TADALAFIL CIPLA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Cipla 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 doubts, 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 Cipla and what is it used for
2. What you need to know before taking Tadalafil Cipla
3. How to take Tadalafil Cipla
4. Possible side effects
5. Storage of Tadalafil Cipla
6. Package contents and additional information

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

Tadalafil Cipla contains the active ingredient tadalafil. 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.

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

2. What you need to know before taking Tadalafil Cipla

Do not take Tadalafil Cipla if you:

• are allergic to tadalafil 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". Tadalafil can 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, 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 Tadalafil Cipla 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, contact your doctor immediately.

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

Children and adolescents

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

Taking Tadalafil Cipla with other medications

Inform 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 or may affect the way 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 HIV/AIDS treatment)
• tablets for treating erectile dysfunction (PDE5 inhibitors)

Taking Tadalafil Cipla with alcohol

Alcohol consumption 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 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 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 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 infertility.

Driving and using machines

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

Tadalafil Cipla contains lactose and sodium

If you know you are intolerant to certain sugars, consult your doctor before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Tadalafil Cipla

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

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.

Method of administration

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

If you take more Tadalafil Cipla than you should

If you or someone else has taken more tablets than they should, consult your doctor or go to the hospital immediately, taking the medication or packaging with you, or contact the Toxicology Information Service, phone 915.620.420. You may experience any of the side effects described in section 4.

If you forget to take Tadalafil Cipla

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 missed dose.

If you stop taking Tadalafil Cipla

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, this medication can cause side effects, although not everyone gets them. These effects are generally mild to moderate.

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

Common(may affect up to 1 in 10 people)

• allergic reactions, including skin rashes.
• chest pain - do not use nitrates, but seek medical help immediately.

Uncommon(may affect up to 1 in 100 people)

• priapism, a prolonged and possibly painful erection after taking tadalafil. If you experience this type of erection, with a continuous duration of more than 4 hours, you should contact a doctor immediately.

Rare(may affect up to 1 in 1,000 people)

• sudden vision loss

Frequency not known(cannot be estimated from available data)

• distorted vision, blurred vision, central blurred vision, or sudden decrease in vision

The following side effects have been reported very frequently in patients taking tadalafil (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:

Common (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.

Uncommon (may affect up to 1 in 100 people)

• seizures,
• temporary 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 inhibitors are also used to treat erectile dysfunction in men. The following side effects have been rarely reported: - Decrease or loss of vision in one or both eyes and severe allergic reaction causing facial or throat swelling. Cases of sudden decrease or loss of hearing have also been reported.

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

• eyelid swelling,
• eye pain,
• red eyes,
• heart attack and
• stroke
• distorted vision, blurred vision, central blurred vision, or sudden decrease in vision.

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 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 Medication Toxicovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tadalafil Cipla

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

Do not use this medication after the expiration date shown 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. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Tadalafil Cipla

The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.

The other ingredients are:

• Core tablet: Lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.
• Coating: Opadry II brown 32K565010 containing HPMC 2910/hypromellose, lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin, red iron oxide (E172).

Appearance of the product and package contents

Tadalafil Cipla 20 mg is presented in film-coated tablets of brown color, capsule-shaped, and marked with "T20" on one side and smooth on the other. The length of each tablet is 14.10 ± 0.20 mm and the thickness is 6.10 ± 0.20 mm.

Tadalafil Cipla is available in aluminum/PVC/PE/PVDC blister packs in cartons with 28 or 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Cipla Europe NV

De Keiserley 58-60

Box-19, 2018 Antwerp.

Belgium

Manufacturer:

Cipla Europe NV

De Keiserley 58-60

Box-19, 2018 Antwerp.

Belgium

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Cipla Europe NV, branch in Spain

C/ Guzmán el Bueno, 133 Edif. Britannia 28003-Madrid

Phone: 91 534 16 73

Date of the last revision of this package leaflet:November 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