Tadalafilo almus 5 mg comprimidos recubiertos con pelicula efg
Introduction
Product Information for the User
Tadalafilo Almus 5 mg Film-Coated Tablets
Read this 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. 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.
Table of Contents
- What Tadalafilo Almus is and what it is used for
- What you need to know before you start taking Tadalafilo Almus
- How to take Tadalafilo Almus
- Possible side effects
- Storage of Tadalafilo Almus
- Contents of the pack and additional information
1. What is Tadalafilo Almus and what is it used for
Tadalafilo Almus contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafilo Almus 5 mg is used to treat adult men with:
- erectile dysfunction. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.
After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that tadalafilo is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.
- urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.
2. What you need to know before starting Tadalafilo Almus
Do not take Tadalafilo Almus if:
- You are allergic to tadalafil or any of the other components of this medication (listed in section 6).
- You are taking any type of organic nitrates or nitric oxide donors, such as amyl nitrite. This is a group of medications ("nitrates") used to treat angina (chest pain). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
- You have a serious heart condition or have had a heart attack recently, within the last 90 days.
- You have had a recent stroke, within the last 6 months.
- You have low or uncontrolled high blood pressure.
- You have had anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction," which has caused vision loss.
- You are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as tadalafil, have been 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 tadalafil.
Be aware that sexual activity can pose a possible risk for patients with heart problems, due to the additional strain it puts on the heart. If you have a heart condition, consult your doctor.
Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:
- Anemia falciforme (a red blood cell abnormality).
- Multiple myeloma (bone marrow cancer).
- Leukemia (blood cell cancer).
- Any penile deformity.
- A severe liver problem.
- A severe kidney problem.
Tadalafil is not known to be effective in patients who have undergone:
- Pelvic surgery.
- A surgical procedure in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).
If you experience a sudden decrease or loss of vision, or your vision is distorted or blurred while taking Tadalafilo Almus, stop taking tadalafil and immediately contact your doctor.
Sudden hearing loss has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience sudden hearing loss, stop taking tadalafil and immediately contact your doctor.
Tadalafil is not intended for use in women.
Children and adolescents
Tadalafil should not be used in children or adolescents under 18 years old.
Other medications and Tadalafilo Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Do not take tadalafil if you are already taking nitrates.
Some medications may be affected by tadalafil or may affect the proper functioning of tadalafil. 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 medications to treat high blood pressure.
- Riociguat.
- An inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia).
- Medications such as ketoconazole tablets (for fungal infections) and protease inhibitors for HIV/AIDS treatment.
- Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
- Rifampicin, erythromycin, clarithromycin, or itraconazole.
- Other treatments for erectile dysfunction.
Taking Tadalafilo Almus with beverages and alcohol
The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafil and should be taken with caution. Consult your doctor for more information.
Fertility
In treated dogs, a decrease in sperm production by the testicles was observed. Some men have experienced a reduction in sperm count. It is unlikely that these effects will cause infertility.
Driving and operating machinery
Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.
Tadalafilo Almus contains lactose
If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
Tadalafilo Almus contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."
3. How to Take Tadalafilo Almus
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Tadalafil tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.
Consuming alcohol 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 it may increase the risk of dizziness when standing up.
Treatment of erectile dysfunction
The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking one 2.5 mg tablet.
Do not take tadalafil more than once a day.
Daily administration of tadalafil allows you to achieve an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil administration may be useful for men who anticipate engaging in sexual activity two or more times a week.
It is essential to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.
Consuming alcohol may affect your ability to achieve an erection.
Treatment of benign prostatic hyperplasia
The doseis one 5 mg tablet once a day, approximately at the same time.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.
Do not take tadalafil more than once a day.
If you take more Tadalafilo Almus than you should
Consult your doctor. You may experience adverse effects described in section 4.
If you forgot to take Tadalafilo Almus
Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take tadalafil more than once a day.
In case of overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
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:
- allergic reactions including rashes (infrequent).
- chest pain - do not use nitrates but seek medical help immediately (infrequent).
- priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
- sudden loss of vision (rare frequency), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).
Other side effects that have been reported:
Frequent(observed in 1 to 10 of every 100 patients)
- headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.
Infrequent(observed in 1 to 10 of every 1,000 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, nasal bleeding, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare(observed in 1 to 10 of every 10,000 patients)
- syncope, seizures and transient loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin surface), bleeding in the penis, blood in the semen and increased sweating.
Also, rare cases of heart attack and stroke have been reported in men taking tadalafil. Most of these men had some heart problem before taking this medicine.
Rarely, cases of partial or permanent loss of vision, temporary or permanent, in one or both eyes have been reported.
Some rare additional side effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:
-migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
- distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).
In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Tadalafilo Almus
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”. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the
medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Tadalafilo Almus
- The active ingredient is tadalafilo.
Each tablet contains 5 mg of tadalafilo.
- The other components are:
Core of the tablet : lactose monohydrate (see section 2 “Tadalafilo Almus contains lactose”), cornstarch, pregelatinized cornstarch, crospovidone, sodium lauryl sulfate (also see “Tadalafilo Almus contains sodium” in section 2), and magnesium stearate.
Coating with a film : lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
Appearance of the product and contents of the packaging
Tadalafilo Almus 5 mg film-coated tablets EFG are oblong, cream to light yellow tablets, 10.0 mm ± 0.2 mm in length and 5.5 mm ± 0.2 mm in width.
Tadalafilo Almus 5 mg is available in blister packs containing 28 or 84 tablets.
Only some package sizes may be marketed.
Holder of the marketing authorization and responsible manufacturer
Holder of the marketing authorization:
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Phone: 93 739 71 80
Email: [email protected]
Responsible manufacturer:
Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal
This medicine is authorized in the member states of the European Economic Area with the following names:
PT: Tadalafil Pentafarma Especialidades
ES: Tadalafilo Almus 5 mg film-coated tablets EFG
FR: Tadalafil Almus 5 mg, film-coated tablet
IT: Tadalafil Almus
Date of the last review of this leaflet: December 2023
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
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