Prospect: Information for the user

Tadalafilo Kern Pharma 20 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Tadalafilo Kern Pharma is and for what it is used

2.What you need to know before starting to take Tadalafilo Kern Pharma

3.How to take Tadalafilo Kern Pharma

4.Possible adverse effects

5Storage of Tadalafilo Kern Pharma

6.Contents of the package and additional information

Tadalafilo Kern Pharma contains the active ingredient tadalafilo.

Tadalafilo Kern Pharma is indicated for the treatment of pulmonary arterial hypertension in adults.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors that act by helping to relax blood vessels surrounding the lungs, improving blood flow in the lungs. The result of this is an improved ability to perform physical activity.

Do not take Tadalafilo Kern Pharma if you:

-are allergic to tadalafilo or any of the other components of this medication (listed in section 6),

-are taking any type of organic nitrates such as amyl nitrite, administered to relieve "chest pain". Tadalafilo may increase the effects of these medications. If you are taking any type of nitrates or are unsure, consult your doctor.

• have previously experienced vision loss, a condition described as "eye infarction" (ischemic anterior non-arteritic optic neuropathy, NAION),

-have had a heart attack in the last 3 months.

-have low blood pressure,

-are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as tadalafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take this medication.

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

-any heart problem other than pulmonary hypertension,

-problems with your blood pressure,

-any hereditary eye disease,

-any anomaly of red blood cells (sickle cell anemia),

-multiple myeloma (bone marrow cancer),

-leukemia (blood cancer),

-any deformity of your penis, or unexpected and unwanted erections that last more than 4 hours,

-severe liver disease,

-severe kidney disease.

If you experience a decrease or sudden loss of vision or your vision is distorted or blurred while taking tadalafilo, stop taking tadalafilo and immediately contact your doctor.

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

Children and adolescents

This medication should not be used in children or adolescents under 18 years old.

Taking Tadalafilo Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take tadalafilo if you are already being treated with nitrates.

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. Inform your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary hypertension)
• nitrates (for chest pain),
• alpha blockers to treat high blood pressure or prostate problems
• riociguat,
• rifampicin (to treat bacterial infections),
• ketoconazole tablets (to treat fungal infections),
• ritonavir (to treat HIV/AIDS)
• tablets to treat erectile dysfunction (PDE5 inhibitors)

Taking Tadalafilo Kern Pharma with food, drink, and alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, avoid excessive alcohol consumption (above 5 units of alcohol), as it may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take tadalafilo during pregnancy, unless it is strictly necessary and you have discussed this with your doctor.

Do not breastfeed while taking these tablets, as it is unknown if the medication passes into breast milk. Consult your doctor or pharmacist before taking any medication if you are pregnant or breastfeeding.

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Cases of dizziness have been reported. Check carefully how you react when taking the tablets before driving or operating machinery.

Tadalafilo Kern Pharma contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult him before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafilo tablets are available in 20 mg tablets. The usual dose is 2 tablets of 20 mg taken once a day. Take the two tablets at the same time, one after the other. If you have a mild to moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet a day.

Swallow the tablets whole with a glass of water. The tablets can be taken with or without food.

If you take more Tadalafilo Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional. You may experience adverse effects described in section 4.

If you forgot to take Tadalafilo Kern Pharma

Take your doses as soon as you remember if it is within 8 hours of the time when you should have taken your dose. DO NOT take a double dose to make up for the missed doses.

If you interrupt treatment with Tadalafilo Kern Pharma

Do not stop taking your tablets unless advised by your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

• Allergic reactions, including skin rashes (frequent, may affect 1 in 10 people).
• Chest pain – do not use nitrates, seek medical help immediately (frequent, may affect 1 in 10 people).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (infrequent, may affect 1 in 100 people). If you experience this type of erection, which may last for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency),distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

The following side effects have been reported very frequently in patients taking tadalafil (may affect more than 1 in 10 people): headache, flushing, nasal congestion (stuffy nose), nausea, indigestion (including abdominal pain and discomfort), muscle pain, back pain and limb pain (including limb discomfort).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• Blurred vision, low blood pressure, nasal bleeding, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeat and fainting.

Infrequent(may affect up to 1 in 100 people)

• Seizures, transient memory loss, urticaria, excessive sweating, bleeding in the penis, presence of blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death and tinnitus.

Cialis is also used to treat erectile dysfunction in men. Rarely reported side effects include:

-Decreased or partial, temporary or permanent loss of vision in one or both eyes and severe allergic reaction causing facial or throat swelling. Additionally, cases of sudden hearing loss have been reported.

Rare additional side effects have been reported in men taking tadalafil for erectile dysfunction. These side effects have not been seen during clinical studies. These include:

-migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death

-distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Most men who reported cases of rapid pulse, irregular heartbeat, heart attack, stroke and sudden cardiac death had some pre-existing heart condition before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Tadalafilo Kern Pharma Composition

-The active ingredient is tadalafilo. Each film-coated tablet contains 20 mg of tadalafilo.

-The other components are:

-Tablet core: lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, and magnesium stearate.

-Coating: Opadry II Yellow 32K12884 containing lactose monohydrate, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172), and triacetin (E-1518).

Product appearance and packaging contents

Yellow film-coated tablets, round, scored on one face, and marked with a “20” on the other.

The score is not for splitting the tablet.

This medication is available in blister packs containing 56 tablets.

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/