Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - adcirca

Document Subject

Generated Narrative: MedicinalProductDefinition mp74802c3f483c85b7b9c5aba153dab57d

identifier: http://ema.europa.eu/identifier/EU/1/08/476/005-006

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ADCIRCA 20 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-74802c3f483c85b7b9c5aba153dab57d

identifier: http://ema.europa.eu/identifier/EU/1/08/476/005-006

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - adcirca

Attesters

What is in this leaflet

1. What ADCIRCA is and what it is used for
2. What you need to know before you take ADCIRCA
3. How to take ADCIRCA
4. Possible side effects
5. How to store ADCIRCA
6. Contents of the pack and other information

ADCIRCA contains the active substance tadalafil. ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above.

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.

Do not take ADCIRCA

• if you are allergic to tadalafil or any of the other ingredients (see section 6).
• if you 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.
• if you have ever had loss of vision a condition described as stroke of the eye (non-arteritic anterior ischemic optic neuropathy - NAION).
• if you have had a heart attack in the last 3 months.
• if you have low blood pressure.
• 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 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 or your vision is distorted, dimmed while you are taking ADCIRCA, stop taking ADCIRCA and 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 recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.

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 arterial 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, 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 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 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 Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.

ADCIRCA 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.

ADCIRCA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

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. Swallow the tablet(s) whole with a drink of water. The tablet(s) can be taken with or without food.

Pulmonary arterial hypertension in adults 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.

Pulmonary arterial hypertension in children (age 2 years and above) weighing at least 40 kg The recommended dose is two 20 mg tablets taken once a day. Both tablets should be taken 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.

Pulmonary arterial hypertension in children (age 2 years and above) weighing less than 40 kg The recommended dose is one 20 mg tablet taken once a day. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take 10 mg once per day.

Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

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.

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), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

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 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.

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 trials for pulmonary arterial hypertension and therefore frequency is unknown:

• swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

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

• distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

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.

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.

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

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 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, see section 2 ADCIRCA contains lactose and ADCIRCA contains sodium .

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 (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/Belgi /Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649
" " . . -
. + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 esk republika ELI LILLY R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2Nederland Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 Eesti Eli Lilly Nederland B.V. Tel: +372 6 817 Norge Eli Lilly Norge A.S. Tlf: + 47 22 88 18

• . . . . : +30 210 629 4 sterreich Eli Lilly Ges.m.b.H.
  Tel: + 43-(0) 1 711 Espa a Lilly S.A.
  Tel: + 34-91 663 50 Polska Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 France Lilly France T l: +33-(0) 1 55 49 34 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351-21-4126Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4Slovenija Eli Lilly farmacevtska dru ba, d.o.o. Tel: +386 (0)1 580 00 sland Icepharma hf. S mi: + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia Eli Lilly Italia S.p.A. Tel: + 39- 055 42Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45
  Phadisco Ltd
  : +357 22 715Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij
  Tel: +371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This leaflet was last revised in

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