Alphagan

Package leaflet: Information for the user

Alphagan 2 mg/ml, eye drops, solution
Brimonidini tartras
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Alphagan is and what it is used for

Alphagan is used to reduce intraocular pressure. The active substance in Alphagan is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure inside the eye.
Alphagan may be used alone in patients for whom treatment with β-adrenergic receptor-blocking eye drops is contraindicated, or as an adjunctive therapy together with other eye drops when monotherapy is insufficient to reduce elevated intraocular pressure. It is used in the treatment of open-angle glaucoma or ocular hypertension.

2. Important information before using Alphagan

When not to use Alphagan

• if the patient is allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking monoamine oxidase inhibitors (MAOIs) or certain other antidepressant medicines. Inform the doctor if taking any antidepressant medicines;
• in breastfeeding women;
• in newborns/children (from birth to 2 years of age).

Warnings and precautions
Before starting treatment with Alphagan, discuss with your doctor:

• if the patient suffers or has previously suffered from depression, has impaired mental function, cerebral circulation disorders, heart disorders, peripheral circulation disorders, or hypotension;
• if the patient has or has previously had kidney or liver function disorders.

Children and adolescents
Alphagan is not recommended for use in children aged 2 to 12 years.
Alphagan should not be used in adolescents aged 12 to 17 years, as clinical studies have not been conducted in this age group.

Alphagan with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:
analgesics, sedatives, opioid analgesics, barbiturates, or regularly consumes alcohol;
anaesthetics;
medicines affecting blood circulation or lowering blood pressure;
medicines affecting metabolism, such as chlorpromazine, methylphenidate, reserpine;
medicines acting on the same receptor as Alphagan, e.g. isoprenaline, prazosin;
monoamine oxidase inhibitors (MAOIs) and other antidepressant medicines;
any other medicines, even if their use is not related to eye disease;
or if the doses of currently used medicines have changed.
All of the above factors may affect treatment with Alphagan.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Alphagan should not be used during pregnancy unless considered necessary by the doctor.
Breastfeeding should be avoided while using Alphagan.

Driving and operating machinery
After instilling Alphagan into the eye, vision may become blurred or impaired. These symptoms may be particularly bothersome at night or in dim light.
In some patients, Alphagan may cause drowsiness or fatigue.
Do not drive or operate machinery until these symptoms have resolved.

Alphagan contains benzalkonium chloride
Alphagan contains 0.25 mg of benzalkonium chloride in each 5 ml of solution, equivalent to 0.05 mg/ml.
Benzalkonium chloride is a preservative which may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using this medicine, contact a doctor.

3. How to use Alphagan

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your
doctor or pharmacist.
Use in adults
The recommended dose of Alphagan is one drop in each affected eye, administered twice daily,
approximately 12 hours apart. Do not change the dose or stop using Alphagan without consulting
your doctor.
Use in children under 12 years of age
Alphagan must not be used in children under 2 years of age.
The use of Alphagan is not recommended in children aged 2–12 years.
How to administer the medicine
Alphagan eye drops should only be instilled into the eye. Always wash your hands thoroughly
before instilling the drops. If you are using Alphagan together with other eye drops, wait at least
5–15 minutes between instilling Alphagan and the other eye drops.
Administer the drops according to the following instructions:

1. Tilt your head backward and look up at the ceiling.
2. Gently pull down the lower eyelid to form a small pocket.
3. Squeeze the inverted dropper and instill one drop into the pocket.
4. Close the eye and, at the same time, press with your finger on the tear duct at the inner corner of the eye (the side where the eye meets the nose) for about 1 minute.

If the drop misses the eye, try instilling again.
Avoid touching the eye or any surface with the dropper tip. Immediately after use, replace the cap and screw the bottle closed.
Use of a higher than recommended dose of Alphagan
Adults
In adult patients who received more drops than recommended, the adverse reactions reported were consistent with those currently known to occur after use of Alphagan.
In adults who accidentally swallowed Alphagan, a drop in blood pressure occurred, followed in some patients by a rise in blood pressure.
Children
Severe adverse reactions have been reported in children who accidentally swallowed Alphagan.
The following symptoms were observed: drowsiness, decreased muscle tone, lowered body temperature, pallor, and breathing difficulties. If any of these symptoms occur, contact a doctor immediately.
Adults and children
In case of accidental ingestion or use of a higher than recommended dose of Alphagan, contact a doctor immediately.
Missed dose of Alphagan
If you miss a dose, instill 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 use a double dose to make up for a missed dose.
Stopping Alphagan
For treatment to be effective, Alphagan must be used every day. Do not stop using Alphagan without consulting 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.
The following adverse effects may occur during treatment with Alphagan.

Eye-related

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

• Eye irritation (redness, burning and stinging, sensation of a foreign body, itching, granules or white spots on the transparent layer covering the surface of the eye)
• Blurred vision
• Allergic reaction in the eye

Common (may affect up to 1 in 10 people)

• Local irritation (inflammation, redness and discomfort in the eye, eyelid swelling, swelling of the transparent layer covering the surface of the eye, sensation of sticky eyes, pain and tearing)
• Light sensitivity
• Corneal erosion and corneal spots
• Dry eye
• Pallor of the conjunctiva
• Visual disturbance
• Conjunctivitis
• Small bumps on the inner surface of the eyelids caused by inflammation

Very rare (may affect up to 1 in 10,000 people)

• Inflammation of the internal parts of the eye
• Miosis (pupil constriction)

Frequency unknown (frequency cannot be estimated from the available data)

• Itching of the eyelids

General body-related

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

• Headache
• Dry mouth
• Feeling of fatigue and (or) drowsiness

Common (may affect up to 1 in 10 people)

• Dizziness
• Upper respiratory tract symptoms
• Gastrointestinal symptoms
• Taste disturbances
• General malaise

Uncommon (may affect up to 1 in 100 people)

• Depression
• Palpitations or arrhythmias
• Nasal dryness
• Generalized allergic reactions

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

• Dyspnoea (shortness of breath)

Very rare (may affect up to 1 in 10,000 people)

• Insomnia
• Fainting
• Hypertension
• Hypotension

Frequency unknown (frequency cannot be estimated from the available data):

• Skin reactions including skin redness, facial swelling, itching, rash, and blood vessel dilation.

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
PL-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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Alphagan

Keep this medicine out of the sight and reach of children.
Alphagan should be stored at a temperature below 25°C.
Do not use this medicine if the bottle's tamper-evident seal is damaged before first opening.
Do not use this medicine after the expiry date stated on the bottle label and outer packaging (EXP). The expiry date refers to the last day of the stated month.
The bottle should be discarded 28 days after opening, even if some solution remains.
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 Alphagan contains

• The active substance is brimonidine tartrate. 1 ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other ingredients are: benzalkonium chloride, polyvinyl alcohol, sodium chloride, disodium citrate dihydrate, citric acid monohydrate, purified water, hydrochloric acid (to adjust pH to between 6.3 and 6.5), and sodium hydroxide (to adjust pH to between 6.3 and 6.5).

What Alphagan looks like and contents of the pack
Alphagan is a clear solution with a slight greenish-yellow or faintly greenish-yellow tint. The solution is contained in a polyethylene bottle with a dropper. One carton contains 1 bottle of 2.5 ml, 5 ml or 10 ml of solution. Not all pack sizes may be marketed.
Marketing Authorisation Holder
AbbVie Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 372 78 00
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, Co. Mayo
Ireland
Other sources of information
To listen to or receive a printed copy of this leaflet in large print or an audio version, please contact the local representative of the Marketing Authorisation Holder.