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

Содержание инструкции

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

Dorzocobbe 20 mg/ml + 5 mg/ml eye drops, solution
Dorzolamide/timolol

Generic medicine
Read this leaflet carefully before 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 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 Dorzocobbe is and what it is used for
2 What you need to know before you use Dorzocobbe
3 How to use Dorzocobbe
4 Possible side effects
5 How to store Dorzocobbe
6 Contents of the pack and other information

1. What is Dorzocobbe and what is it used for

Dorzocobbe is a combination of two medicines: dorzolamide and timolol which reduce the elevated pressure
inside the eye, through different mechanisms.

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

Dorzocobbe is prescribed to reduce the elevated pressure inside the eye in the treatment of glaucoma,
when the beta-blocker based eye drops alone are not sufficient.

2. What you need to know before using Dorzocobbe

Do not use Dorzocobbe

• if you are allergic to dorzolamide hydrochloride, timolol maleate, beta-blockers or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to medicines called sulfonamides. Examples include medicines used for the treatment of diabetes and infections, and also diuretics. Dorzocobbe may cause the same allergy.
• if you suffer from or have suffered in the past from a respiratory disorder such as asthma, severe chronic obstructive bronchitis (a severe lung condition that can cause shortness of breath, difficulty breathing and/or long-lasting cough).
• if you suffer from a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeat)
• if you suffer from severe kidney problems or if you have a previous history of kidney stones
• if you have excessive acidity in the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis)

If you are not sure if you can use this medicine, contact your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Dorzocobbe if you have or have had in the past:

• coronary heart disease (symptoms may consist of chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure. During therapy with Dorzocobbe, your doctor may decide to monitor your heart rate and other possible signs of heart disorder;
• heart rate disorders such as slow heartbeat
• liver problems;
• muscle weakness or myasthenia gravis;
• respiratory problems such as asthma or chronic obstructive pulmonary disease
• Prinzmetal's angina (chest pain at rest)
• diabetes because timolol may mask the signs and symptoms of low blood sugar levels
• hyperthyroidism because timolol may mask signs and symptoms
• poor blood circulation (such as Raynaud's disease or syndrome)
• allergy to a medicine you have taken
• wear contact lenses (see section “Important information about some ingredients of Dorzocobbe”).

Contact your doctor immediately if:

• you develop an infection in the eye, report an eye injury, need to undergo eye surgery, develop other reactions or a worsening of symptoms;
• you develop conjunctivitis (redness and irritation of one or both eyes), swelling of the eyes or eyelids, skin rashes, itching inside and around the eyes. These symptoms may be due to an allergic reaction or may be undesirable effects of Dorzocobbe (see section 4, “Possible side effects”).

Before an operation, inform your doctor or dentist that you are using Dorzocobbe, as timolol may
alter the effects of some medicines used during anesthesia.
For those who play sports: the use of the medicine without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children
Experience relating to the use of Dorzocobbe in newborns and children is limited.

Use in the elderly
In studies with Dorzocobbe, the effects observed were similar in both older and younger patients.

Use in patients with hepatic impairment
Tell your doctor about any liver problems you currently suffer from or have suffered in the past

Other medicines and Dorzocobbe
Dorzocobbe can influence or be influenced by other medicines you are taking, including other eye drops for
the treatment of glaucoma.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
This is particularly important if:

• you are taking medicines to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin);
• you are taking medicines used to treat altered or irregular heartbeat, such as calcium channel blockers, beta-blockers or digoxin
• you are using another eye drop that contains a beta-blocker;
• you are taking another carbonic anhydrase inhibitor, such as acetazolamide.
• you are taking monoamine oxidase inhibitors (MAOIs), for the treatment of depression;
• you are taking a parasympathomimetic medicine, which may have been prescribed to help you urinate. Parasympathomimetics are particular types of medicines that are sometimes also used to help restore normal bowel movements;
• you are taking narcotics such as morphine, used to treat moderate to severe pain.
• you are taking medicines to treat diabetes.
• you are taking antidepressants known as fluoxetine or paroxetine
• you are taking sulfonamide medicines
• you are taking quinidine (used to treat some types of malaria)

Pregnancy and breastfeeding
Pregnancy
Dorzocobbe should not be used during pregnancy.
Breastfeeding
Do not use Dorzocobbe if you are breastfeeding. Dorzolamide and Timolol may be excreted in breast
milk.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
The effects on the ability to drive and operate machines have not been studied. There are side
effects associated with the use of Dorzocobbe, such as blurred vision, which may interfere with the
ability to drive vehicles and use machines. You should avoid driving or using machines until you
feel well or your vision is clear.

Dorzocobbe contains benzalkonium chloride
This medicine contains 0.075 mg of benzalkonium chloride in each ml
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their color. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Dorzocobbe

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

Dosage
The recommended dose is:
one dropin the affected eye(s) twice a day, for example in the morning and in the evening.

Use of Dorzocobbe with another eye drop:
If you use Dorzocobbe together with other eye drops, the different drops must be instilled at intervals of at least
ten minutes.
Do not change the dose of the medicine without consulting your doctor. If you need to stop treatment,
contact your doctor immediately.

Instructions for use
Follow these instructions carefully when using Dorzocobbe eye drops, solution. It is recommended to wash your
hands before applying the eye drops.
Make sure that the end of the container does not come into contact with the eye or the surrounding areas.
This could become contaminated with bacteria, which can cause eye infections resulting in
serious eye damage, in extreme cases even loss of vision. To avoid possible contamination of the
container, keep the end of the container away from any surface.

• 1. Do not use the bottle if the safety seal on the neck of the bottle is broken, before first use
• 2. To open the bottle, unscrew the cap by turning it until the safety seal breaks.
• 3. Tilt your head back and gently pull down your lower eyelid, so as to form a pocket between the eyelid and the eye (fig. 1).

• 4. Turn the bottle upside down and press gently (as shown in figures 2 and 3) until you have dispensed a single drop into the eye, as prescribed by your doctor. Do not touch the eye or eyelid withthe end of the dropper.

• 5. Repeat steps 3 and 4 for the other eye, if so prescribed by your doctor.

• 6. Immediately close the bottle after use by turning the cap all the way and store the bottle in the original packaging.
• 7. The dropper is designed to deliver a pre-measured drop: therefore, do not enlarge the hole located at the end of the dropper.

After using Dorzocobbe, press with a finger on the corner of the eye, near the nose for 2 minutes. In
this way you will prevent dorzolamide/timolol from entering the rest of the body.

If you use more Dorzocobbe than you should
It is important to use the dose prescribed by your doctor. If you instill an excessive number of drops or if you accidentally ingest the contents of the bottle, you may feel unwell, for example dizziness, difficulty
breathing, nausea, headache, fatigue or the sensation that your heartbeat is slower than usual. If you experience any of these effects, seek immediate medical attention.

If you forget to use Dorzocobbe
If you forget to instill a dose, take that dose as soon as possible. However, if it is almost time to
take the next dose, skip the missed dose and continue with the normal dosage schedule. Do not
take a double dose to make up for a missed dose.

If you stop treatment with Dorzocobbe
If you need or want to stop treatment, contact your doctor immediately.
If you have any further questions on the use of 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.
Some side effects may be serious. If you experience severe reactions, contact your doctor immediately
or go to the nearest hospital immediately.

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

• widespread allergic reactions, including swelling under the skin that can occur in areas such as the face and limbs, and can obstruct the airways causing difficulty swallowing or breathing, hives or itching, localized and widespread rash, itching.
• severe, life-threatening sudden allergic reaction.
• severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis with ulcers in the mouth, lips and skin, and detachment of the upper layer of the skin).

Immediately inform your doctor if you experience any changes/discomfort in your vision when using
Dorzocobbe after eye surgery.

The following side effects have been observed with the fixed combination of dorzolamide and timolol or
one of its components:
Very common: (may affect more than 1 in 10 people)

• burning and stinging pain in the eye(s)
• taste alteration

Common (may affect up to 1 in 10 people)

• headache
• redness inside the eye(s) and surrounding areas
• tearing or itching of the eye
• inflammation of the eyelid, irritation of the eye(s), for example dry eye
• swelling and/or irritation of the eye(s) and around the eye(s)
• feeling of a foreign body in the eye
• decreased sensitivity of the eye(s)
• eye pain
• corneal inflammation
• sinusitis
• malaise
• corneal erosion (damage to the front layer of the eyeball)
• muscle weakness/fatigue
• blurred vision

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

• dizziness
• depression
• inflammation of the iris and ciliary body
• visual disturbances, including changes in refraction (due in some cases to discontinuation of miotic therapy)
• slowing of the heartbeat
• sudden loss of consciousness
• dyspnea (shortness of breath)
• indigestion
• development of kidney stones

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

• unusual sensation such as tingling
• difficulty sleeping (insomnia)
• nightmares
• decreased sexual desire
• stroke (cerebrovascular accident)
• irritation of the eye(s), including redness, crusting of the eyelid(s) and eye pain
• low eye pressure
• corneal swelling (with symptoms such as visual disturbances), detachment of the lower layer of the retina containing blood vessels following filtration surgery, which can cause visual disturbances
• tinnitus
• low blood pressure
• chest pain
• palpitations (fast or strong heartbeat)
• slowed heartbeat
• heart rhythm disturbances
• reduced blood flow to the brain (cerebral ischemia)
• congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation)
• cardiac arrest
• cold hands and feet
• Raynaud's phenomenon (numb and cold fingers and toes)
• edema (fluid retention)
• rhinitis and difficulty breathing, such as shortness of breath/breathlessness and more rarely wheezing
• cough and nosebleeds
• respiratory failure
• dry mouth
• contact dermatitis
• hair loss
• skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis
• Peyronie's disease (which can cause a curvature of the penis)
• allergic-type reactions such as rash, hives, itching
• facial rash, joint pain, muscle problems, fever (systemic lupus erythematosus)
• memory loss
• increases in signs and symptoms of myasthenia gravis (muscle disorder)
• temporary blurred vision, which may return to normal upon discontinuation of treatment
• drooping upper eyelids (causing the eye to remain half-closed), double vision
• leg cramps and/or leg pain when walking (claudication)
• sore throat
• diarrhea
• constriction of the airways in the lungs (predominantly in patients with pre-existing disease)
• in rare cases possible swelling of lips, eyes and mouth, labored breathing or severe allergic reactions (Stevens Johnson syndrome, toxic epidermal necrolysis)

As with other ophthalmic medications, timolol is absorbed into the bloodstream. This may
cause effects similar to those observed with beta-blockers given intravenously or orally. The incidence
of side effects after topical application to the eyes is lower than when the medications
are taken, for example, orally or by injection. The side effects listed include reactions
observed within the class of beta-blockers when used to treat eye conditions:
Not known (frequency cannot be estimated based on available data):

• low blood sugar levels
• a type of heart rhythm disturbance
• heart failure
• abdominal pain
• vomiting
• muscle pain not due to exercise.
• sexual dysfunction.
• hallucination

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 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 Dorzocobbe

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 and on the packaging. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening: use within 28 days. After this period, discard any unused portion of
solution.
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 Dorzocobbe contains
The active ingredients are: dorzolamide and timolol. Each ml of solution contains 20 mg of dorzolamide (as
dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate).
The other ingredients are:
mannitol, hydroxyethylcellulose, benzalkonium chloride (as preservative), sodium citrate, sodium hydroxide for
pH adjustment and water for injections.

Description of the appearance of Dorzocobbe and contents of the pack
Dorzocobbe is a slightly viscous, clear, colorless solution in a white opaque polyethylene
bottle of medium density with a welded dropper and a two-piece cap to be assembled. Each bottle contains 5
ml of eye drops solution.
Dorzocobbe is available in packs of 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Famar A.V.E.
Alimos Plant 63,
Agiou Dimitriou str. Alimos, Attiki
17456 Greece
Pharmathen S.A.
Dervenakion 6 Pallini,
Attikis
15351 Greece

This medicinal product is authorised in the Member States of the EEA with the following denominations:
Austria Dorzolamide + Timolol 1A Pharma 20 mg/ml + 5mg/ml - Eye drops, solution
Belgium Dorzolamide/Timolol Sandoz 20 mg/ml + 5 mg/ml eye drops, solution
Denmark Dorlatim
Germany Dorzolamid comp - 1 A Pharma 20 mg/ml + 5 mg/ml Eye drops, solution
Italy Dorzocobbe
Latvia Dotizolil 20 mg/5 mg/ml eye drops, solution
Sweden Dorlatim