Adcirca (previously Tadalafil Lilly)

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  • Adcirca (previously Tadalafil Lilly)
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Staðsetning

  • Fáanlegt í:
  • Adcirca (previously Tadalafil Lilly)
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • UROLOGICALS
  • Lækningarsvæði:
  • Hypertension, Pulmonary
  • Ábendingar:
  • Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
  • Vörulýsing:
  • Revision: 11

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/001021
  • Leyfisdagur:
  • 30-09-2008
  • EMEA númer:
  • EMEA/H/C/001021
  • Síðasta uppfærsla:
  • 30-03-2019

Opinber matsskýrsla

EMA/475361/2015

EMEA/H/C/001021

EPAR summary for the public

Adcirca

tadalafil

This is a summary of the European public assessment report (EPAR) for Adcirca. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Adcirca.

What is Adcirca?

Adcirca is a medicine that contains the active substance tadalafil. It is available as tablets (20 mg).

What is Adcirca used for?

Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity

(the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the

lungs. Adcirca is used in patients with class II or III disease. The ‘class’ reflects the seriousness of the

disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation

of physical activity. Adcirca has been shown to be effective in PAH with no identified cause and in PAH

caused by collagen vascular disease.

The medicine can only be obtained with a prescription.

How is Adcirca used?

Adcirca treatment should only be started and monitored by a doctor who has experience in the

treatment of PAH.

Adcirca is taken as two tablets (40 mg) once a day, with or without food. Patients with mild or

moderate kidney or liver problems should start with a lower dose, but this can be increased if

Previously known as Tadalafil Lilly.

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

necessary depending on the patient’s response. Adcirca is not recommended for patients with severe

kidney or liver problems.

How does Adcirca work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the

lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This

pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical

activity more difficult. The active substance in Adcirca, tadalafil, belongs to a group of medicines called

‘phosphodiesterase type 5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme. This

enzyme is found in the blood vessels of the lungs. When the enzyme is blocked, a substance called

‘cyclic guanosine monophosphate’ (cGMP) cannot be broken down and remains in the vessels where it

causes the relaxation and widening of the blood vessels. In patients with PAH, Adcirca widens the

blood vessels of the lungs, which lowers the blood pressure and improves symptoms.

How has Adcirca been studied?

Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a

dummy treatment) in one main study involving 406 patients with PAH, most of whom had class II or

class III disease that was of unknown cause or caused by collagen vascular disease. The main measure

of effectiveness was the change in exercise capacity (the ability to carry out physical activity)

measured by the distance the patients could walk in six minutes after 16 weeks of treatment.

What benefit has Adcirca shown during the studies?

Adcirca was more effective than placebo at improving exercise capacity. Before treatment, the patients

could walk an average of 343 metres in six minutes. After 16 weeks, this distance had increased by 26

metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.

What is the risk associated with Adcirca?

The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing

(reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or

runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache,

myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).

Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart

attack) within the last three months, or who have severe hypotension (low blood pressure). Adcirca

must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class

‘guanylate cyclase stimulators’ such as riociguat (another medicine to treat pulmonary hypertension).

It must not be used in patients who have ever had loss of vision because of a problem called non-

arteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the

eye.

For the full list of all side effects and restrictions with Adcirca, see the package leaflet.

Why has Adcirca been approved?

The CHMP decided that Adcirca’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

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What measures are being taken to ensure the safe and effective use of

Adcirca?

A risk management plan has been developed to ensure that Adcirca is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Adcirca, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Adcirca

The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly

on 1 October 2008. This authorisation was based on the authorisation granted to Cialis in 2002

(‘informed consent’). The name of the medicine was changed to Adcirca on 21 October 2009.

The full EPAR for Adcirca can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Adcirca,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2015.

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Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

ADCIRCA 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 of the 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

What ADCIRCA is and what it is used for

What you need to know before you take ADCIRCA

How to take ADCIRCA

Possible side effects

How to store ADCIRCA

Contents of the pack and other information

1.

What ADCIRCA is and what it is used for

ADCIRCA contains the active substance tadalafil.

ADCIRCA 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 ADCIRCA

Do not take ADCIRCA if you:

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

are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.

ADCIRCA 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.

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 ADCIRCA, 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 ADCIRCA.

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.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not

known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss,

contact your doctor immediately.

Children and adolescents

ADCIRCA is not indicated for use by children and adolescents under the age of 18.

Other medicines and ADCIRCA

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 nitrates.

Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA 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.

riociguat.

rifampicin (to treat bacterial infections)

ketoconazole tablets (to treat fungal infections)

ritonavir (for HIV treatment)

tablets for erectile dysfunction (PDE5 inhibitors).

ADCIRCA with alcohol

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take

ADCIRCA, 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 ADCIRCA 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.

ADCIRCA contains lactose

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

3.

How to take ADCIRCA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

ADCIRCA 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 ADCIRCA 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 ADCIRCA

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 ADCIRCA

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).

priapism, a prolonged and possibly painful erection after taking ADCIRCA (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 ADCIRCA (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 and 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 or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store ADCIRCA

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

Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP’. The expiry

date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30

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 ADCIRCA contains

The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.

The other ingredients are:

Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline

cellulose, sodium laurilsulfate, magnesium stearate.

Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow

(E172), iron oxide red (E172), talc.

What ADCIRCA looks like and contents of the pack

ADCIRCA 20 mg comes as orange film-coated tablets. They are in the shape of almonds and have

"4467" marked on one side.

ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V.,

Papendorpseweg 83, 3528 BJ Utrecht,

The Netherlands

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY

R, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel: +372 6 817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges.m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France SAS

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10

Ísland

Icepharma hf.

Sími: + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel: +371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu