Package leaflet: Information for the user

Adalift, 2.5 mg, coated tablets
Tadalafil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 cannot achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil has been shown to significantly improve the ability to obtain an erection suitable 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 the penis. As a result, erection is improved. Adalift
does not help men who do not have erectile dysfunction.
It is important to be aware 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 a medicine
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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (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). It has been shown that PDE5 inhibitors such as tadalafil 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 treatment with Adalift, discuss this with your doctor.
Please note that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking Adalift, the patient should inform their doctor if any of the following apply:

sickle cell anemia (abnormal shape of red blood cells).
multiple myeloma (a cancer of the bone marrow).
leukemia (a cancer of blood cells).
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 with nerve-sparing techniques (radical prostatectomy without nerve-sparing).

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with tadalafil, treatment with Adalift should be stopped immediately and the patient should contact their doctor without delay.
In some patients taking tadalafil, worsening 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 deterioration occurs, treatment with Adalift should be stopped and the patient should contact their 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 the patient is currently taking, has recently taken, or plans to take.
Adalift must not be taken if the patient is 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 the patient is taking any of the following medicines:

alpha-adrenergic blocking agents (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. Reduced 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 how they react to the tablets before deciding to drive or operate machinery.
Adalift contains lactose
If the patient has been previously 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 this 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 in men only. The tablets should be swallowed whole with a small amount of water. Adalift tablets may be taken with or without food.
The recommended dose is one 5 mg tablet taken once daily, at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on the patient's response to Adalift. In such case, the 2.5 mg tablet should be used.
Adalift should not be taken more than once a day.
Taking Adalift once daily may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Adalift once daily allows achieving an erection following sexual stimulation at any time within 24 hours.
It is important to be aware that Adalift does 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 experiencing dizziness upon standing.
Taking more than the recommended dose of Adalift
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Adalift
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Adalift more than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

allergic reactions, including rash (uncommon).
chest pain – do not use 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, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

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

fainting, seizures, 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 reactions
have been reported that 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 characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death
distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Adverse reaction: 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 following: Expiry
date (EXP). The expiry date refers to the last day of the stated month. The batch number is indicated after: Batch No. (Lot).
No special storage instructions are required for this medicinal product.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Adalift contains

The active substance is tadalafil. Each tablet of Adalift contains 2.5 mg of tadalafil.
Other ingredients: Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Adalift looks like and contents of the pack
Adalift 2.5 mg is a white or almost white, round, biconvex, film-coated tablet, approximately 5 mm in diameter.
Adalift 2.5 mg tablets are available in blisters containing 28 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