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Tadalafil 20 Mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 00289-1885 change

Package leaflet: Information for the user

TADALAFIL 20 mg FILM-COATED TABLETS

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 or nurse. 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

1. What Tadalafil is and what it is used for

Tadalafil contains the active substance tadalafil.

Tadalafil is a treatment for pulmonary arterial hypertension in adults.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work 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.

2. What you need to know before you take Tadalafil Do NOT take Tadalafil if you:

-    are allergic to tadalafil or any of the other ingredients of this medicine (see section 6).

-    are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. [Invented name] 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 ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).

-    have had a heart attack in the last 3 months

-    have low blood pressure

Warnings and precautions

Talk to your doctor before taking Tadalafil.

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

-    any heart problems other than your pulmonary hypertension

-    problems with your blood pressure

-    any hereditary eye disease

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

-    cancer of the bone marrow (multiple myeloma)

-    cancer of the blood cells (leukaemia)

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

-    a serious liver problem

a serious kidney problem.

If you experience sudden decrease or loss of vision, contact your doctor immediately.

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 these tablets if you are already taking any form of nitrates (See ‘Do NOT take Tadalafil).

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:

-    bosentan (another treatment for pulmonary aterial hypertension)

-    nitrates (for chest pain)

-    alpha blockers used to treat high blood pressure or prostate problems.

-    rifampicin (to treat bacterial infections)

-    ketoconazole tablets (to treat fungal infections)

-    ritonavir (for HIV treatment)

-    tablets for erectile dysfunction    (PDE5    inhibitors).

Tadalafil with alcohol

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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 breastfeed 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 breastfeeding.

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

Dizziness has been reported. Check carefully how you react to the medicines before driving or using any machinery.

Tadalafil contains lactose

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

3. How to take Tadalafil

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

Tadalafil is supplied as a 20 mg tablet. 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.

Swallow the tablets whole with a drink of water. The tablets can be taken with or without food.

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 the one that you have forgotten.

If you stop taking Tadalafil

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.

4.    Possible side effects

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 skin rashes (frequency common).

-    chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).

-    prolonged and possibly painful erection after taking Tadalafil (frequency uncommon). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

-    sudden loss of vision (rarely reported).

The following side effects have been very commonly reported in patients taking Tadalafil (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)

Other side effects have been reported:

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 1in 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

ringing in the ears.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:

-    Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is unknown:

-    swelling    of the eyelids

-    eye pain

-    red eyes

-    heart attack and stroke.

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.

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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Tadalafil

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 medicinal product 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.

6.    Contents of the pack and other information What Tadalafil contains

-    The active substance is tadalafil.

Each tablet contains 20 mg of tadalafil.

-    The other ingredients are lactose monohydrate, sodium laurilsulfate, povidone, crospovidone and sodium stearyl fumarate.

-    The tablet coating is made of poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc and iron oxide yellow (E172).

What Tadalafil looks like and contents of the pack

Tadalafil 20 mg ochre to yellow, oval shaped film coated tablet. 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. Length: 14.0 mm, width: 8.0 mm.

The tablet can be divided into equal doses.

Tadalafil is available in pack sizes of 2, 4, 5, 8, 10, 12, 14, 15, 28, 30, 56, 60 or 84 film-coated tablets in blisters or 4x1, 12x1 or 24x1 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG, UK

*OR

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

TEVA Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private Limited Company), Debrecen, Pallagi ut 13, H-4042, Hungary

*OR

TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom *OR

Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands *OR

Teva Operations Poland Sp. z.o.o, ul. Mogilska 80. , Krakow, 31-546, Poland *OR

TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza, 50016, Spain *OR

Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren, 89143, Germany *OR

Merckle GmbH, Graf-Arco-Str. 3, Ulm, 89079, Germany *OR

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, 10000, Croatia This leaflet was last revised in 02/2016

PL 00289/1885 * Only the actual site of batch release will appear on the printed version of the leaflet