Tadalafil CINFA 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
tadalafil cinfa 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What tadalafil cinfa is and what it is used for
- What you need to know before taking tadalafil cinfa
- How to take tadalafil cinfa
- Possible side effects
- How to store tadalafil cinfa
- Contents of the pack and other information
1. What tadalafil cinfa is and what it is used for
tadalafil cinfa is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. tadalafil cinfa has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.
This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into it. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.
It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner must stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.
2. What you need to know before taking tadalafil cinfa
Do not take tadalafil cinfa
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if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
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if you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
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if you have a severe heart disease or have recently had a heart attack (within the last 90 days).
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if you have recently had a stroke (within the last 6 months).
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if you have low blood pressure or uncontrolled high blood pressure.
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if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
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if you 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
Talk to your doctor or pharmacist before starting to take tadalafil cinfa.
Be aware that sexual activity involves a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.
Before taking the tablets, inform your doctor if you have:
- sickle cell anemia (an abnormality of red blood cells).
- multiple myeloma (a cancer of the bone marrow).
- leukemia (a cancer of blood cells).
- any deformity of the penis.
- severe liver problems.
- severe kidney problems.
It is not known whether tadalafil is effective in patients who have undergone:
- pelvic surgery.
- a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).
If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, stop taking tadalafil immediately and contact your doctor without delay.
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.
Tadalafil is not intended for use in women.
Children and adolescents
Tadalafil must not be used in children or adolescents under 18 years of age.
Taking tadalafil cinfa with other medicines
Tell 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 using nitrates.
Some medicines may be affected by tadalafil or may affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:
- an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
- other medicines for treating high blood pressure.
- riociguat.
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
- medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
- phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
- rifampicin, erythromycin, clarithromycin, or itraconazole.
- other treatments for erectile dysfunction.
Taking tadalafil cinfa with food and alcohol
Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of tadalafil and should be used with caution. Consult your doctor for further information.
Fertility
In treated dogs, a reduction in sperm production by the testes was observed. In some men, a reduction in sperm has been observed. These effects are unlikely to result in infertility.
Driving and use of machines
Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.
tadalafil cinfa 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.
tadalafil cinfa contains sodium.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take tadalafil cinfa
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Tadalafil tablets are for oral use only in men. Swallow the tablet whole with a little water. Tablets may be taken with or without food.
The score line is intended solely for ease of splitting the tablet if you find it difficult to swallow it whole.
The recommended starting dose is one 10 mg tablet taken prior to sexual activity. However, you have been prescribed a dose of one 20 mg tablet because your doctor has determined that the recommended 10 mg dose is too weak for you.
After taking tadalafil, you may initiate sexual activity at least 30 minutes later.
Tadalafil may remain effective for up to 36 hours after taking the tablet.
You must not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg are to be taken prior to anticipated sexual activity and are not recommended for continuous daily use.
It is important to note that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of sexual stimulation that you would normally require if you were not taking a medicine for erectile dysfunction.
Alcohol consumption may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness upon standing.
If you take more tadalafil cinfa than you should
Consult your doctor. You may experience adverse effects described in section 4.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the quantity ingested.
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 produce 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 medical help immediately:
- allergic reactions including rashes (uncommon).
- chest pain – do not use nitrates but seek immediate medical help (uncommon).
- priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). 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, diminished, blurred central vision, or sudden decrease in vision (frequency not known).
Other adverse effects that have been reported:
Frequent (may affect up to 1 in 10 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.
Uncommon (may affect up to 1 in 100 patients)
- dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.
Rare (may affect up to 1 in 1,000 patients)
- fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin rashes), bleeding in the penis, blood in the semen, and increased sweating.
Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.
Rare reports of decreased or lost vision, partial, transient or permanent in one or both eyes, have also occurred.
Some additional rare adverse effects have been reported in men taking tadalafil that were not reported during clinical trials. 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 heartbeats, angina, and sudden cardiac death.
- distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).
In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.
Reporting of adverse effects
If you experience any type of adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of tadalafil cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to 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 empty containers and unused medicines at a SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Detailed composition of tadalafil cinfa
- The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
- The other components are:
Tablet core: lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate, purified water.
Coating: hypromellose, titanium dioxide (E-171), macrogol/PEG, yellow iron oxide (E-172).
Appearance of the product and contents of the pack
tadalafil cinfa 20 mg is a yellow, film-coated, oblong, biconvex tablet, marked with the code TD2 on one side and scored on the other.
tadalafil cinfa 20 mg is available in blister packs containing 4, 8 or 12 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this package leaflet: October 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82012/P_82012.html
QR code to: https://cima.aemps.es/cima/dochtml/p/82012/P_82012.html