Tadalafil Sandoz

2 Important information before taking Tadalafil Sandoz

When not to take Tadalafil Sandoz

• if you are allergic to tadalafil or any of the other ingredients of this medicine

(listed in section 6);

• if you are taking organic nitrates in any form or other donors of nitric oxide, such as amyl nitrite. Nitrates are a group of medicines used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Sandoz enhances the effect of these medicines. If you are taking nitrates in any form or are unsure, you should inform your doctor.
• if your doctor has advised you to avoid sexual activity.
• if you have severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke"
• if you are taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Tadalafil Sandoz, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before starting treatment with Tadalafil Sandoz, use the questionnaire attached to the packaging. If you have any doubts, discuss them with your doctor or pharmacist.
Remember that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If you have heart problems (including those resulting from the questionnaire that indicate you should not take Tadalafil Sandoz due to heart problems), inform your doctor or pharmacist.
Before taking the tablets, tell your doctor or pharmacist if you have any of the following:

• sickle-cell anaemia (abnormal shape of red blood cells),
• multiple myeloma (bone marrow cancer),
• leukaemia (blood cell cancer),
• any penile deformity,
• severe liver disease,
• severe kidney disease,

It is not known if Tadalafil Sandoz is effective in patients:

• after pelvic surgery,
• after total or partial removal of the prostate gland, during which the nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If you experience sudden worsening of vision or sudden loss of vision, or distorted vision, stop taking Tadalafil Sandoz and contact your doctor immediately.
In some patients taking tadalafil, worsening or sudden loss of hearing has been observed.
Although it is not known if this event is directly related to the use of tadalafil, if you experience worsening or sudden loss of hearing, stop taking Tadalafil Sandoz and contact your doctor immediately.

Tadalafil Sandoz is not intended for use in women.

Children and adolescents

Tadalafil Sandoz is not intended for use in children and adolescents under 18 years of age.

Tadalafil Sandoz and other medicines

Before taking Tadalafil Sandoz, use the questionnaire attached to the packaging. If you have any doubts, tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those you plan to take.
Do nottake Tadalafil Sandoz if you are taking nitrates.
Do nottake other medicines for erectile dysfunction or pulmonary hypertension containing sildenafil within 48 hours of taking Tadalafil Sandoz.
Tadalafil Sandoz should not be used in combination with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
Tadalafil Sandoz may affect the action of some medicines or other medicines may affect the action of Tadalafil Sandoz. Tell your doctor or pharmacist if you are taking:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia),
• other medicines used to treat high blood pressure,
• riociguat,
• 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia),
• protease inhibitors used to treat AIDS or HIV infection (ritonavir),
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines),
• rifampicin, erythromycin, or clarithromycin (medicines used to treat bacterial infections),
• medicines such as ketoconazole or itraconazole (used to treat fungal infections),
• other treatments for erectile dysfunction (PDE5 inhibitors).

In some patients taking blood pressure-lowering medicines, a decrease in blood pressure may occur, especially when standing up quickly or sitting down. If you experience symptoms of low blood pressure (dizziness, fainting, feeling of impending faint), lie down or sit down and wait for the symptoms to pass, drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may help. Avoid standing up quickly or sitting down.

Taking Tadalafil Sandoz with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Sandoz, and caution should be exercised when consuming it. For more information, consult your doctor or pharmacist.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes occurred.
A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

In some men taking Tadalafil Sandoz during clinical trials, dizziness was reported. You should be aware of your reaction to the medicine before driving a car or operating machinery.

Tadalafil Sandoz contains lactose and sodium

If your doctor has previously determined that you have an intolerance to some sugars, consult your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3 How to take Tadalafil Sandoz

This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Sandoz tablets are for oral use only in men.
Swallow the tablets whole with a small amount of water.
The tablets can be taken with or without food.
The recommended starting doseis one 10 mg tablet, taken before planned sexual activity. If you feel that the effect of Tadalafil Sandoz is too strong or too weak, consult your doctor or pharmacist. Your doctor may recommend a different dosing regimen after consultation.
Tadalafil Sandoz should be taken at least 30 minutes before planned sexual activity.
Tadalafil Sandoz may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Sandoz more than once a day. Tadalafil Sandoz, 10 mg, is intended for use before planned sexual activity. The medicine should be taken as needed. It is not intended for continuous, daily use.
Do not use more than once a week.
Do not take Tadalafil Sandoz if you have not been diagnosed with erectile dysfunction.
It is essential to be aware that Tadalafil Sandoz does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may reduce the ability to achieve an erection and cause a temporary decrease in blood pressure. If you have taken Tadalafil Sandoz or plan to take it, do not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more Tadalafil Sandoz than recommended

If you or someone else has taken more tablets than recommended, immediately inform your doctor or go to the hospital, taking the medicine or packaging with you.
Side effects may occur, as described in section 4.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are usually mild to moderate.

If you experience any of the following side effects, stop taking Tadalafil Sandoz and contact your doctor immediately.

• allergic reactions, including rash (not very common),
• chest pain - do not take nitrates, but seek medical help immediately (not very common)
• priapism, prolonged and possibly painful erection after taking Tadalafil Sandoz (rare). If such an erection occurs and lasts continuously for more than 4 hours, seek medical help immediately.
• sudden loss of vision (rare), distorted, blurred, or impaired vision (frequency not known).

Other reported side effects:

Common (observed in less than 1 in 10 people)

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

Uncommon (observed in less than 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare (observed in less than 1 in 1000 people)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), penile bleeding, blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking Tadalafil Sandoz. Most of them had heart problems before starting treatment with this medicine.
There are rare reports of cases of partial, transient, or permanent loss of vision or blindness in one or both eyes.
In men taking Tadalafil Sandoz, a few rare additional side effectshave been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted, blurred, or impaired vision or sudden worsening of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5 How to store Tadalafil Sandoz

Keep the medicine out of the sight and reach of children.
Do not use Tadalafil Sandoz after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6 Contents of the pack and other information

What Tadalafil Sandoz contains

The active substance is tadalafil.
Each film-coated tablet contains 10 mg of tadalafil.
The other ingredients are: lactose monohydrate, sodium lauryl sulfate, povidone K-12, crospovidone type B, sodium stearyl fumarate. Tablet coating:hypromellose, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E 172).

What Tadalafil Sandoz looks like and contents of the pack

Oval, yellow to ochre film-coated tablets, approximately 11 x 6 mm in size, with "10" embossed on one side and smooth on the other.
The film-coated tablets are packaged in blisters of aluminum/OPA/aluminum/PVC, PVC/ACLAR/PVC/aluminum, PVC/ACLAR/PVDC/PVC/aluminum, or PVC/PVDC/aluminum in a cardboard box.
Pack sizes: 2x1, 4x1 film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer/Importer:
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
TEVA Pharma, S.L.U.
Polígono Industrial Malpica, C/C, nº4
50016 Zaragoza
Spain

For more information about the medicine, contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 48 22 209 70 00

Date of last revision of the leaflet:

Sandoz logo