0.2% (2 mg / ml) eye drops , solution
brimonidine tartrate
1. WHAT ALPHAGAN IS AND WHAT IT IS USED FOR
Alphagan is used to lower the pressure in the eye. The active substance in Alphagan is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by lowering the pressure in the eyeball.
It can be used either as a single drug, when eye drops containing beta-receptor blockers are inappropriate, or together with another eye drop when a single drug is not sufficient to lower the elevated pressure in the eye, in the treatment of open-angle glaucoma or elevated pressure in the eye.
2. BEFORE YOU USE ALPHAGAN
Do not use Alphagan
- If you are allergic (hypersensitive) 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 certain other antidepressants. Tell your doctor if you are taking any medicine for depression.
- If you are breast-feeding.
- For newborns and toddlers (from birth to 2 years of age).
Take special care with Alphagan
Talk to your doctor before using Alphagan
- If you have or have previously had depression, impaired mental ability decreased blood supply to the brain, heart problems, disorders of the blood supply to the extremities, or problems with blood pressure .
- If you have or have ever had problems with your kidneys or liver.
Children and young people
Alphagan is not recommended for use in children between 2 and 12 years of age.
Alphagan should not normally be used in adolescents between 12 and 17 years of age as clinical trials have not been performed in this age group.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:
- painkillers, sedatives, opiates, barbiturates, or if you regularly consume alcohol.
- anesthetic.
- medicines to treat heart disease or to lower blood pressure.
- drugs that may affect metabolisms, such as chlorpromazine, methylphenidate, and reserpine.
- drugs that act on the same receptor as Alphagan, e.g. isoprenaline and prazosin.
- monoamine oxidase (MAO) inhibitors and other antidepressants.
- medicines for other diseases, even when there is no link to your eye disease
- or if the dose of one of your other medicines changes.
This may affect your treatment with Alphagan.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Alphagan if you are pregnant unless your doctor tells you it is necessary.
Alphagan should not be used if you are breast-feeding.
Driving and using machines
- Alphagan may cause blurred vision or changes in vision. This effect may appear worse at night or at reduced lighting.
- Alphagan may also cause drowsiness or fatigue in some patients.
- 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 sharpened attention. 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.
Important information about some of the ingredients of Alphagan
Alphagan contains 0.25 mg benzalkonium chloride in each 5 ml solution, equivalent to 0.05 mg / ml.
Benzalkonium chloride is a preservative that can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting on contact lenses
again.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. HOW TO USE ALPHAGAN
Always use Alphagan exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose is one drop twice daily in the affected eye (s), at intervals of approximately 12 hours. Do not change the dose or stop using Alphagan without talking to a doctor first.
Children under 12 years
Alphagan should not be used in infants under 2 years of age.
The use of Alphagan is not recommended for children (from 2 to 12 years of age).
User instructions
Alphagan is an eye drop. Always wash your hands before applying eye drops. The pharmacy label indicates how many drops you should take for each dose. If Alphagan is used with other eye drops, wait 5-15 minutes before taking the other type of eye drops.
Take the drops as follows:
- Tilt your head back and look at the ceiling.
- Pull it under the eyelid downwards until a small pocket is formed.
- Hold the bottle upside down and squeeze until there is a drop in the eye.
- Release the lower eyelid, close your eyes and at the same time press your finger against the inner corner of the eye (the side where the eye is closest to the nose) for 1 minute.
If the drop falls outside the eye, try again.
To prevent contamination, avoid the tip of the bottle coming into contact with the eye or anything else. Replace the screw cap and close the bottle immediately after use.
Adults
In adults who used more drops than prescribed, the reported side effects were those already known when using Alphagan.
Adults who accidentally swallowed Alphagan experienced a decrease in blood pressure, which in some
patients were followed by an increase in blood pressure.
Children
Serious side effects have been reported in children who accidentally swallowed Alphagan. Symptoms included drowsiness, lethargy, low body temperature, pallor, and difficulty breathing. Contact your doctor immediately if this should happen.
Adults and children
If anyone has accidentally drunk the eye drops or if you have used more Alphagan than you should, contact your doctor immediately.
If you forget to use Alphagan
If you forget to take a dose, take it as soon as you remember. However, you should skip the missed dose if it is almost time for the next dose. Then follow the normal routine.
If you stop using Alphagan
Alphagan must be used every day to be effective. Do not stop using Alphagan until your doctor tells you to.
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.
The following side effects have been reported with the use of Alphagan.
Side effects are those that affect the eye
Very common (may affect more than 1 user in 10):
- Eye irritation (red eyes, burning sensation, stinging sensation, the feeling of having something in the eye, itching, blisters, or white spots in the transparent membrane that covers the surface of the eye)
- Grumlad syn
- An allergic reaction in the eye
Common (may affect up to 1 in 10 people):
- Local irritation ( inflammation and swelling of the eyelid, swelling of the transparent membrane covering the surface of the eye, sticky eyes, aches, and increased tear flow)
- Photosensitivity
- Abrasion on the surface of the eye and discoloration
- Dry eyes
- The whiteness of the translucent membrane covering the surface of the eye
- Abnormal sight
- Inflammation of the transparent membrane that covers the surface of the eye
Very rare (may affect up to 1 in 1,000 users):
- Inflammation of the eye
- Reduced pupil size.
Has been reported (occurs in an unknown number of users):
- Eyelid itching
Side effects are those that affect the rest of the body
Very common (may affect more than 1 user in 10):
- Headache
- Dry mouth
- Fatigue / drowsiness.
Common (may affect up to 1 in 10 people) :
- Dizziness
- Cold symptoms
- Symptoms from the stomach and digestion
- Taste effect
- Impotence
Uncommon (may affect up to 1 in 100 people) :
- Depression
- Palpitations or changes in heart rate
- Dry nose
- General 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) :
- Insomnia
- Fainting
- High blood pressure
- Low blood pressure
Has been reported (occurs in an unknown number of users):
- Skin reactions including redness, swelling of the face, itching, rash, and dilation of blood vessels
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE ALPHAGAN
- Keep this medicine out of the sight and reach of children.
- Do not store above 25 ° C.
- Do not use the bottle if the seal is broken before the first time you use the bottle.
- Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. The expiration date is the last day of the specified month.
- The bottle should be discarded 28 days after opening, even if there is a solution left.
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. FURTHER INFORMATION
Content declaration
- The active substance is brimonidine tartrate. 1 ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg brimonidine.
- The other ingredients are benzalkonium chloride as a preservative, poly (vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid for pH control.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Allergan. Mayo, Ireland.
Manufacturer
Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Alphagan 0.2% eye drops |
| Germany | Alphagan 0.2% w / v (2 mg / ml) eye drops |
| Belgium, Finland, Greece, Iceland, Luxembourg, Norway, Portugal | Alphagan |
| Denmark, Ireland, Italy, Netherlands, UK | Alphagan 0.2% |
| France | Alphagan 0.2% (2mg / ml), collyre and solution |
| Spain | Alphagan 2 mg / ml colirio in solution |