TADALAFIL NORMOGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Normogen 20 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Tadalafil Normogen and what is it used for
2. What you need to know before taking Tadalafil Normogen
3. How to take Tadalafil Normogen
4. Possible side effects
5. Storage of Tadalafil Normogen
6. Package Contents and Additional Information

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

This medication contains the active ingredient tadalafil.

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

It belongs to a group of medications called phosphodiesterase type 5 inhibitors (PDE5) that work by helping to relax the blood vessels around your lungs, improving blood flow in the lungs. The result is improved ability to perform physical activity.

2. What you need to know before taking Tadalafil Normogen

Do not take Tadalafil Normogen if you:

• are allergic to tadalafil or any of the other ingredients (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 nitrate or are unsure, consult your doctor.
• have previously experienced vision loss - a disease described as "eye infarction" (non-arteritic 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 blood clots). PDE5 inhibitors, such as Tadalafil Normogen, have shown that they 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 problems other than your pulmonary hypertension
• blood pressure problems
• any inherited eye disease
• a red blood cell disorder (sickle cell anemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukemia)
• any penis deformation, or unexpected and unwanted erections that last more than 4 hours
• severe liver problems
• severe kidney problems.

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

A decrease or 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 a decrease or sudden loss of hearing, contact your doctor immediately.

Children and Adolescents

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

Other Medications and Tadalafil Normogen

Tell your doctor if you are taking or have recently taken 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 Tadalafil Normogen or may affect the way this medication works. Tell your doctor or pharmacist if you are taking:

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

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

Taking Tadalafil 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 (more than 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Do not take this medication during pregnancy, unless it is strictly necessary and you have discussed it 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 with tadalafil, a decrease in sperm production by the testicles 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

There have been reports of dizziness. Carefully check how you react to the medication before driving or using machines.

Tadalafil Normogen contains Lactose and Sodium

This medication contains lactose. If your doctor has told you 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; this is essentially "sodium-free".

3. How to take Tadalafil Normogen

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

Tadalafil Normogen is available in 20 mg film-coated tablets. The usual dose is 2 tablets of 20 mg taken once a day. You should take both tablets at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.

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

If you take more Tadalafil Normogen than you should

If you or someone else takes more tablets than they should, consult your doctor or go to the hospital immediately, taking the medication or packaging with you. You may experience any of the 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 medication and the amount ingested.

If you forget to take Tadalafil Normogen

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

If you stop taking Tadalafil Normogen

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

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

4. Possible Side Effects

Like all medications, Tadalafil Normogen can cause side effects, although not everyone will experience them. These 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 (uncommon). If you experience this type of erection, with a duration of more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central blurred vision, 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, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeats, and fainting.

Uncommon(may affect up to 1 in 100 people)

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

PDE5 inhibitorsare also used to treat erectile dysfunction in men. The following side effects have been rarely reported:

• Decrease or partial, temporary, or permanent loss of vision in one or both eyes and severe allergic reaction that causes swelling of the face or throat. Similarly, cases of sudden loss of hearing have been reported.

Some additional rare side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These effects have not been seen during clinical trials for pulmonary arterial hypertension, and their frequency is unknown:

• Swelling of the eyelids, eye pain, red eyes, heart attack, and stroke.
• Distorted, blurred, central blurred vision, 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 pre-existing heart problems before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tadalafil Normogen

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

Do not use this medication after the expiration date stated on the carton and blister pack after "EXP". 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 via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If in doubt, consult your pharmacist about how to dispose of the packaging and medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafil Normogen

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are:

Core of the tablet: lactose monohydrate, lactose monohydrate spray-dried, croscarmellose 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.

Appearance of the Product and Package Contents

Tadalafil Normogen 20 mg are yellow, elliptical, biconvex film-coated tablets marked with "T20" on one side.

Tadalafil Normogen 20 mg is available in blister packs of 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the Last Revision of this Package Leaflet: October 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85659/P_85659.html