Tanof

Package leaflet: Information for the user

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

Latanoprost + Timolol
Equivalent medicine
Read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 using 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 Tanof is and what it is used for

Tanof contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group 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 reducing the production of fluid inside the eye.
Tanof is used to reduce pressure within the eye when affected by conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with increased intraocular pressure, which may eventually impair vision.
Your doctor usually prescribes this medicine when other medicines have not worked adequately.

2. What you need to know before using Tanof
   Tanof can be used in adult women and men (including the elderly), but it is not recommended for individuals under 18 years of age.

Do not use Tanof

• If you are allergic (hypersensitive) to either of the two active substances 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 previously had respiratory problems such as asthma, or severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions
Tell your doctor or pharmacist before using Tanof if you have or have previously had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation)
• Heart failure, low blood pressure
• Heart rhythm disorders such as slow heartbeat
• Respiratory problems, asthma, or chronic obstructive lung disease
• A condition associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar
• Overactive thyroid gland, as timolol may mask its signs and symptoms
• You are about to undergo any eye surgery (including cataract surgery) or have previously undergone eye surgery
• Eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• You know you suffer from dry eye
• You wear contact lenses. You may still use Tanof, following the instructions for contact lens wearers given in section 3
• You know you suffer from angina (particularly a type of angina known as Prinzmetal's angina)
• You know you suffer from severe allergic reactions that usually require hospital treatment
• You have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).
  Before undergoing surgery, inform your doctor that you are using Tanof, as timolol may alter the effects of certain 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 taking, including other eye drops for glaucoma. Inform your doctor if you are using or plan to use medicines to lower blood pressure, for heart conditions, or for diabetes treatment.
In particular, inform 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 certain types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Tanof with food and drink
Eating regular meals, food, or drink does not affect how or when to take Tanof.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use Tanof if you are pregnant unless your doctor considers it necessary. Inform 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 may pass into your breast milk. Ask your doctor to advise you before taking any medicine during breastfeeding.
Fertility
In animal studies, latanoprost and timolol did not show any effect on male or female fertility.

Driving and using machines
When using Tanof, you may experience transient blurred vision. If this occurs, do not drive or operate 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 very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Tanof

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults (including elderly patients) is one drop of Tanof once daily in the eye(s) to be treated.

Do not use Tanof more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.

Use Tanof exactly as prescribed by your doctor, and continue treatment until your doctor tells you to stop.

If you are using Tanof, your doctor may require additional monitoring of your heart and circulation.

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

Instructions for use

• Wash your hands and sit or stand comfortably.
• Remove one single-dose container from the strip and unscrew the cap with a gentle twist.
• Gently pull down with one finger the lower eyelid of the eye to be treated.
• Hold the tip of the single-dose container close to the eye without touching it (it is very important not to let the tip of the container touch the eye or eyelid).
• Gently squeeze the single-dose container so that one drop falls into the eye, then release the lower eyelid.
• After using Tanof, press gently with one finger on the inner corner of the treated eye. Keep your eyes closed for one minute.
• Repeat the procedure in the other eye, if your doctor has instructed you to do so.
• Discard the single-dose container and any remaining contents immediately after use.

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

If you use more Tanof than you should
If you instill too many drops into your eyes, you may experience mild irritation, tearing, and eye redness. These effects are temporary, but if you are concerned, contact your doctor for advice.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You can generally continue using the drops unless the effects you experience are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Tanof without first discussing it with your doctor.

Listed below are the known side effects associated with the use of Tanof. The most important side effect is the possible gradual and permanent change in eye colour. Tanof may also cause serious changes in heart function. If you notice any change in your heartbeat or cardiac function, consult your doctor and inform him or her 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 colour due to increased brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may develop after several years. The colour change may be permanent and may be more noticeable if you use Tanof in only one eye. There appear to be no associated problems 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, sensation of sand in the eyes, itching, stinging pain or sensation of a foreign body in the eyes) and eye pain.

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, irritation or abrasion of the eye surface.
• Skin rash or itching.

Other side effects
Like other eye medicines, 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 orally or by injection. Although not specifically 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 using Tanof. The listed side effects include reactions observed within the class of beta-blockers (e.g., timololo) when used to treat eye disorders:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions including swelling under the skin that may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or skin rash associated with itching, localised and generalised rash, itching, sudden severe allergic reaction with risk of life.
• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, heart attack, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling, and headache.
• Swelling at the back of the eye (macular edema), fluid-filled cyst inside the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).
• Signs and symptoms of eye irritation (such as burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be 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), scarring of the eye surface.
• Ringing or buzzing in the ears (tinnitus).
• Angina, worsening of angina in patients already affected by heart disease.
• Slow heartbeat, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease associated with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, cold hands and feet.
• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, vomiting, indigestion, diarrhoea, dry mouth, abdominal pain.
• Hair loss, skin rash appearing with a silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the outer carton after "Exp.".
The expiry date refers to the last day of the month.
Store in the refrigerator (2°C - 8°C), in the original packaging to protect the medicine from light.
After first opening the aluminium pouch: store at a temperature not exceeding 25°C and use within 7 days; after this period, the containers must be discarded.
The single-dose medicine must be used immediately after opening; any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tanof contains
In 1 ml of solution:

• The active substances are: Latanoprost 50 micrograms and Timolol 5 milligrams (equivalent to timolol maleate 6.83 milligrams).
• The other components are: sodium chloride, monosodium phosphate monohydrate, anhydrous disodium phosphate, water for injections. Description of the appearance of Tanof and package contents Single-dose container made of polyethylene. Package containing 30 single-dose containers of 0.1 ml.

Marketing Authorization 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

Package leaflet: information for the user

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

Latanoprost + Timolol
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 Tanof is and what it is used for

Tanof contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group 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 reducing the production of fluid inside the eye.
Tanof is used to reduce pressure inside the eye when it is affected by conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with increased eye pressure, which may eventually impair vision.
Your doctor usually prescribes this medicine when other medicines have not worked adequately.

2. What you need to know before using Tanof
   Tanof can be used in adult women and men (including the elderly), but it is not recommended for individuals under 18 years of age.

Do not use Tanof

• If you are allergic (hypersensitive) to either of the two active substances in Tanof (latanoprost or timolol), to beta-blockers, or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, or severe chronic obstructive pulmonary disease (COPD) (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions
Tell your doctor or pharmacist before using Tanof if you have or have previously had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, or low blood pressure
• Heart rhythm disorders such as slow heartbeat
• Respiratory problems, asthma, or chronic obstructive lung disease
• A condition associated with poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
• Diabetes, because timolol may mask the signs and symptoms of low blood sugar
• Overactive thyroid gland, because timolol may mask its signs and symptoms
• A planned eye surgery (including cataract surgery), or if you have previously undergone any eye surgery
• Eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• Known dry eye disease
• Wear contact lenses. You may still use Tanof, but follow the instructions for contact lens wearers provided in section 3
• Known angina (particularly a type of angina called Prinzmetal’s angina)
• Known severe allergic reactions that usually require hospital treatment
• Had or currently have a viral eye infection caused by the herpes simplex virus (HSV)

Before undergoing surgery, inform your doctor that you are using Tanof, as timolol may alter the effects of certain 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 glaucoma treatment. Inform your doctor if you are using or plan to use medicines to lower blood pressure, for heart conditions, or for diabetes treatment.
In particular, inform 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 certain types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Tanof with food and drink
Eating regular meals, food, or drinks does not affect how or when to take Tanof.
For athletes: Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use Tanof if you are pregnant unless your doctor considers it necessary. Inform 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 may pass into your breast milk. Ask your doctor for advice before taking any medicine while breastfeeding.
Fertility
Animal studies have shown that latanoprost and timolol do not affect male or female fertility.

Driving and using machines
When using Tanof, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.

Tanof contains benzalkonium chloride and phosphate buffer
This medicine contains 0.2 mg/mL of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may 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 unusual sensation, burning, or pain in the eye after using this medicine, speak with 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, in very rare cases, cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Tanof

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

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

Instructions for use

• Wash your hands and sit or stand comfortably.
• Remove the outer cap by gently rotating it.
• Gently pull down with one finger the lower eyelid of the eye to be treated.
• Hold the dropper tip close to the eye without touching it (it is very important not to let the dropper tip touch the eye or eyelid).
• Gently squeeze the bottle so that a single drop enters the eye, then release the lower eyelid.
• After using Tanof, press gently with one finger on the inner corner of the treated eye. Keep your eyes closed for one minute.
• Repeat the procedure in the other eye if your doctor has instructed 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 any other eye drop.

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

If you swallow Tanof
Consult your doctor if you accidentally swallow Tanof. If you swallow a large amount of Tanof, you may feel unwell, have stomach pain, feel tired, warm, dizzy, and begin to sweat.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You can generally continue using the drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Tanof without first discussing it with your doctor.

Listed below are the known side effects associated with the use of Tanof. The most important side effect is the possible gradual and permanent change in eye colour. Tanof may also cause serious changes in heart function. If you notice any change in your heartbeat or heart function, consult your doctor and inform him/her 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 colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years. The colour change may be permanent and may be more noticeable if you use Tanof in only one eye. There appear to be no associated problems with the change in eye colour. After discontinuation of Tanof treatment, no further change in eye colour has been observed.

Common (may affect up to 1 in 10 people):

• Eye irritation (burning sensation, gritty feeling, itching, stinging pain or sensation of a foreign body in the eyes) and eye pain.

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, irritation or abrasion of the eye surface.
• Skin rash or itching.

Other side effects
Like other eye medicines, Tanof (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse reactions after using eye drops is lower than when medicines are taken orally or by injection. Although not specifically associated with the use of Tanof, the following side effects have been observed with the use of the medicines contained in Tanof (latanoprost and timololo). These side effects may therefore occur when using Tanof. The listed side effects include reactions observed within the class of beta-blockers (e.g., timololo) when used to treat eye conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions including swelling beneath the skin that may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, itching, severe sudden allergic reaction that may be life-threatening.
• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, heart attack, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling, and headache.
• Swelling at the back of the eye (macular oedema), fluid-filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).
• Signs and symptoms of eye irritation (such as burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in eyelids and eyelash hair 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), scarring of the eye surface.
• Ringing in the ears (tinnitus).
• Angina, worsening of angina in patients already affected by heart disease.
• Slow heartbeat, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease associated with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, cold hands and feet.
• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing lung disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, vomiting, indigestion, diarrhoea, dry mouth, abdominal pain.
• Hair loss, skin rash appearing with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the outer carton after "Exp." and on the
bottle. The expiry date refers to the last day of the month.
Before opening, store the Tanof bottle in the refrigerator (2°C - 8°C). After first opening, it is not
necessary to store the bottle in the refrigerator, but it must not be stored at temperatures above 25°C.
Use within 4 weeks after first opening. When not using Tanof, store the bottle in the
outer packaging to protect it from light.
Do not dispose of any medicine via 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 substances are: Latanoprost 50 micrograms and Timolol 5 milligrams (equivalent to timolol maleate 6.83 milligrams).
• The other components are: sodium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, benzalkonium chloride, water for injections.

Description of the appearance of Tanof and contents of the pack
Polyethylene bottle. Pack containing 1 bottle of 2.5 ml.

Marketing Authorization 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