TANOF 50 mikrogramów/ml + 5 mg/ml Krople do oczu, roztwór

Treść ulotki

1. Tanof 50 micrograms/ml and 5 mg/ml eye drops, solution in container
   1. What is Tanof and what is it used for
   2. How to use Tanof
   3. Possible side effects
   4. How to store Tanof
   5. Contents of the pack and other information
2. Tanof 50 micrograms/ml and 5 mg/ml eye drops, solution
   1. What is Tanof and what is it used for
   2. How to use Tanof
   3. Possible side effects
   4. How to store Tanof
   5. Contents of the pack and other information

Tanof 50 micrograms/ml and 5 mg/ml eye drops, solution in container

single-dose
Latanoprost + Timolol
Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. (See section 4).

Contents of this leaflet

• 1. What Tanof is and what it is used for
• 2. What you need to know before you use Tanof
• 3. How to use Tanof
• 4. Possible side effects
• 5. How to store Tanof
• 6. Contents of the pack and other information

1. What is Tanof and what is it used for

Tanof contains two medicines: latanoprost and timolol. Latanoprost belongs to the category of medicines known
as prostaglandin analogues. Timolol belongs to the category of medicines known as beta-blockers.
Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Timolol works by slowing down the production of fluid inside the eye.
Tanof is used to reduce the pressure inside the eye if it is affected by conditions known as
open-angle glaucoma or ocular hypertension. Both of these conditions are linked to an increase in
intraocular pressure, ultimately altering vision.
The doctor usually prescribes this medicine when other medicines have not worked adequately.

• 2.What you need to know before you use TanofTanof can be used in women and adult men (including the elderly) but is not recommended if you are under 18 years of age.

Do not use Tanof

• If you are allergic (hypersensitive) to either of the active ingredients in Tanof (latanoprost or timolol), to beta-blockers or to any of the other ingredients of Tanof (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough).
• If you have severe heart problems or irregular heartbeat. Warnings and precautionsTell your doctor or pharmacist before using Tanof if you have or have had in the past:
• coronary artery disease (symptoms may include chest pain or a feeling of pressure in the chest, shortness of breath or a feeling of suffocation), heart failure, low blood pressure
• heartbeat disorders such as a slowed heartbeat
• breathing problems, asthma or chronic obstructive pulmonary disease
• a disease associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes because timolol can mask the signs and symptoms of low blood sugar
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms
• are about to undergo any eye surgery (including cataract surgery) or if you have had any eye surgery in the past
• have eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• know that you suffer from dry eyes
• wear contact lenses. You can still use Tanof following the instructions for contact lens wearers in section 3
• know that you suffer from angina (especially a form of angina known as Prinzmetal's angina)
• know that you suffer from severe allergic reactions that usually require hospital treatment
• have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV). Before undergoing surgery, tell your doctor that you are using Tanof because timolol can alter the effects of some medicines used during anesthesia.

Other medicines and Tanof
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including eye drops and over-the-counter medicines.
The effect of Tanof may be altered or Tanof may alter the effect of other medicines you are using, including other
eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower
blood pressure, for the heart or for the treatment of diabetes.
In particular, tell your doctor or pharmacist if you are taking a medicine belonging to the following
classes:

• Prostaglandins, prostaglandin analogues or prostaglandin derivatives
• Beta-blockers
• Epinephrine
• Medicines used to treat high blood pressure such as orally administered calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics
• Quinidine (used to treat heart conditions and some types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Tanof with food and drink
Taking normal meals, food or drinks does not affect how and when to take Tanof.

For athletes:the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Tanof if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately
before taking this medicine if you are pregnant, think you may be pregnant or are planning a pregnancy.
Breastfeeding
Do not use Tanof if you are breastfeeding. Tanof can pass into your milk. Ask your doctor to be informed before
taking any medicine while breastfeeding.
Fertility
In animal studies, latanoprost and timolol have not shown any effect on male or female fertility.

Driving and operating machinery
When using Tanof, you may experience transient blurred vision. If this happens, you should not drive
vehicles or operate tools or machinery until your vision is clear again.

Tanof contains phosphate buffer
This medicine contains 9.28 mg of phosphate buffer per ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in rare cases cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use Tanof

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose in adults (including the elderly) is one drop of Tanof once a day
in the eye(s) to be treated.
Do not use Tanof more than once a day, as the effectiveness of the treatment may be reduced if the medicine
is administered more frequently.
Use Tanof as your doctor has instructed you, until your doctor tells you to stop the treatment.
If you are using Tanof, your doctor may request further monitoring of your heart and circulation.

Contact lens wearers
If you wear contact lenses, you must remove them before applying Tanof. After applying Tanof,
you should wait 15 minutes before putting your contact lenses back in.

Instructions for use

• Wash your hands and sit, or stand, comfortably.
• Remove a vial from the strip and unscrew the cap with a slight rotation.
• Gently pull down the lower eyelid of the eye to be treated with your finger.
• Position the tip of the vial close to the eye without touching it (it is very important not to bring the tip of the vial into contact with the eye and with the eyelid).
• Apply slight pressure on the vial so that a single drop goes inside the eye, then release the lower eyelid.
• After using Tanof, press with your finger on the corner of the affected eye. Wait one minute keeping your eyes closed.
• Repeat the operation also in the other eye, if your doctor has told you to do so.
• Throw away the vial and any remaining contents.

If you use Tanof with another eye drop
Wait at least 5 minutes between administering Tanof and administering another eye drop.

If you use more Tanof than you should
If you put too many drops in your eyes, you may experience mild irritation, tearing and redness of the
eyes. These effects are transient, but if you are concerned, contact your doctor for advice.

If you swallow Tanof
Consult your doctor if you accidentally swallowed Tanof. If you have swallowed a large amount of Tanof you may feel
sick, have stomach pain, feel tired, hot, dizzy and start to sweat.

If you forget to use Tanof
Continue to take the usual dosage at the usual time. Do not use a double dose to make up for the
forgotten dose. If you have any doubts, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally you can continue to use the drops, unless the effects experienced are serious. If you are
worried, talk to your doctor or pharmacist. Do not stop using Tanof without talking to your
doctor.
Below are listed the known side effects associated with the use of Tanof. The most important side effect is the possible gradual and permanent alteration of the colour of the eye. It is also possible that Tanof
may cause serious alterations in cardiac function. If you experience a change in heartbeat or cardiac
function, you should see a doctor and tell them that you are taking Tanof.
The known side effects associated with the use of Tanof are:

Very common(may affect more than 1 in 10 people):

• Gradual alteration of the colour of the eye due to an increase in the amount of brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of a mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than a uniform colour (blue, grey, green or brown). Any change in eye colour can occur after years. The colour change may be permanent and may be more noticeable if you use Tanof in only one eye. There do not appear to be any problems associated with the change in eye colour. After stopping treatment with Tanof, no further change in eye colour has been observed. Common(may affect up to 1 in 10 people):
• Eye irritation (burning sensation, gritty sensation, itching, stinging pain or foreign body sensation in the eyes) and eye pain. Uncommon(may affect up to 1 in 100 people):
• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, shiny eyes, eyelid inflammation, irritation or abrasion of the ocular surface.
• Skin rashes or itching. Other side effectsLike other medicines applied to the eyes, Tanof (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse reactions after using eye drops is lower than that observed when medicines are taken, for example, by mouth or by injection. Although not associated with the use of Tanof, the following side effects have been observed with the use of the medicines contained in Tanof (latanoprost and timolol). These effects may therefore occur when you use Tanof. The side effects listed include reactions observed in the beta-blocker class (e.g., timolol) when these are used to treat eye conditions:
• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways causing difficulty swallowing and breathing, hives or itchy rash, localised and generalised rash, itching, a severe, life-threatening allergic reaction.
• Low blood glucose levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, heart attack, reduced blood supply to the brain, increased signs and symptoms of

myasthenia gravis (muscle disease), unusual sensations such as tingling, and headache.

• Swelling of the back of the eye (macular edema), cyst filled with fluid inside the coloured part of the eye (iridic cyst), sensitivity to light (photophobia), sunken eyes (deepening of the palpebral sulcus).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery which can cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision.
• Darkening of the skin around the eyes, changes in eyelids and eyelashes around the eye (increased number, length, thickness, pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis).
• Whistling/Ringing in the ears (tinnitus).
• Angina, worsening of angina in patients already suffering from heart disease.
• Slowed heartbeat, chest pain, palpitations (perception of the heartbeat), edema (fluid accumulation), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease associated with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disturbance, heart attack, heart failure.
• Low blood pressure, poor blood circulation that numbs and turns the fingers of hands and feet pale, cold hands and feet.
• Shortness of breath, narrowing of the airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Changes in taste, nausea, vomiting, indigestion, diarrhea, dry mouth, abdominal pain.
• Hair loss, skin rash that appears with a silvery-white colour (psoriasiform rash) or worsening of psoriasis, rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer in the front part of the eye (the
cornea) have developed cloud-like spots on the cornea, due to calcium accumulation during the
treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tanof

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 outer packaging after Exp.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C), in the original packaging to protect the medicine from light.
After the first opening of the aluminium sachet: store at a temperature not exceeding 25°C and use
within 7 days; after this period the containers must be disposed of.
The single dose medicine must be used immediately after opening; any remaining medicine must
be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tanof contains
In 1 ml of solution:

• the active ingredients are: Latanoprost 50 micrograms and Timolol 5 milligrams (equivalent to timolol maleate 6.83 milligrams).
• the other ingredients are: sodium chloride, sodium phosphate monobasic monohydrate, disodium phosphate anhydrous, water for injections. Description of the appearance of Tanof and contents of the pack Single-dose container in polyethylene. Pack of 30 single-dose containers of 0.1 ml.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last updated on

Tanof 50 micrograms/ml and 5 mg/ml eye drops, solution

Latanoprost + Timolol
Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. (See section 4).

Contents of this leaflet

• 1. What Tanof is and what it is used for
• 2. What you need to know before you use Tanof
• 3. How to use Tanof
• 4. Possible side effects
• 5. How to store Tanof
• 6. Contents of the pack and other information

1. What is Tanof and what is it used for

Tanof contains two medicines: latanoprost and timolol. Latanoprost belongs to the category of medicines known
as prostaglandin analogues. Timolol belongs to the category of medicines known as beta-blockers.
Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Timolol works by slowing down the production of fluid inside the eye.
Tanof is used to reduce pressure inside the eye if it is affected by conditions known as
open-angle glaucoma or ocular hypertension. Both of these conditions are linked to an increase in
intraocular pressure, ultimately altering vision.
The doctor usually prescribes this medicine when other medicines have not worked adequately.

• 2.What you need to know before you use TanofTanof can be used in women and adult men (including the elderly) but is not recommended if you are under 18 years of age.

Do not use Tanof

• If you are allergic (hypersensitive) to any of the active substances contained in Tanof (latanoprost or timolol), to beta-blockers or to any of the other components of Tanof (listed in paragraph 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders. Warnings and precautionsTell your doctor or pharmacist before using Tanof if you have or have had in the past:
• coronary artery disease (symptoms may include chest pain or a feeling of tightness in the chest, shortness of breath or a feeling of suffocation), heart failure, low blood pressure
• heartbeat disorders such as a slowed heartbeat
• respiratory problems, asthma or chronic obstructive pulmonary disease
• a disease associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes because timolol can mask the signs and symptoms of low blood sugar
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms
• are about to undergo any eye surgery (including cataract surgery) or if you have had any eye surgery in the past
• have eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• know that you suffer from dry eyes
• use contact lenses. You can still use Tanof following the instructions for contact lens wearers in paragraph 3
• know that you suffer from angina (especially a form of angina known as Prinzmetal's angina)
• know that you suffer from severe allergic reactions that generally require hospital treatment
• have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV). Before undergoing surgery, tell your doctor that you are using Tanof because timolol can alter the effects of some medicines used during anesthesia.

Other medicines and Tanof
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines including eye drops and over-the-counter medicines.
The effect of Tanof may be altered or Tanof may alter the effect of other medicines you are using, including other
eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower
blood pressure, for the heart or for the treatment of diabetes.
In particular, tell your doctor or pharmacist if you are taking a medicine belonging to the following
classes:

• Prostaglandins, prostaglandin analogues or prostaglandin derivatives
• Beta-blockers
• Epinephrine
• Medicines used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics
• Quinidine (used to treat heart conditions and some types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Tanof with food and drink
Taking normal meals, food or drinks does not affect how and when to take Tanof.

For athletes:the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Tanof if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately
before taking this medicine if you are pregnant, think you may be pregnant or are planning a pregnancy.
Breastfeeding
Do not use Tanof if you are breastfeeding. Tanof can pass into your milk. Ask your doctor to be informed before
taking any medicine while breastfeeding.
Fertility
In animal studies, latanoprost and timolol have not been shown to have any effect on male or
female fertility.

Driving and using machines
When using Tanof you may experience transient blurred vision. If this happens, you should not drive
vehicles or use equipment or machinery until your vision is clear again.

Tanof contains benzalkonium chloride and phosphate buffers
This medicine contains 0.2 mg / ml of benzalkonium chloride per millilitre.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the clear layer at the front of the eye). If you experience an abnormal
sensation in your eye, burning or pain after using this medicine, talk to your doctor.
This medicine contains 9.28 mg of phosphate buffer per ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause, in rare
cases, opaque spots on the cornea due to calcium deposits during treatment.

3. How to use Tanof

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose in adults (including the elderly) is one drop once a day
in the eye(s) to be treated.
Do not use Tanof more than once a day, as the effectiveness of the treatment may be reduced if the medicine
is administered more frequently.
Use Tanof as your doctor has instructed you, until your doctor tells you to stop the treatment.
If you are using Tanof, your doctor may require further monitoring of your heart and circulation.

Contact lens wearers
If you wear contact lenses, you must remove them before applying Tanof. After applying Tanof,
you must wait 15 minutes before putting your contact lenses back in.

Instructions for use

• Wash your hands and sit, or stand, comfortably.
• Remove the outer cap with a slight twist.
• Gently pull down the lower eyelid of the eye to be treated with a finger.
• Position the tip of the bottle close to the eye without touching it (it is very important not to bring the tip of the dropper into contact with the eye and with the eyelid).
• Apply slight pressure to the bottle so that only one drop goes into the eye, then release the lower eyelid.
• After using Tanof, press with a finger on the corner of the affected eye. Wait one minute keeping your eyes closed.
• Repeat the operation in the other eye as well, if your doctor has told you to do so.
• Close the bottle with the inner protective cap.

If you use Tanof with another eye drop
Wait at least 5 minutes between administering Tanof and administering another eye drop.

If you use more Tanof than you should
If you put too many drops in your eyes, you may experience mild irritation, tearing and redness of the
eyes. These effects are transient, but if you are concerned, contact your doctor for advice.

If you swallow Tanof
Consult your doctor if you accidentally swallow Tanof. If you have swallowed a large amount of Tanof you may feel
sick, have stomach pain, feel tired, hot, dizzy and start to sweat.

If you forget to use Tanof
Continue to take the usual dosage at the usual time. Do not use a double dose to make up for a
missed dose. If you have any doubts, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Generally you can continue to use the drops, unless the effects experienced are serious. If you are
worried, consult your doctor or pharmacist. Do not stop using Tanof without talking to your
doctor.
Below are listed the known side effects associated with the use of Tanof. The most important side effect is the
possible gradual and permanent change in the color of the eye. It is also possible that Tanof
may cause serious changes in cardiac function. If you experience a change in heartbeat or cardiac
function, you should consult your doctor and inform them that you are taking Tanof.
The known side effects associated with the use of Tanof are:

Very common(may affect more than 1 in 10 people):

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change is more likely if your eyes are a mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) rather than a uniform color (blue, gray, green, or brown). Any change in eye color can occur after years. The color change may be permanent and may be more noticeable if you use Tanof in only one eye. There do not appear to be any problems associated with the change in eye color. After stopping treatment with Tanof, no further change in eye color has been observed. Common(may affect up to 1 in 10 people):
• Eye irritation (burning sensation, gritty sensation, itching, stinging pain, or foreign body sensation in the eyes) and eye pain. Uncommon(may affect up to 1 in 100 people):
• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, shiny eyes, eyelid inflammation, irritation or abrasion of the ocular surface.
• Skin rashes or itching. Other side effectsLike other medicines applied to the eyes, Tanof (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse reactions after using eye drops is lower than that observed when medicines are taken, for example, orally or by injection. Although not associated with the use of Tanof, the following side effects have been observed with the use of the medicines contained in Tanof (latanoprost and timolol). These effects may therefore occur when you use Tanof. The side effects listed include reactions observed in the beta-blocker class (e.g., timolol) when these are used to treat eye conditions:
• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways causing difficulty swallowing and breathing, hives or itchy rash, localized and generalized rash, itching, severe sudden allergic reaction with a life-threatening risk.

Low blood glucose levels.

• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, heart attack, reduced blood flow to the brain, increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations such as tingling, and headache.
• Swelling of the back of the eye (macular edema), cyst filled with fluid inside the colored part of the eye (iridic cyst), sensitivity to light (photophobia), sunken eyes (deepening of the palpebral groove).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina following filtering surgery that can cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision.
• Darkening of the skin around the eyes, changes to eyelids and eyelashes around the eye (increased number, length, thickness, pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scarring of the surface of the eye.
• Whistling/ringing in the ears (tinnitus).
• Angina, worsening of angina in patients already suffering from heart disease.
• Slowed heartbeat, chest pain, palpitations (perception of heartbeat rhythm), edema (fluid accumulation), changes in heart rate or speed, congestive heart failure (heart disease associated with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disturbance, heart attack, heart failure.
• Low blood pressure, poor blood circulation that numbs and turns the fingers of hands and feet pale, cold hands and feet.
• Shortness of breath, narrowing of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Changes in taste, nausea, vomiting, indigestion, diarrhea, dry mouth, abdominal pain.
• Hair loss, skin rash that appears with a silvery-white color (psoriasiform rash) or worsening of psoriasis, rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer in the front part of the eye (the
cornea) have developed cloud-like spots on the cornea due to calcium accumulation during
treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni- avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tanof

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 outer packaging after Exp. and on the
vial. The expiry date refers to the last day of the month.
Before opening, store the vial of Tanof in a refrigerator (2°C - 8°C). After first opening, it is not
necessary to store the vial in a refrigerator but it must not be stored at a temperature above 25°C.
Use within 4 weeks of first opening. When not using Tanof, store the vial in the outer packaging
to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tanof contains
In 1 ml of solution:

• the active ingredients are: Latanoprost 50 micrograms and Timolol 5 milligrams (equivalent to timolol maleate 6.83 milligrams).
• the other ingredients are: sodium chloride, sodium phosphate monobasic monohydrate, disodium phosphate anhydrous, benzalkonium chloride, water for injections. Description of the appearance of Tanof and contents of the pack. Polyethylene bottle. Pack of 1 bottle of 2.5 ml.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last updated on