Tadulan

Package Leaflet: Information for the User

Tadulan, 5 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 works by helping the blood vessels in your penis to relax and expand, allowing blood to flow into your penis. The result is an improved erection.

Tadulan does not work if you are not sexually aroused.

• symptoms of benign prostatic hyperplasia(enlarged prostate gland). These symptoms may include difficulty starting to urinate, frequent urination, and weak urine flow.

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
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite
• 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye"
• if you are taking riociguat, a medicine used to treat high blood pressure in the lungs

Warnings and precautions

Before taking Tadulan, tell your doctor if you have:

• sickle cell anemia
• multiple myeloma
• leukemia
• penis deformation
• severe liver disease
• severe kidney disease

Tadulan is not intended for use by women.

Children and adolescents

Tadulan should not be used in children and adolescents under 18 years of age.

Tadulan with other medicines

Tell your doctor if you are taking any of the following medicines:

• alpha-blockers
• other medicines for high blood pressure
• riociguat
• 5-alpha reductase inhibitors
• ketoconazole
• phenobarbital
• phenytoin
• carbamazepine
• rifampicin
• erythromycin
• clarithromycin
• itraconazole

Tadulan with food and drink

Grapefruit juice may affect the efficacy of Tadulan, and you should be cautious when consuming it.

Fertility

In animal studies, decreased sperm production was observed.

Driving and using machines

Dizziness has been reported in some men taking tadalafil.

Tadulan contains lactose

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

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.

The recommended dose is one 5 mg tablet taken once a day, at approximately the same time of day.

Treatment of erectile dysfunction

Dosage

The recommended dose is one 5 mg tablet taken once a day.

Treatment of benign prostatic hyperplasia symptoms

Dosage

The recommended dose is one 5 mg tablet taken once a day.

If you take more Tadulan than you should

Consult your doctor.

If you forget to take Tadulan

Take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

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

Stop taking the medicine and seek medical attention immediately if you experience any of the following:

• allergic reactions, including skin rash
• chest pain - do not take nitrates, but seek medical attention immediately
• prolonged and possibly painful erections
• sudden loss of vision

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 erections
• 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
• temporary memory loss
• eyelid swelling
• red eyes
• 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.

Do not throw away any medicines via wastewater or household waste.

6. Contents of the pack and other information

What Tadulan contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, 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, 6.1 ± 0.2 mm in diameter.

Tadulan is available in blister packs of 14 x 1 and 28 x 1 film-coated tablets.

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

Slovakia: Tadulan

Hungary: Tadulan

Date of last revision of the leaflet: