Adalift

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Adalift, 5 mg, film-coated tablets

Tadalafil

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Adalift and what is it used for
• 2. Important information 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 is Adalift and what is it 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 to treat adult men:

• with erectile dysfunction.This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse.

After sexual stimulation, Adalift helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Adalift does not help patients who do not have erectile dysfunction. It is important to be aware that Adalift does not work without sexual stimulation. The patient and their partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

• with symptoms of benign prostatic hyperplasia (BPH), a common condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, feeling of incomplete emptying of the bladder, and needing to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate BPH symptoms. It has been shown that tadalafil alleviates these urinary symptoms within 1-2 weeks of 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, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect 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 in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had a loss of vision 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 phosphodiesterase type 5 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 to take Adalift, the patient should discuss it with their doctor.
It should be remembered that sexual activity is associated with a certain risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform a check for prostate cancer before starting Adalift treatment for BPH symptoms.
Adalift is not used to treat prostate cancer.
The patient should inform their doctor if they have any of the following:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known if Adalift is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden worsening of vision or sudden loss of vision or distorted vision while taking tadalafil, they should stop taking Adalift and contact their doctor immediately.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed.
Although it is not known if this event is directly related to the use of tadalafil, if the patient experiences a worsening or sudden loss of hearing, they should stop taking Adalift and 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Adalift should not be taken if the patient is taking nitrates.
Adalift may affect the way some medicines work or other medicines may affect the way Adalift works. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or BPH symptoms).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat BPH).
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Adalift with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Adalift and should be consumed with caution. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Adalift contains lactose:

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

Adalift contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Adalift

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Adalift tablets are intended for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Adalift or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time of day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Adalift.
The patient should then take a 2.5 mg tablet.
Adalift should not be taken more than once a day.
Taking Adalift once a day allows for an erection to be achieved after sexual stimulation at any time during the 24 hours. Taking Adalift once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is important to be aware that Adalift does not work without sexual stimulation. The patient and their partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection.

Treatment of benign prostatic hyperplasia symptoms

Doseis one 5 mg tablet, taken once a day, at approximately the same time of day. If the patient has BPH and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
Adalift should not be taken more than once a day.

Use of a higher than recommended dose of Adalift

The patient should inform their doctor. Adverse reactions described in section 4 may occur.

Missing a dose of Adalift

The patient should take the dose as soon as they remember, but should not take a double dose to make up for the missed tablet. Adalift should not be taken more than once a day.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Adalift can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.

If the patient experiences any of the following side effects, they should stop taking Adalift and contact their doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking tadalafil (rare). If the patient experiences such an erection and it lasts continuously for more than 4 hours, they should contact their doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or loss of vision (frequency not known).

Other reported side effects:
Common(occurring in less than 1 in 10 patients)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and nausea.

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(occurring in less than 1 in 1000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red swellings on the skin), penile bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take this medicine.
There have been reports of rare cases of partial, transient, or permanent loss of vision or loss of vision in one or both eyes.
Men taking tadalafil have reported a few additional rare side effects, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths
• distorted, blurred, or loss of vision (frequency not known).

The side effect of dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, 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. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Adalift

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Adalift contains

• The active substance of Adalift is tadalafil. Each tablet contains 5 mg of tadalafil.
• Other ingredients: Tablet core:lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, croscarmellose sodium, silicon dioxide, 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, film-coated tablet, approximately 8 mm x 4 mm.
Adalift 5 mg tablets are available in blisters 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
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

Date of last revision of the leaflet: