20 mg / ml + 5 mg / ml eye drops , solution 
dorzolamide / timolol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Dorzolamide / Timolol Actavis is and what it is used for 
2. What you need to know before you use Dorzolamide / Timolol Actavis 
3. How to use Dorzolamide / Timolol Actavis 
4. Possible side effects 
5. How Dorzolamide / Timolol Actavis should be stored 
6. Contents of the pack and other information

What Dorzolamide / Timolol Actavis is and what it is used for

Dorzolamide / Timolol Actavis contains two drug substances: dorzolamide and timolol .

Dorzolamide belongs to a group of medicines called carbanhydrase inhibitors. Timolol belongs to a group of medicines called beta-blockers.

These drugs lower the pressure in the eye in different ways.

Dorzolamide / Timolol Actavis used to lower an elevated pressure in the eye in glaucoma ( glaucoma ) when treatment with eye drops containing only beta-blocker is not sufficient.

Dorzolamide and timolol contained in Dorzolamide / Timolol Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Dorzolamide / Timolol Actavis

DO NOT use Dorzolamide / Timolol Actavis:

  • if you are allergic to dorzolamide, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have previously had any respiratory illness such as asthma, severe chronic obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or prolonged cough).
  • if you have a low heart rate, heart failure, or heart rhythm disturbances (irregular heartbeat).
  • if you have severe kidney disease or severe kidney problems or have had kidney stones in the past.
  • if the acidity of your blood is elevated due to elevated chloride levels in the blood (hyperchloraemic acidosis ).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Warnings and cautions

Talk to your doctor or pharmacist before using Dorzolamide / Timolol Actavis.

Tell your doctor about any medical problems or eye problems you have or have had in the past:

  • coronary heart disease (symptoms may include pain or pressure over the chest, shortness of breath, or difficulty breathing), heart failure, low blood pressure.
  • heart rhythm disorders that cause an abnormally slow pulse.
  • respiratory problems, asthma, or chronic obstructive pulmonary disease (COPD).
  • circulatory disorders (such as Raynaud’s disease or Raynaud’s phenomenon).
  • diabetes, because timolol can mask the signs and symptoms of low blood sugar
  • overactive thyroid gland, as timolol can mask signs and symptoms
  • if you have any muscle weakness or have been diagnosed with myasthenia gravis

Tell your doctor before an operation that you are taking Dorzolamide / Timolol Actavis, as timolol may alter the effect of certain medicines used under anesthesia.

Also tell your doctor about allergies or allergic reactions such as hives, swelling of the face, lips, tongue, and/or throat which may cause breathing and swallowing difficulties.

If you feel irritation of any kind in the eye or have other eye problems, such as. red eyes or swollen eyelids, you should contact your doctor as soon as possible.

If you suspect that Dorzolamide / Timolol Actavis is causing an allergic reaction or hypersensitivity (eg skin rash, severe skin reaction, or redness and itching of the eye), discontinue treatment and contact a doctor immediately.

Tell your doctor if you develop an eye infection, get an eye injury, undergo eye surgery, or develop a reaction with symptoms that worsen or that you have not experienced before.

Dorzolamide / Timolol Actavis eye drops can affect the whole body.

If you wear soft contact lenses, talk to your doctor before using this medicine (see ‘Dorzolamide / Timolol Actavis contains benzalkonium chloride’).

Children and young people

There is limited experience in Dorzolamide / Timolol Actavis in infants and children.

Use in the elderly

In studies with dorzolamide/timolol eye drops, the effect of this drug was similar in elderly and younger patients.

Use in patients with hepatic impairment

Tell your doctor if you have or have had any liver problems in the past.

Other medicines and Dorzolamide / Timolol Actavis

Dorzolamide / Timolol Actavis can 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, have recently taken, or might take any other medicines. This is especially important if you:

  • use medicines that lower blood pressure, to treat heart disease or to treat irregular heartbeat (such as calcium channel blockers, beta-blockers, or digoxin )
  • use other eye drops that contain beta-blockers
  • uses another carbohydrate inhibitor such as acetazolamide
  • uses monoamine oxidase inhibitors ( MAOIs )
  • use medicines you have been given for, for example, vomiting problems (parasympathomimetics). Parasympathomimetics are a type of drug that is sometimes also used to restore normal bowel movements.
  • use certain strong painkillers such as morphine to treat moderate to severe pain
  • use drugs to treat diabetes or high blood sugar
  • use antidepressant drugs called fluoxetine and paroxetine
  • use medicines containing a sulfonamide
  • use quinidine (medicines used to treat heart disease and certain types of malaria )

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Dorzolamide / Timolol Actavis if you are pregnant unless your doctor thinks it is necessary.

Do not use Dorzolamide / Timolol Actavis if you are breast-feeding. Timolol can be transferred to breast milk.

Driving and using machines

Dorzolamide / Timolol Actavis can cause side effects such as blurred vision which may affect your ability to drive or use machines. Wait to drive or use machines until you feel good or your vision is clear.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dorzolamide / Timolol Actavis contains benzalkonium chloride

This medicine contains 0.075 mg of benzalkonium chloride per milliliter.

Benzalkonium chloride can be absorbed by soft contact lenses and may discolor them. You should remove your contact lenses before using the eye drops and wait at least 15 minutes after taking the eye drops before inserting them again (see section 3 “How to use Dorzolamide / Timolol Actavis”).

Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or diseases of the cornea (the transparent membrane on the front of the eye). If you feel an abnormal feeling in the eye, burning, or pain in the eye after using this medicine, talk to your doctor.

How to use Dorzolamide / Timolol Actavis

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The appropriate dose and duration of treatment are determined by your doctor.

The recommended dose is one drop twice a day in the eye (s) to be treated, e.g. in the morning and evening.

If you use this medicine with other eye drops, the eye drops should be taken at least 10 minutes apart.

Do not change the dosage without consulting your doctor.

Make sure that the tip of the bottle does not touch the eye or the area around the eye. This can lead to contamination with bacteria, which can cause an eye infection. Such an infection can lead to serious eye damage, including loss of vision. To avoid contaminating the contents of the bottle, wash your hands before using this medicine and make sure that the tip of the bottle does not come into contact with any objects. If you think that the eye drops are contaminated or if you get an eye infection, contact your doctor as soon as possible to discuss whether you should continue to use the eye drops in the current bottle.

Instructions for use

Wash your hands before using the eye drops.

It may be easier to take the drops in front of a mirror.

How to take the drops
  1. Before using the medicine for the first time, make sure that the seal is unbroken. A gap between the bottle and the lid of an unopened bottle is normal.
  2. Remove the cap to open the bottle.
  3. Tilt your head back and pull down the lower eyelid so that a pocket is formed between the eyelid and the eye (see picture 1).
  4. Turn the bottle upside down and press lightly on the sides of the bottle until a drop has been dropped into the eye, according to the doctor’s instructions. DO NOT TOUCH THE EYE OR LID WITH THE TIP OF THE BOTTLE (see picture 1).
  5. After using this medicine, press a finger against the corner of the eye at the nose for 2 minutes (see picture 2). This helps to stop timolol from entering the rest of the body.
  6. Repeat steps 3 to 5 with one eye if your doctor has instructed you to do so.
  7. Immediately after use, put the cap on and close the bottle.

If you use more Dorzolamide / Timolol Actavis then you should  

If you have taken too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have dropped too many drops in your eye or have swallowed some of the contents of the container, you may become dizzy, have difficulty breathing, or feel your heart beating more slowly. If you suffer from any of these, you should contact a doctor immediately.

If you forget to use Dorzolamide / Timolol Actavis

It is important to always take this medicine exactly as your doctor has told you.

If you forget to take a dose, take it as soon as possible. If, on the other hand, it is time to take the next dose, skip the forgotten dose and then follow the dosing schedule.

Do not take a double dose to make up for a forgotten dose.

If you stop using Dorzolamide / Timolol Actavis

If you want to stop treatment with the medicine, first consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop using this medicine and contact your doctor immediately or go to the nearest emergency department.

  • General allergic reactions with swelling under the skin in e.g. face or on arms and legs. Such reactions can block the airways, which can make it difficult to swallow or breathe. They can also cause hives or itchy rashes, local or general rash, itching, severe sudden life-threatening allergic reaction.
  • Severe conditions with severely scaly and swollen skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms and soles of the feet, and any blisters.

In most cases, you can continue to take eye drops unless the side effects are serious. Talk to your doctor or pharmacist if you are worried. Do not stop taking this medicine without talking to your doctor.

The following side effects have been reported with Dorzolamide / Timolol Actavis or one of its active substances:

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

Burning and stinging sensation in the eye/eyes, taste changes

Common (may affect up to 1 to 10 users):

Redness in and around the eye/eyes, increased tear flow or itching in the eye/eyes, damage to the cornea (damage to the outer layer of the eye, front layer), swelling and/or irritation in and around the eye/eyes1, feeling of having something in the ey, decreased sensitivity of the cornea (does not notice that something has entered the eye and does not feel pain), eye pain, eye dryness, blurred vision, headache, sinusitis (it presses or feels full in the nose), nausea, weakness/fatigue, and fatigue

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

Dizziness, depression, inflammation of the iris, visual disturbances including refractive errors (in some cases due to discontinuation of treatment with so-called miotics), slow heart rhythm, fainting, shortness of breath, indigestion, and kidney stones

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

Systemic lupus erythematosus (an immune disorder that can cause inflammation of internal organs), tingling or numbness in the hands or feet, difficulty sleeping (nightmares), nightmares, memory loss, worsening signs and symptoms of myasthenia gravis (muscle disease), decreased sexual desire, stroke , temporary myopia that can disappear when treatment is stopped, loosening of the blood vessel-containing membrane under the retina after filtration surgery which can cause visual disturbances (loosening of the eye’s varicose veins), drooping eyelids (which makes the eye half closed), double vision, scabs around the eyelids, swelling in the cornea (with symptoms of vision change), low pressure in the eye, earrings, low blood pressure, changes in the rhythm or speed of the heartbeat, chronic heart failure(heart disease with shortness of breath, swollen feet and legs due to fluid retention), edema (fluid retention), cerebral ischemia (decreased blood supply to the brain), chest pain, severe heartbeat or rapid heartbeat ( palpitations), heart attack, Raynaud’s phenomenon (swollen or cold hands and feet and decreased blood circulation in the arms and legs), leg cramps and / or pain in the legs when walking (claudicatio), shortness of breath, impaired lung function, runny or stuffy nose, nosebleeds, contractions of the airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with white silvery appearance (psoriasis-like rash), Peyronie’s disease (which can cause a bend of the penis), weakness / fatigue, allergic reactions such as skin rash, hives , itching , in rare cases possible swelling of lips, eyes and mouth, wheezing or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis ).

Like other medicines given to the eye, Dorzolamide / Timolol Actavis is absorbed into the bloodstream. This can cause similar side effects as those seen with oral beta-blockers. The incidence of side effects when giving medicines locally in the eye is lower than when medicines are taken orally or injected, for example.

Additional noted side effects are reactions observed for the class of beta-blockers in the treatment of eye diseases.

Has been reported (occurs in an unknown number of users):

Low blood sugar, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain that is not due to exercise pain, sexual dysfunction, hallucination, and feeling of debris in the eye

5. How to store Dorzolamide / Timolol Actavis

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 bottle label and carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions

Dorzolamide / Timolol Actavis should be used within 28 days of opening the bottle. After that, discard the bottle, even if there is some solution left. Write on the box what date you opened the bottle and it will be easier to remember.

Medicines should not be disposed of 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 packaging and other information

Content declaration

  • The active substances are dorzolamide and timolol. Each milliliter contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate).
  • The other ingredients are mannitol (E421), hydroxyethylcellulose, benzalkonium chloride (as a preservative ), sodium citrate (E331), sodium hydroxide (E524) for pH adjustment, and water for injections.

What the medicine looks like and the contents of the pack

Dorzolamide / Timolol Actavis is a clear, colorless, slightly viscous aqueous solution.

Five ml Dorzolamide / Timolol Actavis eye drops are filled into a white, opaque plastic eye drop bottle, equipped with a sealed drip insert and a sealing cap with a seal.

Pack sizes: 1, 3, or 6 bottles of 5 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

FAMAR SA

Plant A

63 Agiou Dimitriou Street

174 56 Alimos

Athens, Greece

PHARMATHEN SA

Dervenakion 6

Pallini 14351

Attikis, Greece

Muhammad Nadeem

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