2 mg/ml eye drops, brimonidine tartrate solution

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Glaudin is and what it is used for
2. What you need to know before taking Glaudin
3. How to take Glaudin
4. Possible side effects
5. How to store Glaudin 6. Contents of the pack
and other ingredients information

1. What Glaudin is and what it is used for

Glaudin contains the active substance brimonidine tartrate, which lowers intraocular pressure (pressure in the eye) in patients with open-angle glaucoma or ocular hypertension (increased fluid pressure in the eye).

Glaudin can be used alone or in combination with other medicines that lower intraocular pressure.

Brimonidine tartrate contained in Glaudin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Glaudin

Do not use Glaudin

  • if you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
  • if you are being treated with medicines that are classified as a monoamine oxidase inhibitor ( MAOI ), which are used to treat depression or Parkinson’s disease , such as selegiline , phenelzine.
  • if you are being treated with certain antidepressants (such as tricyclic antidepressants, such as clomipramine, amitriptyline or mianserin).

You must tell your doctor if you are taking any antidepressants.

Do not give to newborns or infants (up to 2 years of age).

Warnings and cautions

Talk to your doctor or pharmacist before using Glaudin

  • if you have a severe or unstable heart disease that is not controlled with treatment.
  • if you suffer from depression.
  • if you have reduced blood flow to the brain (cerebral insufficiency ) or to the heart, such as angina or clogged blood vessels.
  • if you have low blood pressure which causes dizziness and dizziness when you sit up or stand up after lying down ( orthostatic hypotension ).
  • if you have angina in mainly hands and arms ( Raynaud’s disease ), or a chronic inflammatory disease that causes narrowing of the blood vessels due to blood clotting (thrombangiitis obliterans).
  • if you have impaired liver or kidney function.

Children and young people

Glaudin should not be used in newborns or infants (from birth to 2 years of age).

Glaudin is not generally recommended for use in children (2-12 years of age) due to the increased risk of side effects (eg drowsiness).

Other drugs and Glaudin 

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

Do not use Glaudin if you are being treated with MAOIs (monoamine oxidase inhibitors), tricyclic antidepressants, or mianserin (see section Do not use Glaudin).

Substances that affect the central nervous system ( CNS ):

Brimonidine tartrate may increase the effects of substances that affect the central nervous system ( CNS ) (such as alcohol, barbiturates, eg phenobarbital used for epilepsy, opiates for pain relief, eg codeine, sedatives that make you sleepy, eg diazepam, or anesthetics ).

Medicines for the treatment of diseases of the nervous system (chlorpromazine, methylphenidate) and antihypertensive medicines (reserpine):

Caution is advised when treating drugs that may affect the uptake and metabolism of the neurotransmitters adrenaline and noradrenaline and other so-called biogenic amines.

Blood pressure-lowering drugs, heart drugs:

A slight decrease in blood pressure has been observed in patients taking brimonidine tartrate. Caution should be exercised if Glaudin is used concomitantly with blood pressure-lowering drugs or digitalis drugs (for the treatment of heart flutter/fibrillation or heart failure ).

Drugs that enhance or block the transmission of nerve impulses (called adrenoceptor agonists or – antagonist s): Care must be taken if you take the so-called alpha-adrenoceptor agonists such as phenylephrine (used for example in eye drops, nasal sprays) or antagonist s (e.g., isoprenaline or prazosin (used to treat high blood pressure or other circulatory problems)).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Studies have not yet been performed to see if it is safe to use brimonidine tartrate during pregnancy. Glaudin should be used with caution during pregnancy and only if the expected benefit to the mother outweighs the potential risk to the fetus.

Breast-feeding

It is not known whether brimonidine tartrate is excreted in human milk. Glaudin should not be given to breastfeeding women.

Driving and using machines

Glaudin may cause fatigue and/or drowsiness. This may affect your ability to drive or use machines.

Glaudin may cause blurred vision and/or vision changes. This may affect your ability to drive or use machines, especially at night or in low light.

If you experience any of these symptoms, do not drive or use machines until the symptoms have subsided.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Glaudin contains benzalkonium chloride

Glaudin contains the preservative benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses. Benzalkonium chloride may discolor soft contact lenses. Remove contact lenses before using Glaudin and wait at least 15 minutes after taking the medicine before inserting the contact lenses again.

3. How to take Glaudin

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

It is very important that you take Glaudin for as long as your doctor recommends it.

If you have the impression that the effect of Glaudin is too weak or too strong, tell your doctor.

Adults (even older)

If your doctor has not given you other instructions, the recommended dose is 1 drop in the affected eye (s) twice daily with about 12 hours in between.

Instructions for use

Glaudin should only be used for the eyes. Do not swallow.

Always wash your hands before applying the eye drops:

  1. Tilt your head back and look up at the ceiling.
  2. Pull the lower eyelid down until a small pocket is formed.
  3. Hold the bottle upside down and squeeze until there is a drop in the eye.

Immediately after taking the drop, close your eyes and at the same time press your fingertip against the inner corner of the eye (near the nose) for 1 minute. This helps reduce the uptake of brimonidine tartrate into the body.

If you use more than one eye medicine, they should be taken at least 5-15 minutes apart.

Screw on the cap immediately after use. You should avoid touching the eye or other surfaces with the drip tip.

If you take more Glaudin than you should

Adults

The side effects listed in section 4 of this leaflet have been reported in adults who used more drops in the eye than prescribed.

Low blood pressure has been reported in adults who happen to swallow brimonidine tartrate, which was followed by an increase in blood pressure in some patients. Contact a doctor immediately if you accidentally swallow Glaudin. The following side effects have been reported with ingestion of other drugs with similar effects to brimonidine tartrate: weakness, vomiting, fatigue, decreased consciousness, slow heart rate, changes in heart rate, decreased pupil size in the eye, decreased muscle tone, difficulty breathing, and low body temperature.

Children

Cases of overdose have been reported in children who accidentally swallowed brimonidine tartrate. Symptoms include temporary coma or low level of consciousness, fatigue, drowsiness, lethargy, low heart rate, low body temperature, paleness, and difficulty breathing. If any of these occur, consult a physician immediately.

Adults and children

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for an assessment of the risk and advice. Take the medicine pack with you so that the doctor can see what you have taken.

If you forget to take Glaudin

If you forget to take Glaudin, take the missed dose as soon as you remember. But if it is soon time to take the next dose, skip the missed dose and take the next dose instead. Do not take a double dose to make up for a forgotten dose.

Do not change the dose that your doctor tells you to take.

If you stop taking Glaudin

Do not stop or stop treatment with Glaudin without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects, or if they become severe during treatment with Glaudin, contact your doctor or hospital immediately:

Very common: may affect more than 1 in 10 people

– Irritation of the eye, including allergic reactions ( redness, pain, tingling, burning sensation, itching, sensation of foreign objects in the eye).

Common: may affect up to 1 in 10 people

– Discoloration of the cornea/spots on the cornea (surface of the eye), blisters, swelling, or severe damage (which can be diagnosed by an ophthalmologist and which can cause pain or discomfort in the eye) on the surface of the eye (corneal erosion or spots).

Uncommon: may affect up to 1 in 100 people

– Allergic reactions that 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 iris can cause redness, blurred vision and changes in the shape of the pupil (the black dot in the eye), and headache (iritis).

Other side effects include:

Very common: may affect more than 1 in 10 people

– Redness, tearful eyes with itching and suppuration (conjunctivitis which may be due to allergy or infection ), blurred vision, swelling and redness of the eyelid which may be due to allergy ( blepharitis ), bumps on the eye can be ascertained at the optician (conjunctival follicles )

– Headache, dry mouth, fatigue/drowsiness.

Common: may affect up to 1 in 10 people

Runny eyes, photosensitivity, damage to the front layer of the eye (superficial damage to the cornea), dry eyes, abnormal vision

– Symptoms of the upper respiratory tract, dizziness, pain in the stomach and intestines, weakness, taste effects.

Uncommon: may affect up to 1 in 100 people

Palpitations / irregular heartbeats (including slow or fast heartbeats), depression, dry nose.

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

– Shortness of breath.

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

– Decreased pupil size ( mios )

Fainting, high or low blood pressure, insomnia.

No known frequency: can not be calculated from the available data
– Skin reactions, such as swelling of the face, redness of the skin (which may be due to dilation of the blood vessels), itchy skin, rash, itchy eyelids.

Additional side effects are in children and adolescents

Very common: may affect more than 1 in 10 children

– Sleepiness. This can occur in more than 1 in 2 children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glaudin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. and the bottle after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Opened packaging must be used within 28 days

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is brimonidine tartrate1 ml solution contains 2 mg brimonidine tartrate corresponding to 1.3 mg brimonidine.
  • Other ingredients are:Benzalkonium chloride (see section 2 Glaudin contains benzalkonium chloride), poly (vinyl) alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, sodium hydroxide and hydrochloric acid for pH adjustment.

What the medicine looks like and contents of the pack

Glaudin is a clear, slightly greenish-yellow solution. The eye drops are available in 5 ml or 10 ml plastic bottles with a drip tip in packs of 1, 3, or 6 plastic bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan AB

Box 23033

Tel: 08-555 227 50

Fax: 08-555 227 51

Email: inform@mylan.se

Manufacturer:

Pharmastulln GmbH, Werksstraβe 3, 925 51 Stulln, Germany

UAB Santonika, 134B Veiveriu Street, 46353 Kaunas, Lithuania

Muhammad Nadeem

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