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

1. What Cosopt sine is and what it is used for

Cosopt sine contains two drug substances: dorzolamide and timolol.

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

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

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

Cosopt sine is a sterile solution that does not contain preservatives.

Dorzolamide and timolol contained in Cosopt sine 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.

2. What you need to know before using Cosopt sine

Do not use Cosopt sine

  • if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6)
  • if you have now or previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease that can 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 kidney stones
  • 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 before using Cosopt sine if you have or have had:

  • coronary heart disease (symptoms may include chest pain or pressure over the chest, shortness of breath, or suffocation), heart failure, low blood pressure
  • heart rhythm disorders such as low heart rate
  • respiratory distress, asthma, or chronic obstructive pulmonary disease (COPD)
  • a disease that involves poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
  • diabetes, because timolol can mask the signs and symptoms of low blood sugar
  • the overactive thyroid gland, as timolol can obscure the signs and symptoms of this
  • any allergies or anaphylactic reactions
  • muscle weakness or you have been diagnosed with myasthenia gravis (muscle disease)
  • if you wear soft contact lenses. Cosopt sine has not been studied in patients using contact lenses.

If you have a contact allergy to silver, do not use this medicine as the drops may contain traces of silver from the cork of the container.

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

COST eye drops can affect the whole body.

Talk to your doctor if you are taking Cosopt sine:

  • feels irritation of any kind in the eye or has other eye problems, such as red eyes or swollen eyelids.
  • suspects that Cosopt sine causes an allergic reaction or hypersensitivity (eg skin rash, severe skin reaction, or redness and itching of the eye). Discontinue treatment and contact a doctor as soon as possible.
  • develops an eye infection, gets an eye injury, undergoes eye surgery, or develops a reaction with symptoms that worsen or that you have not experienced before.

Use in children

Experience in the treatment of infants and children with Cosopt (containing preservatives ) is limited.

Use in the elderly

In studies with Cosopt (containing preservatives ), the effect was comparable 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 Cosopt sine

Cosopt sine can affect or be affected by other medicines you use, including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or plan to take medicines that lower your blood pressure heart medicine, or medicines used to treat diabetes  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 or to treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin )
  • use drugs to treat irregular heartbeats such as calcium channel blockers, beta-blockers, or digoxin
  • use other eye drops that contain a beta-blocker
  • 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
  • use drugs to treat diabetes
  • use antidepressant drugs called fluoxetine and paroxetine
  • use medicines containing a sulfonamide
  • uses quinidine (used to treat heart conditions and certain types of malaria ).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Do not use Cosopt sine if you are pregnant unless your doctor considers it necessary.

Breast-feeding

Do not use Cosopt sine if you are breast-feeding. Timolol can be excreted in your breast milk. Ask your doctor for advice before taking any medicine while you are breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Cosopt sine 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 increased 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, nurse, or pharmacist.

3. How to use Cosopt sine

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 a drop morning and evening in the eye (s) to be treated.

If Cosopt sine is used with other eye drops, the eye drops should be taken at least 10 minutes apart.

Do not change the dosage without consulting a doctor.

If you have difficulty taking your eye drops, ask for help from a family member or caregiver.

Make sure that the tip of the multi-dose container does not touch the eye or the area around the eye. It can hurt your eye. It can also 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 contamination of the multi-dose container, wash your hands before using this medicine and the tip of the multi-dose container should not touch other surfaces.

Instructions for use

Before using eye drops:

  • Wash your hands before opening the bottle.
  • Do not use this medicine if the seal on the neck of the bottle is broken before using it for the first time.
  • When using the bottle for the first time and before dropping a drop in the eye, practice using the bottle. Gently press the bottle so that a drop appears. Aim the bottle away from the eye.
  • When you are sure that you can drip one drop at a time, choose the position that feels most comfortable for you to drip the drops (you can sit, lie down on your back, or stand in front of a mirror).
  • Each time you open a new bottle, drip a drop away from the eye to activate the bottle.

Do this:

  1. Hold the bottle just below the cap and turn the cap to open the bottle. Do not touch the bottle tip to prevent contamination of the solution.
  2. Tilt your head back and hold the bottle above your eye.
  3. Pull down the lower eyelid and lookup. Press lightly in the middle of the bottle and let a drop fall into the eye. Note that it may take a few seconds for the drop to come out after you press the bottle. Do not press too hard.
  4. Close the eye and press with a finger in the inner corner of the eye for about two minutes. This way you avoid the solution getting into the rest of the body.
  5. Repeat steps 2-4 to drip a drop into the other eye, even if your doctor has told you to. Sometimes only one eye needs to be treated and the doctor will tell you if this applies to you and which eye should be treated.
  6. After each use and before screwing on the cap, shake the bottle down once without touching the drip tip to remove any liquid that may have remained on the tip. This is necessary for the following drops to be able to be dropped. 
  7. Wipe off any solution that may have ended up on the skin around the eye.
  8. After the shelf life has expired after 2 months, there will be some Cosopt sine left in the bottle. Do not try to use the amount left in the bottle after completing the treatment. Do not use the eye drops more than 2 months after the first opening of the bottle.

If you are not sure how to use this medicine, ask your doctor, pharmacist, or nurse.

If you take more Cosopt sine than you should

If you have ingested too much medicine or if, for example, a child has accidentally 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 the eye or have swallowed some of the contents of the container, you can e.g. become dizzy, have difficulty breathing, or feel your heart beating slower.

If you forget to take Cosopt sine

It is important to take Cosopt sine according to your doctor’s instructions.

If you forget to take a dose, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and then follow your usual dosing schedule.

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

If you stop using Cosopt sine

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.

Serious side effects:

If you get any of the following side effects stop using this medicine and seek medical attention immediately as these may be signs of a drug reaction.

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

  • chest pain, edema (fluid retention), changes in rhythm or rate of the heartbeat, heart failure (heart disease with shortness of breath, swelling of the feet and legs due to fluid retention), heart attack, heart block, low blood pressure, cerebral ischemia (reduced blood supply to the brain), stroke
  • shortness of breath, impaired breathing, airway constriction.
  • signs and symptoms of systemic allergic reactions, such as angioedema (swelling of the lips, eyelids, face, tongue, and throat), hives, itching, rash, anaphylactic reaction (severe allergic reaction ).
  • severe skin reactions including swelling under the skin.

Other side effects:

You can usually continue to use the drops unless the side effects are severe. If you have any further questions, ask your doctor or pharmacist. Do not stop using Cosopt sine without talking to a doctor.

The following side effects have been reported with Cosopt sine or any of its ingredients, either in clinical trials or after the drug has started to be sold:

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

  • Burning and stinging sensation in the eyes, taste changes

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

  • Effects in the eye: 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), swelling and/or irritation in or around the eye/eyes feeling of having received something in the eye, decreased sensitivity of the cornea (do not notice that anything has entered the eye), eye pain, eye dryness, blurred vision
  • General side effects: headache, sinusitis (it presses or feels full in the nose), nausea, weakness/fatigue.

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

  • Effects in the eye: inflammation of the iris, visual disturbances including refractive errors (sometimes due to discontinuation of treatment with pupil astringent)
  • Common side effects: dizziness, depression, low heart rate, fainting, shortness of breath, indigestion, and kidney stones.

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

  • Effects in the eye: temporary myopia that may disappear when treatment is stopped, loosening of the blood vessel-containing membrane under the retina after filtration surgery which may cause visual disturbances, drooping eyelids (causing the eye to be half-closed), double vision, crusting on the eyelids, swelling in the cornea (with symptoms of visual disturbance), low pressure in the eye
  • Common side effects: severe heartbeat which may be fast or irregular (palpitations), Raynaud’s phenomenon (swelling or cold hands and feet and decreased blood circulation in the arms and legs), leg cramps, and/or pain in the legs when walking (claudication), dry mouth, cough, throat irritation, dry mouth, difficulty falling asleep, nightmares, memory loss, tingling or numbness in the hands or feet, aggravated signs and symptoms of myasthenia gravis (muscle disease), decreased sexual desire, systemic lupus erythematosus ( SLE, an immune disease that can cause inflammation of internal organs), earrings, runny or stuffy nose, nosebleeds, diarrhea, contact dermatitis(skin inflammation), hair loss, rash with a silvery appearance (psoriasis-like rash), Peyronie’s disease (which can cause a bend of the penis), reactions of an allergic-type such as skin rash, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, hissing breathing.

Like other medicines given to your eyes, timolol is absorbed into your 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 levels, abdominal pain, vomiting, muscle pain that is not caused by exercise, sexual dysfunction, hallucination, and feeling of debris in the eye.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Cosopt sine

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

Do not store above 25 ° C.

The solution is a sturdy 2 Month rafter first opening of the bottle. Close the bottle tightly. 

Do not use this medicine if you notice that the sealing ring around the neck of the bottle is broken when you use the bottle for the first time. 

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 . One ml contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate).
  • The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection.

What the medicine looks like and the contents of the pack

Cosopt sine is a clear, colorless to almost colorless, slightly viscous solution largely free of visible particles. It is supplied in a white plastic bottle with a white Novelia drip applicator and a white plastic screw cap with a sealing ring.

Pack sizes: 1, 2, or 3 bottles in a carton.

Not all pack sizes may be available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer:

Tubilux Pharma

Via Costarica 20

00071 Pomezia (Rome)

Italy

or

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

This medicinal product is authorized under the European Economic Area under the names: Show larger

Austria, Bulgaria, Croatia, Cyprus, Greece, Portugal, Spain COST multi
Belgium, Luxembourg COSOPT Sine Conservans
Czech Republic COST Multi-Dose without preservative
Denmark COST its unpreserved
Estonia, Finland, France, Germany, Iceland, Norway COST sine
Hungary COST Multi
Ireland, United Kingdom COST Multi Preservative Free
Italy COST
Latvia Lithuania COST PF
Poland COST PF Multi
Romania COSOPT fara conservant
Slovakia COST Multi-Dose Free
Slovenia COSOPT brez konzervansa
Netherlands COST Multidose preservative-free

Muhammad Nadeem

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