TADALAFIL JUBILANT 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Jubilant 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Tadalafil contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil acts by helping to relax the blood vessels in your penis, allowing the flow of blood into the penis. The result is an improvement in 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 should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. This occurs when a man cannot get or maintain a firm erection, suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to get an erection, which is firm enough for sexual activity.

2. What you need to know before you take Tadalafil Jubilant

Do not take Tadalafil Jubilantif:

• 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 for the treatment of 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 had a severe heart attack in the last 90 days.
• you have had a recent stroke in 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). PDE5 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

Talk to 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, tell your doctor if you have:

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

It is not known if tadalafil is effective in patients who have been surgically treated:

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

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

A sudden 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 sudden 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.

Other medicines and Tadalafil Jubilant

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 taking 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 associated with 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 Jubilant with drinks and alcohol

Information about 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 has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

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

Tadalafil Jubilant contains lactose

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

3. How to take Tadalafil Jubilant

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration

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

For the treatment of erectile dysfunction

The recommended initial dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.

When you take tadalafil, you can start sexual activity at least 30 minutes after taking it. Tadalafil can still be effective up to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg will be used before anticipated sexual activity and are not recommended for continuous daily use.

Do not take tadalafil more than once a day.

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

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way 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 consumption of alcohol (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafil Jubilant than you should

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

If you forget to take Tadalafil Jubilant

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 about the use of this medicine, 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 to moderate.

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

Uncommon(may affect up to 1 in 100 people)

• allergic reactions, including skin rashes
• chest pain - do not use nitrates, but seek medical help immediately

Rare(may affect up to 1 in 1,000 people)

• priapism, a prolonged and possibly painful erection after taking tadalafil.

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

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,
• flushing
• nasal congestion
• indigestion.

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 1,000 people)

• fainting
• seizures and temporary memory loss
• swelling of the eyelids
• red eyes
• sudden loss of hearing
• hives (red itchy patches on the skin that sting)
• bleeding from the penis
• blood in the semen
• increased sweating

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

Rarely, cases of partial, temporary, or permanent loss of vision have been reported.

Some additional rare side effects have been reported in men taking tadalafil that were not reported during clinical trials, including:

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

In men over 75 years old treated with tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years old 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 package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tadalafil Jubilant

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 is the last day of the month shown.

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 Jubilant

• The active substanceis tadalafil.
• • Each tablet contains 10 mg of tadalafil

• Theotheringredients are:

Core of the tablet:

lactose monohydrate,

hydroxypropylcellulose (E463),

croscarmellose sodium,

sodium lauryl sulfate,

microcrystalline cellulose (E460),

magnesium stearate (E572),

Coating:

hypromellose (E464),

lactose monohydrate,

titanium dioxide (E171),

triacetin (E1518),

talc (E553b).

Appearance of Tadalafil Jubilant and contents of the pack

Tadalafil Jubilant is available in four concentrations:

Tadalafil Jubilant 10 mg film-coated tablets: Film-coated tablets, white to off-white, oval, biconvex, with the inscription "H3" on one face and smooth on the other, 3 mm thick, 10 mm long, and 6 mm wide.

Aluminum/PVC blisters in packs of 1, 2, 4, 7, 8, 10, 12, 14, 28, and 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Jubilant Pharmaceuticals nv

Axxes Business Park

Guldensporenpark 22 - Block C

9820 Merelbeke, Belgium

Manufacturer

1. PSI Supply nv

Axxes Business Park,

Guldensporenpark 22, Block C,

Merelbeke, Belgium

Date of last revision of this package leaflet: May 2021

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