Adalift

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Adalift, 2.5 mg, film-coated tablets

Tadalafil

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

• Please 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 you only. 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.

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 is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance. Adalift contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Adalift helps to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, there is an improvement in erectile function. Adalift does not help patients who do not have erectile dysfunction. It is important to note 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 an erectile dysfunction medicine.

2. Important information before taking Adalift

When not to take Adalift:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking nitrates in any form or are unsure, you should inform your doctor.
• if you have severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• if you are 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, increase the effects of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Adalift, you should discuss this with your doctor. You should remember that sexual activity carries a degree of risk for patients with heart disease, as it puts extra strain on the heart. If you have problems with your heart, you should inform your doctor. Before taking Adalift, you should inform your doctor if you have any of the following:

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

It is not known whether Adalift is effective in patients who have:

• undergone pelvic surgery.
• had their prostate removed (prostatectomy) in which the nerves surrounding the prostate were cut (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or sudden decrease in vision or blurred vision while taking tadalafil, you should stop taking Adalift and contact your doctor immediately. Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known whether this event is directly related to the use of tadalafil, if you experience a sudden decrease or loss of hearing, you should stop taking Adalift and contact your doctor immediately. Adalift is not intended for use by women.

Children and adolescents

Adalift is not intended for use by children and adolescents under 18 years of age.

Adalift and other medicines

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

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate).
• 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 (anti-epileptic 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 therefore, caution should be exercised when consuming it. For more information, you should consult your doctor.

Fertility

When tadalafil was administered to dogs, there was a decrease in sperm production in the testes. Decreased 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 you should be aware of how you react to the tablets before driving or operating machinery.

Adalift contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking Adalift.

Adalift contains sodium

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

3. How to take Adalift

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. Adalift tablets are 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. Recommended doseis one 5 mg tablet, taken once daily, at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to Adalift. You should take one 2.5 mg tablet. You should not take Adalift more than once a day. Taking Adalift once daily may be beneficial for men who intend to have sexual activity twice a week or more frequently. Taking Adalift once daily allows for spontaneous erections in response to sexual stimulation at any time of day. It is important to note 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 an erectile dysfunction medicine. Consuming large amounts of alcohol may impair the ability to achieve an erection and may increase the risk of dizziness when standing up.

What to do if you take more Adalift than you should

You should inform your doctor. You may experience side effects described in section 4.

What to do if you miss a dose of Adalift

Take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. You should not take Adalift more than once a day. If you have any further questions on the use of this product, ask your 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 you experience any of the following side effects, stop taking Adalift and contact your doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking tadalafil (rare). If you experience such an erection, seek medical help immediately.
• sudden loss of vision (rare), blurred vision, or changes in color 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 indigestion.

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, stomach upset, 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, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, 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 disease. There have been reports of rare cases of partial, transient, or permanent decrease in vision or loss of vision in one or both eyes. Men taking tadalafil have reported several additional rare side effects, which were not observed during clinical trials. These include:

• migraine, swelling of the face, severe allergic reactions causing swelling of the face and throat, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• blurred vision, or changes in color vision (frequency not known).

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 you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. By reporting side effects, you can help provide more information on the safety of this 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 EXP. The expiry date refers to the last day of that month. Batch number is stated after Lot. There are no special storage instructions for this medicinal product. Medicines should not be disposed of via wastewater or household waste. Ask your 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 is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredients are: 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).

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 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: