Dorzolamide and timolol Mylan Generics

Patient Information Leaflet

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

dorzolamide and timolol
Generic medicine
Read this entire 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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 Dorzolamide and Timololo Mylan Generics is and what it is used for

Dorzolamide and Timololo Mylan Generics is a combination of two medicines: dorzolamide and timololo.

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

These medicines reduce intraocular pressure in different ways.
Dorzolamide and Timololo Mylan Generics is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma, when the use of a beta-blocker eye drop alone is not sufficient.

2. What you should know before using Dorzolamide and Timolol Mylan Generics

Do not use Dorzolamide and Timololo Mylan Generics:

• if you are allergic to dorzolamide, timolol, or any of the other ingredients of this medicine (listed in section 6);
• if you have or have previously had respiratory problems, such as asthma or severe chronic obstructive bronchitis (a serious lung disease causing wheezing, difficulty breathing and/or persistent cough);
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats);
• if you have severe kidney problems or have previously had kidney stones;
• if you have excess acidity in the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether this medicine is suitable for you, consult your doctor or pharmacist.

Warnings and precautions

Before using Dorzolamide and Timolol Mylan Generics, inform your doctor or pharmacist if you suffer from:

• 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;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes or hypoglycaemia (low blood sugar levels), as timolol may mask the signs and symptoms of hypoglycaemia;
• overactivity of the thyroid gland, as timolol may mask its signs and symptoms.

Before undergoing surgery, inform your doctor that you are using Dorzolamide and Timolol Mylan Generics, as timolol may alter the effects of certain medicines used during anaesthesia. You should also inform your doctor of any allergies or allergic reactions, including hives, swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.

Contact your doctor if you experience muscle weakness or if you have been diagnosed with myasthenia gravis.

Contact your doctor immediately if you develop any eye irritation or any new problems such as eye redness or eyelid swelling.

If you suspect that Dorzolamide and Timolol Mylan Generics is causing an allergic reaction or hypersensitivity (e.g. skin rash, severe skin reaction, or eye redness and itching), stop using this medicine and contact your doctor immediately.

Inform your doctor if you develop an eye infection, suffer an eye injury, undergo eye surgery, or develop other reactions or worsening of symptoms.

When Dorzolamide and Timolol Mylan Generics is instilled into the eye, it may affect the entire body.

For athletes: The use of this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children

There is limited experience with the use of Dorzolamide and Timolol Mylan Generics in infants and children.

Elderly

In clinical studies with Dorzolamide and Timolol Mylan Generics, the effects observed in elderly patients were similar to those in younger patients.

Use in patients with hepatic impairment

Inform your doctor of any current or past liver problems.

Other medicines and Dorzolamide and Timolol Mylan Generics

Dorzolamide and Timolol Mylan Generics may interact with or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. Inform your doctor if you are taking or intend to take other medicines to lower blood pressure, heart medications, or diabetes medications. Inform your doctor or pharmacist if you are taking or have recently taken, or might take, any other medicines, including those without a prescription.

This is particularly important if you are:

• taking medicines to lower blood pressure or treat heart problems (such as calcium channel blockers, beta-blockers, or digoxin);
• taking medicines to treat an irregular heartbeat, such as calcium antagonists, beta-blockers, or digoxin;
• using another eye drop containing a beta-blocker;
• taking another carbonic anhydrase inhibitor such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs) used to treat depression;
• taking a parasympathomimetic medicine that may have been prescribed to help urination. Parasympathomimetics are also a specific type of medicine sometimes used to help normalize intestinal movements;
• taking narcotic drugs such as morphine used for the treatment of moderate to severe pain;
• taking medicines for diabetes;
• taking antidepressants known as fluoxetine and paroxetine;
• taking a sulfonamide;
• taking quinidine (used to treat certain heart conditions and some types of malaria).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not use Dorzolamide and Timolol Mylan Generics if you are pregnant unless your doctor considers it necessary.

Do not use Dorzolamide and Timolol Mylan Generics if you are breastfeeding. Timolol may pass into breast milk.

Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines

The effects of this medicine on the ability to drive and use machines have not been specifically studied. There are side effects associated with the use of Dorzolamide and Timolol Mylan Generics, such as blurred vision, which may impair your ability to drive or use machinery. Do not drive or operate machinery until you feel well or your vision is no longer blurred.

Dorzolamide and Timolol Mylan Generics contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride per millilitre of eye drops.

Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. 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 transparent outer layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Dorzolamide and Timolol Mylan Generics

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop in the affected eye(s) twice daily, for example in the morning and evening.
If you are using this medicine together with another eye drop, Dorzolamide and Timolol Mylan Generics and the other agent should 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 dropper tip must not come into contact with the eye or surrounding areas of the eye. It may become bacterially contaminated, which could lead to eye infections causing serious eye damage, including loss of vision.
To avoid possible contamination of the dropper, you should wash your hands before using this medicine and keep the dropper tip away from contact with any surface. If you suspect the medicine may be contaminated, or if you develop an eye infection, contact your doctor immediately before continuing to use this container.
To ensure correct dosing – the dropper tip must not be widened.

Instructions for use
Do not use the container if the plastic safety seal around the neck of the container is missing or broken. When opening the container for the first time, tear off the plastic safety seal.
Each time you use Dorzolamide and Timolol Mylan Generics:

1. Wash your hands
2. Open the container. Take special care to ensure that the tip of the dropper container does not touch the eye, the skin around the eye, or your fingers.
3. Tilt your head backward and hold the container upside down over the eye.
4. Pull the lower eyelid downward and look upward. Hold the container and gently press the flattened sides of the container to release one drop into the space between the lower eyelid and the eye.
5. Close the eye and press with a finger on the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.
6. Repeat steps 3 to 5 with the other eye if prescribed by your doctor.
7. Replace the cap and close the container tightly.

If you use more Dorzolamide and Timolol Mylan Generics than you should
It is important to follow the dose prescribed by your doctor. If you instill too many drops into the eye or if the contents of the bottle are swallowed, you may feel unwell; for example, you may experience headache, tiredness, a sensation of emptiness in the head or dizziness, difficulty breathing, shortness of breath, or feel that your heartbeat has slowed down. If you experience any of the symptoms listed above, seek immediate medical attention.

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

If you stop using Dorzolamide and Timolol Mylan Generics
If you wish to stop using this medicine, discuss it with your doctor first.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
If you experience any side effect, stop using this medicine and consult your doctor immediately, as these may be signs of a reaction to the medicine.
Generalised allergic reactions including swelling under the skin, which may occur in areas such as the face and limbs and may block the airways, possibly causing difficulty in swallowing, shortness of breath, hives or itchy rash, localized and generalized skin rash, itching, or sudden severe life-threatening allergic reaction.

Usually, you can continue using the drops unless the side effects are severe. If in doubt, consult your doctor or pharmacist. Do not stop using Dorzolamide and Timololo Mylan Generics without speaking to your doctor.

The following side effects have been reported with Dorzolamide and Timololo Mylan Generics or one of its components in clinical studies or after marketing.

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

• burning and stinging in the eyes, altered taste

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

• redness of the eye(s) and surrounding area
• tearing and itching of the eye(s)
• corneal erosion (damage to the front layer of the eyeball)
• swelling and/or irritation of the eye(s) and surrounding area
• sensation of a foreign body in the eye
• reduced corneal sensitivity (inability to feel a foreign body in the eye or absence of pain)
• eye pain
• dry eyes
• blurred vision
• headache
• sinusitis (feeling of pressure or fullness in the nose)
• nausea
• weakness/fatigue (tiredness)

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

• dizziness
• depression
• inflammation of the iris
• visual disturbances including changes in refraction (due in some cases to discontinuation of miotic therapy)
• slow heart rate
• fainting
• shortness of breath
• difficulty breathing
• indigestion
• kidney stones (often signaled by 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):

• systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs)
• tingling or numbness in the hands or feet
• sleep disorders
• nightmares
• memory loss
• worsening of signs and symptoms of myasthenia gravis (a muscle disorder)
• decreased sexual desire
• stroke
• temporary myopia that may resolve upon discontinuation of treatment
• localized detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances
• drooping of the eyelids (causing the eye to remain partially closed)
• double vision
• crusting of the eyelids
• corneal swelling (with symptoms of visual disturbances)
• low eye pressure
• ringing in the ears
• low blood pressure
• changes in heart rhythm or heart rate
• congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation)
• oedema (fluid accumulation)
• cerebral ischemia (reduced blood supply to the brain)
• chest pain
• strong heartbeat that may be rapid or irregular (palpitations)
• heart attack
• Raynaud's phenomenon, swollen or cold hands and feet, and reduced circulation in arms and legs
• leg cramps and/or leg pain while walking (claudication)
• nasal discharge or congestion
• nosebleeds
• airway constriction in the lungs causing breathing difficulties
• cough
• throat irritation
• dry mouth
• diarrhoea
• contact dermatitis
• hair loss
• skin rash with a silvery-white appearance (psoriasiform rash)
• Peyronie's disease (which may cause curvature of the penis)
• allergic-type reactions including skin reactions, hives, itching, and in rare cases possible swelling of lips, eyes and mouth, shortness of breath, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Like other medicines administered by ophthalmic route, timolol is absorbed into the bloodstream.
This may cause side effects similar to those seen with other oral beta-blockers.
The incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken orally or injected.

Additional side effects listed include reactions observed within the class of beta-blockers when used to treat eye conditions:

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

• low blood glucose levels
• heart failure
• a type of heart rhythm disorder
• abdominal pain
• vomiting
• muscle pain not caused by exercise
• sexual dysfunction
• hallucination
• sensation of a foreign body in the eye (feeling that something is in the eye)
• abnormal sensitivity of the eyes to light
• increased heart rate
• increased blood pressure

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
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 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 stated on the bottle label and on the packaging after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from light and moisture.
Dorzolamide and Timololo Mylan Generics must be used within 28 days after first opening the bottle. Furthermore, you must discard the bottle 4 weeks after first opening, even if some of the solution remains. To help you remember, write the date of opening in the designated space on the packaging.
Do not dispose of any medicine 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 Dorzolamide and Timolol Mylan Generics contains
The active substances are dorzolamide and timolol.

• Each mL 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 a preservative) (see section 2 Dorzolamide and Timolol Mylan Generics contains the preservative benzalkonium chloride), sodium citrate, sodium hydroxide, water for injections.

Description of the appearance of Dorzolamide and Timolol Mylan Generics and contents of the
pack
Dorzolamide and Timolol Mylan Generics is a sterile, clear, colourless, slightly viscous aqueous solution.
Dorzolamide and Timolol Mylan Generics is contained in a white opaque bottle made of medium-density polyethylene with a dropper dispenser sealed in low-density polyethylene and a screw cap made of high-density polyethylene with a tamper-evident seal, containing 5 mL of ophthalmic solution.
Pack sizes: 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

Responsible manufacturer 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
Viatris Sante, 1 Rue de Turin, 69007 Lyon, France

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Dorzolamid + Timolol Viatris 20 mg/mL + 5 mg/mL - Augentropfen
Belgium Tensoc Viatris 20 mg/mL + 5 mg/mL oogdruppels, oplossing
France Dorzolamide/Timolol Viatris 20 mg/mL + 5 mg/mL, collyre en solution
Italy Dorzolamide e Timololo Mylan Generics
Netherlands Dorzolamide/Timolol Viatris 20/5 mg/mL, oogdruppels, oplossing
Portugal Timolol + Dorzolamida Mylan
United Kingdom
(Northern Ireland) Dorzolamide/Timolol 20 mg/mL + 5 mg/mL eye drops
Czech Republic Dorzogen Combi
Spain Dorzolamida Timolol Viatris 20 mg/mL + 5 mg/mL, colirio en solución