamida Timolol Mylan 20 mg/ml + 5 mg/ml, eye drops solution
……………..