Tadalafil Sandoz

Patient Information Leaflet

Tadalafil Sandoz 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tadalafil Sandoz is and what it is used for
2. What you need to know before taking Tadalafil Sandoz
3. How to take Tadalafil Sandoz
4. Possible side effects
5. How to store Tadalafil Sandoz
6. Contents of the pack and other information

1. What Tadalafil Sandoz is and what it is used for

Tadalafil Sandoz contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors.
Tadalafil Sandoz 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablets is a treatment for adult men with erectile dysfunction.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Sandoz has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.
Following sexual stimulation, Tadalafil Sandoz helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Sandoz will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Sandoz for the treatment of erectile dysfunction has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
Tadalafil Sandoz 5 mg film-coated tablets is a treatment for adult men with urinary symptoms associated with a common condition called benign prostatic hyperplasia.
This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and a more frequent need to urinate, including during the night. Tadalafil Sandoz improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil Sandoz has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Sandoz

Do not take Tadalafil Sandoz if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6);
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil Sandoz has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor;
• you have a severe heart disease or have recently had a heart attack (within the last 90 days);
• you have recently had a stroke (within the last 6 months);
• you have low blood pressure or uncontrolled high blood pressure;
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye";
• you are taking riociguat. This medicine 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 Sandoz, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Sandoz.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, inform your doctor.
If you are being treated for benign prostatic hyperplasia with Tadalafil Sandoz 5 mg film-coated tablets: since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Sandoz for benign prostatic hyperplasia. Tadalafil Sandoz does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (a blood disorder affecting red blood cells);
• multiple myeloma (a malignant tumor of the bone marrow);
• leukemia (a malignant blood cell disorder);
• any deformity of the penis;
• a serious liver problem;
• a serious kidney problem.

It is not known whether Tadalafil Sandoz is effective in patients who have undergone:

• pelvic surgery;
• removal of all or part of the prostate gland where the nerves to the prostate have been severed (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Sandoz and contact your doctor immediately.
Tadalafil Sandoz is not intended for use by women.
Children and adolescents
Tadalafil Sandoz is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Sandoz
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Sandoz if you are already taking nitrates.
Some medicines may be affected by Tadalafil Sandoz, or may themselves affect how Tadalafil Sandoz works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia);
• other medicines for high blood pressure;
• riociguat;
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadalafil Sandoz with beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Sandoz works and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Sandoz in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Sandoz contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Sandoz

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Sandoz tablets are for oral use and are intended only for men. Swallow the tablet whole with water, without chewing. Tadalafil Sandoz 20 mg tablets may be divided into two equal doses. The tablets can be taken regardless of food intake.
Consumption of alcoholic beverages may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Sandoz, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

• Flexible, on-demand dosing with 10 mg or 20 mg film-coated tablets: The recommended starting dose is one 10 mg tablet taken before sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil Sandoz tablets are for oral use. You should take one Tadalafil Sandoz tablet at least 30 minutes before sexual activity. Tadalafil Sandoz may remain effective for up to 36 hours after taking the tablet. Tadalafil Sandoz 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for daily continuous use.
• Once-daily dosing with 2.5 mg or 5 mg film-coated tablets: If taken once daily, Tadalafil Sandoz allows you to achieve an erection, provided there is sexual stimulation, at any time within 24 hours of dosing. Daily administration of Tadalafil Sandoz may benefit men who expect to have sexual activity two or more times per week. The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Sandoz. This lower dose will be provided as a 2.5 mg tablet.

Do not take Tadalafil Sandoz more than once a day.
It is important to note that Tadalafil Sandoz will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Consumption of alcoholic beverages may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia, with 5 mg film-coated tablets
The dose is one 5 mg tablet taken once daily at approximately the same time each day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take Tadalafil Sandoz more than once a day.

If you take more Tadalafil Sandoz than you should
Contact your doctor. You may experience the side effects described in section 4.

If you forget to take Tadalafil Sandoz
If you are supposed to take Tadalafil Sandoz once daily, take the missed dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil Sandoz more than once a day.

If you have any doubts about how to use this medicine, consult 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 in severity.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

• allergic reactions including skin rashes (uncommon frequency, may affect up to 1 in 100 people);
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency, may affect up to 1 in 100 people);
• prolonged and possibly painful erection after taking Tadalafil Sandoz (rare frequency, may affect up to 1 in 1,000 people). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately;
• sudden loss of vision (rare frequency, may affect up to 1 in 1,000 people).

Other side effects reported include:
Common (may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach discomfort, feeling unwell, malaise (vomiting), reflux, blurred vision, eye discomfort, breathing difficulties, blood in the urine, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ear ringing, swelling of the hands, feet or ankles, and feeling tired.

Rare (may affect up to 1 in 1,000 people)

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), penile bleeding, blood in the semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking Tadalafil Sandoz. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have also been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Sandoz. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect "dizziness" has been reported more frequently in men over 75 years of age taking Tadalafil Sandoz. "Diarrhoea" has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Sandoz contains
Tadalafil Sandoz 2.5 mg film-coated tablets
The active substance is tadalafil.
Each film-coated tablet contains 2.5 mg of tadalafil.
Tadalafil Sandoz 5 mg film-coated tablets
The active substance is tadalafil.
Each film-coated tablet contains 5 mg of tadalafil.
Tadalafil Sandoz 10 mg film-coated tablets
The active substance is tadalafil.
Each film-coated tablet contains 10 mg of tadalafil.
Tadalafil Sandoz 20 mg film-coated tablets
The active substance is tadalafil.
Each film-coated tablet contains 20 mg of tadalafil.

The other components are:
Tablet core:
monohydrate lactose, sodium lauryl sulfate, povidone K-12, crospovidone (type B), sodium stearate fumarate.
Film coating:
polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172).

Description of the appearance of Tadalafil Sandoz and contents of the pack
Tadalafil Sandoz 2.5 mg film-coated tablets
Film-coated tablet, yellowish to yellow in colour, circular in shape, approximately 5 mm in diameter, marked with "2.5" on one side and smooth on the other.
Tadalafil Sandoz 5 mg film-coated tablets
Film-coated tablet, yellowish to yellow in colour, oval-shaped, approximately 8 x 4 mm in size, marked with "5" on one side and smooth on the other.
Tadalafil Sandoz 10 mg film-coated tablets
Film-coated tablet, yellowish to yellow in colour, oval-shaped, approximately 11 x 7 mm in size, marked with "10" on one side. The other side is smooth.
Tadalafil Sandoz 20 mg film-coated tablets
Film-coated tablet, yellowish to yellow in colour, oval-shaped, approximately 14 x 8 mm in size, with a score line on one side and the numbers "2" to the left and "0" to the right of the score line. The other side is smooth. The tablet may be divided into two equal doses.

Packaging materials:
Al-Al (Al-OPA/AL/PVC)
Blister PVC/ACLAR/PVC-AL
Blister PVC/ACLAR/PVdC/PVC-AL

Tadalafil Sandoz 2.5 mg film-coated tablets
28 film-coated tablets.
Tadalafil Sandoz 5 mg film-coated tablets
14, 28 film-coated tablets.
Tadalafil Sandoz 10 mg film-coated tablets
4, 12 film-coated tablets.
Tadalafil Sandoz 20 mg film-coated tablets
2, 4, 8, 12, 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni, 1 - 21040 Origgio (VA), Italy

Manufacturers
LEK Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, Croatia

This medicinal product is authorized in the European Economic Area Member States under the following names: