Tyra® 20 mg Film Coated Tablets
| Dosage form | Active Ingredient | Pack | |
Tablets | Tadalafil 20 mg | 4 Tablets | |
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tyra® is and what it is used for
2. Before you take Tyra®
3. How to take Tyra®
4. Possible side effects
5. How to store Tyra®
6. Further information
1. What Tyra® is and what it is used for
Tyra® is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tyra® has beenshown to significantly improve the ability of obtaining a hard erect penis suitable forsexual activity.
Tyra® contains the active substance tadalafil which belongs to a group of medicinescalled phosphodiesterase type 5 inhibitors. Following sexual stimulation Tyra®works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tyra® will not help you if you do not have erectile dysfunction. It is important to note that Tyra® does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
2. Before you take Tyra® Do not take Tyra® tablets if you:
− are allergic to tadalafil or any of the other ingredients of this medicine.
− are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
− have serious heart disease or recently had a heart attack within the last 90 days.
− recently had a stroke within the last 6 months.
− have low blood pressure or uncontrolled high blood pressure.
− ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
− are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Take special care with Tyra®
Talk to your doctor before taking Tyra®.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
− sickle cell anaemia (an abnormality of red blood cells).
− multiple myeloma (cancer of the bone marrow).
− leukaemia (cancer of the blood cells).
− any deformation of your penis.
− a serious liver problem.
− a severe kidney problem.
It is not known if Tyra® is effective in patients who have had:
− pelvic surgery.
− removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tyra® and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil.
Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tyra® and contact your doctor immediately.
Tyra® is not intended for use by women.
Children and adolescents
Tyra® is not intended for use by children and adolescents under the age of 18.
Taking other medicines, herbal or dietary supplements Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tyra® if you are already taking nitrates.
Some medicines may be affected by Tyra® or they may affect how well Tyra® will
work. Tell your doctor or pharmacist if you are already taking:
− an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
− other medicines to treat high blood pressure.
− riociguat.
− a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
− medicines such as ketoconazole tablets (to treat fungal infections) and protease
inhibitors for treatment of AIDS or HIV infection.
− phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
− rifampicin, erythromycin, clarithromycin or itraconazole.
− other treatments for erectile dysfunction.
Taking Tyra® with food and drink
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how
well Tyra® will work and should be taken with caution. Talk to your doctor for further information. Fertility
A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines Some men taking tadalafil reported dizziness. Check carefully how you react to the tablets before driving or using machines. Important information about some of the ingredients of Tyra® tablets Tyra® tablets contain lactose, if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Tyra®
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tyra® tablets are for oral use in men only. Swallow the tablet whole with some water.
The tablets can be taken with or without food. The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
You may take a Tyra® tablet at least 30 minutes before sexual activity.
Tyra® may still be effective up to 36 hours after taking the tablet.
Do not take Tyra® more than once a day. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tyra® does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tyra® , avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up. If you take more Tyra® tablets than you should Contact your doctor. You may experience side effects described in section 4. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature. If you experience any of the following side effects stop using the medicine and
seek medical help immediately:
− allergic reactions including rashes (frequency uncommon).
− chest pain – do not use nitrates but seek immediate medical assistance (frequency uncommon).
− prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
− sudden loss of vision (frequency rare).
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
− headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal
congestion, indigestion and reflux.
− Uncommon (seen in 1 to 10 in every 1,000 patients)
Dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients) Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin),
penile bleeding, presence of blood in semen and increased sweating. Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known heart problems before taking this medicine. Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking tadalafil.
These include:
− migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking tadalafil. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Tyra®
Keep out of the reach and sight of children.
Do not use Tyra® after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store below 30°C in the original package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. Further information
What Tyra® tablets contains The active substance is tadalafil. Each tablet contains 10 or 20 mg tadalafil.
Other ingredients are lactose, croscarmellose sodium, sodium laurilsulphate, hypromellose, microcrystalline cellulose, magnesium stearate, yellow iron oxide (E172), triacetin, titanium dioxide. What Tyra® tablets looks like and contents of the pack
Tyra® 10 mg are yellow almond shape film coated tablet coded (C163) in one side,
plain on the other side.
Tyra® 20 mg film-coated tablets are yellow almond shaped biconvex tablets coded with (C112) on one side, plain from the other side.
Tyra® film-coated tablets are available in packs of 4 tablets.
| Dosage form | Active Ingredient | Pack | Public Price |
Tablets | Tadalafil 20 mg | 4 Tablets | 15.60 JDs |
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tyra® is and what it is used for
2. Before you take Tyra®
3. How to take Tyra®
4. Possible side effects
5. How to store Tyra®
6. Further information
1. What Tyra® is and what it is used for
Tyra® is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tyra® has beenshown to significantly improve the ability of obtaining a hard erect penis suitable forsexual activity.
Tyra® contains the active substance tadalafil which belongs to a group of medicinescalled phosphodiesterase type 5 inhibitors. Following sexual stimulation Tyra®works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tyra® will not help you if you do not have erectile dysfunction. It is important to note that Tyra® does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
2. Before you take Tyra® Do not take Tyra® tablets if you:
− are allergic to tadalafil or any of the other ingredients of this medicine.
− are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
− have serious heart disease or recently had a heart attack within the last 90 days.
− recently had a stroke within the last 6 months.
− have low blood pressure or uncontrolled high blood pressure.
− ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
− are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Take special care with Tyra®
Talk to your doctor before taking Tyra®.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
− sickle cell anaemia (an abnormality of red blood cells).
− multiple myeloma (cancer of the bone marrow).
− leukaemia (cancer of the blood cells).
− any deformation of your penis.
− a serious liver problem.
− a severe kidney problem.
It is not known if Tyra® is effective in patients who have had:
− pelvic surgery.
− removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tyra® and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil.
Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tyra® and contact your doctor immediately.
Tyra® is not intended for use by women.
Children and adolescents
Tyra® is not intended for use by children and adolescents under the age of 18.
Taking other medicines, herbal or dietary supplements Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tyra® if you are already taking nitrates.
Some medicines may be affected by Tyra® or they may affect how well Tyra® will
work. Tell your doctor or pharmacist if you are already taking:
− an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
− other medicines to treat high blood pressure.
− riociguat.
− a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
− medicines such as ketoconazole tablets (to treat fungal infections) and protease
inhibitors for treatment of AIDS or HIV infection.
− phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
− rifampicin, erythromycin, clarithromycin or itraconazole.
− other treatments for erectile dysfunction.
Taking Tyra® with food and drink
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how
well Tyra® will work and should be taken with caution. Talk to your doctor for further information. Fertility
A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines Some men taking tadalafil reported dizziness. Check carefully how you react to the tablets before driving or using machines. Important information about some of the ingredients of Tyra® tablets Tyra® tablets contain lactose, if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Tyra®
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tyra® tablets are for oral use in men only. Swallow the tablet whole with some water.
The tablets can be taken with or without food. The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
You may take a Tyra® tablet at least 30 minutes before sexual activity.
Tyra® may still be effective up to 36 hours after taking the tablet.
Do not take Tyra® more than once a day. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tyra® does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tyra® , avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up. If you take more Tyra® tablets than you should Contact your doctor. You may experience side effects described in section 4. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature. If you experience any of the following side effects stop using the medicine and
seek medical help immediately:
− allergic reactions including rashes (frequency uncommon).
− chest pain – do not use nitrates but seek immediate medical assistance (frequency uncommon).
− prolonged and possibly painful erection after taking tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
− sudden loss of vision (frequency rare).
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
− headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal
congestion, indigestion and reflux.
− Uncommon (seen in 1 to 10 in every 1,000 patients)
Dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients) Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin),
penile bleeding, presence of blood in semen and increased sweating. Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had known heart problems before taking this medicine. Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking tadalafil.
These include:
− migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking tadalafil. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Tyra®
Keep out of the reach and sight of children.
Do not use Tyra® after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store below 30°C in the original package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. Further information
What Tyra® tablets contains The active substance is tadalafil. Each tablet contains 10 or 20 mg tadalafil.
Other ingredients are lactose, croscarmellose sodium, sodium laurilsulphate, hypromellose, microcrystalline cellulose, magnesium stearate, yellow iron oxide (E172), triacetin, titanium dioxide. What Tyra® tablets looks like and contents of the pack
Tyra® 10 mg are yellow almond shape film coated tablet coded (C163) in one side,
plain on the other side.
Tyra® 20 mg film-coated tablets are yellow almond shaped biconvex tablets coded with (C112) on one side, plain from the other side.
Tyra® film-coated tablets are available in packs of 4 tablets.