TADALAFIL HEC PHARM 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil HEC Pharm 2.5 mg film-coated tabletsEFG

Read all of this leaflet carefully before you start 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Tadalafil HEC Pharm and what is it used for

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before you take Tadalafil HEC Pharm

Do not take tadalafil if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or 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 increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• you have a severe heart disease or have had a recent heart attack within the last 90 days.

• you have had a recent stroke within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking tadalafil.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, consult your doctor.

Before taking the tablets, inform your doctor if you have:

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

It is not known if tadalafil is effective in patients who have undergone:

• surgery in the pelvic area.
• a surgical procedure in which the prostate was partially or completely removed and the nerves of the prostate were cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision, stop taking tadalafil and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil should not be used in children and adolescents under 18 years of age.

Using tadalafil with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take tadalafil if you are already using nitrates.

Some medicines may be affected by tadalafil or may affect the way tadalafil works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking tadalafil with drinks and alcohol

Information on the effect of alcohol is in section 3. Grapefruit juice may affect the way tadalafil works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects will affect fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil HEC Pharm contains lactose:

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Tadalafil HEC Pharm containssodium:

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Tadalafil HEC Pharm

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafil tablets are for oral administration only in men. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended doseis one 5 mg tablet per day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil administered daily may be useful in men who anticipate having sexual activity at least twice a week.

Tadalafil administered daily allows you to get an erection at any time during the 24 hours of the day, provided that you are sexually stimulated.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more tadalafil than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take tadalafil

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take tadalafil more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rash (uncommon).
• chest pain - do not use nitrates but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon(seen in 1 to 10 in every 1,000 patients)

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

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures, and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Rarely, cases of decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.

In men over 75 years of age treated with tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil HEC Pharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should 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

Composition of Tadalafil HEC Pharm

• The active substanceis tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredientsare:

Core of the tablet: lactose monohydrate (see the end of section 2), microcrystalline cellulose, croscarmellose sodium, hypromellose, laurilsulfate sodium, magnesium stearate.

Coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), red iron oxide (E172).

Appearance of the product and contents of the pack

Tadalafil HEC Pharm 2.5 mg film-coated tablets are round, pink, and have “C27” engraved on one side and are smooth on the other.

Tadalafil HEC Pharm 2.5 mg film-coated tablets are available in cardboard boxes of 14 and 28 tablets in PVC/PVDC/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin

Germany

Date of last revision of this leaflet:August2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/