Brimonidine Mylan Generics
Italy
Table of Contents
Package leaflet: Information for the patient
Brimonidina Mylan Generics 2 mg/ml Eye drops, solution
brimonidine tartrate
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
- 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 only. Do not pass it on to others, even if their symptoms are the same as yours, because it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Brimonidina Mylan Generics is and what it is used for
- What you need to know before using Brimonidina Mylan Generics
- How to use Brimonidina Mylan Generics
- Possible side effects
- How to store Brimonidina Mylan Generics
- Contents of the pack and other information
1. What Brimonidina Mylan Generics is and what it is used for
Brimonidina Mylan Generics contains the active substance brimonidine tartrate, which works by reducing
intraocular pressure (pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension (elevated pressure of the fluid in the eye).
Brimonidina Mylan Generics can be used alone or in combination with other medicines to reduce intraocular pressure.
2. What you need to know before using Brimonidine Mylan Generics
Do not use Brimonidine Mylan Generics:
if you are allergic to brimonidine or to any of the other ingredients of this medicine (listed in section 6).
if you are being treated with a medicine classified as a monoamine oxidase inhibitor (MAO inhibitor) used to treat depression or Parkinson's disease, e.g. selegiline, phenelzine.
if you are being treated with certain antidepressant agents (such as tricyclic antidepressants, e.g. clomipramine, amitriptyline or mianserine).
You must inform your doctor if you are taking any antidepressant medicine.
in newborns and children (from birth up to 2 years of age).
Warnings and precautions
Talk to your doctor or pharmacist before using Brimonidine Mylan Generics
if you suffer from severe or unstable cardiovascular diseases not controlled by treatment,
if you suffer from depression,
if you suffer from a disorder causing reduced blood circulation to the brain (cerebral insufficiency) or to the heart, e.g. angina or blocked blood vessels,
if you suffer from low blood pressure causing dizziness and lightheadedness when sitting or standing up after lying down (orthostatic hypotension),
if you suffer from narrowing of blood vessels, mainly in the hands and arms (Raynaud's disease) or from a chronic inflammatory vascular disease with obstruction of blood vessels as a consequence of a blood clot (thromboangiitis obliterans),
if you have liver or kidney problems.
Children and adolescents
Brimonidine Mylan Generics must not be used in newborns and infants (from birth up to 2 years of age).
Brimonidine Mylan Generics is generally not recommended for use in children (from 2 to 12 years of age) due to an increased risk of side effects (e.g. drowsiness).
Other medicines and Brimonidine Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Brimonidine Mylan Generics if you are being treated with an MAO inhibitor (monoamine oxidase inhibitor), a tricyclic antidepressant or mianserine (see section "Do not use").
Medicines acting on the central nervous system (CNS): the effect of substances acting on the central nervous system (such as alcohol, barbiturates, e.g. those used in epilepsy like phenobarbital, opioids used to relieve pain, e.g. codeine, sedatives used to induce sedation, e.g. diazepam, or anaesthetics) may be increased by brimonidine tartrate.
Medicines used to treat nervous system disorders (chlorpromazine, methylphenidate), antihypertensive drugs (reserpine): caution is recommended in patients treated with medicines affecting the uptake and metabolism of adrenaline, noradrenaline and other so-called biogenic amines in the blood.
Antihypertensives, heart medications: in some patients, a slight decrease in blood pressure may occur after administration of brimonidine tartrate. Caution should be exercised when Brimonidine Mylan Generics is used concomitantly with antihypertensives (used to treat high blood pressure) and/or heart medications of the digitalis glycoside group.
Adrenergic receptor agonists or antagonists: caution should be exercised if you are taking α-adrenergic receptor agonists such as phenylephrine (used e.g. in eye drops, nasal sprays) or antagonists (e.g. isoprenaline or prazosin) (which may be used to treat high blood pressure or other circulatory problems).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
No studies have yet been conducted to establish whether the use of brimonidine tartrate is safe during pregnancy. Brimonidine Mylan Generics should be used with caution during pregnancy and only if the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
It is not known whether brimonidine tartrate passes into breast milk. Brimonidine Mylan Generics must not be used by breastfeeding mothers.
Driving and using machines
Brimonidine Mylan Generics may cause tiredness and/or drowsiness: this may affect your ability to drive or use machinery safely.
Brimonidine Mylan Generics may cause blurred vision and/or abnormal vision. This may affect your ability to drive or use machinery safely, particularly in the dark or under low-light conditions.
Wait until these effects have passed before driving or operating machinery.
Brimonidine Mylan Generics contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per millilitre of eye drops. Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.
3. How to use Brimonidina Mylan Generics
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
It is very important to use Brimonidina Mylan Generics for the length of time prescribed by your doctor.
If you feel that the effect of Brimonidina Mylan Generics is too strong or too weak, talk to your doctor.
Adults (including elderly)
Unless otherwise instructed by your doctor, the recommended dose is one drop in the affected eye or eyes, twice daily, approximately 12 hours apart.
Instructions for use
Brimonidine Mylan Generics is for ophthalmic use only. Do not ingest.
Always wash your hands before applying the eye drops.
Apply the eye drops as follows:
- Tilt your head backward and look up at the ceiling
- Gently pull down the lower eyelid until a small pocket forms
- Squeeze the inverted bottle to release one drop into the eye.
Immediately after instilling each drop, close the eye and press with the fingertip on the tear duct
at the inner corner of the closed eye (near the nose) for one minute. This minimizes
the absorption of brimonidine tartrate into the bloodstream.
If you use more than one ophthalmic medicinal product, the products should be administered at intervals of at least 5–15 minutes.
Replace and screw on the cap immediately after use. Avoid touching the eye with the dropper tip or any other object.
If you use more Brimonidine Mylan Generics than you should
Adults
The adverse effects listed in section 4 of the package leaflet have been reported in adults who instilled more Brimonidine Mylan Generics than recommended.
Low blood pressure has been reported in adults who accidentally ingested brimonidine tartrate. This was followed by a marked increase in blood pressure in some patients.
Contact your doctor immediately if you have ingested Brimonidine Mylan Generics. The following adverse effects have been reported with other drugs having a similar action to brimonidine when ingested: unusual weakness, feeling unwell (vomiting), fatigue, reduced level of consciousness, slow heart rate, changes in heart rate, decreased pupil size, reduced muscle tone, breathing difficulties, low body temperature, and seizures.
Children
Cases of overdose have been reported in neonates who accidentally ingested brimonidine tartrate. Symptoms include: temporary coma, low levels of consciousness, fatigue, drowsiness, lethargy, slow heart rate, hypothermia, pale skin, and breathing difficulties. If any of these events occur, contact your doctor immediately.
Adults and children
If you suspect an overdose, contact your doctor immediately. Bring the medicine packaging with you so the doctor can see what has been taken.
If you forget to use Brimonidine Mylan Generics
If you forget to use Brimonidine Mylan Generics, apply the missed dose as soon as you remember.
However, if it is already time for the next dose, skip the missed dose and continue with the next scheduled dose.
Do not use a double dose to make up for a forgotten dose. Do not change the prescribed dose on your own initiative.
If you stop using Brimonidine Mylan Generics
Do not interrupt or stop treatment with Brimonidine Mylan Generics without first talking to your doctor!
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, or if they become severe during treatment with Brimonidine Mylan Generics, contact your doctor or hospital immediately.
Very common: may affect more than 1 in 10 people
Eye irritation, including allergic reactions (flushing (redness), pain, stinging, burning, itching, sensation of a foreign body in the eye).
Common: may affect up to 1 in 10 people
Discoloration/staining of the cornea (the surface of the eye), blisters, swelling or serious damage (which may be observed by an ophthalmologist or cause discomfort or eye pain) on the surface of the eye (corneal erosion and staining).
Uncommon: may affect up to 1 in 100 people
- Allergic reactions, which may cause difficulty breathing, shortness of breath, swelling of the face, throat or tongue.
Very rare: may affect up to 1 in 10,000 people
- Inflammation of the colored part of the eye, which may cause redness, blurred vision, changes in pupil size (the black part of the eye), and headache (iritis).
Other side effects include:
Very common: may affect more than 1 in 10 people
- Redness, tearing of the eyes, and itchy eye with sticky discharge (conjunctivitis, which may be due to allergy or infection), blurred vision, swelling and redness of the eyelid (which may be due to allergy (blepharitis)), raised areas on the eye surface, which may be observed by an ophthalmologist (conjunctival follicles),
- Headache, dry mouth, fatigue/somnolence.
Common: may affect up to 1 in 10 people
- Watery eyes, light sensitivity, damage to the front part of the eye (superficial corneal damage), dry eyes, abnormal vision,
- Upper respiratory tract symptoms, dizziness, stomach and intestinal pain, weakness, altered taste.
Uncommon: may affect up to 1 in 100 people
- Pounding or irregular heartbeat (including increased or decreased heart rate), depression, dryness of nasal mucous membranes.
Rare: may affect up to 1 in 1,000 people
- Shortness of breath (dyspnea).
Very rare: may affect up to 1 in 10,000 people
- Reduction in pupil size (miosis),
- Fainting, increased blood pressure (hypertension), decreased blood pressure (hypotension), insomnia.
Not known: frequency cannot be estimated from the available data
- Skin reactions including facial swelling, skin redness (which may be due to dilation of blood vessels), itching, rash, eyelid itching.
Additional side effects in children and adolescents
Very common: may affect more than 1 in 10 children
- Somnolence. This may affect more than 1 in 2 children.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Brimonidina Mylan Generics
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
After first opening, Brimonidina Mylan Generics must be used within 28 days of opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the packaging and other information
What Brimonidina Mylan Generics contains
The active substance is brimonidine tartrate.
1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
The other ingredients are: benzalkonium chloride (see section 2, Brimonidina Mylan Generics contains
benzalkonium chloride), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water,
sodium hydroxide and hydrochloric acid for pH adjustment.
Description of the appearance of Brimonidina Mylan Generics and contents of the packaging
Brimonidina Mylan Generics is a slightly yellow-greenish clear solution. The eye drops solution is
available in 5 ml plastic bottles with dropper caps, in pack sizes of 1, 3 or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy
Manufacturer
Viatris Santé
1 rue de Turin,
69007 Lyon
France
Famar A.V.E.
Alimos Plant, 63
Agiou Dimitriou str.,
Alimos Attiki, 17456,
Greece
This medicine is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria: Brimonidin Arcana 2 mg/ml – Augentropfen
Denmark: Glaudin
France: Brimonidine Viatris 0,2 % (2mg/ml), collyre en solution
Italy: Brimonidina Mylan Generics
Netherlands: Brimonidinetartraat Mylan 2 mg/ml, oogdruppels, oplossing
Portugal: Brimonidina Mylan, 2 mg/mL, colirio solução
Spain: Brimonidina Viatris 2mg/ml colirio en solución
United Kingdom: Brimonidine tartrate 2 mg/ml Eye drops, solution