Patient Medication Information: uses, side effects, how to take - Saflutan
What is SAFLUTAN used for?
SAFLUTAN lowers the pressure in the eye for conditions such as open-angle glaucoma or ocular hypertension.
SAFLUTAN increases the flow of fluid out of the eye thereby reducing eye pressure.
How does SAFLUTAN work?
SAFLUTAN belongs to a group of medicines called prostaglandin analogues. SAFLUTAN increases the flow of fluid out of the eye. This helps lower the pressure in the eye.
What are the ingredients in SAFLUTAN?
Medicinal ingredients: tafluprost
Non-medicinal ingredients: disodium edetate, glycerol, polysorbate 80, and sodium dihydrogen phosphate dihydrate.
Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.
SAFLUTAN is preservative-free. It does not contain the preservative benzalkonium chloride.
SAFLUTAN comes in the following dosage forms:
SAFLUTAN is a clear, colorless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 mL of solution (tafluprost 4.5 mcg). Ten single-dose containers are provided in one foil pouch and 3 pouches are in a carton.
Do not use SAFLUTAN if:
Do not use SAFLUTAN if you are allergic to any of its ingredients. (See What are the ingredients in SAFLUTAN?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SAFLUTAN. Talk about any health conditions or problems you may have, including if you:
- have any medical problems you have now or have had in the past. This includesany other eye disease.
- have any allergies.
are breast feeding or intend to breast feed.
- are breast feeding or intend to breast feed.
are of child-bearing years. You should use an effective form of birth control when taking
SAFLUTAN.
- have now or have had in the past liver problems
- have now or have had in the past kidney problems
- have now or have had in the past any lung problems, including asthma.
Other warnings you should know about:
While using SAFLUTAN you may experience the following side effects, some of which may be permanent. These effects may occur slowly and it may be several months before you notice them. SAFLUTAN may:
- increase the length, thickness, color and/or number of your eyelashes. It may cause unusual hair growth on your eyelids.
- cause darkening of the color of the skin around the eyes. Blot off any excess solution from the skin. This will reduce the risk of skin darkening.
- change the color of your iris (the colored part of your eye). If SAFLUTAN is used in one eye only, the color of the treated eye may become different from the color of the other eye. This may be permanent.
You may find that your vision is blurred for a time just after you put SAFLUTAN in your eye. Do not drive or use any tools or machines until your vision is clear.
SAFLUTAN is not recommended for use in children or adolescents below 18 years of age.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
No drug interaction studies have been done for SAFLUTAN. Tell your doctor about all drugs, including other eyedrops, that you are using or plan to use.
How to take SAFLUTAN:
- Always use SAFLUTAN exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure how to use
SAFLUTAN.
- Remove contact lenses before using SAFLUTAN. They can be reinserted 15 minutes after using SAFLUTAN.
Instructions for Use:
When you start a new pouch:
Do not use the single-dose containers if the pouch is broken. Open the pouch along the dashed line. Write down the date you opened the pouch in the space reserved for the date on the pouch.
Every time you use SAFLUTAN:
Step 1 Wash your hands.
Step 2 Take the strip of containers from the pouch.
Step 3 Detach one single-dose container from the strip.
Step 4 Put the remaining strip back in the pouch and fold the edge to close the pouch. 
Step 5 Make sure that the solution is in the bottom part of the single-dose container.
Figure A
Step 6 To open the container, twist off the tab.
Figure B
Step 7 Tilt your head backwards. If you are unable to tilt your head, lie down.
Place the tip of the container close to your eye. Be careful not to touch the tip of the container to the eye itself.
Figure C
Step 8
Step 9 Pull the lower eyelid downwards and look up.
Step 10 Gently squeeze the container and let one drop fall into the space between the lower eyelid and the eye.
Figure D
Step 11 Close your eye for a moment and press the inner corner of the eye with your finger for about one minute. This helps to prevent the eye drop from draining down the tear duct.
Blot off any excess solution from the skin around the eye with a tissue.
Figure E
Step 12
If a drop misses your eye, try again.
If your doctor has told you to use drops in both eyes, repeat steps 7 to 12 for your other eye.
The contents of one container of SAFLUTAN are enough for both eyes. Use the solution immediately after opening. Discard the opened container with any remaining contents immediately after use.
Usual dose:
The dose is 1 drop of SAFLUTAN in the eye or eyes, once daily in the evening. Only use SAFLUTAN in both eyes if your doctor told you to. Discard the single-use container immediately after use.
Do not instill more drops or use more often than as instructed by your doctor. This may make SAFLUTAN less effective.
If you use other medicines in the eye, leave at least 5 minutes between putting in SAFLUTAN and the other medication.
Do not stop using SAFLUTAN without asking your doctor. If you stop using SAFLUTAN, the pressure in the eye will increase again. This may cause a permanent injury to your eye.
Overdose:
If you use more SAFLUTAN than you should, contact your doctor, but do not stop taking your medicine.
SAFLUTAN is for use as eye drops only and should not be swallowed. If the medicine is accidentally swallowed, please contact a doctor for advice.
If you think you have taken too much SAFLUTAN, contact a health care practitioner (e.g. doctor), hospital emergency department or the regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
It is important to take SAFLUTAN as prescribed by your doctor. If you forget to use SAFLUTAN, use a single drop as soon as you remember, and then put in your next dose at the usual time. Do not use a double dose to make up for a forgotten dose.
What are possible side effects from using SAFLUTAN?
These are not all the possible side effects you may feel when taking SAFLUTAN. If you experience any side effects not listed here, contact your healthcare professional.
- Eye redness
- Itchy eyes
- Eye pain
- Tired eyes
- Burning or stinging eyes
- Dryness and irritation of the eye
- Feeling of something in the eye
- Sensitivity to light
- Change in eyelash colour, thickness, or growth
- Eye or eyelid swelling
- Red, puffy, or itchy eyelid
- Hair growth on the eyelids
- Watery eye
- Eye discharge
- Blurred vision
- Reduction in the ability to see details
- Changes to the surface of the eye
- Changes to the colour of the iris (may be permanent). The iris is the coloured part of the eye.
- Changes in the skin colour around the eye.
- Deepening of the eyelid crease (eyes appear sunken)
- Headache
- Dizziness
- Dry mouth
- Cough or sore throat
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Iritis/uveitis (inflammation of the iris or uvea (part of the | √ | ||
| eye)): pain and sensitivity to light, possibly with blurred vision. | |||
| Cataract: clouding of the lens in the eye, blurry vision, dim vision and/or eye pain. | √ | ||
| Corneal erosion (damage to the front layer of the eyeball): eye redness, pain, tears, burry vision, and feeling of something in the eye. | √ | ||
| retinal detachment (separation of the back part of the eye): seeing flashing light or floating spots in the vision, blurry or decreased vision. | √ | ||
| Worsening of asthma, shortness of breath. | √ | ||
| Anaphylactic shock (Allergic Reaction): rash, hives, swelling of the mouth, throat, and lips, difficulty breathing, blue skin, shock, loss of consciousness, low blood pressure. | √ |
This is not a complete list of side effects. For any unexpected effects while taking SAFLUTAN, contact your doctor or pharmacist.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store the unopened foil pouches of SAFLUTAN in a refrigerator (2°C - 8°C).
- Do not open the pouch until you are about to start using the eye drops.
- Keep out of the sight and reach of children.
After opening the foil pouch:
- Keep the single-dose containers in the original foil pouch.
- Do not store above 25°C.
- Discard any unused single-dose containers after 28 days from date of first opening of the foil pouch.
- Discard an opened single-dose container with any remaining solution immediately after use.
Do not use this medicine after the expiry date stated on the single-dose container, pouch and the outer carton after ‘EXP’. The expiry date refers to the last day of that month.
If you want more information about SAFLUTAN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.purdue.ca, or by calling 1-800-837-4501.
Last Revised: July 29, 2020
Saflutan™ is a trademark of Purdue Pharma.