What is LUXFEN and what it is used for
Luxfen is used to lower the intraocular pressure. It can be used either alone when eye drops containing beta-blocker are contraindicated or with other eye drops when only one drug is not enough to lower the pressure in the eye, treat open-angle glaucoma or ocular hypertension.
The active ingredient of Lufffen is brimonidine tartrate, which acts by reducing the pressure in the eyeball.
2. What you need to know before using LUXFEN
Do not use LUXFEN:
If you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6);
If you are taking monoamine oxidase (MAO) inhibitors or some antidepressants. You should inform your doctor if you are taking antidepressant medications;
In newborns and infants (from birth to 2 years of age).
During breastfeeding, use of Lufffen is not recommended.
Warnings and precautions
Talk to your doctor or pharmacist before using LUXFEN:
If you suffer from depression, reduced mental capacity, decreased blood supply to the brain, heart problems, abnormal blood supply to the extremities or abnormal blood pressure.
If you have or have had liver or kidney problems in the past.
If given to a child between 2 and 12 years of age as Lufffen is not recommended for use in this age group.
Consult a doctor if any of these conditions are true for you!
Children and adolescents
Brimonidine is not recommended for use in children (from 2 to 12 years) and is contraindicated in newborns and infants (under 2 years of age).
Other medicines and LUXFEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:
painkillers, sedatives, opiates, barbiturates or regular alcohol use;
anesthetics;
medicines to treat heart disease or to lower blood pressure;
chlorpromazine, methylphenidate and reserpine;
drugs that act on the same receptor as Luxfen, for example isoprenaline and prazosin;
monoamine oxidase (MAO) inhibitors and other antidepressants;
medicines to treat any illness, even if not related to eye disease;
or if the dose of any of the medicines you are taking currently changes.
This may affect your treatment with Lufffen.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Luffen should not be used while you are breast-feeding.
Driving and using machines
Luxfen may cause blurred vision and / or visual disturbances. This effect may be even stronger at night or in dim light.
Luxfen may also cause drowsiness and fatigue in some patients.
If you have any of these symptoms, do not drive or use machines until the symptoms go away.
Luxfen contains benzalkonium chloride. This may cause irritation in the eyes. Avoid contact with soft contact lenses. Remove the contact lenses before administration and wait for at least 15 minutes before reinserting. It is known to discolour soft contact lenses.
3. How to use LUXFEN
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults
The usual dose is one drop twice a day in the affected eye (eyes) at approximately 12 hours.
Children under 12 years of age
Luxfen should not be used for newborns and babies under 2 years of age.
Lufffen is not recommended for use in children (from 2 years to 12 years of age).
Instruction for use
Brimonidine is only for use as eye drops. Do not be swallowed.
Always wash your hands before dropping. Your prescription will tell you how many drops to use at each dose. If you use Luxfen with other eye drops, wait 5-15 minutes before putting the second eye drops.
Apply the eye drops as follows:
1. Bend your head back and look at the ceiling.
2. Gently pull the lower eyelid down until a small pocket is formed.
3. Squeeze the drop-down bottle with a dropper to drop a drop in your eye.
4. Immediately after putting each drop, close the eye and press the fingertip against the inner corner of the closed eye (near the nose) for 1 minute. This helps reduce the absorption of brimonidine in your body.
Avoid touching your eye or other objects with the tip of the dropper.
If you use more Luffen than you should
Adults
In adults who have put more drops of the prescribed, the reported side effects are those that are already known to occur at LUXFEN.
Adults who have accidentally swallowed Luffen have experienced a decrease in blood pressure, which in some patients is followed by an increase in blood pressure.
Children
Serious side effects have been reported in children who have accidentally swallowed Luffen. Signs include drowsiness, looseness, low body temperature, paleness and difficulty in breathing. If any of these symptoms occur, contact your doctor immediately.
Adults and children
If you accidentally swallow Luffen or if you have used more Lufffen than you should, please contact your doctor immediately.
If you forget to use Luxfen
If you have forgotten to put Luffen on the missed dose as soon as you remember. But if it's almost time for the next dose, skip the forgotten dose and continue with the usual schedule. Do not take a double dose to make up for the missed dose.
If you stop taking LUXFEN
To be effective, Lufffen should be used every day. Do not stop using Luffen until your doctor tells you this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. The likelihood of an adverse reaction is determined by the following categories:
Very common: may affect more than 1 in 10 people;
Common: may affect up to 1 in 10 people;
Uncommon: may affect up to 1 in 100 people;
Rare: may affect up to 1 in 1,000 people;
Very rare: may affect up to 1 in 10,000 patients;
Not known: can not be estimated from the available data.
The following side effects may occur during treatment with Lufffen
Affecting the eye
Very common:
Eye irritation (redness, burning, twitching, feeling of something in the eye, itching, follicles or white spots on the transparent layer that covers the surface of the eye);
Unclear vision;
Eye allergic reactions.
Common:
Local irritation (inflammation and swelling of the eyelid, conjunctival swelling, sticky eyes, pain and tearing);
Sensitivity to light;
Eyelidation of the surface of the eye and stain formation;
Dry eyes;
Sweating the conjunctiva;
Deviations in vision;
Conjunctival inflammation.
Very rare:
Irites;
Collapse of the pupils.
Not known:
Itching of the eyelids.
Affecting the body
Very common:
Headache;
Dry mouth;
Fatigue / Drowsiness.
Common:
Dizziness;
Flu-like symptoms;
Symptoms affecting stomach and digestion;
Unusual taste;
General weakness.
Uncommon:
Depression;
Increased heart rate or change in heart rate;
Dryness in the nose;
General allergic reactions.
Rare:
Shortness of breath (shortness of breath).
Very rare:
Drowsiness;
Fake;
High blood pressure;
Low blood pressure.
How to store LUXFEN
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle box and label. The expiry date refers to the last day of that month.
After the first opening, Luxfen can be stored for up to 28 days.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Luffen 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, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid to adjust pH.
What Lufffeld looks like and what the package contains
Luxfen is a clear, pale greenish-yellow solution.
Available in bottles with a dropper of 5 ml or 10 ml eye drops, 1, 3 or 6 solution in pack.
Not all pack sizes may be marketed.