TADALAFIL KERN PHARMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Kern Pharma 20 mg film-coated tablets EFG

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

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tadalafil Kern Pharma and what is it used for
2. What you need to know before you take Tadalafil Kern Pharma
3. How to take Tadalafil Kern Pharma
4. Possible side effects

5 Storage of Tadalafil Kern Pharma

1. Contents of the pack and further information

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

Tadalafil Kern Pharma contains the active substance tadalafil.

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

It belongs to a group of medicines 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 an improved ability to perform physical activity.

2. What you need to know before you take Tadalafil Kern Pharma

Do not take Tadalafil Kern Pharma if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6),
• are taking any form of organic nitrates, such as amyl nitrite, which are given to relieve "chest pain" Tadalafil can increase the effects of these medicines. If you are taking any form of nitrate or are unsure, consult your doctor.
• have previously experienced loss of vision, a condition 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 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

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,
• 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 penile deformity, or unexpected and unwanted erections that last more than 4 hours,
• a severe liver problem,
• a severe kidney problem.

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

Children and adolescents

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

Taking Tadalafil Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 the way tadalafil works. Tell your doctor or pharmacist if you are taking:

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

Taking Tadalafil Kern Pharma with food, drink, and alcohol

Consuming alcohol may 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 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 are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take tadalafil 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 not known if the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine 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 when taking the tablets before driving or using machines.

Tadalafil Kern Pharma contains lactose

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

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

3. How to take Tadalafil Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafil tablets are available in 20 mg tablet form. 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 a mild to moderate liver or kidney problem, 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 Kern Pharma than you should

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

It is recommended to take the package and the leaflet of the medicine to the healthcare professional. You may experience side effects described in section 4.

If you forget to take Tadalafil Kern Pharma

Take your doses as soon as you remember if it is within 8 hours after the time you should have taken your dose. 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 your doctor has advised you to do so.

If you have any further questions on 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 generally mild to moderate.

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

• Allergic reactions, including skin rash (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 (uncommon, may affect 1 in 100 people). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• Sudden loss of vision (rare), distorted, blurred, central blurred vision, or sudden loss of vision (frequency not known).

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 aches, 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 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 ringing in the ears

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

• decrease or loss of vision of one or both eyes, and severe allergic reaction causing swelling of the face or throat. Additionally, 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. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rash, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death
• distorted, blurred, central blurred vision, or sudden loss of 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 problems before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

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 leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side 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 which is stated on the package 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. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tadalafil Kern Pharma

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other ingredients are:
• Core of the tablet: lactose monohydrate, hydroxypropylcellulose, 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).

Appearance and packaging

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

The score line is not intended for breaking the tablet.

This medicine is available in blister packs of 56 tablets.

Marketing authorisation holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet:October 2023

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