BetacLAR

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

BETACLAR

20 mg/ml + 5 mg/ml eye drops, solution
(dorzolamide/timolol)
Please read all of this leaflet carefully before taking this medicine
because it contains important information.

• 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. Do not give it to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT BETACLAR IS AND WHAT IT IS USED FOR

Betaclar 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 lower eye pressure in different ways.
Betaclar is prescribed to reduce intraocular pressure in the treatment of glaucoma when therapy with a beta-blocker eye drop alone is not sufficient.

2. WHAT YOU NEED TO KNOW BEFORE USING BETACLAR

Do not use Betaclar

• if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or to any of the other ingredients of Betaclar (listed in section 6);
• if you have or have previously had respiratory problems such as asthma or severe chronic obstructive pulmonary disease (severe lung disease that may cause shortness of breath, difficulty breathing and/or long-lasting cough);
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat);
• if you have severe kidney impairment or kidney problems, or a history of kidney stones;
• if you suffer from excess acidity in the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are unsure whether you should use Betaclar, contact your doctor or pharmacist.
Exercise special caution with Betaclar
Inform your doctor if you have or have previously had any of the following medical conditions, including eye problems:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure;
• heart rate abnormalities such as a slow heartbeat;
• respiratory 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;
• overactivity of the thyroid gland, as timolol may mask its signs and symptoms.

Also inform your doctor:

• before undergoing surgery, that you are using Betaclar, since timolol may alter the effect of certain medicines used during anesthesia;
• if you suffer from muscle weakness or have been diagnosed with myasthenia gravis;
• if you develop eye irritation or any new eye problems such as redness or swelling of the eyelids, contact your doctor immediately;
• if you develop an eye infection, suffer an eye injury, undergo eye surgery, or experience other reactions including new symptoms or worsening of pre-existing symptoms.

Instillation of Betaclar into the eye may have effects on the entire body.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Use in children and adolescents
Experience with dorzolamide/timolol in neonates and children is limited.
Use in the elderly
In studies with Betaclar, the effects of Betaclar were found to be similar in elderly and younger patients.
Use in patients with hepatic impairment
Inform your doctor if you have any liver problems or have had them in the past.
Use of Betaclar with other medicines
Betaclar may affect or be affected by other medicines, including other eye drops used to treat glaucoma. Inform your doctor if you are using or plan to use other medicines to lower blood pressure, treat heart conditions, or diabetes. Inform your doctor or pharmacist if you are taking or plan to take any other medicines, including those without a prescription.
This is particularly important especially if:

• you are taking medicines to lower blood pressure or to treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin);
• you are taking medicines to treat heart rhythm disorders or irregularities such as calcium channel blockers, beta-blockers, or digoxine;
• 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), used to treat depression;
• you are taking a parasympathomimetic medicine prescribed to promote diuresis. Parasympathomimetics are a specific type of medicine sometimes used to restore normal intestinal movements;
• you are taking narcotics such as morphine, used to treat severe pain;
• you are taking medicines to treat diabetes;
• you are taking antidepressants known as fluoxetine and paroxetine;
• you are taking sulfonamides;
• you are taking quinidine (used to treat heart disorders and certain types of malaria).

Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use during pregnancy
Do not use Betaclar during pregnancy unless your doctor considers it necessary.
Use during breastfeeding
Do not use Betaclar if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medicine during breastfeeding.
Driving and use of machines
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. However, there are side effects associated with Betaclar, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel better or your vision is clear.
Betaclar contains benzalkonium chloride
This medicine contains 0.003 mg of benzalkonium chloride per drop, equivalent to 0.075 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. HOW TO USE BETACLAR

Always use Betaclar exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop in the affected eye in the morning and evening.
If you are using Betaclar together with other eye drops, the drops should be administered at least 10 minutes apart.
Do not change the dose of this medicine without consulting your doctor.
Avoid letting the container cap touch the eye or the area around the eye. It may become contaminated with bacteria that can cause eye infections, potentially leading to serious eye damage, including loss of vision. To avoid possible contamination, wash your hands before using this medicine and avoid contact between the container and any surface. If you think the medicine may be contaminated or if you develop an eye infection, contact your doctor immediately before continuing to use this bottle.

Instructions for use

Always wash your hands before applying the eye drops.
Apply the eye drops as follows:

1. Unscrew the protective cap;
2. Tilt your head backwards and look at the ceiling;
3. Gently pull down the lower eyelid to form a small pocket;
4. Squeeze the inverted bottle to release one drop into the eye;
5. While keeping the treated eye closed, press a finger against the inner corner of the closed eye (where the eye meets the nose) and wait for about 2 minutes. This helps prevent the medicine from spreading to the rest of the body. Avoid touching the tip of the dropper to the eye or any other surface. Replace and immediately screw on the cap after use.

If you use more Betaclar than you should
If you instil too many drops into the eye or swallow the contents of the bottle, you may feel dizzy, have difficulty breathing or notice a slow heartbeat. Contact your doctor immediately.

If you forget to use Betaclar
It is important to use this medicine exactly as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for the 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 Betaclar
If you wish to stop using this medicine, speak to your doctor first.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Betaclar can cause adverse reactions, although not everyone experiences them.
You can usually continue using the drops unless the effects are severe. If you are concerned, speak to your doctor or pharmacist.
Do not stop using Betaclar without consulting your doctor.

Serious adverse reactions
If you experience allergic reactions including facial swelling causing difficulty in breathing or swallowing and swelling of the limbs, hives or itchy skin rash, localized and generalized skin rash, itching, or a sudden, severe, life-threatening allergic reaction, you must stop using this medicine and seek immediate medical help.

The frequency of the 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 )

The following adverse reactions have been reported with dorzolamide-timolol ophthalmic solution or one of its components, either during clinical trials or post-marketing experience:

Very common
Burning and stinging pain in the eyes, altered taste.

Common
Redness inside and around the eye, tearing or eye itching, corneal erosion (damage to the outer 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 having something in the eye or to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), weakness/tiredness and fatigue.

Uncommon
Dizziness, depression, inflammation of the iris, visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy), slowed heart rate, fainting, difficulty breathing (dyspnea), indigestion, and kidney stones.

Rare
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, sleep disorders, nightmares, memory loss, worsening of symptoms of myasthenia gravis (a muscle disease), decreased sexual desire, stroke, 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 due to fluid accumulation, drooping of the eyelids, double vision, crusting of the eyelids, corneal edema (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or heart rate, congestive heart failure (a heart condition with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, strong heartbeat that may be rapid or irregular (palpitations), heart attack, Raynaud's phenomenon, swollen and cold hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, impaired lung function, stuffy or runny nose, nosebleeds, narrowing of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic-type reactions such as skin rash, urticaria, itching, rarely swelling of lips, eyes and mouth, breathlessness or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other ophthalmic medicines applied locally, timolol maleate is absorbed into the bloodstream. This may cause adverse effects similar to those observed with oral beta-blockers. The incidence of adverse effects after ophthalmic administration is lower than with oral or injectable administration. The adverse effects listed include reactions observed within the class of ophthalmic beta-blockers:

Not known
Low blood sugar levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not due to physical exercise, sexual dysfunction, shortness of breath, sensation of a foreign body in the eye (feeling that something is in the eye), hallucination, increased heart rate, increased blood pressure.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BETACLAR

Keep out of the reach and sight of children.
Do not use this medicinal product after the six-digit expiry date stated after EXP on the bottle and
on the carton. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions. Store the bottle in the
original packaging to protect it from light.
Discard Betaclar 28 days after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Betaclar contains

• The active substances are dorzolamide and timolol.
• Each ml contains 20 mg of dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride) and 5 mg of timolol (equivalent to 6.84 mg of timolol maleate).
• The other components are hydroxyethylcellulose, mannitol, disodium citrate dihydrate, sodium hydroxide, hydrochloric acid, and water for injections. Benzalkonium chloride is added as a preservative.

Appearance and contents of the Betaclar package
Betaclar is a slightly viscous, clear, colourless or almost colourless solution.
Pack sizes:
1 x 5 ml (single 5 ml bottle)
3 x 5 ml (three 5 ml bottles)
6 x 5 ml (six 5 ml bottles)
Not all pack sizes may be commercially available.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
UK
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops solution
ITALY
Betaclar 20 mg/ml + 5 mg/ml eye drops, solution