Dorzolamide and timolol Sandoz

Package leaflet: Information for the user

Dorzocobbe 20 mg/ml + 5 mg/ml eye drops, solution
Dorzolamide/timolol
Generic medicine
Read all of this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 using 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 Dorzocobbe is and what it is used for

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

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timololo belongs to a group of medicines called "beta-blockers".

Dorzocobbe is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma, when a beta-blocker eye drop alone is 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 to treat diabetes, infections, or diuretics. Dorzocobbe may cause the same allergic reaction.
• if you currently have or have previously had a respiratory disorder such as asthma, or severe chronic obstructive pulmonary disease (a serious lung condition that may cause shortness of breath, difficulty breathing, and/or long-lasting cough)
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeat)
• if you have severe kidney disease or a 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 unsure whether 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 previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, or low blood pressure. During treatment with Dorzocobbe, your doctor may decide to monitor your heart rate and other possible signs of heart problems;
• heart rhythm 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
• overactive thyroid gland, because timolol may mask signs and symptoms
• poor blood circulation (such as Raynaud's disease or syndrome)
• allergy to any medicine you have taken
• wear contact lenses (see section “Important information about some ingredients of Dorzocobbe”).

Contact your doctor immediately if:

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

Before surgery, inform your doctor or dentist that you are using Dorzocobbe, as timolol may
alter the effects of certain medicines used during anesthesia.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may
lead to a positive anti-doping test.
Children
Experience with the use of Dorzocobbe in neonates and children is limited.
Use in elderly patients
In studies with Dorzocobbe, the observed effects were similar in both older and younger patients.
Use in patients with hepatic impairment
Inform your doctor of any liver problems you currently have or have had in the past.
Other medicines and Dorzocobbe
Dorzocobbe may affect or be affected by other medicines you are taking, including other eye drops for the
treatment of glaucoma.
Inform 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 treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin);
• you are taking medicines to treat irregular or abnormal heartbeat, such as calcium channel blockers, beta-blockers, or digoxin;
• you are using another eye drop containing a beta-blocker;
• you are taking another carbonic anhydrase inhibitor, such as acetazolamide;
• you are taking monoamine oxidase inhibitors (MAOIs), used to treat depression;
• you are taking a parasympathomimetic medicine, which may have been prescribed to help with urination. Parasympathomimetics are a specific type of medicine 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 certain types of malaria).

Pregnancy and breastfeeding
Pregnancy
Dorzocobbe must 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 you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
The effects of Dorzocobbe on the ability to drive or use machines have not been studied. There are side effects associated with the use of Dorzocobbe, such as blurred vision, which may impair your ability to drive or use machines. You should avoid driving or operating machinery until you feel well or your vision is clear.
Dorzocobbe contains benzalkonium chloride
This medicine contains 0.075 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. How to use Dorzocobbe

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is:
one drop in the affected eye(s) twice daily , for example in the morning and in the evening.
Use of Dorzocobbe with another eye drop:
If you are using Dorzocobbe together with other eye drops, the different drops should be administered at least
ten minutes apart.
Do not change the dose of this medicine without first 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.
Ensure that the tip of the container does not come into contact with the eye or surrounding areas.
This could become contaminated by bacteria, which may cause eye infections leading to serious eye damage, and in extreme cases even loss of vision. To avoid possible contamination of the
container, keep the tip of the dropper away from any surface.

1. Do not use the bottle if the tamper-evident seal on the neck of the bottle is broken, prior to first use.
2. To open the bottle, unscrew the cap by turning it until the tamper-evident seal breaks.
3. Tilt your head backwards and gently pull down the lower eyelid to form a pouch between the eyelid and the eye (fig. 1).

4. Turn the bottle upside down and gently squeeze (as shown in figures 2 and 3) until a single drop has been dispensed into the eye, as prescribed by your doctor. Do not touch the eye or eyelid with the tip of the dropper.

5. Repeat steps 3 and 4 for the other eye, if so prescribed by your doctor.
6. Immediately after use, close the bottle by screwing the cap tightly and store the bottle in its original packaging.
7. The dropper has been designed to deliver a pre-measured drop: therefore, do not enlarge the hole at the tip of the dropper.

After using Dorzocobbe, press with one finger at the inner corner of the eye, near the nose, for 2 minutes. This will prevent dorzolamide/timolol from being absorbed into 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 instil too many drops or accidentally ingest the contents of the bottle, you may feel unwell, for example experiencing dizziness, breathing difficulties, nausea, headache, fatigue, or a sensation that your heartbeat is slower than usual. If you experience any of these effects, you must contact a doctor immediately.
If you forget to use Dorzocobbe
If you forget to instil 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 use a double dose to make up for a forgotten dose.
If you stop using Dorzocobbe
If you need or wish to stop treatment, contact your doctor immediately.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be serious. If you experience severe reactions, contact your doctor immediately or go to the nearest hospital straight away.

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

• generalized allergic reactions, including swelling under the skin that may occur in areas such as the face and limbs, and may block the airways causing difficulty in swallowing or breathing, urticaria or itching, localized and generalized skin rash, pruritus.
• severe, sudden, life-threatening 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 skin).

Immediately inform your doctor if you experience any changes or disturbances in vision while 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 in the eye(s)
• altered taste

Common (may affect up to 1 in 10 people)

• headache
• redness inside the eye(s) and surrounding areas
• tearing or itching of the eye
• eyelid inflammation, eye irritation, for example dry eye
• swelling and/or irritation of the eye(s) and around the eye(s)
• sensation of 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 (in some cases due to discontinuation of miotic therapy)
• slow heart rate
• sudden loss of consciousness
• dyspnea (shortness of breath)
• indigestion
• development of kidney stones

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

• unusual sensations such as tingling
• difficulty sleeping (insomnia)
• nightmares
• decreased sexual desire
• stroke (cerebrovascular accident)
• eye irritation, including redness, crusting of the eyelid(s), and eye pain
• low intraocular pressure
• corneal swelling (with symptoms such as visual disturbances), detachment of the lower layer of the retina containing blood vessels following filtration surgery, which may cause visual disturbances
• ringing in the ears
• low blood pressure
• chest pain
• palpitations (rapid or strong heartbeat)
• slowed heartbeat
• heart rhythm disorders
• 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, cold fingers and toes)
• edema (fluid accumulation)
• rhinitis and breathing difficulties, such as breathlessness/shortness of breath, and more rarely wheezing
• cough and nosebleeds
• respiratory failure
• dry mouth
• contact dermatitis
• hair loss
• silvery-white rash (psoriasiform rash) or worsening of psoriasis
• Peyronie's disease (which may cause penile curvature)
• allergic-type reactions such as rash, urticaria, pruritus
• facial rash, joint pain, muscle problems, fever (systemic lupus erythematosus)
• memory loss
• increased signs and symptoms of myasthenia gravis (muscle disorder)
• temporary decrease in vision, which may return to normal upon discontinuation of treatment
• drooping upper eyelids (causing the eye to remain partially closed), double vision
• leg cramps and/or leg pain when walking (claudication)
• throat irritation
• diarrhea
• airway constriction in the lungs (mainly 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 medicines, timolol may be absorbed into the bloodstream. This may cause effects similar to those observed with intravenous or oral beta-blockers. The incidence of side effects after topical ocular administration is lower than when medicines are taken orally or by injection. The listed side effects include reactions observed within the class of beta-blockers when used to treat ocular conditions.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label and on the carton. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
After first opening: use within 28 days. After this period, discard any unused portion of the solution.
Do not dispose of medicines via wastewater 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 Dorzocobbe contains
The active substances 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 components 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 package
Dorzocobbe is a slightly viscous, clear, colourless solution in a white, opaque, low-density polyethylene bottle
with a welded dropper and a two-part cap. Each bottle contains 5 ml of ophthalmic solution.
Dorzocobbe is available in packages containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorization 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 EEA Member States under the following names:
Austria Dorzolamid + Timolol 1A Pharma 20 mg/ml + 5mg/ml - Augentropfen, Lösung
Belgium Dorzolamide/Timolol Sandoz 20 mg/ml + 5 mg/ml oogdruppels, oplossing
Denmark Dorlatim
Germany Dorzolamid comp - 1 A Pharma 20 mg/ml + 5 mg/ml Augentropfen, Lösung
Italy Dorzocobbe
Latvia Dotizolil 20 mg/5 mg/ml acu pilieni, šķīdums
Sweden Dorlatim