Tadulan

Package Leaflet: Information for the User

Tadulan, 10 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

• 1. What Tadulan is and what it is used for
• 2. 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 there is no sexual stimulation.

2. 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’). Tadalafil 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), a condition described as ‘stroke of the eye’
• if 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the effects of this medicine.

Warnings and precautions

Before taking Tadulan, tell your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells)
• multiple myeloma (a cancer of the bone marrow)
• leukaemia (a cancer of the blood cells)
• any deformation of your penis
• severe liver or kidney disease

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

• undergone pelvic surgery
• prostate removal (radical prostatectomy)

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

Children and adolescents

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

Tadulan with other medicines

Do not take Tadulan if you are already taking nitrates.

Tadulan may interact with some medicines, especially those used to treat high blood pressure, chest pain, or heart rhythm problems.

Tadulan with food and drink

Grapefruit juice may affect how Tadulan works.

Fertility

There is no evidence that Tadulan affects fertility.

Driving and using machines

Some men taking Tadulan have reported dizziness. Check that you are able to tolerate Tadulan before driving or operating machinery.

Tadulan contains lactose

If you have been told by your doctor 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, that is to say 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 starting dose is one 10 mg tablet before sexual activity.

You may take Tadulan with or without food.

Do not take Tadulan more than once a day.

If you take more Tadulan than you should

Consult a doctor. 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 seek medical help immediately if you have any of the following symptoms:

• allergic reactions, including rashes (uncommon)
• chest pain (uncommon)
• prolonged and possibly painful erections (rare). If you have an erection that lasts more than 4 hours, 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
• facial 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 the hands, feet or ankles
• feeling tired

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

• fainting
• seizures
• temporary memory loss
• swelling of the eyelids
• redness of the eyes
• sudden decrease or loss of hearing
• hives (itchy, raised patches of skin)
• penile bleeding
• presence of 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

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

6. Contents of the pack and other information

What Tadulan contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hypromellose, polysorbate, 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

Yellow, round, biconvex, film-coated tablets with a line on one side, white core and a diameter of 8.1 ± 0.2 mm. The tablets can be divided into equal doses.

Tadulan is available in blister packs of 4, 8, or 12 tablets.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany