Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tafluprost may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What kind of medicine is it and how does it work? SAFLUTAN eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. SAFLUTAN lowers the pressure in the eye. It is used when the pressure in the eye is too high. What is your medicine for? SAFLUTAN is used to treat a type of glaucoma called open angle glaucoma and also a condition known as ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye and eventually they may affect your eyesight.
2.
What you need to know before you take it
e SAFLUTAN
Do not use SAFLUTAN: • if you are allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using SAFLUTAN. Please note that SAFLUTAN may have the following effects and that some of them may be permanent: • SAFLUTAN may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids. • SAFLUTAN may cause darkening of the colour of the skin around the eyes. Wipe off any excess solution from the skin. This will reduce the risk of skin darkening. • SAFLUTAN may change the colour of your iris (the coloured part of your eye). If SAFLUTAN is used in one eye only, the colour of the treated eye may permanently become different from the colour of the other eye. 1 saflutan-sd-en-uk_ie_mt APPR2 20210907 [048 BR_names]
•
SAFLUTAN may cause hair growth in areas where the solution comes repeatedly in contact with the skin surface.
Tell your doctor • if you have kidney problems • if you have liver problems • if you have asthma • if you have other eye diseases. Children and adolescents SAFLUTAN is not recommended for children and adolescents below 18 years due to a lack of data on safety and efficacy. Other medicines and SAFLUTAN Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines. If you use other medicines in the eye, leave at least 5 minutes between putting in SAFLUTAN and the other medication. Pregnancy, breast-feeding and fertility If you may become pregnant, you must use an effective method of birth control during SAFLUTAN therapy. Do not use SAFLUTAN if you are pregnant. You should not use SAFLUTAN if you are breast-feeding. Ask your doctor for advice. Driving and using machines SAFLUTAN has no influence on the ability to drive and use machines. 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 contains phosphates This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1.2 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
3.
How to take it
SAFLUTAN
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 drop of SAFLUTAN in the eye or eyes, once daily in the evening. Do not instil more drops or use more often than as instructed by your doctor. This may make SAFLUTAN less effective. Only use SAFLUTAN in both eyes if your doctor told you to. For use as eye drops only. Do not swallow. 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.
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Every time you use SAFLUTAN: 1. Wash your hands. 2. Take the strip of containers from the pouch. 3. Detach one single-dose container from the strip. 4. Put the remaining strip back in the pouch and fold the edge to close the pouch. 5.
Make sure that the solution is in the bottom part of the single-dose container.
6.
To open the container, twist off the tab.
7. 8.
Tilt your head backwards. Place the tip of the container close to your eye.
9.
Pull the lower eyelid downwards and look up. Gently squeeze the container and let one drop fall into the space between the lower eyelid and the eye.
10.
11.
12.
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. Wipe off any excess solution from the skin around the eye.
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 single-dose container are sufficient for both eyes. Discard the opened container with any remaining contents immediately after use. If you use other medicines in the eye, leave at least 5 minutes between putting in SAFLUTAN and the other medication. If you use more SAFLUTAN than you should, it is unlikely to cause you any serious harm. Put in your next dose at the usual time. 3 saflutan-sd-en-uk_ie_mt APPR2 20210907 [048 BR_names]
If the medicine is accidentally swallowed, please contact a doctor for advice. If you forget to use SAFLUTAN, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten dose. 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. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are not serious. Common side effects The following may affect up to 1 in 10 people: Effects on the nervous system:
- headache. Effects on the eye:
- itching of the eye
- irritation in the eye
- eye pain
- redness of the eye
- changes in the length, thickness and number of eyelashes
- dry eye
- foreign body sensation in the eye
- discolouration of eyelashes
- redness of the eyelids
- small spotlike areas of inflammation on the surface of the eye
- sensitivity to light
- watery eyes
- blurred vision
- reduction in the eye's ability to see details
- change of colour of the iris (may be permanent). Uncommon side effects The following may affect up to 1 in 100 people: Effects on the eye:
- change of colour of the skin around the eyes
- puffy eyelids
- tired eyes
- swelling of the eye's surface membranes
- eye discharge
- inflammation of the eyelids
- signs of inflammation inside the eye
- discomfort in the eye
- pigmentation of the eye's surface membranes
- follicles in the surface membranes of the eye
- allergic inflammation 4 saflutan-sd-en-uk_ie_mt APPR2 20210907 [048 BR_names]
•
abnormal sensation in the eye.
Effects on the skin and tissue under the skin:
- unusual hair growth on eyelids. Not known: frequency cannot be estimated from the available data Effects on the eye:
- inflammation of the iris/uvea (middle layer of the eye)
- eyes appear sunken
- macular oedema/cystoid macular oedema (swelling of the retina within the eye leading to worsening vision). Effects on the respiratory system:
- worsening of asthma, shortness of breath
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal
5.
How to store it
SAFLUTAN
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 single-dose container, pouch and the carton after 'Exp'. The expiry date refers to the last day of that month. Store the unopened foil pouches in a refrigerator (2°C – 8°C). Do not open the pouch until you are about to start using the eye drops as unused containers in an open pouch must be discarded 28 days after first opening the pouch. After opening the foil pouch:
- Keep the single-dose containers in the original foil pouch.
- Do not store above 25°C
- Discard 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What SAFLUTAN contains
- The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One singledose container (0.3 ml) contains 4.5 micrograms of tafluprost. One drop (about 30 microlitre) contains about 0.45 micrograms of tafluprost. 5 saflutan-sd-en-uk_ie_mt APPR2 20210907 [048 BR_names]
- The other ingredients are glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80 and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH. What SAFLUTAN looks like and contents of the pack SAFLUTAN is a clear, colourless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 ml of solution. Ten single-dose containers are provided in one pouch. SAFLUTAN is supplied in packs containing 30 or 90 single-dose containers. Not all pack sizes may be marketed. Marketing Authorisation Holder (UK/Ireland/Malta): Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland Manufacturer: Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Bulgaria, Czech Republic, Denmark, Estonia, Finland, Hungary, Iceland, Latvia, Lithuania, Norway, Poland, Slovakia, Sweden Germany Austria, Belgium, Cyprus, France, Greece, Ireland, Italy, Luxembourg, Malta, The Netherlands, Portugal, Romania, Slovenia, Spain, United Kingdom (Northern Ireland)
Taflotan Taflotan sine Saflutan
This leaflet was last revised in July 2021
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Frequently asked questions about SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container
How do I take SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container?
SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container comes as eye drops containing 15micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container?
The active substance in SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container is tafluprost.
Are there equivalent medicines to SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container?
Medicines with the same active substance, strength and form include: Saflutan 15 micrograms/ml eye drops, solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tafluprost
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
As monotherapy in patients:
o who would benefit from preservative free eye drops
o insufficiently responsive to first line therapy
o intolerant or contra-indicated to first line therapy.
As adjunctive therapy to beta-blockers.
SAFLUTAN is indicated in adults ≥ 18 years.
4.2. Posology and method of administration
Posology
The recommended dose is one drop of SAFLUTAN in the conjunctival sac of the affected eye(s) once daily in the evening.
The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.
For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use.
Use in elderly
No dosage alteration in elderly patients is necessary.
Paediatric population
The safety and efficacy of tafluprost in children below age 18 has not yet been established. No data are available.
Use in renal/hepatic impairment
Tafluprost has not been studied in patients with renal/hepatic impairment and should therefore be used with caution in such patients.
Method of administration
To reduce the risk of darkening of the eyelid skin the patients should wipe off any excess solution from the skin. As with any other eye drops, nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route.
If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
4.3. Contraindications
Hypersensitivity to the active substance tafluprost or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.
The change in iris pigmentation occurs slowly and may not be noticeable for several months. The change in eye colour has predominantly been seen in patients with mixed coloured irises, e.g. blue-brown, grey-brown, yellow-brown and green-brown. The risk of lifelong heterochromia between the eyes in unilateral cases is obvious.
There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.
There is no experience with tafluprost in neovascular, angle-closure, narrow-angle or congenital glaucoma. There is only limited experience with tafluprost in aphakic patients and in pigmentary or pseudoexfoliative glaucoma.
Caution is recommended when using tafluprost in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema or iritis/uveitis.
There is no experience in patients with severe asthma. Such patients should therefore be treated with caution.
4.5. Interaction with other medicinal products and other forms of interaction
No interactions are anticipated in humans, since systemic concentrations of tafluprost are extremely low following ocular dosing. Therefore, specific interaction studies with other medicinal products have not been performed with tafluprost.
In clinical studies tafluprost was used concomitantly with timolol without evidence of interaction.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception
SAFLUTAN must not be used in women of childbearing age/potential unless adequate contraceptive measures are in place (see section 5.3).
Pregnancy
There are no adequate data from the use of tafluprost in pregnant women. Tafluprost can have harmful pharmacologic effects on pregnancy and/or the fetus/newborn child. Studies in animals have shown reproductive toxicity (see section 5.3). Therefore, SAFLUTAN should not be used during pregnancy unless clearly necessary (in case no other treatment options are available).
Breast-Feeding
It is unknown whether tafluprost or its metabolites are excreted in human milk. A study in rats has shown excretion of tafluprost and/or its metabolites in breast milk after topical administration (see section 5.3). Therefore, tafluprost should not be used during breast-feeding.
Fertility
In female and male rats, mating performance and fertility was unaffected by intravenous tafluprost doses up to 100 μg/kg/day.
4.7. Effects on ability to drive and use machines
Tafluprost has no influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
4.8. Undesirable effects
In clinical studies, over 1,400 patients have been treated with preserved tafluprost either as monotherapy or as adjunctive therapy to timolol 0.5%. The most frequently reported treatment-related adverse event was ocular hyperaemia. It occurred in approximately 13% of the patients participating in clinical studies with preserved tafluprost in Europe and the US. It was mild in most cases and led to discontinuation on an average in 0.4% of patients participating in the pivotal studies. In a 3-month, phase III study in the US comparing the non-preserved formulation of tafluprost with the non-preserved timolol formulation, ocular hyperemia occurred in 4.1% (13/320) of patients treated with tafluprost.
The following undesirable effects related to treatment were reported during clinical trials with tafluprost in Europe and the US after a maximum follow-up of 24 months:
Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
Nervous system disorders
Common (≥1/100 to <1/10): headache
Eye disorders
Common (≥1/100 to <1/10): eye pruritus, eye irritation, eye pain, conjunctival/ocular hyperaemia, changes in eyelashes (increased length, thickness and number of lashes), dry eye, foreign body sensation in eyes, eyelash discolouration, erythema of eye lid, superficial punctate keratitis (SPK), photophobia, increased lacrimation, blurred vision, reduced visual acuity and increased iris pigmentation.
Uncommon (≥1/1,000 to <1/100): blepharal pigmentation, eyelid oedema, asthenopia, conjunctival oedema, eye discharge, blepharitis, anterior chamber cells, ocular discomfort, anterior chamber flare, conjunctival pigmentation, conjunctival follicles, allergic conjunctivitis and abnormal sensation in eye.
Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Respiratory disorders
Not known (cannot be estimated from the available data): exacerbation of asthma, dyspnea
Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 to <1/100): hypertrichosis of eyelid
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose is unlikely to occur after ocular administration.
If overdose occurs, treatment should be symptomatic.
💬 Ask about this leaflet
Ask anything about SAFLUTAN 15 micrograms/ml eye drops, solution, in single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.