Adcirca 20 mg film-coated tablets

XPIL (Text-only Patient Information Leaflet)

Source: ADCIRCA_PIL_AD025_SEPT-23_IE-MT-NI.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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Contents of 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

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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 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.

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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).

- if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. ADCIRCA increases the effects of these medicines.

- if you have ever had loss of vision – “stroke of the eye” (non-arteritic anterior ischaemic 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 (used to treat pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension). PDE5 inhibitors like ADCIRCA increase its hypotensive effects.

Warnings and precautions

Talk to your doctor before taking ADCIRCA. Tell your doctor if you have:

- any heart problems other than pulmonary hypertension

- problems with blood pressure

- hereditary eye disease

- sickle cell anaemia

- multiple myeloma

- leukaemia

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

- serious liver problems

- serious kidney problems

If you experience sudden decrease or loss of vision, or your vision is distorted or dimmed, stop taking ADCIRCA and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. If this occurs, contact your doctor immediately.

Children and adolescents

ADCIRCA is not recommended for children under 2 years of age.

Other medicines and ADCIRCA

Do not take ADCIRCA if you are already taking nitrates. Tell your doctor or pharmacist if you are taking:

- bosentan (another treatment for pulmonary arterial hypertension)

- alpha blockers (for high blood pressure or prostate problems)

- riociguat

- rifampicin (antibiotic)

- ketoconazole (for fungal infections)

- ritonavir (for HIV)

- PDE5 inhibitors for erectile dysfunction

ADCIRCA with alcohol

Drinking alcohol may temporarily lower your blood pressure. Avoid excessive drinking (over 5 units) as this may increase dizziness when standing.

Pregnancy, breast-feeding and fertility

Do not take ADCIRCA if pregnant unless strictly necessary and advised by your doctor. Do not breast-feed while taking ADCIRCA, as it is not known if it passes into breast milk.

Animal studies showed reduced sperm development. A reduction in sperm was seen in some men, though unlikely to lead to infertility.

Driving and using machines

Dizziness has been reported. Check how you react before driving or using machines.

ADCIRCA contains lactose

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

ADCIRCA contains sodium

Each tablet contains less than 1 mmol sodium (23 mg) — essentially sodium-free.

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3. How to take ADCIRCA

Always take ADCIRCA exactly as your doctor has told you. Swallow tablets whole with water, with or without food.

Adults

The usual dose is two 20 mg tablets once a day (taken together). If you have mild or moderate liver or kidney problems, your doctor may reduce to one 20 mg tablet per day.

Children aged ≥2 years and weighing ≥40 kg

The usual dose is two 20 mg tablets once a day (taken together). Reduced to one 20 mg tablet daily if liver/kidney problems.

Children aged ≥2 years and weighing <40 kg

The usual dose is one 20 mg tablet daily. Reduced to 10 mg if liver/kidney problems. Other forms may be more suitable.

If you take more ADCIRCA than you should

Contact your doctor or hospital immediately. You may experience side effects (see section 4).

If you forget a dose

Take it as soon as you remember if within 8 hours of the scheduled time. Do not double the dose.

If you stop taking ADCIRCA

Do not stop without your doctor’s advice.

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4. Possible side effects

Like all medicines, ADCIRCA can cause side effects, usually mild to moderate.

Stop treatment and seek medical help immediately if you experience:

- allergic reactions (including rashes) – common

- chest pain (do not use nitrates) – common

- priapism (painful erection >4 hours) – uncommon

- sudden loss of vision, blurred or dimmed central vision – rare/not known

Very common (more than 1 in 10):

- headache, flushing, blocked nose/sinuses, nausea, indigestion (including abdominal pain/discomfort), muscle aches, back pain, limb pain

Common (up to 1 in 10):

- blurred vision, low blood pressure, nosebleeds, vomiting, abnormal uterine bleeding, swelling of face, acid reflux, migraine, irregular heartbeat, fainting

Uncommon (up to 1 in 100):

- seizures, memory loss, hives, sweating, penile bleeding, blood in semen or urine, high blood pressure, fast heartbeat, sudden cardiac death, ringing in ears

Rare/unknown:

- partial, temporary or permanent loss of vision in one/both eyes

- serious allergic reaction with swelling of face/throat

- sudden hearing loss

- eyelid swelling, eye pain, red eyes, heart attack, stroke

Most men reporting heart-related events already had existing heart problems.

Reporting of side effects

Report to your doctor, pharmacist, or directly via:

- UK (NI): Yellow Card Scheme (www.mhra.gov.uk/yellowcard or app)

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

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5. How to store ADCIRCA

- Keep out of sight and reach of children.

- Do not use after expiry date (last day of month).

- Store in original package to protect from moisture.

- Do not store above 30°C.

- Do not throw away via wastewater or household waste. Ask pharmacist for proper disposal.

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6. Contents of the pack and other information

What ADCIRCA contains

- Active substance: tadalafil. Each tablet contains 20 mg.

- Other ingredients:

 * 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

- Orange almond-shaped film-coated tablets, marked “4467”.

- Packs: 28 or 56 tablets (not all sizes marketed).

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

Local representatives

- Ireland & UK (NI): Eli Lilly and Company (Ireland) Limited, Tel: +353-(0)1-661-4377

- Malta: Charles de Giorgio Ltd., Tel: +356-25600-500

This leaflet was last revised in September 2023.

Further information: www.ema.europa.eu

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Reference code: AD025