Glaubrim

Patient Information Leaflet

Glaubrim 2 mg/ml eye drops, solution

Brimonidine tartrate
Generic 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Glaubrim is and what it is used for
2. What you need to know before using Glaubrim
3. How to use Glaubrim
4. Possible side effects
5. How to store Glaubrim
6. Package contents and other information

1. What Glaubrim is and what it is used for

Glaubrim is an eye drop solution and each bottle contains 5 ml of the medicinal product.
The active substance of Glaubrim is Brimonidine tartrate.
Glaubrim is used to reduce intraocular pressure in patients with glaucoma or
ocular hypertension (increased pressure in the eye).

2. What you need to know before using Glaubrim

Do not use Glaubrim:

• If you are allergic to brimonidine tartrate or to any of the other components of this medicine listed in section 6;
• If you are taking monoamine oxidase inhibitors (MAO inhibitors), e.g. phenelzine or isocarboxazid, which are often used to treat depression;
• If you are taking tricyclic antidepressants (e.g. amitriptyline, imipramine) or mianserin, which are often used to treat depression;
• If you are breastfeeding or intend to breastfeed;
• In neonates or children (from birth up to 2 years of age).

Warnings and precautions
Talk to your doctor or pharmacist before using Glaubrim if:

• You suffer or have suffered from depression, reduced blood flow to the brain, heart problems, blood pressure disorders, or poor blood circulation in the limbs;
• You have or have previously had kidney or liver problems;
• You wear soft (hydrophilic) contact lenses.

Children and adolescents under 17 years of age
Glaubrim must not be used in children under 2 years of age.
Glaubrim is not recommended in children (from 2 to 12 years of age).
Clinical studies with Glaubrim have not been conducted in adolescents (12–17 years of age).

Other medicines and Glaubrim
Before using Glaubrim, inform your doctor or pharmacist if you have other eye disorders and also if you are taking, have recently taken, or might take any other medicines, especially:

• Painkillers (e.g. co-codamol), sedatives (anti-anxiety drugs or sleeping pills, e.g. diazepam or alprazolam), opioids (e.g. morphine), barbiturates (e.g. phenobarbital), or if you are a regular consumer of alcoholic beverages;
• Medicines to treat depression (e.g. fluoxetine, paroxetine or venlafaxine), heart conditions (e.g. digoxin), or to lower blood pressure (e.g. bendroflumethiazide, atenolol, lisinopril or reserpine);
• Prazosin, a medicine often used to treat enlarged prostate;
• Chlorpromazine and methylphenidate, often used to treat certain nervous disorders.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, or if the dosage of any medicine you regularly take has changed.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Glaubrim should be used during pregnancy only if specifically recommended by your doctor. Do not use Glaubrim if you are breastfeeding or intend to breastfeed.

Driving and use of machinery
In some patients, Glaubrim may cause drowsiness or fatigue. It may also cause blurred/changed vision; these effects may appear worse at night or in conditions of reduced lighting. Wait until these effects have disappeared before driving or using machinery.

Glaubrim contains the preservative benzalkonium chloride which may cause eye irritation and is known to cloud soft contact lenses.

3. HOW TO USE GLAUBRIM

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Avoid contact with soft contact lenses. If you wear soft contact lenses, remove them before using Glaubrim and wait at least 15 minutes before reinserting them.
The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart (for example, once in the morning and once in the evening).
If you are using Glaubrim with another eye drop, wait between 5 and 15 minutes before applying the second eye drop.

Use in children and adolescents under 17 years of age
Glaubrim must not be used in children below 2 years of age.
Glaubrim is not recommended in children (from 2 to 12 years).
Clinical studies with Glaubrim have not been conducted in adolescents (12–17 years).

Instructions for use:

Glaubrim is for ophthalmic use only; do not ingest.

Always wash your hands before applying eye drops. Apply one drop of Glaubrim into each affected eye as follows:

1. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to form a small pouch.
3. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
4. Keep the treated eye closed, pressing a finger against the inner corner for about 1 minute.
5. Immediately screw the cap back on after use.

Avoid letting the tip of the bottle touch the eye or any other surface.
If you use more Glaubrim than you should
If you have instilled too many drops of Glaubrim into your eye(s), it is unlikely to cause harm. Apply the next dose at your usual time. In case of ingestion, contact your doctor immediately, as it may cause low blood pressure, high blood pressure, reduced cognitive ability, low heart rate, decreased muscle tone, respiratory depression, and lowered body temperature—symptoms that could require hospitalization.
If you forget to use Glaubrim
If you forget to take a dose, apply it as soon as you remember. However, if it is already time for the next dose, skip the missed dose and apply the next one at the regular time. The dose must not exceed one drop twice daily in the affected eye(s).
If you stop using Glaubrim
Do not stop treatment with this medicine without first informing your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop using Glaubrim and contact your doctor immediately if you notice any of the following symptoms (systemic allergic reactions):

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Skin rash or breathing difficulties

Very common: may affect more than 1 in 10 people

• Allergic reaction in the eye, follicles or white spots on the eyes, blurred vision, red eye, burning, stinging, sensation of foreign body or itching
• Headache, dry mouth and fatigue/somnolence

Common: may affect up to 1 in 10 people

• Changes in the eye surface, redness, swelling, pain and sensitivity of the eye or eyelids, altered vision, sticky eyes, light sensitivity, irritation, dryness, tearing or whitening of the eye
• Dizziness, flu-like symptoms, gastrointestinal symptoms, altered taste or general weakness

Uncommon: may affect up to 1 in 100 people

• Depression, palpitations (awareness of heartbeat), changes in heart rate, dry nose and systemic allergic reactions

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

• Shortness of breath

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

• Inflammation in the eye or reduced pupil size
• Insomnia, fainting, and high or low blood pressure

Some of these effects may be due to allergic reactions to one of the ingredients in Glaubrim.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Glaubrim

Keep out of the sight and reach of children.
Do not use the bottle if the bottle's tamper-evident seal is broken before first use.
Do not use Glaubrim after the expiry date stated on the label of the bottle and on the carton after Exp. The expiry date refers to the last day of that month.
Do not use the bottle more than 28 days after first opening, even if it is not yet empty.
Do not store the bottle at temperatures above 25 °C.
Keep the bottle in the outer carton to protect it from light.
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. Package contents and other information

What Glaubrim contains

• The active substance in Glaubrim is brimonidine tartrate 2 mg/ml, equivalent to brimonidine 1.3 mg/ml.
• The other components are: benzalkonium chloride (preservative), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide or hydrochloric acid (to adjust pH).

Description of the appearance of Glaubrim and contents of the pack
Glaubrim is a clear solution ranging in colour from yellowish-green to slightly yellowish-green, contained in a plastic bottle with a volume of 5 ml.
Glaubrim is available in packs containing 1, 2 or 3 bottles.
Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Farmigea SpA, Via G.B. Oliva, 8 – 56121 Pisa, Italy
Manufacturer:
Farmigea SpA, Via G.B. Oliva, 8 – 56121 Pisa, Italy

This medicinal product is authorised in the European Economic Area member states under the following names:

This leaflet was last approved in MM/YYYY