Briglau pph

Package leaflet: Information for the user

Briglau PPH, 2 mg/ml, eye drops, solution
Brimonidini tartras
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Briglau PPH is and what it is used for

Briglau PPH is a medicine that reduces intraocular pressure (pressure inside the eye).
Briglau PPH is used alone or in combination with other medicines to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension (elevated pressure of the fluid in the eye).
The active substance in Briglau PPH is brimonidine tartrate, which lowers pressure within the eye.

2. Important information before using Briglau PPH

When not to use Briglau PPH

• if the patient is allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking a medicine from the group of monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressants (such as tricyclic antidepressants or mianserin). Please consult your doctor whether Briglau PPH can be used if the patient is taking an antidepressant;
• if the patient is breastfeeding;
• in newborns and infants (from birth to 2 years of age).

Warnings and precautions
Before starting treatment with Briglau PPH, discuss with your doctor if:

• the patient has depression, reduced mental capacity, cerebral circulation disorders, heart disease, circulatory disorders in the limbs, or blood pressure-related disorders;
• the patient has or has previously had liver or kidney function disorders.

Children
Briglau PPH is not recommended for use in children under 12 years of age. If the medicine has been prescribed to a child under 12 years of age, talk to your doctor before using it.
Briglau PPH and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Inform your doctor if the patient is taking any of the following medicines, as they may affect treatment with Briglau PPH:

• painkillers, sedatives, opioids, barbiturates, or regularly consumed alcohol;
• anaesthetics;
• medicines used to treat heart conditions or to lower blood pressure;
• medicines affecting metabolism, such as chlorpromazine, methylphenidate, and reserpine;
• medicines acting on the same receptor as Briglau PPH, such as isoprenaline and prazosin;
• monoamine oxidase inhibitors and other antidepressants;
• medicines used for other conditions, even if unrelated to eye disease. Also inform your doctor about any dosage changes of currently used medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Do not use Briglau PPH during breastfeeding.
Driving and operating machinery
Briglau PPH may cause blurred vision or visual disturbances, especially at night or in low-light conditions.
In some patients, Briglau PPH may also cause fatigue or drowsiness.
If these symptoms occur, the patient should not drive or operate machinery until these symptoms have resolved.
Briglau PPH contains benzalkonium chloride
The medicine contains 0.05 mg of benzalkonium chloride per millilitre of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients 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 the medicine, contact your doctor.

3. How to use Briglau PPH

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Adults and adolescents aged over 12 years
The recommended dose is one drop into the affected eye(s) twice daily, approximately 12 hours apart.
Children under 12 years of age
Briglau PPH must not be used in children under 2 years of age.
The use of Briglau PPH is not recommended in children aged between 2 and 12 years.
Method of administration
Briglau PPH is for ophthalmic use only. Do not take this medicine by mouth.
Always wash your hands before instilling the drops. Use only the number of drops prescribed by your doctor. If more than one eye medicine is being used, administer the medicines at least 5–15 minutes apart.
To instill the drops, follow these steps:

1. Tilt your head backward and look up at the ceiling.
2. Gently pull down the lower eyelid to form a small pocket.
3. Hold the bottle upside down and squeeze to instill one drop into the eye.
4. Immediately after instilling each drop, close the eye and press gently with the fingertip on the inner corner of the eye (near the nose) and maintain pressure for 1 minute.

Avoid touching the dropper tip to the eye or any other surface. Replace and tighten the cap after use. If you wear soft contact lenses, remove them before using this medicine and wait 15 minutes before reinserting them after instillation. The preservative in the drops may stain soft contact lenses.
Accidental overdose of Briglau PPH
Adults
In adults who received more drops than recommended, the adverse reactions reported were consistent with those currently known to occur after using Briglau PPH.
In adults who accidentally ingested Briglau PPH orally, 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 ingested Briglau PPH orally. 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
If anyone accidentally swallows this medicine, contact a doctor immediately.
Missed dose of Briglau PPH
If a dose is missed, administer it as soon as possible. However, if it is nearly time for the next dose, skip the missed dose and continue with the regular dosing schedule.
Stopping treatment with Briglau PPH
For the medicine to be effective, it must be used daily. Do not stop or discontinue treatment without consulting your doctor first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur with a defined frequency, described as follows:

After administration of the medicine Briglau PPH, the following adverse reactions related to the eye may occur:
Very common: Eye irritation (eye redness, burning and stinging, sensation of
foreign body, itching, granules or white spots on the conjunctiva), blurred
vision, allergic reactions of the eye.
Common: Changes on the eye surface, eyelid inflammation, conjunctivitis,
visual disturbances, eyelid or conjunctival swelling, light sensitivity,
irritation, redness, pain, dry eye sensation, superficial
damage or discoloration on the eye surface, tearing or conjunctival pallor.
Very rare: Iritis, miosis.
Frequency unknown: Eyelid itching.

The following adverse reactions affecting other parts of the body may also occur:
Very common: Headache, dry mouth, and feeling of fatigue and (or) drowsiness.
Common: Dizziness, cold-like symptoms, stomach and (or) intestinal pain,
taste disturbances, and weakness.
Uncommon: Depression, palpitations or irregular heartbeat, dryness of the nasal mucosa, generalized allergic reactions.
Rare: Dyspnea.
Very rare: Insomnia, fainting, high or low blood pressure.
Frequency unknown: Skin reactions including skin redness, facial swelling,
itching, rash, and blood vessel dilation.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather additional information on the safety of the medicine.

5. How to store Briglau PPH

Do not store above 25°C.
Keep the medicine out of sight and reach of children.
Do not use the drops if the tamper-evident ring is damaged before first use.
Do not use this medicine after the expiry date stated on the bottle and carton after EXP.
The expiry date refers to the last day of the stated month.
The labelling on the packaging: EXP indicates the expiry date, and Lot indicates the batch number.
The bottle must be discarded 28 days after first 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. This helps protect the environment.

6. Contents of the packaging and other information

What Briglau PPH contains

• The active substance is brimonidine tartrate. Each ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other ingredients are: benzalkonium chloride (as a preservative), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections.

What Briglau PPH looks like and contents of the pack
Briglau PPH is a clear, slightly yellowish solution in a plastic bottle.
The bottle contains 5 ml of solution.
Pack sizes: 1 x 5 ml, 3 x 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01