Adcirca

Package leaflet: Information for the user

ADCIRCA 20 mg film-coated tablets

tadalafil
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ADCIRCA is and what it is used for
2. What you need to know before taking ADCIRCA
3. How to take ADCIRCA
4. Possible side effects
5. How to store ADCIRCA
6. 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 and children aged 2 years and older.
It belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which help relax the blood vessels in the lungs, improving blood flow to the lungs. This results in improved ability to exercise.

2. What you should know before taking ADCIRCA

Do not take ADCIRCA

• if you are allergic to tadalafil or to any of the excipients (see section 6).
• if you are taking any form of nitrates, such as amyl nitrite used to treat chest pain. ADCIRCA has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• if you have previously experienced vision loss—a condition described as "eye stroke" (non-arteritic anterior ischemic optic neuropathy - NAION).
• if you have had a heart attack within 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). Phosphodiesterase-5 (PDE5) inhibitors such as ADCIRCA have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking ADCIRCA.
Before taking the tablets, inform your doctor if you have:

• any heart problems other than pulmonary arterial hypertension
• blood pressure problems
• any hereditary eye diseases
• a red blood cell disorder (sickle cell anemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukemia)
• any penile deformity or involuntary or persistent erections lasting more than 4 hours
• severe liver problems
• severe kidney problems

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.
Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether the event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, 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, as it has not been studied in this age group.

Other medicines and ADCIRCA
Inform 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 may affect how ADCIRCA works. Inform your doctor or pharmacist if you are 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 the treatment of HIV)
• tablets for erectile dysfunction (PDE5 inhibitors)

ADCIRCA and alcohol
Drinking alcohol may temporarily cause you to have lower blood pressure. If you have taken or plan to take ADCIRCA, avoid excessive alcohol consumption (more than 5 units of alcohol), as this may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy, ask your doctor for advice before taking this medicine. Do not take ADCIRCA during pregnancy unless absolutely necessary and only after discussing it with your doctor.
Do not breastfeed while taking these tablets, as it is not known whether the medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would cause infertility.

Driving and using machines
Dizziness has been reported. Carefully assess how you react to this medicine before driving or operating machinery.

ADCIRCA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

ADCIRCA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ADCIRCA

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
ADCIRCA is available in 20 mg tablets. Swallow the tablets whole with water.
The tablets may be taken with or without food.
Pulmonary arterial hypertension in adults
The usual dose is two 20 mg tablets taken once daily. You should take the tablets at the same time, one after the other. If you have mild or moderate liver or kidney problems,
your doctor may advise you to take only one 20 mg tablet daily.
Pulmonary arterial hypertension in children (aged 2 years and above) weighing at least 40 kg
The recommended dose is two 20 mg tablets taken once daily. Both tablets should be taken simultaneously, one after the other. If you have mild or moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet daily.
Pulmonary arterial hypertension in children (aged 2 years and above) weighing less than 40 kg
The recommended dose is one 20 mg tablet once daily. If you have mild or moderate liver or kidney problems, your doctor may advise you to take 10 mg once daily.
Other forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.
If you take more ADCIRCA than you should
If you or someone else takes more tablets than prescribed, inform your doctor or go immediately to hospital, taking the medicine or its packaging with you. The side effects described in section 4 may occur.
If you forget to take ADCIRCA
Take the missed dose as soon as you remember, provided it is within 8 hours of the scheduled dose.
DO NOT take a double dose to make up for the forgotten dose.
If you stop taking ADCIRCA
Do not stop treatment unless your doctor advises you to do so.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking the medicine and
seek immediate medical help:

• allergic reactions, including skin rash (common frequency).
• chest pain – do not use nitrates but seek immediate medical help (common frequency).
• priapism, a prolonged and sometimes painful erection after taking ADCIRCA (uncommon frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (reported rarely), distorted central vision, blurred, hazy, or sudden decrease in vision (frequency not known).

The following side effects have been reported very commonly in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain or discomfort), muscle pain, back pain, and pain in the extremities (including limb discomfort).

Other side effects reported:
Common (may affect up to 1 in 10 people)

• blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraine, irregular heartbeat, and fainting.

Uncommon (may affect up to 1 in 100 people)

• seizures, transient memory loss, urticaria, excessive sweating, penile bleeding, blood in semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death, and tinnitus.

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

• Partial, temporary or permanent reduction or loss of vision in one or both eyes, and severe allergic reaction causing 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 observed in clinical studies for pulmonary arterial hypertension and therefore the frequency is not known:

• eyelid swelling, eye soreness, red eyes, heart attack, and stroke.

Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• distorted, blurred, hazy central vision or sudden decrease in vision (frequency not known).

Most, but not all, of the men who experienced rapid heartbeat, irregular heartbeat, heart attack, stroke, and sudden cardiac death had pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly associated with tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ADCIRCA contains
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other components are:
Tablet core: monohydrate lactose, croscarmellose sodium, hydroxypropylcellulose, microcrystalline
cellulose, sodium lauryl sulfate, magnesium stearate; see section 2 “ADCIRCA contains lactose” and
“ADCIRCA contains sodium”.
Film coating: monohydrate lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.
Description of the appearance of ADCIRCA and pack contents
ADCIRCA 20 mg are orange, film-coated tablets. They are almond-shaped and marked with “4467” on one side.
ADCIRCA 20 mg is available in blisters 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A/N.V. Eli Lilly Lietuva
Tél/Tel: +32-(0) 2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A/N.V.
тел. + 359 2 491 41 40 Tél/Tel: +32-(0) 2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 3726441100 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Eli Lilly Ges. m.b.H
Τηλ: +30 210 629 4600 Tel: +43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel.: +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0)1 55 49 34 34 Tel: +351-21-4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: +353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Simi: + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: +46-(0) 8 737 88 00
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: +371 67364000 Tel: 353-(0) 1 661 4377
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

Package leaflet: Information for the user

ADCIRCA 2 mg/mL oral suspension

tadalafil
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ADCIRCA is and what it is used for
2. What you need to know before taking ADCIRCA
3. How to take ADCIRCA
4. Possible side effects
5. How to store ADCIRCA
6. 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 and children aged 2 years and older. The oral suspension is intended for paediatric patients who are unable to swallow tablets and whose dose is 20 mg.
It belongs to a class of medicines known as phosphodiesterase type 5 (PDE5) inhibitors, which help relax the blood vessels in the lungs, improving blood flow to the lungs. The result is an improved ability to exercise.

2. What you need to know before taking ADCIRCA

Do not take ADCIRCA

• if you are allergic to tadalafil or to any of the excipients (see section 6)
• if you are taking any form of nitrates, such as amyl nitrite used to treat chest pain. ADCIRCA has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor
• if you have previously experienced vision loss – a condition described as "stroke of the eye" (non-arteritic anterior ischemic optic neuropathy - NAION)
• if you have had a heart attack within 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). Phosphodiesterase-5 (PDE5) inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking ADCIRCA.
Before taking ADCIRCA, inform your doctor if you have:

• any heart problems other than pulmonary arterial hypertension
• blood pressure problems
• any hereditary eye diseases
• a red blood cell disorder (sickle cell anaemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukaemia)
• any penile deformity or involuntary or prolonged erections lasting more than 4 hours
• severe liver problems
• severe kidney problems

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, 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, as it has not been studied in this age group.

Other medicines and ADCIRCA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
DO NOT take this oral suspension if you are already taking nitrates.
Some medicines may be affected by ADCIRCA or may affect how ADCIRCA works. Inform your doctor or pharmacist if you are 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 (for treating bacterial infections)
• ketoconazole tablets (for treating fungal infections)
• ritonavir (for the treatment of HIV)
• tablets for erectile dysfunction (PDE5 inhibitors)

ADCIRCA with alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take ADCIRCA, avoid excessive alcohol consumption (more than 5 units of alcohol), as this may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy, ask your doctor for advice before taking this medicine. Do not take ADCIRCA during pregnancy unless absolutely necessary and only after discussing it with your doctor.
Do not breastfeed while taking this oral suspension, as it is not known whether the medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would cause infertility.

Driving and using machines
Dizziness has been reported. Carefully assess how you react to this medicine before driving or operating machinery.

ADCIRCA contains sodium benzoate (E211)
This medicine contains 2.1 mg of sodium benzoate per mL.

ADCIRCA contains sorbitol (E420)
This medicine contains 110.25 mg of sorbitol per mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, talk to your doctor before you (or your child) take this medicine.

ADCIRCA contains propylene glycol (E1520)
This medicine contains 3.1 mg of propylene glycol per mL.

ADCIRCA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e. essentially 'sodium-free'.

3. How to take ADCIRCA

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
ADCIRCA oral solution is supplied in a bottle. This is part of a pack which also includes an administration device containing two 10 mL oral syringes marked in 1 mL increments and a press-in bottle adapter. Read the instruction leaflet included in the pack for directions on how to use the adapter and syringe.
The recommended dose is 10 mL of oral suspension once daily for children aged 2 years and above who weigh less than 40 kg.
If you have mild or moderate liver or kidney problems, your doctor may prescribe a lower dose.
The oral suspension should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you take more ADCIRCA than you should
If you or someone else takes more oral suspension than prescribed, inform your doctor immediately or go to hospital, taking the medicine bottle with you. You may experience the adverse effects described in section 4.

If you forget to take ADCIRCA
Take the missed dose as soon as you remember, provided it is within 8 hours of the scheduled dose.
DO NOT take a double dose to make up for the forgotten dose.

If you stop taking ADCIRCA
Do not stop treatment unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking the medicine and
seek immediate medical help:

• allergic reactions, including skin rashes (common frequency).
• chest pain – do not use nitrates but seek immediate medical help (common frequency).
• priapism, a prolonged and sometimes painful erection after taking ADCIRCA (uncommon frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (reported rarely), distorted central vision, blurred or unfocused vision, or sudden decrease in vision (frequency not known).

The following side effects have been reported very commonly in patients taking
ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and
sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain or discomfort), muscle pain,
back pain and pain in the extremities (including limb discomfort).
Other side effects have been reported:
Common (may affect up to 1 in 10 people)

• blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraine, irregular heartbeat and fainting.

Uncommon (may affect up to 1 in 100 people)

• seizures, transient memory loss, urticaria, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death and tinnitus.

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

• Partial, temporary or permanent reduction or loss of vision in one or both eyes, and severe allergic reaction causing 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 observed in clinical studies for pulmonary arterial
hypertension and therefore the frequency is not known:

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

Some additional rare side effects not observed during clinical studies have
been reported in men taking tadalafil. These include:

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

Most, but not all, of the men who experienced rapid heartbeat, irregular heartbeat, heart attack, stroke and sudden cardiac death had pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly associated with tadalafil.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 pack and on the bottle after
Exp. The expiry date refers to the last day of that month.
Do not use the medicine if the bottle has been open for more than 110 days. This medicine does not require
any special storage conditions.
Store in the original packaging. Store the bottle in an upright position.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ADCIRCA contains
The active substance is tadalafil. Each mL contains 2 mg of tadalafil.
The other components are: xanthan gum, microcrystalline cellulose, sodium carmellose, citric acid,
sodium citrate, sodium benzoate (E211), silica (anhydrous colloidal), sorbitol (E420) (crystallizing liquid),
polysorbate 80, sucralose, simeticone emulsion (simeticone, methylcellulose, sorbic acid, purified water),
artificial cherry flavour (containing propylene glycol (E1520) and water). See section 2 “ADCIRCA contains” for further information on sorbitol, sodium benzoate, propylene glycol and sodium.

Description of the appearance of ADCIRCA and the pack contents
ADCIRCA 2 mg/mL is a white or almost white oral suspension.
ADCIRCA is supplied in a bottle containing 220 mL of oral suspension, with a removable seal and child-resistant closure, packed in a carton. Each pack contains one bottle, two 10 mL graduated syringes with 1 mL graduations, and a press-in bottle adapter.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturers:

• Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
• Delpharm Huningue SAS, 26 rue de la Chapelle, Huningue, 68330, France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A/N.V. Eli Lilly Lietuva
Tél/Tel: +32-(0) 2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
TP "Eli Lilly Nederlands" B.V. - Bulgaria Eli Lilly Benelux S.A/N.V.
tel. + 359 2 491 41 40 Tél/Tel: +32-(0) 2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 3726441100 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
FARMASERV-LILLY S.A. Eli Lilly Ges. m.b.H
Tel: +30 210 629 4600 Tel: +43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel.: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0)1 55 49 34 34 Tel: +351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: +353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Simi: + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Tel: +357 22 715000 Tel: +46-(0) 8 737 88 00

Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A. Representation in Latvia Eli Lilly and Company (Ireland) Limited
Tel: +371 67364000 Tel: +353-(0) 1 661 4377

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

INSTRUCTIONS FOR USE

ADCIRCA 2 mg/mL oral suspension

tadalafil
Before using ADCIRCA oral suspension, read and carefully follow all instructions step by
step.
These “Instructions for Use” contain information on how to use ADCIRCA oral
suspension

IMPORTANT INFORMATION YOU SHOULD KNOW BEFORE USING ADCIRCA
ORAL SUSPENSION.

The adapter is a CHOKING HAZARD – small parts. Do not insert the oral
syringe into the adapter until the adapter is fully inserted into the
bottle. It must be fully inserted into the bottle for safe use. Use only under
adult supervision.
Do not give the medicine to the child without your help.
Do not use the medicine if the bottle, seal, adapter, or oral syringe is damaged.
Do not use the medicine if the bottle has been open for more than 110 days. See the Disposal section to
learn what to do with unused medicine.
Record the date of first opening of the bottle here: _____________________
Do not wash the oral syringe with soap or detergent. Please refer to steps 4b–4c for cleaning
instructions.
Do not place the oral syringe in the dishwasher. The syringe may not function properly.
Use a new oral syringe after 30 days.
It is not recommended to mix the medicine with food or water. This may affect the taste or prevent
administration of a complete dose.
Administer ADCIRCA oral suspension using only the oral syringe provided with the
medicine.
The medicine is white. Air bubbles may be difficult to see in the oral syringe
during dose preparation and may result in an incorrect dose.

In case of overdose, contact your doctor, pharmacist, or nurse immediately. Prompt medical
attention is important for both adults and children, even if no signs or
symptoms are apparent.
Components of the ADCIRCA oral suspension delivery system

Child-resistant
closure
Syringe tip
Adapter
Lift-off and
removable seal
Medicine
Flange
Plunger
Oral syringe
Medicine bottle

STEP 1: PREPARE THE BOTTLE
1a Take the medicine bottle and the adapter.

Wash your hands with soap and water.
1b Remove the cap from the bottle.

Press down firmly and twist the cap counterclockwise.
Remove the cap from the bottle.
1c Only before first use, remove the lift-off and

removable seal.
Ensure the seal is completely removed.
1d Only before first use, push the adapter firmly down into the

opening of the bottle.

The adapter is a CHOKING HAZARD – small parts. It must be
fully inserted into the bottle for safe use.
Do not insert the oral syringe into the adapter until the adapter is fully inserted into the bottle.
Do not rotate the adapter.
1e Screw the cap back onto the bottle tightly.

The cap will fit over the adapter.
STEP 2: PREPARE THE DOSE
2a Take the medicine bottle with the adapter attached and the

oral syringe.

Ensure the cap is tightly closed.
Wash your hands with soap and water.
2b Shake the bottle.

Shake the medicine bottle well for at least 10 seconds
before each use to completely mix the
suspension.
Shake the bottle again if it has been left undisturbed for more than 15 minutes.
2c Remove the cap from the bottle.
2d
Firmly insert the oral syringe into the opening of the

adapter.
Ensure the tip of the syringe is fully inside the adapter and that the plunger is pushed fully
into the end of the syringe.
2e Turn the bottle upside down, holding the syringe in place.

Ensure the bottle is inverted.
Ensure the oral syringe remains fully inserted in the adapter.
2f Draw up the dose.

Slowly pull down the plunger until the graduation mark in mL is visible below the bottom
of the flange for the prescribed dose for your child.
The graduation mark is located on the plunger of the oral syringe.
Ensure the top edge of the graduation mark is aligned with the bottom of the flange.

2g

Turn the bottle upright and carefully check for air in the oral syringe.

The presence of air may cause an incorrect dose.
The medicine is white, the same color as the oral syringe.
Air bubbles may be difficult to see.
If air is present, empty the medicine back into the

bottle and repeat steps 2e to 2g.
2h Remove the oral syringe from the bottle.

Do not touch the plunger.
STEP 3: ADMINISTER THE DOSE
Place the oral syringe into a corner of your child’s

mouth. Tell the child not to bite the syringe.
Do not spray the medicine at the back of the throat.
Slowly and gently push the plunger to the end of the syringe so that all the medicine is
delivered into the child’s mouth.
Ensure the child swallows all the medicine.
STEP 4: CLEANING
4a Screw the cap back onto the bottle tightly.

Do not remove the adapter. The cap will fit over the adapter.
4b Fill the oral syringe with clean water.

Do not wash the oral syringe with soap or detergent.
Do not remove the plunger from the oral syringe.
Fill a cup with clean water, insert the oral syringe, and pull the plunger up to fill the syringe with water.
4c Push the plunger down and spray the water into the

cup or sink.
Ensure all water is removed from the oral syringe.
Remove excess water by shaking the syringe and dry it with a paper towel.
Store the oral syringe and bottle in the original packaging.
Wash your hands with soap and water.
DISPOSAL OF MEDICINE
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
DISPOSAL OF THE SYRINGE
Ask your doctor, pharmacist, or nurse how to dispose of the syringe.
HOW TO STORE THE MEDICINE
This medicine does not require special storage conditions.
Store the bottle in an upright position.
Keep the bottle and oral syringe out of sight and reach of children.
FREQUENTLY ASKED QUESTIONS
Q. What should I do if I see air in the oral syringe?
A. Do not administer the medicine. Air may cause an incorrect dose. Empty the medicine back into the
bottle and repeat steps 2e to 2g.
Q. What should I do if there is too much medicine in the oral syringe?
A. Keep the tip of the syringe in the bottle. Keep the bottle upright. Push the plunger down until the correct dose remains in the oral syringe.
Q. What should I do if there is not enough medicine in the oral syringe?
A. Keep the tip of the syringe in the bottle. Keep the bottle inverted. Pull the plunger down until the correct dose is drawn into the oral syringe.
Q. What should I do if the medicine gets into my eyes or my child’s eyes?
A. Immediately rinse the eyes with water and contact your doctor, pharmacist, or nurse.
Wash your hands and any surfaces that may have come into contact with the medicine as soon as possible.
Q. How should I travel with this medicine?
A. Make sure you have enough medicine for the entire trip. Keep the oral syringe and medicine in the original container. Store the medicine in a safe place, upright.
Q. Can I mix this medicine with food or water before giving it to my child?
A. It is not recommended to mix this medicine with food or water. This may affect the taste or prevent administration of a complete dose. You may give the child a glass of water to drink after the full dose of medicine has been taken.
Q. What should I do if the child spits out the medicine?
A. Do not administer additional medicine to the child. Contact your doctor, pharmacist, or nurse.
Q. What should I do if the child does not swallow all the medicine?
A. Contact your doctor, pharmacist, or nurse.
Q. What should I do if the child swallows too much medicine?
A. Contact your doctor, pharmacist, or nurse immediately.
FOR QUESTIONS OR MORE INFORMATION ABOUT ADCIRCA ORAL SUSPENSION
For questions or more information about ADCIRCA

• Contact your doctor, pharmacist, or nurse
• Contact Lilly

Read the entire package leaflet of ADCIRCA inside this package for more information
about the medicine.
For questions or additional information about ADCIRCA oral suspension
If you have any questions or problems with the oral suspension syringe, contact Lilly or your doctor,
pharmacist, or nurse for assistance. Report all MEDICAL DEVICE COMPLAINTS or ADVERSE EVENTS, including SUSPECTED SERIOUS INCIDENTS, to Lilly.