Dotimir

PACKAGE LEAFLET

Package leaflet: information for the patient

Dotimir 20 mg/mL + 5 mg/mL eye drops, solution

Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dotimir is and what it is used for
2. What you need to know before using Dotimir
3. How to use Dotimir
4. Possible side effects
5. How to store Dotimir
6. Contents of the pack and other information

1. What Dotimir is and what it is used for

Dotimir contains two medicines: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". These medicines reduce intraocular pressure in different ways.

Dotimir is prescribed to lower intraocular pressure in the treatment of glaucoma when therapy with beta-blocker eye drops alone is not sufficient.
Dotimir eye drops is a sterile solution that does not contain preservatives.

2. What you need to know before using Dotimir

Do not use Dotimir

• if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have previously had respiratory problems, such as asthma or severe chronic obstructive bronchitis (a severe lung disease that may cause 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 disease or kidney problems, or a history of kidney stones.
• if you have excessive blood acidity due to accumulation of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before using Dotimir. Contact your doctor if you currently have or have previously had:

• 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 syndrome).
• diabetes, because timolol may mask signs and symptoms of low blood sugar levels.
• overactive thyroid gland, because timolol may mask its signs and symptoms.
• any allergies or anaphylactic reactions.
• muscle weakness or if you have been diagnosed with myasthenia gravis.
• if you wear soft contact lenses, as Dotimir has not been studied in patients wearing contact lenses.

If you have a history of contact hypersensitivity to silver, you must not use this medicine because the dispensed drops may contain traces of silver originating from the container closure.
Before undergoing surgery, inform your doctor that you are using Dotimir, because timolol may alter the effects of certain medicines used during anesthesia.
When Dotimir is administered into the eye, it may affect the entire body.
Contact your doctor if, during treatment with Dotimir:

• you develop any eye irritation or any new eye problems such as eye redness or eyelid swelling.
• you suspect that Dotimir is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or eye redness and itching). Stop using this medicine and contact your doctor immediately.
• you develop an eye infection, suffer an eye injury, undergo eye surgery, or develop a reaction involving new or worsening symptoms.

Use in children
There is limited experience with dorzolamide-timolol (preserved formulation) in newborns and children.
Use in elderly
In studies with dorzolamide-timololo (preserved formulation), effects were similar in elderly and younger patients.
Use in patients with hepatic impairment
Inform your doctor about any liver problems you have or have had in the past.
Other medicines and Dotimir
Dotimir may interact with other medicines you are using, including other eye drops for glaucoma treatment.
Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or medicines for diabetes treatment.
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
This is particularly important especially if:

• you are taking medicines to lower blood pressure or for treating heart diseases (such as calcium antagonists, beta-blockers, or digoxin).
• you are taking medicines for treating heart rhythm disorders or irregularities such as calcium antagonists, beta-blockers, or digoxin.
• you are using another eye drop containing a beta-blocker.
• you are taking another carbonic anhydrase inhibitor, such as acetazolamide.
• you are taking monoamine oxidase inhibitors (MAOIs).
• you are taking a parasympathomimetic medicine that may have been prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal bowel movements.
• you are taking narcotic painkillers such as morphine used to treat moderate to severe pain.
• you are taking medicines for diabetes treatment.
• you are taking antidepressants known as fluoxetine and paroxetine.
• you are taking a sulfonamide medicine.
• you are taking quinidine (used to treat heart conditions and some types of malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Use during pregnancy
Do not use Dotimir during pregnancy unless your doctor considers it necessary.
Use during breastfeeding
Do not use Dotimir if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medicine while breastfeeding.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive or use machines. However, side effects associated with Dotimir, such as blurred vision, may affect your ability to drive and/or use machines. You should not drive or operate machinery until you feel well or your vision is clear.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Dotimir

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor. The appropriate dose and duration of treatment will be determined by your doctor.
Recommended dose: One drop into the affected eye or eyes, in the morning and evening.
If you are using Dotimir together with another eye drop, the drops should be administered at least 10 minutes apart.
Do not change the dose of this medicine without first consulting your doctor.
If you have difficulty administering the eye drops, ask a family member or caregiver for help.

Instructions for use
Avoid letting the tip of the multidose container touch the eye or surrounding areas. This could cause eye injury. The eye drop could also become contaminated by bacteria, which may lead to eye infections causing serious eye damage, including loss of vision. To avoid possible contamination of the multidose container, wash your hands before using this medicine and keep the tip of the multidose container away from contact with any surface.

1. Before the first use, write the date of opening in the designated space on the bottle label. Remove the protective cap before each use. Do not let the tip of the bottle touch anything.

2. At the first use of the Dotimir bottle, press several times (up to 10 times) to activate the pumping mechanism until the first drop appears. Afterwards, discard the first two drops as well. During this process, hold the bottle upside down as shown in the picture. This applies only for the first use and is not required for subsequent uses. Please avoid any contact between the dropper tip, fingers, and the eye.

3. Hold the bottle as shown in the picture. Make sure your thumb rests on the wide, non-slip finger support.

4. Tilt your head slightly backwards (neck position) and use your free hand to gently pull down the lower eyelid. Administer one drop of Dotimir into the conjunctival sac of the affected eye by pressing the pump mechanism once. Ensure the bottle is held vertically.

5. Close the eye and press gently on the inner corner of the eye with your finger for about two minutes. This helps prevent the medicine from entering the rest of the body.
6. Repeat steps 3 and 4 to administer one drop into the other eye, if your doctor has instructed you to do so. Sometimes only one eye needs to be treated, and your doctor will inform you if this applies to you and which eye requires treatment.

After using the multidose container, replace the protective cap. Wipe away any excess liquid from the skin around the eyes.
Once opened, the bottle may be used for 2 months. After this time, the bottle must be discarded, even if some solution remains.

If you use more Dotimir than you should
If you instill too many drops into the eye or accidentally swallow the contents of the container, you may experience, among other effects, dizziness, difficulty breathing, or a slowed heart rate. Seek immediate medical attention.

If you forget to use Dotimir
It is important to use Dotimir as prescribed by your doctor.
If you miss a dose, administer it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

If you stop using Dotimir
If you wish to stop using this medicine, discuss it with your doctor first.
If you have any doubts about how to use 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 of the following side effects, stop using this medicine and consult a doctor immediately, as these may be signs of a reaction to the medicine.

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

• Chest pain, oedema (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), cardiac arrest, heart block, low blood pressure, cerebral ischaemia (reduced blood supply to the brain), stroke.
• Shortness of breath, respiratory failure, airway constriction in the lungs.
• Signs and symptoms of systemic allergic reactions, including angioedema, urticaria, itching, rash, anaphylaxis.
• Severe skin reactions, including swelling under the skin.

Other side effects:
You can usually continue using the drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Dotimir without first discussing it with your doctor.
The following side effects have been reported with dorzolamide/timolol or one of its components during clinical trials or post-marketing experience:

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

• Burning or stinging sensation in the eyes, altered taste.

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

• Eye effects: redness inside and around the eyes, tearing or itchy eyes, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation inside and around the eyes, sensation of a foreign body in the eye, reduced corneal sensitivity (inability to notice something in the eye or to feel pain), eye pain, dry eyes, blurred vision.
• General side effects: headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness/tiredness and fatigue.

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

• Eye effects: inflammation of the iris, visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy).
• General side effects: dizziness, depression, slow heart rate, fainting, difficulty breathing (dyspnea), indigestion, and kidney stones.

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

• Eye effects: temporary myopia which may resolve upon discontinuation of treatment, 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 intraocular pressure.
• General side effects: strong heartbeat that may be fast or irregular, Raynaud's phenomenon, swelling or cold sensation in hands and feet and reduced blood circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), cough, throat irritation, dry mouth, insomnia, nightmares, memory loss, tingling or numbness in hands or feet, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs), tinnitus, rhinitis, nosebleeds, diarrhoea, contact dermatitis, hair loss, silvery-white skin rash (psoriasiform rash), Peyronie’s disease (which may cause penile curvature), allergic-type reactions such as rash, urticaria, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. The incidence of side effects after local ophthalmic administration is lower than when medicines are taken, for example, orally or by injection. Additional side effects listed include those observed within the class of beta-blockers when used to treat ocular conditions:

Not known (frequency cannot be estimated from the available data):
Low blood sugar levels, abdominal pain, vomiting, muscle pain not caused by physical exercise, sexual dysfunction, hallucinations, 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, and 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 the national reporting system at: 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 Dotimir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening the bottle, the solution can be used for 2 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Dotimir contains

• The active substances are dorzolamide and timolol.
• Each mL contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (equivalent to 6.83 mg of timolol maleate). One drop (approximately 0.028 mL) contains approximately 0.56 mg of dorzolamide and 0.14 mg of timolol.
• The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

Description of the appearance of Dotimir and pack contents
Dotimir is a clear, colourless to almost colourless, slightly viscous solution supplied in a
white multidose container (HDPE) with a dropper (PP, HDPE, LDPE) and cap (HDPE), together with an
ergonomic aid for application (PP).
Pack sizes:
1 x 5 mL bottle
1 x 9 mL bottle
2 x 9 mL bottles
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano, Italy

Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22, 00071 Pomezia (Rome), Italy

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Austria DorzoComp-Vision sine 20 mg/mL + 5 mg/mL eye drops, solution
France Dotimir 20 mg/5 mg per mL, eye drops in solution
Germany DorzoComp-Vision sine 20 mg/mL + 5 mg/mL eye drops, solution
Italy Dotimir 20 mg/mL + 5 mg/mL eye drops, solution
Spain Dotimir 20 mg/mL + 5 mg/mL eye drops, solution