Leaflet: information for the user

Tadalafilo Cipla 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, ask 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 Tadalafilo Cipla is and what it is used for

2. What you need to know before you start taking Tadalafilo Cipla

3. How to take Tadalafilo Cipla

4. Possible side effects

5. Storage of Tadalafilo Cipla

6. Contents of the pack and additional information

Tadalafilo Cipla contains the active ingredient tadalafilo. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors that work by helping to relax the blood vessels around your lungs, improving blood flow in the lungs. The result of this is an improved ability to perform physical activity

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

Do not take Tadalafilo Cipla 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". Tadalafil may increase the effects of these medications. If you are taking any type of nitrates or are unsure, consult your doctor.
• have previously experienced loss of vision - a condition described as "eye stroke" (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 tadalafil, 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 Tadalafilo Cipla if you have:

• any heart problem other than pulmonary hypertension
• problems with your blood pressure
• any inherited eye disease
• an abnormality of red blood cells (sickle cell anemia)
• 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 tadalafil, contact your doctor immediately.

There have been observations of sudden decrease or loss of hearing in some patients taking tadalafil. Although, it is not known if the event is directly related to tadalafil, if you experience 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 Tadalafilo Cipla with other medications

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 tadalafil or may affect the correct 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 to treat high blood pressure or prostate problems
• riociguat
• rifampicin (to treat bacterial infections)
• tablets for fungal infections (ketoconazole)
• ritonavir (to treat HIV/AIDS)
• tablets for erectile dysfunction (PDE5 inhibitors)

Taking Tadalafilo Cipla with alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, 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, or plan to become pregnant, consult your doctor before using this medication.

Do not take Tadalafilo 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 reduction in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Cases of dizziness have been reported. Check carefully how you react to the medication before driving or operating machinery.

Tadalafilo Cipla contains lactose and sodium

If you know you have an intolerance to certain sugars, consult your doctor before taking this medication.

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

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

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.

Administration Form

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

If you take more Tadalafilo Cipla 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 the packaging with you, or consult the Toxicological Information Service, phone 915.620.420. You may experience any of the adverse effects described in section 4.

If you forgot to take Tadalafilo Cipla

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 Cipla

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 medicines, this medicine can 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 medicine and seek medical help immediately:

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• 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 must contact a doctor immediately.

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

• sudden loss of vision.

Frequency unknown(cannot be estimated from available data)

• distorted, blurred, central vision loss, or sudden vision decrease.

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:

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 heartbeat, and
• syncope.

Infrequent (may affect up to 1 in 100 people)

• seizures,
• transient memory loss,
• urticaria,
• excessive sweating,
• penile bleeding,
• blood in semen and/or urine,
• high blood pressure,
• rapid pulse,
• sudden cardiac death, and
• tinnitus.

PDE5 inhibitors are also used to treat erectile dysfunction in men. Rarely reported side effects include: - Decreased or permanent loss of vision in one or both eyes and severe allergic reaction causing facial or throat swelling. Additionally, cases of sudden hearing loss have been reported.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Tadalafilo Cipla Composition

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

The other components are:

• Tablet core: Lactose monohydrate, croscarmelose sodium, hydroxypropylcellulose, laurilsulfate sodium, microcrystalline cellulose, magnesium stearate.
• Film coating: Opadry II brown 32K565010 containing HPMC 2910/hypromellose, lactose monohydrate, titanium dioxide (E171), yellow iron oxide (E172), triacetin, red iron oxide (E172).

Product appearance and container content

Tadalafilo Cipla 20 mg is presented in film-coated tablets with a brown color, capsule-shaped, marked with “T20” on one face 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.

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

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cipla Europe NV

De Keiserley 58-60

Box-19, 2018 Antwerp.

Belgium

Responsible manufacturer:

Cipla Europe NV

De Keiserley 58-60

Box-19, 2018 Antwerp.

Belgium

For more information about this medication, please contact the local representative of the marketing authorization holder:

Cipla Europe NV subsidiary in Spain

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

Phone: 91 534 16 73

Last review date of this leaflet:November 2023

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es