Leaflet: information for the user

Tadalafilo Normogen 20 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTadalafilo Normogenand what it is used for

2. What you need to know before starting to takeTadalafilo Normogen

3. How toTadalafilo Normogen

4. Possible side effects

5. Storage ofTadalafilo Normogen

6. Contents of the pack and additional information

This medication contains the active ingredient tadalafilo.

This medication is indicated for the treatment of pulmonary arterial hypertension in adults.

It belongs to a group of medications 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 Normogen if you:

• are allergic to tadalafilo or any of the other components (see section 6).
• are taking any type of nitrates such as amyl nitrite, which are administered to relieve "chest pain". This medication 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" (anterior ischemic 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 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 clots). PDE5 inhibitors, such as Tadalafilo Normogen, 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, tell your doctor if you have:

• any heart problem other than pulmonary hypertension
• problems with your blood pressure
• any hereditary eye disease
• anemia (sickle cell disease)
• multiple myeloma (bone marrow cancer)
• leukemia (blood cell 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 Normogen, contact your doctor immediately.

Decreased or sudden 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 decreased or sudden loss of hearing, contact your doctor immediately.

Children and adolescents

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

Other medications and Tadalafilo Normogen

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

Do not take these tablets if you are being treated with nitrates.

Some medications may be affected by Tadalafilo Normogen or may affect the correct way this medication works. Inform your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension)
• nitrates (for chest pain)
• alpha blockers to treat high blood pressure or prostate problems

-riociguat

• rifampicin (to treat bacterial infections)
• tablets of ketoconazole (to treat fungal infections)
• ritonavir (to treat HIV/AIDS)
• tablets for erectile dysfunction treatment (PDE5 inhibitors)

Taking Tadalafilo Normogen with alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take this medication, 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 this medication 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

Dizziness has been reported. Check carefully how you react to the medication before driving or operating machinery.

Tadalafilo Normogen contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) 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 Normogen is 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 Normogen than you should

If you or someone else takes more tablets than you should, consult your doctor or go immediately to a hospital, bringing the medication or packaging with you. You may experience any of the adverse effects described in section 4.

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

If you forget to take Tadalafilo Normogen

Take your dose 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 one you missed.

If you interrupt treatment with Tadalafilo Normogen

Do not stop taking your tablets unless advised to do so by your doctor.

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

Like all medications, Tadalafilo Normogen may 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 medication and seek medical help immediately:

• allergic reactions, including skin rashes (frequent).
• chest pain - do not use nitrates, but seek medical help immediately (frequent).
• priapism, a prolonged and possibly painful erection after taking this medication (rare). If you experience this type of erection, with a continuous duration of 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 this medication (may affect more than 1 in 10 people): headache, flushing, nasal and sinus 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 heartbeats and fainting.

Rare(may affect up to 1 in 100 people)

• seizures, temporary loss of memory, hives, excessive sweating, bleeding in the penis, presence of blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death and ringing in the ears.

Also used for the treatment of erectile dysfunction in men. Rarely reported side effects:

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

Some rare additional side effects have been reported in men taking tadalafilo for erectile dysfunction. These side effects have not been seen during clinical studies for pulmonary arterial hypertension, and therefore their frequency is unknown:

• swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

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

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 http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD” and “EXP” respectively. 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 containers 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Tadalafilo Normogen Composition

• The active ingredient is tadalafilo. Each tablet contains 20 mg of tadalafilo.
• The other components are:

Tablet core: lactose monohydrate, lactose monohydrate dried by spraying, croscarmelose sodium, hydroxypropylcellulose (E-463), microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Coating: lactose monohydrate, hypromellose 2910, triacetin, titanium dioxide (E-171), yellow iron oxide (E-172), talc.

Product appearance and packaging content

Tadalafilo Normogen 20 mg are yellow-coated, elliptical, biconvex tablets marked with “T20” on one face.

Tadalafilo Normogen 20 mg is available in blister packs containing 56 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (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