Tadalafil Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tadalafilo Kern Pharma 20 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tadalafilo Kern Pharma is and what it is used for
2. What you need to know before taking Tadalafilo Kern Pharma
3. How to take Tadalafilo Kern Pharma
4. Possible side effects
5. How to store Tadalafilo Kern Pharma
6. Contents of the pack and other information

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

Tadalafilo Kern Pharma contains the active substance tadalafil.

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, which work by helping the blood vessels around your lungs to relax, thereby improving blood flow to the lungs. This results in an improved ability to exercise.

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

Do not take Tadalafilo Kern Pharma if you:

• are allergic to tadalafil or any of the other components of this medicine (listed in section 6),

• are taking any type of organic nitrates such as amyl nitrite, which are administered to relieve "chest pain." Tadalafil may increase the effects of these medicines. If you are taking any type of nitrate or are unsure, consult your doctor.

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

• have had a heart attack within the last 3 months,

• have low blood pressure,

• 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 been shown to 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 starting to take this medicine.

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

• any heart problems other than your pulmonary hypertension,
• problems with your blood pressure,
• any hereditary eye disease,
• a red blood cell disorder (sickle cell anemia),
• bone marrow cancer (multiple myeloma),
• blood cell cancer (leukemia),
• any deformity of your penis, or unexpected and unwanted erections lasting more than 4 hours,
• severe liver problems,
• severe kidney problems.

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

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

Children and adolescents

This medicine must not be used in children or adolescents under 18 years of age.

Taking Tadalafilo Kern Pharma with other medicines

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

DO NOT take tadalafil if you are already being treated with nitrates.

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Inform 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 (for treating bacterial infections),
• ketoconazole tablets (for treating fungal infections),
• ritonavir (for treating AIDS - HIV),
• tablets for treating erectile dysfunction (PDE5 inhibitors).

Taking Tadalafilo Kern Pharma with food, drink, and alcohol

Drinking alcohol can temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (more than 5 units of alcohol), as this 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 medicine. Do not take tadalafil during pregnancy unless strictly necessary and only after discussing it with your doctor.

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

In treated dogs, a decrease in sperm production by the testes was observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would lead to infertility.

Driving and using machines

Dizziness has been reported. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Tadalafil Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafil tablets are available as 20 mg tablets. The usual dose is 2 tablets of 20 mg taken once daily. 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 may be taken with or without food.

If you take more Tadalafil Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

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

If you forget to take Tadalafil Kern Pharma

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

If you stop taking Tadalafil Kern Pharma

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

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

4. Possible adverse effects

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

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

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

The following adverse effects have been reported very commonly 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 aches, back pain, and limb pain (including limb discomfort).

Other adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Seizures, transient memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death, and tinnitus (ringing in the ears).

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. The following adverse effects have been reported rarely:

• Decrease or partial, temporary, or permanent loss of vision in one or both eyes, and severe allergic reaction causing swelling of the face or throat. Cases of sudden decrease or loss of hearing have also been reported.

Additional rare adverse effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These effects were not observed during clinical studies. These include:

• Migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• Distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Kern Pharma

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:
• Tablet core: monohydrate lactose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose and magnesium stearate.
• Coating: Opadry II Yellow 32K12884 containing monohydrate lactose, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172) and triacetin (E-1518).

Appearance of the product and contents of the container

Yellow, round, film-coated tablets, scored on one side and marked with "20" on the other.

The score line is not intended to divide the tablet into equal doses.

This medicine is available in blister packs containing 56 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: October 2023

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/