Tadalafil sandoz

The medicine Tadalafil Sandoz is used in men aged ≥18 years with erectile dysfunction
(impotence), i.e. the inability to achieve or maintain an erection sufficient for sexual intercourse.
Before taking the medicine, carefully read the package leaflet and review the "Patient Questionnaire"
included with the package. To use the medicine safely, please answer all the questions in the questionnaire.

Package leaflet: information for the patient

Tadalafil Sandoz, 10 mg, film-coated tablets
Tadalafilum
Please read this leaflet carefully before taking the medicine, as it contains important information
for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your doctor or pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after taking the medicine, or if you feel worse, contact your doctor.

Table of contents of the leaflet

1. What Tadalafil Sandoz is and what it is used for
2. Important information 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 is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Sandoz
has been shown to significantly improve the ability to achieve an erection suitable for sexual intercourse.
Tadalafil Sandoz contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. During sexual stimulation, Tadalafil Sandoz helps to
dilate the blood vessels in the penis, allowing increased blood flow. This results in improved erection.
Tadalafil Sandoz does not help patients who do not have erectile dysfunction.
It is important to understand that Tadalafil Sandoz does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking
an erectile dysfunction medicine.

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

Warnings and precautions
Before starting Tadalafil Sandoz, complete the questionnaire included with the package. If you have any doubts, discuss them with your doctor or pharmacist.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If you have heart problems (including those identified in the questionnaire as contraindications to using Tadalafil Sandoz due to heart conditions), inform your doctor or pharmacist.
Before taking the tablets, inform your doctor or pharmacist if any of the following apply:

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

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

• after pelvic surgery,
• after radical prostatectomy with nerve-sparing not performed (complete or partial removal of the prostate gland with cutting of the nerves).

If you experience sudden worsening of vision, sudden vision loss, or distorted, dimmed vision while taking Tadalafil Sandoz, stop taking the medicine immediately and contact your doctor without delay.
Some patients taking tadalafil have reported worsening or sudden hearing loss. Although it is not known whether this event is directly related to tadalafil use, if you experience hearing loss or sudden hearing deterioration, 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, complete the questionnaire included with the package. If in doubt, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those you plan to use.
Do not take Tadalafil Sandoz if you are using nitrates.
Do not take other medicines for erectile dysfunction or pulmonary hypertension containing sildenafil within 48 hours of taking Tadalafil Sandoz.
Tadalafil Sandoz should not be used simultaneously with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
Tadalafil Sandoz may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Sandoz. Inform your doctor or pharmacist if you are taking any of the following:

• alpha-blockers (used to treat high blood pressure or urinary symptoms due to 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 in the treatment of AIDS or HIV infection (ritonavir),
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant 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, blood pressure may drop, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), lie down or sit down and wait until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may help. Avoid standing up or sitting down quickly.
Use of Tadalafil Sandoz with alcohol
Information on the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Sandoz, and therefore caution should be exercised when consuming it. For more information, consult your doctor or pharmacist.
Fertility
When tadalafil was administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking Tadalafil Sandoz reported dizziness. You should assess your individual response to the medicine before deciding to drive or operate machinery.
Tadalafil Sandoz contains lactose and sodium
If your doctor has previously diagnosed you with an intolerance to certain sugars, consult your doctor before starting this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning it is considered "sodium-free".

3. How to use Tadalafil Sandoz

This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tadalafil Sandoz tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water.
Tadalafil Sandoz tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet taken prior to anticipated sexual activity. If the effect of Tadalafil Sandoz seems too strong or too weak, consult your doctor or pharmacist. After consultation, your doctor may recommend a different dosing regimen.
Tadalafil Sandoz should be taken at least 30 minutes before anticipated sexual activity.
Tadalafil Sandoz may remain effective for 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 prior to anticipated sexual activity. The medicine should be taken on an as-needed basis. This medicine is not intended for regular, daily use.
Do not use more frequently than once a week.
Do not take Tadalafil Sandoz if erectile dysfunction has not been diagnosed.
It is important to understand that Tadalafil Sandoz does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
Alcohol consumption may reduce the ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil Sandoz, he should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking more than the recommended dose of Tadalafil Sandoz
If a patient or another person takes more tablets than recommended, contact a doctor immediately or go to a hospital, taking the medicine or its packaging along.
Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
These adverse reactions are usually mild to moderate.
If any of the adverse reactions listed below occur, discontinue use of Tadalafil Sandoz immediately
and seek medical advice without delay.

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

Other reported adverse reactions:
Common (observed in less than 1 in 10 people)

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

Not common (observed in less than 1 in 100 people)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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, urticaria (itchy, red skin welts), rectal bleeding, presence of blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking Tadalafil Sandoz.
Most of these men had pre-existing heart conditions before starting treatment with this medicine.
There have been rare reports of partial, transient, or permanent visual impairment or vision loss in one or both eyes.
In men taking Tadalafil Sandoz, several additional rare adverse reactions have been reported
that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders manifesting as ocular hyperaemia, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or impaired central vision or sudden worsening of vision (frequency not known).

The adverse reaction: dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 Tadalafil Sandoz after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

What Tadalafil Sandoz looks like and contents of the pack
Oval, film-coated tablets in ochre to yellow colour, approximately 11 x 6 mm in size, embossed with the
number "10" on one side and plain on the reverse.
The film-coated tablets are packed in blisters made of Aluminium/OPA/Aluminium/PVC, blisters made
of PVC/ACLAR/PVC/Aluminium, blisters made of PVC/ACLAR/PVDC/PVC/Aluminium or blisters made
of PVC/PVDC/Aluminium, placed in a cardboard box.

Pack sizes:
2x1, 4x1 film-coated tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicinal product, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 48 22 209 70 00