BETACLAR 20 мг/мл + 5 мг/мл Глазные капли, раствор

Содержание инструкции

1. BETACLAR
   1. WHAT IS BETACLAR AND WHAT IS IT 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. PACKAGE CONTENTS AND FURTHER INFORMATION

BETACLAR

20 mg/ml + 5 mg/mleye drops, solution
(dorzolamide/timolol)

Read this leaflet carefully before you start using this medicinebecause 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 pass it on to others, even if their symptoms are the same as yours.

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 you use 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 IS BETACLAR AND WHAT IS IT USED FOR

Betaclar contains two medicinal products: dorzolamide and timolol.

• Dorzolamide belongs to the group of medicines called “carbonic anhydrase inhibitors”
• Timolol belongs to the group of medicines called “beta-blockers”.

These medicines lower the pressure in the eye in different ways.
Betaclar is prescribed to lower the pressure in the eye in the treatment of glaucoma when
therapy with only beta-blocker eye drops 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 any of the other ingredients of Betaclar (listed in section 6);
• if you have or have had in the past respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease that can cause shortness of breath, difficulty breathing and/or prolonged cough);
• if you have a slowing of the heartbeat, heart failure or heart rhythm disorders (irregular heartbeat);
• if you have severe kidney impairment or kidney problems, or a previous history of kidney stones;
• if you suffer from an excess of acidity in the blood, caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are not sure whether you should use Betaclar, contact your doctor or pharmacist.

Take special care with Betaclar
Tell your doctor if you have or have had in the past some of the following medical problems, including problems
with your eyes:

• coronary heart disease (symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure;
• abnormal heart rate such as slowing of the heartbeat;
• respiratory problems, asthma or chronic obstructive pulmonary disease;
• poor blood circulation (such as Raynaud's disease or syndrome);
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
• hyperactivity of the thyroid gland as timolol may mask its signs and symptoms.

Also, tell your doctor:

• before undergoing surgery, that you are using Betaclar, as timolol may alter the effect of some medicines used during anesthesia;
• if you suffer from muscle weakness or if you 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 an eye infection develops, you suffer an eye injury, you undergo eye surgery or other reactions occur including new symptoms or a worsening of existing symptoms.

Instilling Betaclar into the eye may have effects on the whole body.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in a positive doping test.

Use in children and adolescents
Experience with dorzolamide timolol in newborns and children is limited.

Use in the elderly
In studies with Betaclar, the effects of Betaclar were similar in elderly and younger
patients.

Use in patients with hepatic impairment
Tell your doctor if you have any liver problems or if you have suffered from them in the past.

Use of Betaclar with other medicines
Betaclar can influence or be influenced by the use of other medicines, including other eye drops for the
treatment of glaucoma. Tell your doctor if you are taking or intend to take other
medicines to lower blood pressure, for the treatment of heart disease or
diabetes. Tell your doctor or pharmacist if you are taking or intend to take any
other medicine, including those available without a prescription.
This is particularly important if:

• you are taking medicines to lower blood pressure or for the treatment of heart disease (such as calcium antagonists, beta-blockers or digoxin);
• you are taking medicines for the treatment of disturbances or irregularities of the heartbeat such as calcium antagonists, beta-blockers or digoxin;
• you are using another eye drop that contains a beta-blocker;
• you are taking another carbonic anhydrase inhibitor, such as acetazolamide;
• you are taking monoamine oxidase inhibitors (MAOIs), used for the treatment of depression;
• you are taking a parasympathomimetic medicine prescribed to you to promote diuresis. Parasympathomimetics are a particular type of medicine sometimes used to restore normal bowel movements;
• you are taking narcotics such as morphine, used for the treatment of severe pain;
• you are taking medicines for the treatment of diabetes;
• you are taking antidepressants known as fluoxetine and paroxetine;
• you are taking sulfonamides;
• you are taking quinidine (used for the treatment of heart disorders and some types of malaria).

Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
Do not use Betaclar during pregnancy unless your doctor considers it necessary.
Use in 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 using machines
Studies have not been conducted on the effects of this medicine on the ability to drive or
use machines. However, there are side effects associated with Betaclar, such as blurred vision,
which may alter your ability to drive and/or use machines. Do not drive or use machines
until you feel better or your vision is clear.

Betaclar contains benzalkonium chloride
This medicine contains 0.003 mg of benzalkonium chloride in each drop equivalent to 0.075
mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
a change in their color. Remove contact lenses before using this medicine and wait 15
minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the transparent outermost layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. HOW TO USE BETACLAR

Always use Betaclar exactly as your doctor has told you. If you have any doubts, consult your doctor
or pharmacist. The appropriate dose and duration of treatment will be established by the doctor.
The recommended dose is one drop in the morning and one in the evening in the eye to be treated.
If you are using Betaclar at the same time as other eye drops, the drops must be instilled at
intervals of at least 10 minutes.
Do not change the dose of the medicine without consulting your doctor.
Avoid letting the container cap touch your eye or the area around your eye. It may become contaminated with
bacteria that cause eye infections, resulting in serious eye damage, including loss of
vision. To avoid possible contamination, wash your hands before using this medicine
and avoid contact of the container with any surface. If you think the medicine may be
contaminated or if you develop an eye infection, contact your doctor immediately before
continuing with the use of 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 back and look at the ceiling;
• 3. Gently pull down your lower eyelid to form a small pocket;
• 4. Press the inverted bottle to release one drop into the eye;
• 5. While keeping the treated eye closed, hold your finger against the inner corner of the closed eye (the part where the eye meets the nose) and wait for about 2 minutes. This precaution helps prevent the medicine from spreading throughout the body. Avoid touching the tip of the dropper with your eye or anything else. Replace the cap and screw it on immediately after use.

If you use more Betaclar than you should
If you instill too many drops into your eye or ingest the contents of the bottle, you may feel dizzy,
have difficulty breathing, or feel a slowing of your heartbeat. Seek immediate medical
attention.

If you forget to use Betaclar
It is important to use this medicine as prescribed by your doctor. If you miss a dose, proceed
with the application 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 the
missed dose.

If you stop using Betaclar
If you want to stop using this medicine, talk to your doctor first.
If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Betaclar can cause side effects, although not everybody gets them.
Usually it is possible to continue using the drops unless the effects are serious. If you are
worried, talk to your doctor or pharmacist. Do not stop using Betaclar without
consulting your doctor.
Serious side effects
If you experience allergic reactions including swelling of the face causing difficulty in breathing or
swallowing and of the limbs, hives or itchy rash, localized and
widespread rash, itching or a severe, life-threatening allergic reaction, you must
stop using this medicine and seek immediate medical help.
The frequency of the possible side effects listed below is defined based on the following
convention:
Very common ( affects more than 1 in 10 patients)
Common ( affects between 1 and 10 patients in 100)
Uncommon ( affects between 1 and 10 patients in 1,000)
Rare ( affects between 1 and 10 patients in 10,000)
Not known ( frequency cannot be estimated from the available data)
The following adverse reactions have been reported with dorzolamide timolol eye drops or one of
its components both during clinical studies and during post-marketing experience:
Very common
Burning and stinging sensation in the eyes, taste alteration.
Common
Redness inside and around the eye, watering or itching of the eye, corneal erosion (damage
to the front layer of the eyeball), swelling and/or irritation inside and around the eyes,
feeling of a foreign body in the eye, decreased corneal sensitivity (inability to realize you have something in your eyes and to feel pain), eye pain, dry eyes,
blurred vision, headache, sinusitis (feeling of tension or fullness in the nose),
weakness/fatigue and exhaustion.
Uncommon
Dizziness, depression, inflammation of the iris, visual disturbances, including changes in refraction
(due in some cases to discontinuation of miotic therapy), slowing of the heartbeat,
fainting, difficulty breathing (dyspnea), indigestion and kidney stones.
Rare
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of the
internal organs), tingling or numbness in the hands or feet, sleep disturbances, nightmares,
memory loss, increased manifestations and symptoms of myasthenia gravis (a
muscle disease), decreased libido, stroke, temporary myopia that can
resolve upon discontinuation of treatment, detachment of the underlying layer of the retina that contains
blood vessels following filtering surgery which can cause visual disturbances due to fluid accumulation,
lowering of the eyelids, double vision, formation of crusts on the eyelids, corneal edema
(with symptoms of visual disturbances), low eye pressure, tinnitus (ringing in the ears), low
blood pressure, changes in the rhythm or rate of the heartbeat, congestive heart failure
(heart disease, with shortness of breath and swelling of the feet and legs due to
fluid accumulation), edema (fluid retention), cerebral ischemia (reduced blood flow to the
brain), chest pain, strong heartbeat that may be fast or irregular
(palpitations), heart attack, Raynaud's phenomenon, swollen and cold hands and feet and reduced
circulation to arms and legs, leg cramps and/or leg pain when walking
(claudication), shortness of breath, impaired lung function, stuffy or runny nose,
nosebleeds, constriction of the airways in the lungs, cough, sore throat, dry mouth, diarrhea, contact dermatitis, hair loss, rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which can cause a curvature of the penis),
allergic-type reactions such as rash, hives, itching, rarely swelling of lips,
eyes and mouth, difficulty breathing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal
necrosis).
As with other ophthalmic medicines applied locally, timolol maleate is absorbed into the blood.
This can cause side effects similar to those observed with oral or injectable beta-blockers.
The incidence of side effects after ophthalmic administration is lower than with
oral or injectable administration. The side 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 exercise, sexual dysfunction, labored breathing, foreign body sensation in the eye (feeling that something is
in the eye), hallucination, increased heart rate, increased blood pressure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 BETACLAR

Keep out of the reach and sight of children.
Do not use this medicine after the six-digit date reported after SCAD on the bottle and
on the package. 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 medicine does not require special storage conditions. Store the bottle in the
original package to protect it from light.
Dispose of Betaclar after 28 days from the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND FURTHER INFORMATION

What Betaclar contains

• The active ingredients 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 package contents of Betaclar
Betaclar is a slightly viscous, clear, colorless or almost colorless 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 available.

Marketing Authorisation Holder
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
UK
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops solution

ITALY
Betaclar 20 mg/ml + 5 mg/ml eye drops, solution