Patient Information Leaflet

Adalift, 20 mg, coated tablets
Tadalafil
Please read all of this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What Adalift is and what it is used for
What you need to know before taking Adalift
How to take Adalift
Possible side effects
How to store Adalift
Contents of the pack and other information

1. What Adalift is and what it is used for

Adalift is a medicine intended for adult men with erectile dysfunction. This is a condition in which
a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil has been shown to significantly improve the ability to obtain an erection adequate for
sexual intercourse.
Adalift contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Adalift helps widen the blood
vessels in the penis, allowing blood to flow into it. As a result, erection improves. Adalift does not
benefit men who do not have erectile dysfunction.
It is important to understand that Adalift does not work without sexual stimulation. The patient
and his partner should engage in foreplay, just as they would if the patient were not taking
medication for erectile dysfunction.

2. Important information before using Adalift

When not to use Adalift:

if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
if the patient has severe heart disease or has had a heart attack within the last 90 days.
if the patient has had a stroke within the last 6 months.
if the patient has low blood pressure or uncontrolled high blood pressure.
if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke".
if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as tadalafil have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting to take Adalift, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Before taking this medicine, the patient should inform the doctor if any of the following apply:

sickle cell anemia (abnormally shaped red blood cells).
multiple myeloma (a bone marrow tumor).
leukemia (a blood cell cancer).
any deformity of the penis.
severe liver disease.
severe kidney disease.

It is not known whether Adalift is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland, during which the nerves of the prostate are severed (non-nerve-sparing radical prostatectomy).

If sudden vision loss, blurred vision, or distorted vision occurs while taking tadalafil, stop taking Adalift immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden hearing loss occurs, stop taking Adalift and contact a doctor immediately.
Adalift is not intended for use in women.
Children and adolescents
Adalift is not intended for use in children and adolescents under 18 years of age.
Adalift and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Adalift if you are using nitrates.
Adalift may affect the action of certain medicines, or other medicines may affect the action of Adalift. Tell your doctor or pharmacist if you are taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia).
other medicines used to treat high blood pressure.
riociguat.
5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Adalift, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Adalift, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Adalift was administered to dogs, a reduction in sperm production in the testes was observed.
A decrease in sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand their individual response to the tablets before deciding to drive or operate machinery.
Adalift contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Adalift contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Adalift

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Adalift tablets are intended for oral use only in men. The tablet should be swallowed whole with a
small amount of water. Adalift tablets may be taken independently of meals.
Recommended dose: The initial recommended dose is one 10 mg tablet taken prior to planned
sexual activity. If your doctor determines that the 10 mg dose is insufficient, then one 20 mg tablet
should be taken as directed by your doctor.
Adalift may be taken at least 30 minutes before planned sexual activity. Adalift may remain effective
for up to 36 hours after taking the tablet.
Do not take Adalift more than once a day. Adalift 10 mg and 20 mg are intended to be taken prior
to planned sexual activity. Regular, daily use of this medicine is not recommended.
It is important to understand that Adalift will not work in the absence of sexual stimulation. The
patient and his partner should engage in foreplay, just as they would if the patient were not taking
medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient
lowering of blood pressure. If the patient has taken or plans to take Adalift, he should not consume
large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the
risk of dizziness upon standing.
The division line on the tablet is not intended for breaking the tablet.
Taking more than the recommended dose of Adalift
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate.
If any of the adverse effects listed below occur, stop taking the
medicine and seek immediate medical advice:

allergic reactions, including rashes (uncommon).
chest pain – do not take nitrates, but seek immediate medical help (uncommon).
priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Other reported adverse effects:
Common (occur in no more than 1 in 10 patients)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (occur in no more than 1 in 100 patients)

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur in no more than 1 in 1000 patients)

fainting, convulsions and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent
visual impairment or loss of vision in one or both eyes.
In men taking tadalafil, several additional rare adverse effects
have been reported, which were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders manifesting as blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Adverse effect: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Adalift

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP). The expiry date refers to the last day of the stated month. The batch number is indicated after: Batch No. (Lot).
There are no special storage instructions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adalift contains

The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
Other components: Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Adalift looks like and contents of the pack
Adalift 20 mg is a light pink, elongated, biconvex coated tablet, approximately 15 mm x 7 mm, with a score line on one side.
Adalift 20 mg tablets are available in blisters containing 2, 4, 8, 10 or 12 tablets.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Pharmaceutical Works POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Pharmaceutical Works POLPHARMA SA
ul. Metalowca 2
39-460 Nowa Dęba
Poland

Importer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Pharmaceutical Works POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Hal Far Birzebbugia,
BBG 3000
Malta
Pharmaceutical Works POLPHARMA SA
ul. Metalowca 2
39-460 Nowa Dęba
Poland