Tadulan

Package Leaflet: Information for the User

Tadulan, 20 mg, Film-Coated Tablets

Tadalafil

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Tadulan is and what it is used for

Tadulan contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadulan is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

After sexual stimulation, Tadulan helps to relax the blood vessels in the penis, allowing blood to flow into the penis. This helps to produce an erection.

Tadulan does not help patients who have no erectile dysfunction. It is important to note that Tadulan does not work if there is no sexual stimulation.

2. What you need to know before you take Tadulan

Do not take Tadulan

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). Tadulan has been shown to increase the effects of these medicines.
• 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 had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye"
• if you are taking riociguat. This is a medicine used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the effects of this medicine.

Warnings and precautions

Before taking Tadulan, tell your doctor if you have:

• sickle cell anemia (abnormal red blood cells)
• multiple myeloma (bone marrow cancer)
• leukemia (blood cell cancer)
• any deformation of the penis
• severe liver disease
• severe kidney disease

It is not known if Tadulan is effective in patients who have:

• undergone pelvic surgery
• had a radical prostatectomy (removal of the prostate gland)

If you experience sudden loss of vision or loss of hearing, stop taking Tadulan and contact your doctor immediately.

Children and adolescents

Tadulan is not intended for use by children and adolescents under 18 years of age.

Tadulan with other medicines

Tell your doctor about all the medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate)
• certain medicines used to treat fungal infections (e.g., ketoconazole), HIV infection (e.g., ritonavir), or other conditions

Tadulan with food and drink

Grapefruit juice may affect the efficacy of Tadulan. Be cautious when consuming grapefruit juice.

Fertility

Animal studies have shown that tadalafil may reduce sperm production in the testes. This effect has been observed in some men.

Driving and using machines

Some men taking tadalafil have reported dizziness. Be aware of how you react to the tablets before driving or operating machinery.

Tadulan contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Tadulan.

Tadulan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Tadulan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 10 mg tablet taken before planned sexual activity.

Tadulan can be taken with or without food.

Do not take Tadulan more than once a day.

If you take more Tadulan than you should

Contact your doctor or pharmacist. You may experience side effects described in section 4.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience any of the following:

• allergic reactions, including skin rash (not very common)
• chest pain - do not take nitrates, but seek medical attention immediately (not very common)
• priapism, a prolonged and possibly painful erection after taking Tadulan (rare). If you experience this, contact your doctor immediately
• sudden loss of vision (rare)

Other reported side effects

Common(may affect up to 1 in 10 people):

• headache
• back pain
• muscle pain
• limb pain
• flushing
• nasal congestion
• indigestion

Uncommon(may affect up to 1 in 100 people):

• dizziness
• abdominal 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
• fatigue

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Tadulan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Do not use divided tablets after 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadulan contains

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other ingredients are: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, microcrystalline cellulose, magnesium stearate

Coating:

Hypromellose

Lactose monohydrate

Titanium dioxide (E 171)

Triacetin

Yellow iron oxide (E 172)

Talc

What Tadulan looks like and contents of the pack

Light yellow, round, biconvex film-coated tablets with a dividing line on both sides, with a white core and a diameter of 10.1 ± 0.2 mm. The tablets can be divided into equal doses.

Tadulan is available in single-dose blisters containing 2x1, 4x1, 8x1, and 12x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel, Germany

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

Netherlands

Tadulan

Romania

Tadulan 20 mg film-coated tablets

Slovakia

Tadulan

Hungary

Tadulan

Date of last revision of the leaflet: