Package leaflet: Information for the patient SZ00000LT000

Tadalafil 2.5 mg Film-coated Tablets Tadalafil 5 mg Film-coated Tablets Tadalafil 10 mg Film-coated Tablets Tadalafil 20 mg Film-coated Tablets

tadalafil

Read all of this leaflet carefully before you start 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.

What is in this leaflet

1.    What Tadalafil is and what it is used for

2.    What you need to know before you take Tadalafil

3.    How to take Tadalafil

4.    Possible side effects

5.    How to store Tadalafil

6.    Contents of the pack and other information

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

Tadalafil 2.5 mg, 5 mg, 10 mg and 20 mg 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. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Following sexual stimulation Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Tadalafil 5 mg is used to treat adult men with urinary symptoms associated with a common condition called

benign prostatic hyperplasia.

This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. Tadalafil improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.

Tadalafil 20 mg is used to treat pulmonary arterial hypertension in adults

It works by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

Do not take Tadalafil if you:

•    are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)

•    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 are taking any form of nitrate or are unsure tell your doctor.

•    have serious heart disease or recently had a heart attack within the last 90 days

•    recently had a stroke within the last 6 months

•    have low blood pressure or uncontrolled high blood pressure

•    ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”

•    are taking riociguat

This drug 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 secondary to blood clots). PDE5 inhibitors, such as Tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor before taking Tadalafil.

If you are treated for erectile dysfunction or benign prostatic hyperplasia: be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

If you are treated for benign prostatic hyperplasia: since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with Tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:

•    sickle cell anaemia (an abnormality of red blood cells)

•    multiple myeloma (cancer of the bone marrow)

•    leukaemia (cancer of the blood cells)

•    any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours

•    a serious liver problem

•    a severe kidney problem

•    any hereditary eye disease

•    any heart problems other than your pulmonary hypertension

•    problems with your blood pressure

It is not known if Tadalafil in treatment of erectile dysfunction is effective in patients who have had:

•    pelvic surgery

•    removal of all or part of the prostate gland in which nerves of the prostate are cut (radical

non- nerve-sparing prostatectomy)

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

Tadalafil should not be used as treatment of erectile dysfunction or benign prostatic hyperplasia by women because these are health problems specific to men.

Children and adolescents

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

Other medicines and Tadalafil

Tell your doctor if you are taking, have recently taken or might take any other medicines. Do not take Tadalafil if you are already taking nitrates.

Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work. Tell your doctor or pharmacist if you are already taking:

•    an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia)

•    other medicines to treat high blood pressure

•    nitrates (for chest pain)

•    riociguat

•    a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia)

•    protease inhibitors for treatment of AIDS or HIV infection (ritonavir)

•    phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines)

•    rifampicin, erythromycin or clarithromycin (to treat bacterial infections)

•    medicines such as ketoconazole or itraconazole (to treat fungal infections)

•    bosentan (another treatment for pulmonary arterial hypertension)

•    other treatments for erectile dysfunction (PDE5 inhibitors)

Tadalafil with drink and alcohol

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to your doctor for further information.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Tadalafil when pregnant, unless it is strictly necessary and you have discussed this with your doctor.

Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil contains lactose

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

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

Swallow the tablet un-chewed with some water. Tadalafil 10 mg and 20 mg tablets can be divided into equal doses.

The tablets can be taken with or without food.

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction • Flexible-dose, on demand:

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak

your doctor may increase the dose to 20 mg.

Tadalafil tablets are for oral use.

You may take Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective up to 36 hours after taking the tablet.

Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

• Once a day dosing:

When taken once a day Tadalafil allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of Tadalafil may be useful to men who anticipate having sexual activity two or more times per week.

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil. This will be given as a 2.5 mg tablet.

Do not take Tadalafil more than once a day.

It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection.

For the treatment benign prostatic hyperplasia

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

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

Do not take Tadalafil more than once a day.

For the treatment of pulmonary arterial hypertension

The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

If you take more Tadalafil than you should

If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.

If you forget to take Tadalafil

Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil more than once a day.

If you stop taking Tadalafil

For the treatment of pulmonary arterial hypertension do not stop taking your tablets, unless advised otherwise by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

•    allergic reactions including rashes (frequency common, may affect up to 1 in 10 people)

•    chest pain - do not use nitrates but seek immediate medical assistance (frequency common, may affect up to 1 in 10 people)

•    prolonged and possibly painful erection after taking Tadalafil (frequency uncommon, may affect up to 1 in 100 people)

If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

•    sudden loss of vision (frequency rare, may affect up to 1 in 1,000 people)

Other side effects have been reported and these are listed below, separated by indication:

Side effects in erectile dysfunction or benign prostatic hyperplasia

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

•    dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired

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

•    fainting, passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating

Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of these men had known heart problems before taking this medicine

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil that were not seen in clinical trials. These include:

•    migraine, seizures, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Side effects in pulmonary arterial hypertension

Very common (may affect more than 1 in 10 people)

•    headache, flushing, nasal and sinus congestion

(blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)

Common (may affect up to 1 in 10 people)

•    blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting

Uncommon (may affect up to 1 in 100 people)

•    seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil (see paragraph “Side effects in erectile dysfunction and benign prostatic hyperplasia” above).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov. uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

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.

This medicine does not require any special storage conditions.

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.

What Tadalafil contains

Tadalafil 2.5 mg film-coated tablets

The active substance is tadalafil. Each film-coated tablet

contains 2.5 mg of tadalafil.

Tadalafil 5 mg film-coated tablets

The active substance is tadalafil. Each film-coated tablet

contains 5 mg of tadalafil.

Tadalafil 10 mg film-coated tablets

The active substance is tadalafil. Each film-coated tablet

contains 10 mg of tadalafil.

Tadalafil 20 mg film-coated tablets

The active substance is tadalafil. Each film-coated tablet

contains 20 mg of tadalafil.

The other excipients are:

Tablet core:

Lactose monohydrate, sodium laurilsulfate, povidone K-12, crospovidone (Type B), sodium stearyl fumarate

Film-coating:

Polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide yellow (E172)

What Tadalafil looks like and contents of the pack

Tadalafil 2.5 mg film-coated tablets

Ochre to yellow, round shaped film coated tablet of approximately 5 mm in diameter. On one side debossed with “2.5” and plain on the other side.

Tadalafil 5 mg film-coated tablets

Ochre to yellow, oval shaped film coated tablet of approximately 8 x 4 mm. On one side debossed with “5” and plain on the other side.

Tadalafil 10 mg film-coated tablets

Ochre to yellow, oval shaped film coated tablet of approximately 11 x 7 mm. On one side scored and debossed with “1” on the left side of the score and with “0” on the right side of the score. The other side of the tablet is plain. The tablet can be divided into equal halves.

Tadalafil 20 mg film-coated tablets

Ochre to yellow, oval shaped film coated tablet of approximately 14 x 8 mm. On one side scored and debossed with “2” on the left side of the score and with “0” on the right side of the score. The other side of the tablet is plain. The tablet can be divided into equal halves.

Alu-Alu (Al-OPA/Al/PVC) blisters:

PVC/ACLAR/PVC - Alu blisters PVC/ACLAR/PVdC/PVC- Alu blisters

Pack sizes:

Tadalafil 2.5 mg film-coated tablets

28 film-coated tablets.

Tadalafil 5 mg film-coated tablets

14, 24, 28, 84 film-coated tablets.

Tadalafil 10 mg film-coated tablets

4, 12, 24 film-coated tablets.

Tadalafil 20 mg film-coated tablets

4, 8, 12, 24, 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK

Manufacturer

Lek Pharmaceuticals d.d., Verovskova ulica 57,

1526 Ljubljana, Slovenia

This leaflet was last revised in 11/2016

00000000

SZ00000LT000