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What ZENAVIL is and what it is used for
ZENAVIL contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
ZENAVIL is used to treat:
Elderly men with erectile dysfunction. This is a condition in which a man cannot reach or hold a hard, erect penis suitable for sexual activity. Tadalafil shows a significant improvement in the ability to obtain a hard erect penis suitable for sexual activity. After sexual stimulation, ZENAVIL works by helping the blood vessels in your penis to relax, allowing blood to flow into your penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that ZENAVIL for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner should start foreplay, just as you would if you were not taking erectile dysfunction medication.
Adults with pulmonary arterial hypertension. It works by helping the blood vessels around your lungs to relax, improving blood flow to your lungs. The result is an improved ability for physical activity.
2. What you need to know before you take ZENAVIL
Do not take NOTE:
if you are allergic to tadalafil or any of the other ingredients and medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrate. These are a group of medicines ("nitrates") used to treat angina pectoris (chest pain). ZENAVIL has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
if you suffer from severe heart disease or have recently had a heart attack - in the last 3 months.
if you have recently had a stroke - in the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you have ever had loss of vision as a result of non-arterial anterior ischemic ocular neuropathy (NAION), a condition described as 'eye stroke'.
If you are taking Riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this drug. If you are taking riociguat or are unsure, tell your doctor.
Warnings and precautions
Talk to your doctor before taking ZENAVIL.
Keep in mind that sexual activity carries potential risks in patients with heart disease, as it puts 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 suffer from:
sickle cell anemia (red blood cell disorder).
multiple myeloma (bone marrow cancer).
leukemia (cancer of blood cells).
any deformity of the penis or an unwanted or prolonged erection that lasts more than 4 hours.
serious liver problem.
serious kidney problem.
any heart problems other than pulmonary hypertension.
blood pressure problems.
some inherited eye disease.
It is not known whether ZENAVIL is effective in patients who have:
removal of all or part of the prostate gland, in which the nerves of the prostate are severed (radical, non-nerve-preserving prostatectomy).
If you experience sudden reduction or loss of vision, stop taking ZENAVIL and contact your doctor immediately.
Decreased or sudden hearing loss has been reported in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience reduced or sudden hearing loss, stop taking ZENAVIL and contact your doctor immediately.
ZENAVIL should not be used by women to treat erectile dysfunction, as these are health problems specific to men.
Children and adolescents
ZENAVIL is not for use in children and adolescents under 18 years of age
Other medicines and ZENAVIL
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take ZENAVIL if you are already taking nitrates.
Some medicines may be affected by ZENAVIL or they may affect the way ZENAVIL works. Tell your doctor or pharmacist if you are already taking:
bosentan (another medicine for pulmonary arterial hypertension).
nitrates (for chest pain).
alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
other medicines to treat high blood pressure.
5-alpha reductase inhibitor (used to treat benign hyperpl
ZENAVIL with drinks and alcohol
Information on the effects of alcohol is given in section 3.
Grapefruit juice may affect the way ZENAVIL works and should be taken with caution. Talk to your doctor for more information.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take tadalafil during pregnancy unless absolutely necessary and you have discussed this with your doctor.
Do not breast-feed while taking these tablets, as it is known that the medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Decreased sperm production in the testes has been observed in the treatment of dogs. Decreased sperm count has also been observed in some men. These effects are unlikely to lead to loss of fertility.
Driving and using machines
Some men taking tadalafil during clinical trials reported dizziness. Make sure you react to the medicine before driving or using machines.
ZENAVIL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take ZENAVIL
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
ZENAVIL tablets are for oral use. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Drinking alcohol can temporarily lower your blood pressure. If you are taking or planning to take ZENAVIL, avoid drinking too much alcohol (blood alcohol levels of 0.08% or more or more than 5 units of alcohol), as this may increase the risk of dizziness when standing up.
For the treatment of erectile dysfunction:
Flexible dose, if needed: ZENAVIL 10 mg or 20 mg; the recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.
You can take ZENAVIL at least 30 minutes before sexual activity. ZENAVIL may still be effective up to 36 hours after taking the tablet. Do not take ZENAVIL more than once a day.
ZENAVIL 10 mg and 20 mg is for use before expected sexual activity and is not recommended for long-term daily use.
It is important to note that ZENAVIL does not work if there is no sexual stimulation. You and your partner need to start a love game, just as you would if you were not taking medication for erectile dysfunction.
Alcohol use can affect your ability to get an erection.
For the treatment of pulmonary arterial hypertension
The usual dose is 2 tablets of 20 mg once a day. You should take both tablets at the same time, one after the other.
If you suffer from mild to moderate kidney disease, your doctor may advise you to take only 20 mg a day.
If you take more ZENAVIL than you should
If you or anyone else has taken more tablets than you should, tell your doctor or visit the nearest hospital immediately. You may experience the side effects described in section 4.
If you forget to take ZENAVIL
Take your dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. You should not take ZENAVIL more than once a day.
If you stop taking ZENAVIL
For the treatment of pulmonary arterial hypertension, do not stop taking the tablets unless your doctor tells you to.
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 usually mild to moderate in nature.
Adverse reactions in erectile dysfunction
If you experience any of the following side effects, stop taking the medicine and seek medical help immediately:
allergic reactions including rash (frequency - uncommon).
chest pain - do not take nitrates, but seek medical attention immediately (frequency - uncommon).
priapism, prolonged and possibly painful erection after taking tadalafil (frequency - rare). If you have such an erection that lasts more than 4 hours, you should contact your doctor immediately.
sudden loss of vision (frequency - rare).
Other reported adverse reactions are listed below, by indication:
Erectile dysfunction side effects Common (may affect up to 1 in 10 people)
headache, back pain, muscle aches, arm and leg pain, flushing, nasal congestion, indigestion.
Uncommon (may affect up to 1 in 100 people)
dizziness, stomach pain, nausea, vomiting
5. How to store ZENAVIL
Keep out of reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP and the blisters after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines 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. Contents of the package and additional information
What ZENAVIL contains
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, hydroxypropylcellulose, croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.
Film-coated: hypromellose, lactose monohydrate, triacetin, titanium dioxide (E171), talc, yellow iron oxide (E 172).
What ZENAVIL looks like and contents of the pack
ZENAVIL 20 mg tablets are yellow, round, convex film-coated tablets with a core diameter of 10.3 mm.
The 20 mg tablets are packed in PVC / PE / PVDC-A1 or oPa-Al-PVC / Al blisters in cardboard boxes containing 2, 4, 8, 10, 12, 28 and 56 tablets. Not all pack sizes may be marketed.
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