Adalift

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Adalift, 20 mg, film-coated tablets

Tadalafil

Read 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.
• 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 tell 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, erection is improved. 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 to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect of these medicines. If you are taking nitrates in any form, or are unsure, you should tell 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, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat, or are unsure, you should tell your doctor.

Warnings and precautions

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

• sickle-cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any deformity of the penis.
• severe liver disease.
• severe kidney disease.

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

• had pelvic surgery.
• had prostate removal, during which the nerves of the prostate are cut (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of vision, or blurred vision, you should stop taking Adalift and contact your doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if you experience a decrease in hearing or sudden hearing loss, you should 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

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.
Do 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 ask your 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 you should be aware of how you react to the tablets before driving or operating machinery.

Adalift contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

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 ask 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 10 mg tablet, taken before planned sexual activity. If your doctor has found that the 10 mg dose is too weak, you should take one 20 mg tablet, as directed by your doctor.
Adalift can be taken at least 30 minutes before planned sexual activity. Adalift may still be effective up to 36 hours after taking the tablet.
Do not take Adalift more than once a day. Adalift 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis.
It is important to remember 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 alcohol may affect your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Adalift or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or above), as this may increase the risk of dizziness when standing up.
The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.

Taking a higher dose of Adalift than recommended

You should inform your doctor. Side effects may occur, as described in section 4.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 the medicine and contact your doctor immediately:

• allergic reactions, including 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 such an erection occurs and lasts for more than 4 hours, you should contact your doctor immediately.
• sudden loss of vision (rare), blurred vision, 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 hearing loss, hives (itchy, red bumps 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 taking the medicine.
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 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
• blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea 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 tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 authorisation 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: Expiry date (EXP). The expiry date refers to the last day of that month. Batch number is stated after: Batch number (Lot).
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should 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 20 mg of tadalafil.
• The other ingredients are: Tablet core:lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, 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, film-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
phone: +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: