Tadalafil 10 mg. 8 tablets
Tadalafil is for the treatment of elderly men with erectile dysfunction. This is a condition in which a man cannot reach or retain 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.
What Tadalafil is and what it is used for
Tadalafil is a herd for the treatment of elderly men with erectile dysfunction. This is a condition in which a man cannot reach or retain a hard, erect penis suitable for sexual activity. Tadalafil herd shows a significant improvement in the ability to obtain a hard, erect penis suitable for sexual activity. TADALAFIL contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, TADALAFIL STADA acts to help the blood vessels in your penis relax and allow your blood flow. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.
It is important to note that TADALAFIL does not work unless there is sexual stimulation. You and your partner will need to get involved in the love game just as you would if you did not take erectile dysfunction medicine.
2. What you need to know before you take TADALAFIL
Do not take tadalafil herd
if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
if you take any kind of organic nitrate or nitric oxide donor such as amyl nitrite. These are a group of medicines ("nitrates") used in the treatment of angina ("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;
if you have a serious heart condition or have a recent heart attack in the last 90 days;
if you have a recent 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 eye neuropathy (NAION), a condition described as "eye stroke";
you are taking riotsiguat. 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 LAFILE, have been shown to potentiate the blood pressure lowering effect of this drug. If you are taking rhiziguat or you are not sure, tell your doctor.
Warnings and precautions
Talk to your doctor before taking TADALAFIL.
Please note that sexual activity carries potential risks for patients with heart disease because it puts additional strain on your heart. If you have heart problems, you should tell your doctor.
Before you take the tablets, tell your doctor if you have:
sickle cell anemia (anomaly of red blood cells);
multiple myeloma (bone marrow tumor);
leukemia (tumor of blood cells);
any deformity of the penis;
a serious liver problem;
a serious kidney problem.
It is unknown whether TADALAFIL 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, nerve-preserving prostatectomy).
If you experience a sudden decrease or loss of vision, stop taking TADALAFIL and contact your doctor immediately.
In some patients taking tadalafil, there is a decrease in hearing or sudden hearing loss. Although it is not known if the event is directly related to tadalafil, if you experience hearing loss or sudden hearing loss, stop taking TADALAFIL and contact your doctor immediately.
TADALAFIL is not intended for use by women.
Children and adolescents
TADALAFIL is not intended for use in children and adolescents under 18 years of age.
Other medicines and tadalafil become herd
Tell your doctor or pharmacist 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 or they may affect how well 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 (enlargement));
other medicines for the treatment of high blood pressure;
5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia (enlargement));
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-seizure medicines);
rifampicin, erythromycin, clarithromycin or itraconazole;
other treatments for erectile dysfunction.
Tadalafil is taken with food, drink and alcohol
Pregnancy, breastfeeding and fertility
In the treatment of dogs, decreased semen formation in the testes was observed. Semen reduction is observed in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines
In clinical studies, some men taking TADALAFIL have reported dizziness. Check carefully how you tolerate the tablets before you drive or use machines.
Tadalafil herd 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 men. Swallow the tablet whole with some water. You can take the tablets with or without food.
The recommended dose is one tablet of 10 mg before sexual activity.
However, your doctor may recommend a dose of one 20 mg tablet if you consider the effect of the 10 mg tablet to be too weak.
You may take TADALAFIL at least 30 minutes before sexual activity. TADALAFIL may be effective up to 36 hours after tablet administration.
Do not take TADALAFIL more than once a day.
Administration of TADALAFIL 10 mg and 20 mg is intended for use before anticipated sexual activity and is not recommended for prolonged daily use.
It is important to note that TADALAFIL does not act without sexual stimulation. You and your partner will need to get involved in a pre-game just as you would if you were not taking erectile dysfunction medicine.
Alcohol use can affect your ability to erect and can temporarily lower your blood pressure. If you take or plan to take TADALAFIL , avoid excessive alcohol use (blood alcohol levels of above and above 0.08%) as this may increase your risk of dizziness when you get up.
If you take more Tadalafil than you should
Contact your doctor. You may get 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 everybody gets them. These effects are usually mild to moderate in nature.
If you experience any of the following side effects, stop using the medicine and seek medical advice immediately:
allergic reactions, including rashes (frequency - uncommon);
chest pain - do not use nitrates, but seek immediate medical attention (frequency - uncommon);
prolonged and possibly painful erection after taking TADALAFIL (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 aches, pain in the arms and legs, redness of the face, obstruction of the nose, poor digestion.
Uncommon: (observed in 1 to 10 in every 1,000 patients)
dizziness, abdominal pain, nausea, vomiting, heartburn, blurred vision, eye pain, increased sweating, difficulty breathing, presence of blood in the urine, prolonged erection, palpitations, increased heart rate, increased blood pressure, low blood pressure, blood flow, bleeding from the nose and tinnitus, ankle inflammation and fatigue.
Rare: (observed in 1 to 10 in 10,000 patients)
weakness, seizures and transient memory loss, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing and urticaria (itchy red patches on the skin surface), bleeding from the penis, presence of blood in the seminal fluid and increased sweating.
Rarely, in men, heart attacks and strokes have been reported with the use of tadalafil. Most of these men had known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision of one or both eyes has rarely been reported.
Some additional rare side effects have been reported in men taking TADALAFIL herds that have not been observed in clinical trials. They include:
migraine, facial edema, severe allergic reaction causing facial or throat edema, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
The side effects of dizziness and diarrhea have been reported more commonly in men over 75 years of age who are taking TADALAFIL Adverse reaction diarrhea has been reported in men over 65 years of age who have taken TADALAFIL .
How to store Tadalafil is herd
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 sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Tadalafil contains
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:
The core of the tablet
Anhydrous lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate
Tablet coating: Hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172)
What Tadalafil looks like and contents of the pack
TADALAFIL 10 mg: yellow, oblong, biconvex film-coated tablets with 'T 10' embossed on one side.
TADALAFIL 20 mg: yellow, oblong, biconvex film-coated tablets with 'T 20' embossed on one side.
PVC / PVDC / Aluminum blister packs are available.
TADALAFIL STAD 10 mg:
Packs of 4 film-coated tablets.
Tadalafil 20 mg:
Packs of 2,4, 8 or 12 film-coated tablets.
Not all pack sizes may be marketed.