Adalift

Package leaflet: Information for the user

Adalift 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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

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

1. What Adalift is and what it is used for

Adalift contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Adalift 5 mg is used in adult men:

• for 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 sufficient for sexual intercourse.

Following sexual stimulation, Adalift helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Adalift does not help patients who do not have erectile dysfunction. It is important to know 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.

• to treat urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the muscles of the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before taking Adalift

When not to take 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 group of medicines (‘nitrates’) is 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 medicine is 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 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.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore your doctor will perform tests to rule out prostate cancer before starting treatment with Adalift for symptoms of benign prostatic hyperplasia.
Adalift is not intended for the treatment of prostate cancer.
Before taking Adalift, the patient should inform the doctor if any of the following apply:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (a tumor of the bone marrow).
• 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 complete or partial removal of the prostate gland with cutting of the nerves supplying the prostate (non-nerve-sparing radical prostatectomy).

If sudden vision loss, sudden decrease in vision, or distorted, blurred vision occurs while taking tadalafil, stop taking Adalift immediately and contact your doctor without delay.
In some patients taking tadalafil, hearing loss or sudden decrease in hearing has been observed.
Although it is not known whether this event is directly related to tadalafil use, if hearing loss or sudden decrease in hearing occurs, stop taking Adalift and contact your 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, have recently taken, or 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 due to 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, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Adalift, and caution should therefore be exercised when consuming it. For more information, consult your doctor.

Fertility
When given to dogs, the medicine caused reduced sperm production in the testes. Reduced sperm count has been observed in some men. It is unlikely that this would lead to infertility.

Driving and using machines
Dizziness has been reported in some men taking tadalafil during clinical trials; therefore, patients should understand how they react 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:
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use 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.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken or plans to take Adalift, large amounts of alcohol (blood alcohol concentration of 0.08% or higher) should be avoided, as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: 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 cases, the 2.5 mg tablet should be used.
Adalift should not be taken more than once a day.
Taking Adalift once daily allows for achieving an erection following sexual stimulation at any time within 24 hours. Daily administration of Adalift may be beneficial for men who plan to engage in sexual activity two or more times per week.
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.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia
Dose: One 5 mg tablet taken once daily at approximately the same time each day. If a patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg tablet once daily.
Adalift must not be taken more than once a day.

Overdose of Adalift
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Adalift
Take the missed dose as soon as remembered, 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 experiences 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 skin 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 vision loss (rare), distorted, blurred, or dim central vision, or sudden worsening of vision (frequency unknown).

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 vision loss 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 rush to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

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 symptoms occur, including any adverse symptoms 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adalift

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month. The batch number is indicated after: Lot.
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 5 mg of tadalafil.
• Other components: Tablet core: monohydrate lactose (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 5 mg is a light brown, elongated, biconvex, coated tablet, approximately 8 mm x 4 mm.
Adalift 5 mg tablets are available in blister packs containing 14, 28, 56, or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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
Zakłady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Zakłady Farmaceutyczne POLPHARMA SA
(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
Zakłady Farmaceutyczne POLPHARMA SA
(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
Zakłady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
ul. Metalowca 2
39-460 Nowa Dęba
Poland