Duokopt 10ml.

What DUOKOPT is and what it is used for
DUOKOPT are eye drops, without preservative, DUOKOPT solution contains two active ingredients: 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 in the eye in different ways.
DUOCOPT is prescribed to reduce the increased pressure in the eye in the treatment of glaucoma, when the use of beta-blocker eye medication alone is inadequate.

2. What you need to know before using DUOCOPT
Do not use DUOCOPT:
if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6)
if you now have or have had respiratory problems in the past, such as asthma, or acute chronic obstructive bronchitis (an acute lung disease that can cause wheezing, difficulty breathing and / or a prolonged cough)
if you have a slow heartbeat, heart failure or heart rhythm disturbances (irregular heartbeat)
if you have acute kidney disease or problems, or a previous history of kidney stones
if you have excessive blood acidity caused by blood (hyperchloraemic acidosis)
Contact your doctor or pharmacist if you are not sure if you can use DUOCOPT.

Warnings and precautions:
Talk to your doctor or pharmacist or nurse before using DUOCOPT. for problems or eye problems you have now or in the past:

coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation), heart failure, low blood pressure
heart rate disturbances such as slow heart rate
respiratory problems, asthma or chronic obstructive pulmonary disease
poor circulation (such as Raynaud's disease or Raynaud's syndrome)
diabetes because timolol can mask the signs and symptoms of low blood sugar
Hyperactivity of the thyroid gland, as timolol may mask signs and symptoms
any allergies or anaphylactic reactions
muscle weakness, especially in the case of diagnosed myasthenia gravis
Tell your doctor before surgery that you are using DUOCOPT, as timolol may change the effects of some medicines used during anesthesia.

During treatment with DUOCOPT. contact your doctor immediately if
develop eye inflammation or a new eye problem, such as redness of the eye or swelling of the eyelids
If you suspect that DUOCOPT is causing an allergic reaction or hypersensitivity (eg skin rash, acute skin reaction, or redness and itching of the eye), stop using DUOCOPT
you develop an eye infection, you get an eye injury, you have eye surgery, or you develop a reaction that includes new or worsening symptoms.
When DUOCOPT is instilled into the eye, it can affect the whole body.

If you wear contact lenses:
There are no studies in DUOCOPT in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using DUOCOPT.

Children
There is limited experience with the combined dorzolamide / timolol formulation with preservative in adolescents and children. DUOKOPT is not recommended for children aged 0 to 18 years.

Adults
In studies with the combined dorzolamide / timolol formulation with a preservative, the effects of this medicine were the same in adults and younger patients.

Patients with hepatic impairment
Tell your doctor about liver problems you have now or have had in the past.

Patients with renal impairment
Tell your doctor about kidney problems you have now or have suffered in the past.

Sports
The use of DUOCOPT can give positive results in doping control.

Other medicines and DUOKOPT
DUOCOPT may affect or be affected by other medicines you use, including other eye drops for the treatment of glaucoma.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

This is especially important if:
you are taking a medicine to lower your blood pressure or to treat a heart attack
disease (such as calcium channel blockers, beta-blockers or digoxin)
you are taking medicines to treat an abnormal or arrhythmic heartbeat, such as calcium channel blockers, beta-blockers or digoxin
use other eye drops that contain a beta-blocker
you are taking another carbonic anhydrase inhibitor such as acetazolamide
you are taking monoamine oxidase inhibitors (MAOIs), which are used to treat depression
you are taking a parasympathomimetic medicine, which may be prescribed to help you pass urine. Parasympathomimetics are also a special type of medicine that is sometimes used to help restore normal stomach movements.
you are taking drugs like morphine, used to treat moderate to acute pain, you are taking medication to treat
3. How to use DUOCOPT
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. The recommended dose and duration of treatment will be determined by your doctor.

Dosage
The usual dosage is one drop in the affected eye (s) in the morning and evening.
If you are using DUOCOPT with another eye medicine, the drops should be applied at an interval of at least 10 minutes.
Do not change the dose of the medicine without consulting your doctor.
Do not allow the tip of the bottle to touch the eye or the area around the eye. It can be contaminated with bacteria that can cause infections leading to serious eye damage, even vision loss. To avoid possible contamination of the bottle, keep the top of the bottle away from contact with any surface.
Instructions for use
It is important to follow these instructions when using this product:

Before using the medicine for the first time, make sure that the screw cap with the protective ring is not broken. Then unscrew the cap tightly to open the bottle.
Before each use, wash your hands and remove the cap from the top of the bottle. Avoid any contact with the tip of the bottle with your fingers.
With the vial upside down, press several times to activate the pump mechanism until the first drop appears. This propee is for first use only and will not be needed for subsequent applications.
Place your thumb on the tip of the bottle and the index finger on the base of the bottle. Then place your middle finger on the second tip at the base of the bottle. Hold the bottle upside down.
To use, tilt your head back slightly and hold the top of the bottle vertically over your eye. With the index finger of the other hand, pull the lower eyelid slightly down. The resulting space is called the lower connective sac. Avoid contact of the top of the bottle with your fingers or eyes.
To place a drop in the lower conjunctival sac of the affected eye (s), press briefly and firmly onto the bottle. Due to the automatic dosing, exactly one drop is released at each pumping.
If the drop does not fall, shake the bottle slightly to remove the remaining drop on top. In this case, repeat step 3.
Close the eyelid and press the inner corner of the eye from the nose with your finger for 2 minutes. This helps prevent eye drops from spreading to the rest of your body.
Close the top of the bottle with the cap immediately after use
If you use more DUOCOPT than you should
If you put a lot of drops in your eye or swallow the contents of the bottle * among other effects, you may experience dizziness, difficulty breathing, or feel that your heart rate is slow. Contact your doctor immediately.
If you forget to use DUOCOPT
It is important that you use DUOCOPT as prescribed by your doctor.
If you miss a dose, use it as soon as possible. But if it is time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using DUOCOPT
If you want to stop using this medicine, talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can continue taking the drops unless the effects are severe.

If you are worried, talk to your doctor or pharmacist. Do not stop using DUOCOPT without talking to your doctor.

Allergic reactions
Generalized allergic reactions including swelling under the skin, which may occur in areas such as the face and limbs and may block the airways, which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itching, acute sudden life-threatening allergic reaction. If you have any of these effects, stop taking DUOCOPT and contact your doctor immediately.

Very common: may affect more than 1 in 10 people:

Burning and stinging of the eyes, disturbance / change of taste
Common: may affect up to 1 in 10 users:

Redness in and around the eye (s), wetting or itching of the eye (s), corneal erosion (damage to the anterior layer of the eyeball), swelling and / or inflammation in and around the eye (s), feeling that there is something in the eye, reduced sensitivity of the cornea (do not perceive that you have something in the eye and lack of pain), eye pain, dry eye, blurred vision, headache, sinusitis (feeling of tension or fullness to the nose). nausea, weakness / exhaustion and fatigue
Uncommon: may affect up to 1 in 100 users:

Dizziness, depression, inflammation of the iris, spectator
5. How to store DUOCOPT
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
DUOKOPT can be used up to 2 months after first opening. Write the date of first opening on the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What DUOKOPT contains
The active substances are: dorzolamide and timolol. 1 ml contains 20 mg dorzolamide (as 22.25 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate)
The other excipients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide for pH adjustment, and water for injections.
What DUOKOPT looks like and contents of the pack:
DUOCOPT is a clear, colorless to slightly yellowish solution.
DUOKOPT is delivered in the following package sizes:

5 ml multi-dose bottle (at least 125 g drops without preservative, 1-month treatment) including a pump equipped with an ergonomic support device.
10 ml multi-dose bottle (at least 250 g drops without preservative, 2-month treatment) including a pump equipped with an ergonomic support device.
1 box with 3 multidose bottles of 5 ml (3-month treatment) including one pump equipped with a device with ergonomic support.
3 boxes of one 5 ml multi-dose bottle, wrapped in foil (3-month treatment) including a pump equipped with a device with ergonomic support.
1 box of two 10 ml multi-dose bottles (4-month treatment), including one pump for each bottle fitted with a device, with an ergonomic support,
2 boxes of one 10 ml multi-dose bottle wrapped in foil (4 months treatment) including a pump equipped with a device with ergonomic support.
Not all pack sizes may be marketed.

 

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