Tadalafil 10 mg. 4 tablets
What is TADALAFIL and what it is used for
TADALAFIL is for the treatment of elderly men with erectile dysfunction. This is a condition where the male can not reach or hold a hard, erect penis suitable for sexual activity. TADALAFIL shows a significant improvement in the ability to produce a hard, erect penis suitable for sexual activity. TADALAFIL STADA 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 and allow the blood flow to your penis. The result is an improved erectile function. TADALAFIL will not help if you do not have erectile dysfunction.
It is important to note that TADALAFIL does not work if there is no sexual stimulation. You and your partner will have to engage in the love game as you would if you did not take a medicine for erectile dysfunction.
2. What you need to know before taking TADALAFIL
Do not take TADAFAIL
if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking some kind of organic nitrate or nitric oxide donors like amyl nitrite. These are a group of drugs (“nitrates”) used in the treatment of angina pectoris (“chest pain”). TADALAFIL STADA 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 have a serious heart disease or have a recent heart attack in the last 90 days;
if you have a recent stroke (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 due to non-arterial anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke.”
Warnings and precautions
Talk to your doctor before taking TADALAFIL
Note that sexual activity carries possible risks for patients with heart disease because it adds more to your 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 tumor);
leukemia (blood cell tumor);
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 a sudden decrease or loss of vision, stop taking TADALAFIL and contact your doctor immediately.
TADALAFIL STADA is not intended for use in women.
Children and adolescents
TADALAFIL STADA is not intended for use by children and adolescents under 18 years of age.
Other drugs and TADALAFIL
Tell your doctor or pharmacist if you are taking, have recently taken or may be taking other medicines.
Do not take TADALAFIL if you are already taking nitrate.
Some medications may be affected by a TADALAFIL or they may affect how well the TADALAFIL will work. Tell your doctor or pharmacist if you are already taking:
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 prostatic hyperplasia);
medicines such as ketoconazole 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.
Taking TADALAFIL with food, drink, and alcohol
The information on the effect of alcohol is in Section 3. Grapefruit juice may have an impact on how well TADALAFIL should work and should be taken with caution. Talk to your doctor for more information.
Pregnancy, breastfeeding and fertility
In dog treatment, decreased sperm formation in the testicles was observed. Reduction of sperm is seen in some men. These effects are unlikely to result in a lack of fertility.
Driving and using machines
In clinical trials, some men taking Tadalafil have reported dizziness. Check carefully how you are taking the tablets before driving or using machines.
TADALAFILE contains lactose:
If 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 males. Swallow the tablet whole with some water. You can take the tablets with or without food.
The recommended dose is one 10 mg tablet before sexual activity.
However, your doctor may recommend a dose of one 20 mg tablet if he / she finds that the effect of the 10 mg tablet is too weak.
You may take TADALAFIL at least 30 minutes before sexual activity. TADALAFIL can be effective up to 36 hours after taking the tablet.
Do not take TADAFALIL more than once a day.
The administration of TADALAFIL 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 STADA does not work without sexual stimulation. You and your partner will have to join a pre-game as you would if you did not take a medicine for erectile dysfunction.
Alcohol use may affect your ability to erect and may temporarily reduce your blood pressure. If you have taken or plan to take TADALAFIL , avoid excessive alcohol consumption (blood alcohol levels of over and above 0.08%), as this may increase the risk of dizziness when you get 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 effects are usually mild to moderate in nature.
If you get any of the following side effects, stop using the medicine and seek immediate medical attention:
allergic reactions including rash (frequency – uncommon);
chest pain – do not use nitrates but seek immediate medical attention (frequency – uncommon);
prolonged and possibly painful erection after receiving a TADAFILA (frequency rare). If you have a similar erection that lasts for more than 4 hours, you should contact your doctor immediately.
sudden loss of vision (frequency – rare).
Other reported side effects:
Common: (seen in 1 to 10 in every 100 patients):
headache, back pain, muscle pain, pain in the arms and legs, flushing, nose obstruction, indigestion.
Uncommon: (seen in between 1 and 10 in every 1,000 patients):
nausea, abdominal pain, nausea, vomiting, heartburn, blurred vision, eye pain, increased sweating, difficulty in breathing, blood in the urine, feeling of palpitations, increased heartbeat, high blood pressure, low blood pressure, ringing in the ears, inflammation of the ankles and fatigue.
Rare: (seen in between 1 and 10 in every 10,000 patients):
weakness, seizures and transient loss of memory, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, and urticaria (itchy red spots on the surface of the skin), bleeding from the penis, the presence of blood in the seminal fluid and increased sweating.
Rare stroke and stroke have been reported in men when used with TADALAFIL Most of these men had known 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 that 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 flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Adverse reactions, dizziness and diarrhea, have been reported more commonly in men
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 after EXP. The expiry date refers to the last day of that month.
This medicinal product 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 contains TADALAFIL
The active substance is tadalafil
TADALAFIL 10 mg: Each film-coated tablet contains 10 mg tadalafil.
TADALAFIL 20 mg: Each film-coated tablet contains 20 mg tadalafil.
The other ingredients (excipients) are:
Tablet core: Anhydrous lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate;
Tablet coat: Hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172).
What TADALAFIL looks like and what the package contains
TADALAFIL 10 mg: yellow, oblong, biconvex, film-coated tablets with embossed “T 10” on one side.
TADALAFIL 20 mg: yellow, oblong, biconvex, film-coated tablets with embossed “T 20” on one side.
PVC / PVDC / Aluminum blister packs are available.
TADALAFIL 10 mg:
Pack sizes of 4 film-coated tablets.
TADALAFIL 20 mg:
Pack sizes of 2, 4, 8 or 12 film-coated tablets.
Not all pack sizes may be marketed.