Cosopt pf multi

Patient Information Leaflet

Cosopt PF Multi, 20 mg/ml + 5 mg/ml, eye drops, solution
Dorzolamide + Timolol
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Cosopt PF Multi is and what it is used for
2. Important information before using Cosopt PF Multi
3. How to use Cosopt PF Multi
4. Possible side effects
5. How to store Cosopt PF Multi
6. Contents of the pack and other information

1. What Cosopt PF Multi is and what it is used for

Cosopt PF Multi 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 PF Multi 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.
Cosopt PF Multi eye drops are a sterile solution that does not contain preservatives.

2. Important information before using Cosopt PF Multi

When not to use Cosopt PF Multi

• 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 condition that may cause wheezing, breathing difficulties, and/or a long-lasting cough);
• if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat);
• if the patient has severe kidney disease or severe impairment of kidney function, or a history of kidney stones;
• if the patient has hyperchloremic acidosis (excessive blood acidity due to accumulation of chloride ions in the body).

If in doubt whether this medicine can be used, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Cosopt PF Multi, discuss with your doctor if you currently have or have previously had:

• ischemic heart disease (symptoms include chest pain or pressure, shortness of breath, or a feeling of suffocation), 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 blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, because timolol may mask the subjective and objective symptoms of hypoglycemia (low blood sugar);
• hyperthyroidism, because timolol may mask its subjective and objective symptoms;
• any allergies or anaphylactic reactions;
• muscle weakness or diagnosed myasthenia gravis (Myasthenia gravis);
• if the patient wears soft contact lenses, as studies on the use of Cosopt PF Multi in patients wearing contact lenses have not been conducted.

Patients with a history of contact hypersensitivity to silver should not use this medicinal product, as the drops may contain trace amounts of silver from the container.
Before undergoing surgery, inform the attending physician about the use of Cosopt PF Multi, as timolol may alter the effects of certain anesthetic drugs.
After ocular administration, Cosopt PF Multi may cause systemic effects.
During treatment with Cosopt PF Multi, inform your doctor:

• if eye irritation or any new eye problem occurs, such as eye redness or eyelid swelling;
• if the patient suspects that Cosopt PF Multi is causing an allergic or hypersensitivity reaction (e.g., skin rash, severe skin reaction, or skin redness and itchy eyes), the use of this medicine should be discontinued and the patient should contact a doctor immediately;
• if an eye infection develops, an eye injury occurs, eye surgery is performed, or if a reaction occurs accompanied by new symptoms or worsening of existing symptoms.

Children and adolescents
Experience with the use of COSOPT (preserved formulation) in infants and children is limited.
Use in elderly patients
In clinical studies with COSOPT (preserved formulation), effects were similar in elderly patients and younger patients.
Use in patients with liver function disorders
Inform your doctor about any current or past liver diseases.
Cosopt PF Multi and other medicines
Cosopt PF Multi may affect the action of other medicines, or other medicines taken by the patient may affect the action of Cosopt PF Multi. 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 antidiabetic 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 if:

• 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 in urinary disorders; parasympathomimetic drugs are also sometimes used to restore normal intestinal motility;
• taking opioid drugs such as morphine, used to treat moderate to severe pain;
• taking antidiabetic drugs;
• taking antidepressants such as fluoxetine and paroxetine;
• taking chemotherapeutic sulfonamides;
• taking quinidine (a drug used in the treatment of heart conditions and certain forms of malaria).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use during pregnancy
Cosopt PF Multi should not be used during pregnancy unless considered necessary by a doctor.
Use during breastfeeding
Cosopt PF Multi should not be used during breastfeeding. Timolol may pass into breast milk.
Driving and operating machinery
No studies have been conducted on the effects on the ability to drive or operate machinery. Some adverse effects associated with the use of Cosopt PF Multi, such as blurred vision, may affect the ability to drive and/or operate machinery. Patients who feel unwell or have blurred vision should not drive or operate machinery.

3. How to use Cosopt PF Multi

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist. Your doctor will determine the correct dose and duration of treatment.
The recommended dose is one drop into the affected eye(s) in the morning and evening.
If you are using other eye drops in addition to Cosopt PF Multi, you should wait at least 10 minutes before applying the next medicine.
Do not change the dose of this medicine without consulting your doctor.
If you have difficulty administering the drops, ask a family member or caregiver for help.
Do not allow the tip of the multidose container to touch the eye or surrounding area. This could lead to eye injury, as well as bacterial contamination of the container, which may result in eye infection causing serious damage and even loss of vision. To avoid possible contamination of the multidose container, always wash your hands before using this medicine and avoid contact between the tip of the container and any surface.

Instructions for use
Before administering eye drops:

• Wash your hands before opening the bottle.
• Do not use the medicine if the safety ring around the neck of the bottle is damaged before first use.
• At first use, before applying the drops to the eye, the patient should test the dropper bottle by gently squeezing it until one drop is dispensed away from the eye.
• If the patient is confident they can administer a single drop, they should assume the most comfortable position for instillation (sitting, lying on the back, or standing in front of a mirror).
• When opening the bottle for the first time, discard the first drop away from the eye.

Instillation of the medicine:

1. Hold the bottle directly below the cap and open it by unscrewing the cap. Do not touch the dropper tip to any surface to avoid contaminating the solution.

2. Tilt your head backward and hold the bottle over the eye.
3. Pull the lower eyelid downward and look upward. Gently squeeze the bottle so that one drop falls into the eye. Note that it may take a few seconds after squeezing the bottle for the drop to appear. Do not squeeze too hard.

4. Close the eye and press gently 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.

5. To instill the medicine into the second eye, if directed by your doctor, repeat steps 2 to 4. Consult your doctor about how to use this medicine, as sometimes only one eye requires treatment.
6. After each use, shake the bottle downward to remove any remaining solution from the dropper tip. Do not touch the dropper tip. This is necessary to ensure continued proper dispensing.

7. Wipe away any excess solution from the skin around the eyes.
8. After 2 months of using Cosopt PF Multi, a small amount of solution will remain in the bottle. Do not attempt to use the remaining medicine left in the bottle. Do not use this medicine for longer than 2 months after first opening the bottle.

If you have any doubts about how to use the medicine, consult your doctor, pharmacist, or nurse.
If you use more Cosopt PF Multi than you should
If too many drops are instilled into the eye or if the contents of the container are swallowed, symptoms such as dizziness, breathing difficulties, or a sensation of slowed heart rate may occur. Contact your doctor immediately.
If you forget to use Cosopt PF Multi
Cosopt PF Multi should be used as directed 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 administer the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.
Stopping Cosopt PF Multi
Before stopping the medicine, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects:
If any of the following adverse effects occur, you should stop using this
medicine and seek immediate medical help, as these may be symptoms of a reaction to the medicine.
Rare (may affect up to 1 in 1,000 people):

• Chest pain, swelling (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (a heart condition causing breathlessness and swelling of the feet and legs due to fluid accumulation), cardiac arrest, heart block, low blood pressure, cerebral ischemia (reduced blood flow to the brain), stroke.
• Shortness of breath, respiratory failure, narrowing of the airways in the lungs.
• Objective and subjective symptoms of systemic allergic reactions, including angioedema, urticaria, itching, rash, anaphylaxis.
• Severe skin reactions, including subcutaneous swelling.

Other adverse effects:
Treatment with eye drops can usually be continued unless the adverse effects are severe. If concerned, contact your doctor or pharmacist. Do not stop treatment with Cosopt PF Multi without consulting your doctor.
The following adverse effects have been reported during clinical studies or after the medicine has been placed on the market and are associated with Cosopt PF Multi or one of its components:
Very common (may affect more than 1 in 10 people)
Sensation of burning and stinging in the eye, altered taste sensation.
Common (may affect up to 1 in 10 people)

• Eye-related adverse effects: Redness of the eyeballs and skin around the eyes, tearing or itchy eyes, corneal abrasions (damage to the front layer of the eyeball), swelling and/or irritation of the eyeballs and skin around the eyes, sensation of a foreign body in the eye, decreased corneal sensitivity (inability to feel a foreign body in the eye), eye pain, dry eyes, blurred vision.
• General adverse effects: Headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness and feeling of fatigue.

Uncommon (may affect up to 1 in 100 people)

• Eye-related adverse effects: Iritis, visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs).
• General adverse effects: Dizziness, depression, bradycardia, fainting, shortness of breath, indigestion, and kidney stones.

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

• Eye-related adverse effects: Transient myopia, which may resolve after discontinuation of the medicine, retinal detachment following filtering procedures of the layer beneath the retina containing blood vessels, possibly causing visual disturbances, ptosis (drooping eyelid, with eyelids half-closed), double vision, formation of crusts on the eyelids, corneal edema (with subjective symptoms of visual disturbance), low intraocular pressure.
• General adverse effects: Palpitations, which may be fast or irregular (pounding heartbeat), Raynaud's disease, swelling of hands and feet or cold hands and feet and poor circulation in the upper and lower limbs, leg muscle cramps and/or leg pain while walking (claudication), cough, throat irritation, dry mouth,

insomnia, nightmares, memory loss, tingling or numbness in hands or feet,
worsening of objective and subjective symptoms of myasthenia (muscle disorder),
decreased libido, systemic lupus erythematosus (an autoimmune disease
which may cause inflammation of internal organs), tinnitus, rhinitis (nasal inflammation),
nosebleeds, diarrhea, contact dermatitis, hair loss, white-silvery rash (psoriasiform rash),
Peyronie's disease (which may lead to penile curvature), allergic reactions such as
rash, urticaria, itching, and in rare cases, swelling of the lips, eyelids, and oral cavity, wheezing.
Like other medicines administered locally to the eyes, timolol is absorbed into the bloodstream, which
may result in adverse effects similar to those observed after oral administration of beta-adrenergic
receptor blocking medicines. Adverse effects occur less frequently with topical eye drops than with
oral or injectable administration of these medicines.
Among the additional adverse effects listed above are reactions typical of the therapeutic class of
beta-adrenergic blocking agents used in ophthalmic disorders.
Unknown (frequency cannot be estimated from available data)
Low blood sugar levels, abdominal pain, vomiting, muscle pain not related to physical exertion,
sexual dysfunction, hallucinations, sensation of a foreign body in the eye (feeling that something is
in the eye), increased heart rate and elevated blood pressure.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Cosopt PF Multi

Keep this medicine out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
After first opening the bottle, the solution can be used for 2 months. The bottle must be tightly closed.
Do not use the medicinal product if the container's seal is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cosopt PF Multi contains

• The active substances are dorzolamide and timolol. Each milliliter of solution contains 20 mg of dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (6.83 mg of timolol maleate).
• Other components are: sodium citrate, hydroxyethylcellulose, mannitol, sodium hydroxide (for pH adjustment), and water for injections.

What Cosopt PF Multi looks like and contents of the pack
Cosopt PF Multi is a clear, colourless or almost colourless, slightly viscous solution, practically free from visible solid particles. The solution is contained in a white plastic bottle with a white Novelia dropper and a white protective cap.
Pack sizes: 1, 2 or 3 bottles containing 10 ml of solution each, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
Tubilux Pharma S.P.A.
Via Costarica 20/22
00071 Pomezia (Roma)
Italy
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: