Olatalin

Patient Information Leaflet: Information for the User

Olatalin 20 mg/ml + 5 mg/ml eye drops, solution

dorzolamide/timolol
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Olatalin is and what it is used for

Olatalin contains two active substances: dorzolamide and timolol. Olatalin is available as a sterile preservative-free ophthalmic solution.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". Together, these medicines reduce the pressure inside the eye in different ways.

Olatalin is prescribed to lower intraocular pressure in the treatment of glaucoma when beta-blocker eye drops used alone are not sufficient.

2. What you need to know before using Olatalin

Do not use Olatalin

• 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 or have previously had breathing problems such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing and/or long-lasting cough),
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats),
• if you have severe kidney problems or a history of kidney stones,
• if you have excess acidity in the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether you should use Olatalin, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Olatalin.
Inform your doctor of any medical or eye conditions you currently have or have had in the past, especially if you have:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure,
• respiratory rhythm disorders such as slow heartbeat,
• breathing problems, asthma or chronic obstructive lung disease,
• poor blood circulation (such as Raynaud's disease or syndrome),
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia,
• overactive thyroid gland, as timolol may mask its signs and symptoms,
• any allergies or anaphylactic reactions,
• muscle weakness or a diagnosis of myasthenia gravis.

Before undergoing surgery, inform your doctor that you are using Olatalin, as timolol may alter the effect of certain medicines used during anesthesia.
Contact your doctor if, during treatment with Olatalin:

• you develop eye irritation or any new eye problems such as redness or swelling of the eyelids, contact your doctor immediately.
• you suspect Olatalin is causing an allergic or hypersensitivity reaction (e.g. rash, severe skin reaction, or redness and itching of the eye), stop using the medicine and contact your doctor immediately.
• you develop an eye infection, suffer eye trauma, undergo eye surgery, or develop a reaction including new symptoms or worsening of existing ones.

Olatalin has not been studied in patients who wear contact lenses. If you wear soft contact lenses, you must consult your doctor before using Olatalin.
Children
Experience with dorzolamide and timolol in preservative-containing formulations in neonates and children is limited.
Elderly
In studies with dorzolamide and timolol in preservative-containing formulations, effects were similar in both elderly and younger patients.
Use in patients with hepatic impairment
Inform your doctor of any liver problems you currently have or have had in the past.
Other medicines and Olatalin
Olatalin may affect or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medications, or medicines for the treatment of diabetes.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is particularly important if:

• you are taking medicines to lower blood pressure or medicines for heart disease and for treating irregular or fast heartbeat (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, for example acetazolamide,
• you are taking monoamine oxidase (MAO) inhibitors – medicines used to treat depression or other nervous system disorders,
• you are taking a parasympathomimetic medicine, which may have been prescribed to help you urinate. Parasympathomimetics are a particular type of medicine sometimes used to restore normal bowel movements.
• you are taking opioids such as morphine for moderate to severe pain,
• you are taking medicines for diabetes,
• you are taking medicines for depression called fluoxetine and paroxetine,
• you are taking a sulfonamide medicine – used, for example, to treat infections,
• you are taking quinidine (used to treat heart problems and some types of malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy
Do not use Olatalin during pregnancy.
Use during breastfeeding
Do not use Olatalin if you are breastfeeding. Timolol may pass into breast milk.
Driving and using machines
No studies have been conducted on the effects on the ability to drive or use machines.
Olatalin may cause side effects such as blurred vision which may impair your ability to drive or use machines.
Wait before driving or using machines until you feel well or your vision is clear. It is your responsibility to assess whether you are fit to drive vehicles or perform work requiring greater attention. One of the factors that may affect your abilities in this regard is the use of medicines due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Therefore, read all the information contained in this leaflet. If you are unsure, consult your doctor, pharmacist, or nurse.

3. How to use Olatalin

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will determine the appropriate dosage and duration of treatment.
The recommended dose is one drop into the affected eye(s) in the morning and evening.
If you are using Olatalin together with another eye drop, the drops should be administered at least 10 minutes apart. Ocular ointments should be administered last.
Do not change the dose of this medicine without first consulting your doctor.
Avoid letting the tip of the bottle come into contact with the eye or surrounding area. Contamination with bacteria may occur, which could lead to eye infections and potentially result in damage to the eye, including loss of vision. To prevent any contamination of the bottle, wash your hands before using this medicine and ensure that the tip of the bottle does not touch any surface.

Before instilling the eye drops:

• When using the medicine for the first time, before administering a drop into the eye, first practice using the dropper by gently pressing it to release one drop into the air, away from the eye.
• Once you feel confident about administering one drop at a time, choose the most comfortable position for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).

Instructions for use:

1. Wash your hands thoroughly before using this medicine.
2. Do not use the medicine if the packaging or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap only after ensuring that the tamper-evident seal is intact. You should feel slight resistance until the tamper-evident ring breaks ( see figure 1 ).

Figure 1

4. If the tamper-evident ring becomes loose, discard it, as it could fall into the eye and cause injury.
5. Tilt your head backward and gently pull down the lower eyelid to create a pouch between the eyelid and the eye ( see figure 2 ). Avoid contact between the tip of the bottle and the eye, eyelid, or fingers to prevent contamination of the solution.

Figure 2

6. Instill one drop into the pouch by gently pressing the bottle. Gently press the center of the bottle to release one drop into the eye. There may be a delay of a few seconds between pressing the bottle and the drop coming out ( see figure 3 ). Do not press too hard. If you are unsure about how to administer the medicine, ask your doctor, pharmacist, or nurse.

Figure 3
7. Close your eye and press gently with your finger on the inner corner of the eye for about two minutes ( see figure 4 ). This helps prevent the medicine from draining into the rest of the body.

Figure 4

8. Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.
9. After use and before recapping the bottle, turn it upside down once without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure proper delivery of subsequent drops. After instillation, screw the cap back onto the bottle ( see figure 5 ).

Figure 5
If a drop misses the eye, try again.
If you use more Olatalin than you should
If you instill too many drops into the eye or swallow the contents of the bottle, you may experience dizziness, difficulty breathing, or a slowed heart rate. Contact your doctor immediately.
If you forget to use Olatalin
It is important to use Olatalin as prescribed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.
If you stop using Olatalin
If you wish to discontinue treatment with this medicine, consult your doctor first.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects:
If you experience any of the following side effects, stop taking this medicine
and contact your doctor immediately or go to the nearest emergency department.
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 buildup), cardiac arrest, heart block, low blood pressure, cerebral ischaemia (reduced blood supply to the brain), stroke.
shortness of breath, respiratory failure, constriction of the pulmonary airways
signs and symptoms of systemic allergic reactions, including angioedema, urticaria, pruritus, skin rash, anaphylaxis
severe skin reactions, including subcutaneous swelling.

Other side effects:
You may generally continue using the drops unless the side effects are severe. If you are concerned, speak to a doctor or pharmacist. Do not stop using Olatalin without first talking to your doctor.
The following adverse reactions have been reported with dorzolamide and timolol, or with either of the two substances:

Very common (may affect more than 1 in 10 people):
Burning and eye irritation, altered taste.

Common (may affect up to 1 in 10 people):
Eye effects: redness inside and around the eye(s), tearing or itching of the eye(s), corneal erosion (damage to the surface of the eyeball), swelling and/or irritation inside and around the eye(s), sensation of a foreign body in the eye, reduced corneal sensitivity (inability to notice having something in the eye), eye pain, dry eyes, blurred vision.
General side effects: headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness/tiredness, fatigue.

Uncommon (may affect up to 1 in 100 people):
Eye effects: inflammation of the iris, visual disturbances including refractive changes (sometimes due to discontinuation of miotic therapy).
General side effects: dizziness, depression, slowed heart rate, fainting, shortness of breath, indigestion, 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 (eye remains 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 rapid or irregular (palpitations),
• Raynaud's phenomenon, swelling or coldness in hands and feet and reduced 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, and worsening of signs and symptoms of myasthenia gravis (a muscle disorder),
• decreased sexual desire,
• systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs),
• ringing in the ears, rhinitis, nosebleeds,
• diarrhoea,
• contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash),
• Peyronie's disease (which may cause penile curvature),
• allergic-type reactions such as rash, urticaria, pruritus, and in rare cases possible swelling of lips, eyes and mouth, wheezing.

Frequency not known (frequency cannot be estimated from the available data):
General side effects: hallucination, increased heart rate, increased blood pressure.
Eye effects: sensation of a foreign body in the eye (feeling that something is in the eye).

As with other ophthalmic medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. Fewer side effects occur after topical application to the eyes compared to when medicines are taken orally or by injection. The additional side effects listed include reactions observed within the class of beta-blockers when used to treat ocular conditions.

Not known:
General side effects: low blood sugar levels, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olatalin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the label of the
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, store at a temperature below 30°C.
5 ml bottle
Discard 60 days after first opening of the bottle, even if some solution remains.
10 ml bottle
Discard 90 days after first opening of the bottle, even if some solution remains.
To help you remember the date of first opening, write the date on the box.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Olatalin contains

• The active substances are dorzolamide and timolol. Each ml contains dorzolamide hydrochloride equivalent to 20 mg of dorzolamide and timolol maleate equivalent to 5 mg of timolol. Each drop (approximately 35 µl) contains 0.70 mg of dorzolamide and 0.18 mg of timololo.
• The other components are: hydroxyethylcellulose, mannitol (E421), sodium citrate (E331), sodium hydroxide (E524) (for pH adjustment), and purified water.

Description of the appearance of Olatalin and contents of the pack
Olatalin is a clear, colourless, slightly viscous solution.
This medicinal product is available in white LDPE bottles with a multidose dropper applicator in HDPE, equipped with a silicone valve and a tamper-evident screw cap in HDPE, and presented in a cardboard carton.
Pack sizes: 1 bottle x 5 ml, 3 bottles x 5 ml, 1 bottle x 10 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
Italy

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa
Poland

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Austria | Tidimaz 20 mg/ml + 5 mg/ml Augentropfen, Lösung | | Czech Republic | Dorzolamide/Timolol Polpharma | | Denmark | Tidimaz | | Finland | Tidimaz | | France | Olatalin 20 mg/mL + 5 mg/mL, eye drops, solution | | Ireland | Tidimaz 20 mg/ml + 5 mg/ml eye drops, solution | | Italy | Olatalin | | Norway | Tidimaz | | Portugal | Olatalin | | Sweden | Tidimaz |