Cosopt
Poland
Table of Contents
Patient Information Leaflet: Instructions for the User
Cosopt, (20 mg + 5 mg)/ml, eye drops, solution
Dorzolamide + Timolol
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of Contents
- What Cosopt is and what it is used for
- Important information before using Cosopt
- How to use Cosopt
- Possible side effects
- How to store Cosopt
- Contents of the pack and other information
1. What Cosopt is and what it is used for
Cosopt contains two active substances: dorzolamide and timolol.
- Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
- Timolol belongs to a group of medicines known as "beta-adrenergic receptor blockers" (beta-blockers). These medicines reduce intraocular pressure through two different mechanisms.
Cosopt is indicated for the treatment of glaucoma to reduce elevated intraocular pressure when treatment with eye drops containing only a beta-adrenergic receptor blocker is insufficient.
2. Important information before using Cosopt
When not to use Cosopt
- if the patient is allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
- if the patient currently has or has previously had respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, breathing difficulties, and/or persistent cough);
- if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat);
- if the patient has severe kidney disease, significantly impaired kidney function, or a history of kidney stones;
- if the patient has excessive blood acidity due to accumulation of chloride ions in the body (hyperchloremic acidosis).
If in doubt whether this medicine can be used, consult a doctor.
Warnings and precautions
Before starting treatment with Cosopt, discuss it with your doctor or pharmacist.
Inform your doctor about any current or past eye disorders or medical conditions, including:
- ischemic heart disease (symptoms include chest pain or pressure, shortness of breath, or a choking sensation), heart failure, or low blood pressure;
- disturbances in heart rate, such as bradycardia;
- breathing problems, asthma, or chronic obstructive pulmonary disease;
- conditions associated with poor circulation (such as Raynaud's disease or Raynaud's phenomenon);
- diabetes, because timolol may mask the signs and symptoms of hypoglycemia (low blood sugar levels);
- hyperthyroidism, because timolol may mask its signs and symptoms.
Before undergoing surgery, inform the attending physician that you are using Cosopt, as timolol may alter the effects of certain anesthetic agents.
Also inform your doctor about any allergies or allergic reactions, including hives, facial swelling, swelling of the lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if the patient experiences muscle weakness or has been diagnosed with myasthenia gravis (Myasthenia gravis).
If eye irritation or any new eye problem occurs, such as eye redness or eyelid swelling, consult a doctor immediately.
If the patient suspects that Cosopt is causing an allergic reaction or hypersensitivity (e.g. skin rash, severe skin reaction, eye redness, or itching), discontinue use of this medicine and contact a doctor immediately.
Inform your doctor if an eye infection occurs, the eye is injured, after eye surgery, or if new symptoms appear or existing symptoms worsen.
After administration into the eye, Cosopt may cause systemic effects.
Children
Experience with the use of Cosopt in infants and children is limited.
Elderly patients
In clinical studies, Cosopt produced similar effects in elderly and younger patients.
Patients with liver function disorders
Inform your doctor about any current or past liver diseases.
Cosopt and other medicines
Cosopt may affect the action of other medicines, or other medicines taken by the patient may affect the action of Cosopt. This also applies to other ophthalmic anti-glaucoma medications. Inform your doctor if you are taking or plan to take medicines that lower blood pressure, heart medications, or anti-diabetic drugs. Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use. This is particularly important when:
- taking medicines that lower blood pressure or are used for heart conditions (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
- taking medicines used for cardiac arrhythmias or to restore normal heart rhythm (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
- using other eye drops containing beta-adrenergic receptor antagonists;
- taking other carbonic anhydrase inhibitors, such as acetazolamide;
- taking monoamine oxidase inhibitors (MAOIs);
- taking parasympathomimetic (cholinergic) drugs, which may be used for urinary disorders. Parasympathomimetic drugs are also sometimes used to restore normal intestinal motility;
- taking narcotics such as morphine, used to treat moderate to severe pain;
- taking anti-diabetic medicines;
- taking antidepressants such as fluoxetine and paroxetine;
- taking chemotherapeutic sulfonamides;
- taking quinidine (a medicine used to treat heart conditions and certain forms of malaria).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy.
Do not use this medicine while breastfeeding. Timolol may pass into human milk. Consult a doctor before taking any medicine during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of Cosopt on the ability to drive or operate machinery. Some adverse effects associated with the use of Cosopt, such as blurred vision, may affect the ability to drive and/or operate machinery. Patients should not drive or operate machinery until these symptoms have completely resolved.
Cosopt contains benzalkonium chloride
This medicine contains approximately 0.002 mg of benzalkonium chloride per drop, equivalent to 0.075 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses should be removed before instilling the drops and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations occur in the eye, such as stinging or pain after using the medicine, contact a doctor.
3. How to use Cosopt
This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your doctor.
The usual dose is one drop instilled into the conjunctival sac of the affected eye(s) in the morning and evening.
If another ophthalmic medicine is being used in addition to Cosopt, at least 15 minutes should be left between instilling the different eye drops. Ointments should always be applied last.
Do not change the dose of this medicine without consulting your doctor.
Do not allow the dropper tip to touch the eye or surrounding areas. The medicine may become contaminated with bacteria which could cause an eye infection leading to serious damage to the eye, and even loss of vision. To avoid possible contamination, wash your hands before using this medicine and avoid contact between the dropper tip and any surface. If you suspect the medicine may have become contaminated or if you develop an eye infection, contact your doctor immediately regarding continued use of the current container.
Instructions for use
Bottle with dropper
Do not use if the plastic tamper-evident band around the neck of the bottle is broken or missing. When opening the bottle for the first time, remove the plastic tamper-evident band.
Before each use of Cosopt:
- Wash your hands
- Open the bottle. Take special care to ensure the dropper does not touch the eye, skin around the eyes, fingers, or any other surface.
- Tilt your head back and hold the bottle upside down over the eye.
- Pull the lower eyelid down and look
upwards. Gently squeeze the bottle to release a single drop into the space between the lower eyelid and the eye.
- 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 being absorbed into the rest of the body.
- To instil the medicine into the second eye, if recommended by your doctor, repeat steps 3 to 5.
- Replace the cap and close the bottle tightly.
Use of more Cosopt than prescribed
If too many drops are instilled into the eye or if the contents of the bottle are swallowed, symptoms such as dizziness, breathing difficulties, or a sensation of slowed heartbeat may occur. Seek immediate medical advice.
Missing a dose of Cosopt
Cosopt should be used exactly as prescribed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Cosopt
Do not stop using this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Adverse reactions:
If any of the following adverse reactions occur, stop using this medicine and seek immediate medical help, as these may be symptoms of a drug reaction.
Generalised allergic reactions, including subcutaneous swelling, may occur in the areas of the face and limbs and may cause airway obstruction and difficulty swallowing, breathlessness, urticaria or itchy rash, localised and generalised rash, itching, and severe, sudden and life-threatening allergic reaction.
Treatment with eye drops can usually be continued unless the adverse reactions are severe. If in doubt, consult a doctor or pharmacist. Do not stop using Cosopt without consulting your doctor.
The frequency of possible adverse reactions listed below is defined according to the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
During clinical studies or after marketing of the medicine, the following adverse reactions have been reported with Cosopt or with one of its active ingredients:
Very common:
Sensation of burning and stinging in the eye, altered taste sensation.
Common:
Redness of the eyes and skin around the eyes, tearing or itchy eyes, corneal abrasion (damage to the front layer of the eyeball), swelling and/or irritation of the eyes and skin around the eyes, foreign body sensation in the eye, decreased corneal sensitivity (inability to feel a foreign body in the eye or inability to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness and feeling of fatigue.
Uncommon:
Dizziness, depression, uveitis, visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs), bradycardia (slowed heart rate), fainting, breathlessness, dyspepsia, and nephrolithiasis (kidney stones).
Rare:
Systemic lupus erythematosus (an autoimmune disease which may cause inflammation of internal organs), tingling or numbness of hands or feet, insomnia, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia (a muscle disorder), decreased libido, stroke, transient myopia which may resolve after discontinuation of the medicine, retinal detachment following filtration surgery of the layer beneath the retina containing blood vessels, which may cause visual disturbances, ptosis (drooping eyelid, eyelid half-closed), double vision, formation of crusts on the eyelids, corneal edema (with subjective visual disturbances), low intraocular pressure, tinnitus, hypotension (low blood pressure), changes in heart rhythm or rate, congestive heart failure (a heart condition characterised by breathlessness and swelling of feet and legs due to fluid accumulation), oedema (fluid accumulation), cerebral ischaemia (reduced blood flow to the brain), chest pain, strong, possibly rapid or irregular heartbeat (palpitations), myocardial infarction, Raynaud's disease, swelling of hands and feet or cold hands and feet and poor circulation in upper and lower limbs, leg muscle cramps and/or leg pain while walking (claudication), breathlessness, respiratory failure, rhinitis (nasal inflammation), nosebleeds, narrowing of airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, silvery-white rash (psoriasis-like rash), Peyronie's disease (which may lead to penile curvature), allergic reactions such as rash, urticaria, itching, and in rare cases, swelling of lips, eyelids and oral cavity, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Like other medicines administered locally to the eyes, timolol is absorbed into the bloodstream, which may result in adverse reactions similar to those observed after oral administration of beta-blocking agents. Adverse reactions occur less frequently after topical application of eye drops than after systemic administration, for example orally or by injection.
Among the additional adverse reactions listed above, reactions typical of the therapeutic class of beta-adrenergic blocking agents used in eye diseases have been included.
Not known:
Low blood sugar levels, heart failure, cardiac rhythm disturbances, abdominal pain, vomiting, muscle pain not related to physical exertion, sexual dysfunction, hallucination, foreign body sensation in the eye (feeling that something is in the eye), unusual sensitivity of the eyes to light, increased heart rate and elevated blood pressure.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store the medicine Cosopt
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (six digits following the abbreviation "EXP"). The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month.
Store below 25°C, in the outer packaging, to protect from light.
Period of use after first opening of the bottle: 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps protect the environment.
6. Contents of the pack and other information
What Cosopt contains
- The active substances in this medicinal product are dorzolamide and timolol.
- Each millilitre of solution contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
- Other components are: benzalkonium chloride, hydroxyethylcellulose, mannitol, disodium citrate dihydrate, sodium hydroxide, water for injections.
What Cosopt looks like and contents of the pack
Cosopt is a clear, colourless or almost colourless, slightly viscous solution.
Cosopt is available in a white, semi-transparent bottle with a transparent dropper tip and a white cap, containing 5 ml of solution.
An unbroken security band on the bottle label indicates that the product has not been used.
Pack sizes:
1 x 5 ml (1 bottle of 5 ml)
3 x 5 ml (multipack containing 3 bottles of 5 ml each)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer/Importer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland