Patient Information Leaflet

Tadalafil Adamed, 10 mg, film-coated tablets
Tadalafil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 a specific individual. Do not give it to others. This medicine may harm others, 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.

Table of contents

What Tadalafil Adamed is and what it is used for
What you need to know before taking Tadalafil Adamed
How to take Tadalafil Adamed
Possible side effects
How to store Tadalafil Adamed
Contents of the pack and other information

1. What Tadalafil Adamed is and what it is used for

Tadalafil Adamed is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil has been shown to significantly improve the ability to achieve an erection suitable for
sexual intercourse.
Tadalafil Adamed contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Adamed helps widen
the blood vessels in the penis, allowing increased blood flow into the penis. This results in
improved erection. Tadalafil Adamed does not benefit men who do not have erectile dysfunction.
It is important to be aware that Tadalafil Adamed will not work without sexual stimulation.
You and your partner should engage in foreplay, just as you would if you were not taking
medication for erectile dysfunction.

2. Important information before using Tadalafil Adamed

When not to use Tadalafil Adamed:

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 (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 Tadalafil Adamed, patients should discuss this with their doctor.
Patients should be aware that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if any of the following conditions apply:

sickle cell anemia (abnormally shaped red blood cells).
multiple myeloma (a bone marrow cancer).
leukemia (a blood cell cancer).
any deformity of the penis.
severe liver disease.
severe kidney disease.

It is not known whether Tadalafil Adamed is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland with nerve damage (non-nerve-sparing radical prostatectomy).

If sudden vision loss or sudden decrease in vision occurs during treatment with tadalafil, or if vision appears blurred or distorted, the patient should stop taking Tadalafil Adamed and contact their doctor immediately.
In some patients taking tadalafil, decreased 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 hearing loss or sudden decrease in hearing occurs, the patient should stop taking Tadalafil Adamed and contact their doctor immediately.
Tadalafil Adamed is not intended for use in women.
Children and adolescents
Tadalafil Adamed is not intended for use in children and adolescents under 18 years of age.
Tadalafil Adamed with 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.
Tadalafil Adamed must not be taken if the patient is using nitrates.
Tadalafil Adamed may affect the action of certain medicines or other medicines may affect the action of Tadalafil Adamed. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

alpha-adrenergic receptor 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 oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Adamed with alcohol and food
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Adamed, and therefore caution should be exercised when consuming it. For further information, the patient should consult their doctor.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. 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 a car or operate machinery.
Tadalafil Adamed contains lactose:
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tadalafil Adamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Adamed

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Adamed tablets are intended for oral use only in men. The tablet should be swallowed whole with a small amount of water. The tablets may be taken regardless of meals.
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not sufficient, your doctor may increase the dose to 20 mg (two 10 mg tablets). Tadalafil Adamed tablets are intended for oral administration.
Tadalafil Adamed may be taken at least 30 minutes before planned sexual activity.
Tadalafil Adamed may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Adamed more than once a day. Tadalafil Adamed 10 mg is intended for use prior to planned sexual activity. Regular, daily use of the medicine is not recommended. The division line on the tablet is not intended for splitting the tablet.
It is important to understand that Tadalafil Adamed 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 erectile dysfunction medication.
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 Tadalafil Adamed, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking a higher than recommended dose of Tadalafil Adamed
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the
medicine and seek immediate medical advice:

allergic reactions, including rash (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 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, sensation of heart palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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

fainting, convulsions 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 conditions 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 which 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, 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Adamed

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 the stated month. The batch number is indicated after: Batch number (Lot).
There are no special requirements for storage.
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. Package contents and other information

What Tadalafil Adamed contains

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
Excipients: Lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Tablet coating (Opadry II Orange 85F230012)
Polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)

What Tadalafil Adamed looks like and contents of the pack
Tadalafil Adamed 10 mg is a light orange, elongated, biconvex coated tablet, approximately 11 mm x 6 mm, with a score line on one side.
Tadalafil Adamed 10 mg tablets are available in blisters made of Aluminum/PVC/PVDC, packed in cardboard boxes. The pack contains 2, 4, 8, or 12 film-coated 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.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
Zakłady Farmaceutyczne Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Zakłady Farmaceutyczne Polpharma S.A.
ul. Metalowca 2
39-460 Nowa Dęba
Poland