DORZAMOX 20 mg /Ml + 5 Mg/Ml Krople Do Oczu, Roztwór

Treść ulotki

1. DORZAMOX 20 mg/ml + 5 mg/ml eye drops, solution
   1. What is DORZAMOX and what is it used for
   2. What you need to know before you take DORZAMOX
   3. How to take DORZAMOX
   4. Possible side effects
   5. How to store DORZAMOX
   6. Contents of the pack and other information

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

Dorzolamide and timolol
Generic medicine

Read this leaflet carefully before you start to take 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 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 DORZAMOX is and what it is used for
• 2. What you need to know before you take DORZAMOX
• 3. How to take DORZAMOX
• 4. Possible side effects
• 5. How to store DORZAMOX
• 6. Contents of the pack and other information

1. What is DORZAMOX and what is it used for

DORZAMOX 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”.
These medicines reduce the pressure inside the eye in different ways.
DORZAMOX is prescribed to reduce high 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 you take DORZAMOX

Do not take DORZAMOX:

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

If you are not sure whether you should take this medicine, contact your doctor or pharmacist.

Warnings and precautions:
Talk to your doctor or pharmacist before taking DORZAMOX.
Tell your doctor about any eye disease or problem that you have now or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure
• heart rhythm disorders such as slow heartbeat
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar
• hyperactivity of the thyroid gland as timolol may mask signs and symptoms

Tell your doctor before surgery that you are taking DORZAMOX as the
timolol may affect the effects of some medicines used during anesthesia.
Also tell your doctor about any allergies or allergic reactions including hives, swelling of the face,
lips, tongue, and/or throat that may cause difficulty breathing or swallowing.
Tell your doctor if you experience muscle weakness or have been diagnosed with myasthenia gravis.
Contact your doctor immediately if you develop any eye irritation or any new
eye problem such as eye redness or swelling of the eyelids.
If you suspect that DORZAMOX is causing an allergic reaction or hypersensitivity (for
example, rash, severe skin reaction, or redness and itching of the eye), stop
taking this medicine and contact your doctor immediately.
Tell your doctor if you develop an eye infection, suffer eye injury, need to be
undergoing eye surgery or develop a reaction including new symptoms or worsening
of symptoms.
When DORZAMOX is instilled into the eye it may have effects throughout the body.
If you wear soft contact lenses, you should consult your doctor before using this medicine.
Children
Experience with dorzolamide+timolol, eye drops in newborns and children is limited.
Elderly
In studies with dorzolamide/timolol, eye drops, the effects of this medicine are similar for both
elderly and young patients.
Patients with hepatic impairment
Tell your doctor about any liver problems you have now or have had in the past.

If you participate in competitive sports: the use of the medicine without therapeutic need constitutes doping and

may still result in a positive doping test.

Other medicines and DORZAMOX
DORZAMOX 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
treating diabetes.
Tell your doctor or pharmacist if you are using, have recently used or might use any
other medicine. This is particularly important if you:

• are taking medicines to reduce high blood pressure or medicines to treat heart disorders (such as calcium channel blockers, beta-blockers or digoxin)
• are taking medicines to treat a fast or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin
• are using another eye drop that contains a beta blocker
• are taking another carbonic anhydrase inhibitor such as acetazolamide
• are taking monoamine oxidase inhibitors (MAOIs) used to treat depression
• are taking a parasympathomimetic medicine that may be prescribed to help you urinate. Parasympathomimetics are also a particular type of medicine that is sometimes used to help restore normal movements through the intestine
• are taking narcotics such as morphine used to treat moderate to severe pain
• are taking medicines to treat diabetes
• are taking antidepressants known as fluoxetine and paroxetine
• are taking a sulfonamide
• are taking quinidine (used to treat heart conditions and some types of malaria)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
Do not use DORZAMOX if you are pregnant unless your doctor considers it necessary.

Breastfeeding
Do not use DORZAMOX if you are breastfeeding. Timolol may be excreted in breast
milk.

Driving and using machines
Studies have not been performed on the effects on the ability to drive or operate machines.
There are undesirable effects related to the association of dorzolamide hydrochloride+timolol maleate
eye drops, such as blurred vision, which may affect the ability to drive and/or use
machines. Do not drive or use machines until you feel well or your vision is clear.

DORZAMOX contains the preservative benzalkonium chloride.
This medicine contains 0.075 mg of benzalkonium chloride in 1 ml of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can change the color
of contact lenses. You should remove your contact lenses before using this medicine and
reinsert them 15 minutes later.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes
or corneal disorders (the clear layer in front of the eye). Talk to your doctor if you feel
an abnormal sensation in your eye, stinging or pain in your eye after using this medicine.

3. How to take DORZAMOX

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doctor will establish the appropriate dose and duration of treatment.
The recommended dose is one drop in the affected eye or eyes in the morning and evening.
If you are using this medicine with another eye drop, the drops must be instilled at an interval of
at least 10 minutes.
Do not change the dose of the medicine without consulting your doctor.
Make sure that the tip of the dropper does not touch the eye or the areas around the eye. It may
become contaminated with bacteria that can cause eye infections leading to serious damage to
the eye, even loss of vision. To avoid possible contamination of the dropper, keep the
tip away from any surface. If you think the medicine may have become contaminated, or if you
develop an eye infection, contact your doctor immediately regarding continued use of this bottle.
In order to guarantee the correct dose, the tip of the dropper must not be widened.

Instructions for use:
It is recommended to wash your hands before putting in the eye drops.
It may be easier to put in the eye drops in front of a mirror.

• 1) Before using the medicine for the first time, check that the safety seal 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 the lower eyelid, so as to form a pocket between the eyelid and the eye.
• 4) Turn the bottle upside down and press until a single drop is introduced into the eye as indicated by your doctor. DO NOT TOUCH THE EYE OR EYELID WITH THE TIP OF THE DROPPER.
• 5) After using DORZAMOX, press your finger on the corner of the eye near the nose or close your eyelids for two minutes. This helps to stop the passage of the medicine into the rest of the body.
• 6) Repeat steps 3 and 5 for the other eye, if your doctor has told you to do so.
• 7) Replace the cap and close the bottle tightly immediately after using it.

Close your eye and press with your finger on the inner corner of the eye for about two minutes. This helps to
prevent the medicine from passing into the rest of the body.

If you take more DORZAMOXthan you should
If you have put too many drops in an eye or ingest part of the contents of the bottle, among other
effects, you may feel lightheaded, have difficulty breathing or feel that your heart
is beating slowly. Contact your doctor immediately.

If you forget to take DORZAMOX
It is important that you use this medicine as your doctor has told you.
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the
missed dose and return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.

If you stop taking DORZAMOX
If you want to stop using this 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 gets them.
In general, you can continue to use the eye drops unless the effects are serious. If you have any
doubts, consult your doctor or pharmacist. Do not stop using DORZAMOX without consulting your
doctor.
If you experience widespread allergic reactions including swelling under the skin (which can
manifest in areas such as the face and limbs and may obstruct the airways, which can cause
difficulty swallowing or breathing), urticaria or itchy rash, localized or widespread skin rash,
itching, severe and life-threatening allergic reaction, you should stop treatment with DORZAMOX
and speak to your doctor immediately.
The following side effects have been reported with dorzolamide+timolol, eye drops solution or
one of its components during clinical studies or during post-marketing experience.

Very common(affects more than 1 in 10 people):
Burning and irritation of the eyes, taste disturbances

Common(affects up to 1 in 10 people):
Redness in and around the eye(s), tearing or itching of the eye(s), corneal erosion
(damage to the front layer of the eyeball), swelling and/or irritation of the eye(s), sensation
of having something in the eye (corneal erosion), decreased corneal sensitivity (you do not
notice having something in your eye and do not feel pain), eye pain, dry eye,
blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), feeling
of unwellness also called nausea, weakness/fatigue and tiredness

Uncommon(affects up to 1 in 100 people):
Dizziness, depression, inflammation of the iris, visual disturbances including changes in
refraction (in some cases due to discontinuation of medicines used to treat excessive
pupil constriction), slowed heartbeat, weakness, difficulty breathing
(dyspnea), indigestion and kidney stones (which often manifest with sudden sharp pain
and spasms in the lower and/or side of the back, in the groin or abdomen)

Rare(affects up to 1 in 1,000 people):
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal
organs), tingling or numbness in the hands or feet, difficulty falling asleep (insomnia),
nightmares, memory loss, an increase in the signs and symptoms of myasthenia gravis (muscle
disease), decreased sexual drive, stroke, temporary myopia that may resolve
when treatment is stopped, detachment of the inner layer of the retina containing blood
vessels as a result of filtering surgery which can cause visual disturbances, drooping
of the eyelids (causing the eye to be half-closed), double vision, crusting on
the eyelids, corneal swelling (with symptoms of visual disturbances), low eye pressure,
ringing in the ears, low blood pressure, changes in heart rate or rhythm,
congestive heart failure (heart condition with shortness of breath and swelling of legs and
feet due to fluid buildup), edema (fluid retention), cerebral ischemia (reduced
blood flow to the brain), palpitations (faster and/or irregular heartbeat), heart attack,
Raynaud's phenomenon, swelling or coldness of the hands and feet and reduced circulation in the
arms and legs, cramps and/or pain in the legs while walking (claudication), shortness of
breath, feeling of breathlessness, runny or stuffy nose, nosebleeds,
constriction of the airways in the lungs causing difficulty breathing, cough, sore throat,
dry mouth, diarrhea, contact dermatitis, hair loss, skin rash that appears silvery white (psoriasiform rash), Peyronie's disease (which can cause a curvature
of the penis), allergic reactions such as rash, urticaria, itching, in rare cases possible swelling
of lips, eyes and mouth, wheezing or severe skin reactions (Stevens-Johnson syndrome,
toxic epidermal necrolysis).
As with other medicines applied to the eyes, timolol is absorbed into the bloodstream. This can
cause side effects similar to those observed with oral beta-blockers. The incidence
of side effects after topical ophthalmic administration is lower than when the
medicines are, for example, taken by mouth or injected. Further side effects listed
include reactions observed within the beta-blocker class when used for the
treatment of eye conditions.

Not known(frequency cannot be estimated from the available data):
Low blood sugar levels, heart failure, a type of heart rhythm disorder,
abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction,
hallucinations, labored breathing, foreign body sensation in the eye (feeling that there is
something in the eye), strong heartbeat that may be fast or irregular (palpitations),
increased heart rate, increased blood pressure.

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 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 DORZAMOX

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
pack after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
DORZAMOX must be used within 28 days of first opening the bottle. Therefore, you must
discard the bottle 4 weeks after you opened it for the first time, even if some of the
solution remains. To help you remember, write the date you opened it in the space on the pack and on
the bottle.
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 DORZAMOX contains

• The active ingredients are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate)
• The other ingredients are: mannitol (E421), hydroxyethylcellulose, benzalkonium chloride solution 50% (as preservative), sodium citrate, sodium hydroxide for pH adjustment and water for injectable preparations

Description of the appearance of DORZAMOX and contents of the pack
DORZAMOX is a sterile, clear, slightly viscous, colorless, aqueous solution.
DORZAMOX is presented in an opaque white MDPE bottle with a sealed LDPE dropper and
an HDPE cap with a tamper-evident screw closure, containing 5 ml of eye drops.
Pack sizes: 1 bottle of 5 ml, 3 bottles of 5 ml or 6 bottles of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturer responsible for batch release
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini Attiki
Greece
FAMAR S.A.
Plant A
63 Agiou Dimitriou Street
174 56 Alimos
Athens
Greece

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
United Kingdom:
Estonia:
Iceland:
Dorzolamide/Timolol
Dorzolamide/Timolol ELVIM
Dorzolamide/Timolol Alvogen
Italy: DORZAMOX
Latvia:
Lithuania:
Dorzolamide/Timolol ELVIM
Dorzolamide/Timolol ELVIM
Czech Republic: DOZOTIMA
Hungary: DOZOPRES COMBI

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