What Tadalafil 1A Farma is and what it is used for
Tadalafil 1A Farma contains the active substance tadalafil which belongs to a group of drugs called phosphodiesterase type 5 inhibitors.
Tadalafil 1A Farma 5 mg, 10 mg, and 20 mg are used for the treatment of adult men with erectile dysfunction.
This means that a man cannot get, or maintain, a hard and erect penis, sufficient for sexual intercourse. Tadalafil 1A Pharma has been shown to significantly improve the ability to have a hard, erect penis, sufficient for sexual intercourse.
Tadalafil 1A Farma works during sexual stimulation by relaxing the blood vessels in the penis, so that blood can flow in. This results in improved erectile function. If you do not have erectile dysfunction, Tadalafil 1A Farma will not help.
It is important to remember that tadalafil used for erectile dysfunction has no effect if you are not sexually stimulated. The need for foreplay for you and your partner is the same as when you have not taken any medication for erectile dysfunction.
Tadalafil 1A Farma 5 mg is used to treat adult men with urinary tract symptoms associated with a commonly occurring condition called benign prostatic hyperplasia.
This is when the prostate gland becomes larger with increasing age. Symptoms include difficulty starting to pass water, a feeling of not being able to empty the bladder, and having to pass water more often, even at night. Tadalafil 1A Farma improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce symptoms of benign prostatic hyperplasia. Tadalafil has shown an effect on these urinary tract symptoms as early as 1–2 weeks after starting treatment.
Tadalafil 1A Farma 20 mg is used for the treatment of pulmonary arterial hypertension in adults.
It improves blood flow to the lungs by causing the blood vessels around the lungs to relax. The result is improved capacity during physical exertion.
Tadalafil contained in Tadalafil 1A Farma may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Tadalafil 1A Farma
Do not take Tadalafil 1A Farma if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking medicines that contain organic nitrates or nitric oxide donors such as amyl nitrite. These medicines (“nitrates”) are used to treat angina (chest pain). Tadalafil has been shown to increase the effect of these drugs. If you are taking any form of nitrates or if you are not sure, talk to your doctor.
- have a serious heart condition or have recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- have low blood pressure or uncontrolled high blood pressure.
- have ever lost sight due to non-arteritic anterior ischemic optic neuropathy (NAION), the so-called “stroke in the eye”.
- taking riociguat.
This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Tadalafil 1A Farma, have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil 1A Farma.
If you are being treated for erectile dysfunction: be aware that sexual intercourse is a possible risk for patients with heart disease, as it puts more strain on the heart than usual. If you have heart problems, tell your doctor.
If you are being treated for benign prostatic hyperplasia: as benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will examine you regarding prostate cancer before starting treatment with Tadalafil 1A Farma for benign prostatic hyperplasia. Tadalafil 1A Farma is not a treatment for prostate cancer.
Before taking the tablets, tell your doctor if you have:
- sickle cell anemia (abnormal red blood cells )
- multiple myeloma (cancer of the bone marrow )
- leukemia (blood cell cancer)
- a deformed penis, or unwanted or persistent erection lasting more than 4 hours
- severe liver disease
- severe kidney disease
- any hereditary eye disease
- heart problems other than your high blood pressure in the lungs
- problems with your blood pressure.
It is not known whether Tadalafil 1A Farma in the treatment of erectile dysfunction is effective in patients who have undergone:
- pelvic surgery
- surgery where part or all of the prostate gland is removed and where the nerves are not preserved (radical non-nerve-sparing prostatectomy ).
If you experience a sudden decrease or loss of vision, stop treatment with Tadalafil 1A Farma and contact your doctor immediately.
Impaired hearing or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known whether the events are directly related to tadalafil, you should stop taking Tadalafil 1A Farma and contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Children and young people
Other medicines and Tadalafil 1A Farma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not take Tadalafil 1A Farma if you are already taking nitrates.
Some medicines can be affected by Tadalafil 1A Farma or affect how well Tadalafil 1A Farma will work. Tell your doctor or pharmacist if you are already taking:
- alpha-blockers (used to treat high blood pressure or urinary tract symptoms related to benign prostatic hyperplasia )
- any other medicine for high blood pressure
- nitrates (for chest pain)
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia )
- protease inhibitors for the treatment of AIDS or HIV infection (ritonavir )
- phenobarbital, phenytoin and carbamazepine (antiepileptic drugs)
- rifampicin, erythromycin, or clarithromycin (to treat bacterial infections )
- medicines such as ketoconazole or itraconazole (to treat fungal infections)
- bosentan (another medicine used to treat pulmonary arterial hypertension )
- other treatments for erectile dysfunction (PDE5 inhibitors).
Tadalafil 1A Pharma with drink and alcohol
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 or pharmacist for advice before using this medicine. Do not use Tadalafil 1A Farma during pregnancy, unless it is necessary and you have discussed it with your doctor.
Do not breastfeed while taking these tablets, as it is not known whether the drug passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
When dogs were treated, a decrease in sperm was seen. A decrease in sperm has been seen in some men. It is unlikely that this decrease in sperm would lead to infertility.
Driving ability and use of machinery
Dizziness has been reported. Feel careful how you react to the tablets before driving a car or using machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tadalafil 1A Farma contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tadalafil 1A Pharma
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Swallow the tablet whole with a little water. Tadalafil 1A Farma 20 mg tablets can be divided into equal doses.
The tablet can be taken regardless of a meal.
For the treatment of erectile dysfunction
- Flexible dosing, if needed: The recommended starting dose is a 10 mg tablet before sexual intercourse. If the effect of this dose is too weak, the doctor can increase the dose by one to 20 mg. Tadalafil 1A Farma tablets are taken by mouth. You can take a Tadalafil 1A Farma up to 30 minutes before sexual intercourse. The effect of Tadalafil 1A Farma can persist up to 36 hours after tablet intake. Tadalafil 1A Farma 10 mg and 20 mg is intended for use before expected sexual intercourse and is not recommended for continuous use every day.
- Daily dosage: The recommended dose is one 5 mg tablet a day, taken at approximately the same time each day. The doctor may adjust the dose from one to 2.5 mg depending on how you react to Tadalafil 1A Farma. Dose one is then given as a 2.5 mg tablet. Since Tadalafil 1A Farma 2.5 mg is not available, other tadalafil drugs of this strength should be used. When you take Tadalafil 1A Farma once a day, you can get an erection at any time during the 24 hours, if you are sexually stimulated. The daily dosing of Tadalafil 1A Farma may be suitable for men who are expected to have sexual intercourse two or more times per week.
Do not take Tadalafil 1A Farma more than once per day.
It is important to remember that Tadalafil 1A Farma has no effect if you are not sexually stimulated. The need for foreplay for you and your partner is the same as when you have not taken any medication for erectile dysfunction.
Alcohol intake can affect your ability to get an erection and can temporarily lower your blood pressure. If you have taken or plan to take Tadalafil 1A Farma, avoid consuming large amounts of alcohol (0.8 per mille or more in the blood) as this may increase the risk of dizziness when standing up.
For the treatment of benign prostatic hyperplasia
Dose one is one 5 mg tablet a day, taken at about the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose is still one 5 mg tablet a day.
Do not take Tadalafil 1A Farma more than once daily.
For the treatment of pulmonary arterial hypertension
The usual dose is two 20 mg tablets once daily. You should take both tablets at the same time, one after the other. Your doctor may have prescribed only one 20 mg tablet daily if you have mild to moderate liver or kidney problems.
If you have taken too much Tadalafil 1A Farma
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you. You may experience some of the side effects described in section 4.
If you forget to take Tadalafil 1A Farma
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do not take a double dose to make up for a missed dose. You should not take Tadalafil 1A Farma more often than once a day.
If you stop taking Tadalafil 1A Farma
For the treatment of benign prostatic hyperplasia and pulmonary arterial hypertension: do not stop taking your tablets, unless your doctor has told you to do so.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are usually mild or moderate.
If you experience any of the following side effects, stop using the medicine and see a doctor immediately:
- allergic reactions with rash (frequency common, may affect up to 1 in 10 users).
- chest pain – do not use nitrates but see a doctor immediately (frequency common, may affect up to 1 in 10 users).
- priapism, prolonged and possibly painful erection after taking Tadalafil 1A Farma (frequency less common, may affect up to 1 in 100 users).If you get an erection that lasts continuously for more than 4 hours, consult a doctor immediately.
- sudden loss of vision (frequency rare, may affect up to 1 in 1,000 users).
Other side effects have been reported and are described below according to indication.
Side effects are in the treatment of erectile dysfunction or benign prostatic hyperplasia
Common (may affect up to 1 in 10 users):
- headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.
Uncommon (may affect up to 1 in 100 users):
- dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, pain in the eyes, difficulty breathing, presence of blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus (sound in the ears without an external sound source), swollen hands, feet or ankles, and tiredness.
Rare (may affect up to 1 in 1,000 users):
- fainting, seizures and temporary memory loss, swollen eyelids, red eyes, sudden deterioration or loss of hearing, hives (itchy red spots on the skin), bleeding from the penis, presence of blood in semen, and increased sweating
- heart attack and stroke have also been reported rarely in men taking tadalafil. Most had known heart problems before taking the drug.
- partial, temporary, or permanent visual impairment or loss of vision in one or both eyes.
A few additional rare side effects that were not observed in the clinical trials have been reported by men taking tadalafil. These are:
- migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin rash, disturbances in blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
The side effect of dizziness has been reported more often in men over 75 years of age taking tadalafil. Diarrhea has been reported more often in men over 65 years of age taking tadalafil.
Adverse effects in the treatment of pulmonary arterial hypertension
Very common (may affect more than 1 in 10 users):
- headache, flushing, nasal congestion and blocked sinuses, nausea, indigestion (including pain or discomfort in the stomach), muscle pain, back pain, and pain or discomfort in the arms and legs.
Common (may affect up to 1 in 10 users):
- blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal abdominal bleeding, facial swelling, acid reflux, migraine, irregular heartbeat, and fainting.
Uncommon (may affect up to 1 in 100 users):
- seizures, temporary memory loss, hives, profuse sweating, bleeding from the penis, presence of blood in semen and/or urine, high blood pressure, palpitations, sudden cardiac death, and tinnitus (ringing in the ears without an external sound source).
Most but not all men who reported palpitations, irregular heartbeats, heart attack, stroke, or sudden cardiac death had known heart problems before taking the drug. It is not possible to determine whether these reactions were directly related to tadalafil (see section “Side effects in the treatment of erectile dysfunction or benign prostatic hyperplasia” above).
How to store Tadalafil 1A Farma
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister card after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is tadalafil.One tablet contains 5 mg, 10 mg or 20 mg tadalafil.
- Other ingredients are lactose monohydrate, sodium lauryl sulfate, povidone K-12, crospovidone (type B), sodium stearyl fumarate in the tablet core; polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), titanium dioxide (E 171), talc, yellow iron oxide (E 172) in the film coating.
Appearance and package sizes of the medicine
5 mg film-coated tablets:
Other or yellow-colored, oval, film-coated tablet, approximately 8 x 4 mm. The tablet is marked with “5” on one side and plain on the other side.
10 mg film-coated tablets:
Other or yellow-colored, oval, film-coated tablet, approximately 11 x 6 mm. The tablet is marked with “10” on one side and plain on the other side.
20 mg film-coated tablets :
Other or yellow, oval, film-coated tablet, approximately 15 x 9 mm, with “20” debossed on one side. The other side of the tablet has two break notches.
The tablet can be divided into two or four equal doses.
The film-coated tablets are packed in aluminum/OPA/aluminum/PVC blisters or PVC/Aclar/PVC-aluminium blisters or PVC/Aclar/PVdC/PVC/aluminum blisters in a carton.
5 mg: 14×1, 24×1, 28×1 and 84×1 film-coated tablets.
10 mg: 4×1, 12×1 and 24×1 film-coated tablets.
20 mg: 4×1, 8×1, 12×1, 24×1 and 56×1 film-coated tablets.
Marketing Authorisation Holder
1A Farma A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
TEVA PHARMA, SLU, Polígono Industrial Malpica, C/C, no. 4, 50016, Zaragoza, Spain