Tadalafil 20 mg. 12 tablets
What Tadalafil is and what it is used for
Tadalafil is for the treatment of elderly men with erectile dysfunction. This is a condition in which a man can not reach or hold a hard penis in an erection suitable for sexual activity. It has been shown that Tadalafil greatly improves the ability to produce a hard penis in an erection suitable for sexual activity.
Tadalafil contains the active substance tadalafil, which belongs to the group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation Tadalafil works by helping the blood vessels in your penis relax, allowing blood to flow into your penis. The result is an improved erectile function. Tadalafil Actavis will not help if you do not have erectile dysfunction.
It is important to note that Tadalafil Actavis does not work if there is no sexual stimulation. You and your partner will have to engage in the love game just as you would if you do not take a medication for erectile dysfunction.
2. What you need to know before taking Tadalafil
Do not take Tadalafil
if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking any kind of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of drugs (“nitrates”) used in the treatment of angina (“chest pain”). There is evidence that Tadalafil Actavis enhances the effects of these medicines. If you are taking any form of nitrate or are not sure, tell your doctor.
if you have a serious heart disease or have recently had a heart attack in the last 90 days;
if you have recently suffered a stroke (during the last 6 months);
if you have low blood pressure or uncontrolled high blood pressure;
if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;
if you are taking rhizogyat. 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 Actavis have been shown to enhance the hypotensive effect (lowering of blood pressure) of this drug. If you are taking a rhizogue or are not sure, tell your doctor.
Warnings and precautions
Talk to your doctor before taking Tadalafil
Keep in mind that sexual activity carries potential risks to patients with heart disease because it adds to the heart. If you have heart problems, you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
sickle cell anemia (red blood cell anomaly);
multiple myeloma (bone marrow cancer);
leukemia (blood cell cancer);
some deformation of the penis;
serious liver problem;
serious kidney problem.
It is not known whether Tadalafil is effective in patients who have:
removal of all or part of the prostate gland, in which the nerve of the prostate is broken (radical, non-conservative nerve prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tadalafil Actavis and contact your doctor immediately.
Tadalafil Actavis is not intended for use in women.
Children and adolescents
Tadalafil Actavis is not intended for use by children and adolescents under 18 years of age.
Other medicines and Tadalafil
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadalafil if you are already taking nitrates.
Some medicines may be affected by Tadalafil Actavis or they may affect how well Tadalafil Actavis will work. Tell your doctor or pharmacist if you are already taking:
alpha blocker (used to treat high blood pressure or urinary tract symptoms associated with benign hyperplasia (enlargement) of the prostate);
other medicines to treat high blood pressure;
5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia);
medicines such as ketoconazole in the form of tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection;
phenobarbital, phenytoin and carbamazepine (anti-inflammatory drugs);
rifampicin, erythromycin, clarithromycin or itraconazole;
other types of erectile dysfunction treatments.
Tadalafil with beverages and alcohol
The information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Actavis works and should be taken with caution. Talk to your doctor for more information.
In dog treatment, decreased sperm formation in the testicles was observed. Some men have seen a decrease in sperm. These effects are unlikely to lead to lack of fertility.
Driving and using machines
Some men who have taken Tadalafil Actavis in clinical trials have reported dizziness. Before you drive or use machines, check carefully how you react to the tablets.
Tadalafil contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Tadalafil
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Tadalafil tablets are for oral use only in men. Swallow the tablet whole with some water. You can take the tablets with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity.
However, when your doctor decides that the recommended dose of 10 mg is too weak, you should be given the dose of one 20 mg tablet.
You can take a Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil can be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Actavis more than once a day. Tadalafil Actavis 10 mg and 20 mg is intended for use before expected sexual activity and is not recommended for prolonged daily use.
It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will have to participate in the love game just as you would if you did not take a medicine for erectile dysfunction.
Using alcohol can affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Actavis, avoid excessive drinking (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Tadalafil than you should
Contact your doctor. You may experience the 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 everyone gets them. These side effects are usually mild to moderate.
If you get any of the following side effects, stop using the medicine and seek immediate medical attention:
allergic reactions, including rash (uncommon frequency);
chest pain – do not use nitrates but immediately seek medical attention (uncommon);
prolonged and possibly painful erection after taking Tadalafil Actavis (rare in frequency). If you have a similar erection lasting more than 4 hours, you should contact your doctor immediately.
sudden loss of vision (rare in frequency).
Other reported side effects:
Common (may affect up to 1 in 10 patients):
headache, back pain, muscle aches, pain in the arms and legs, reddening of the face, nasal congestion and indigestion.
Uncommon (may affect up to 1 in 100 patients):
stomach pain, nausea, vomiting, reflux (burning and heartburn), blurred vision, eye pain, difficulty in breathing, blood in the urine, feeling of palpitations, accelerated heart rhythm, high blood pressure, low blood pressure blood pressure, nose bleeding, tinnitus, swelling of the hands, legs or ankles and a feeling of fatigue.
Rare (may affect up to 1 in 1,000 patients):
weakness, convulsions and transient loss of memory, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, urticaria (itchy red spots on the skin surface), bleeding from the penis, blood in the seminal fluid, increased sweating.
In men taking Tadalafil Actavis, infarction of the heart and stroke was also rarely reported. Most of these men had established heart problems before taking this medicine.
Rarely, temporary or permanent decrease or loss of vision on one or both eyes has been reported rarely.
Some additional rare side effects have been reported in men taking Tadalafil Actavis, which have not been seen in clinical trials. They include:
migraine, facial swelling, serious allergic reaction causing facial or throat edema, severe skin rashes, some disorders affecting the blood supply to the eyes, impaired heart rhythm, angina and sudden cardiac death.
Adverse reaction dizziness has been reported more commonly in men over 75 years of age who take Tadalafil . Diarrhea is reported more frequently in men over 65 years of age who are taking Tadalafil .
How to Store Tadalafil
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Tadalafil contains
The active substance is tadalafil. Each tablet contains 20 mg tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, pregelatinized starch, colloidal anhydrous silica, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
What Tadalafil looks like and contents of the pack
20 mg Tadalafil tablets are light yellow, oval film-coated tablets (tablets) engraved with “20” on one side and smooth on the other side. The tablet has a diameter of 12 mm x 7.4 mm and a thickness of 4.60 – 5.20 mm.
Types of packaging
The 20 mg tadalafil tablets are available in blister packs containing 2,4, 8, 12 and 56 film-coated tablets.
Not all pack sizes may be marketed.