5 mg film-coated tablets
tadalafil
What Tadalafil STADA is and what it is used for
Tadalafil Stada contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Stada 5 mg is used to treat adult men with:
- erectile dysfunction. This means that a man cannot get, or maintain, a hard and erect penis, sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to have a hard and erect penis, sufficient for sexual intercourse. Tadalafil Stada 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 Stada will not help. It is important to remember that Tadalafil Stada 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.
- urinary tract symptoms are associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland becomes larger with increasing age. Symptoms include difficulty passing water, a feeling of not being able to empty the bladder, and having to pass water more often, even at night. Tadalafil Stada 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 contained in Tadalafil Stada may also be approved to treat other conditions 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 you use Tadalafil STADA
Do not use Tadalafil STADA
- if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)
- if you take medicines containing 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
- if you have a serious heart condition or have recently had a heart attack within the last 90 days.
- if you have recently had a stroke within the last 6 months.
- if you have low blood pressure or uncontrolled high blood pressure.
- if you have ever lost your sight due to non-arteritic anterior ischemic optic neuropathy (NAION), the so-called ‘stroke in the eye’.
- if you take 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, have been shown to increase the blood pressure-lowering effect of this drug. 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 Stada.
Keep in mind that sexual intercourse poses 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.
As benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will investigate you regarding prostate cancer before starting treatment with Tadalafil Stada for benign prostatic hyperplasia.
Tadalafil Stada 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)
- deformed penis
- severe liver disease
- severe kidney disease.
It is not known whether Tadalafil Stada 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 taking Tadalafil Stada 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 related to tadalafil, you should stop taking Tadalafil Stada and contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Tadalafil Stada is not intended for use by women.
Children and young people
Tadalafil Stada is not intended for use by children and adolescents under 18 years of age.
Other medicines and Tadalafil STADA
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Stada if you are already taking nitrates.
Some medicines can be affected by Tadalafil Stada or affect how well Tadalafil Stada 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
- riociguat
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia )
- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors to treat AIDS or HIV infection.
- phenobarbital, phenytoin and carbamazepine (antiepileptic drugs)
- rifampicin, erythromycin, clarithromycin, or itraconazole.
- other treatments for erectile dysfunction.
Tadalafil STADA with food, drink, and alcohol
For information on the effect of alcohol, see section 3. Grapefruit juice can affect how well Tadalafil Stada will work and should be taken with caution. Talk to your doctor for more information.
Pregnancy, breastfeeding, and fertility
Fertility
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 reduction in sperm would lead to infertility.
Driving ability and use of machinery
Dizziness has been reported by some of the men taking tadalafil in clinical trials. Feel how you react to the tablets before driving 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/or 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 STADA contains lactose and sodium
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Tadalafil STADA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Tadalafil Stada tablets are taken by mouth and are intended for men only. Swallow the tablet whole with a little water. The tablet can be taken regardless of a meal.
Alcohol intake can temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Stada, 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 erectile dysfunction
The recommended dose is one 5 mg tablet a day, taken at about the same time each day. Your doctor may change the dose from one to 2.5 mg depending on how Tadalafil Stada works for you. Dose one is then given as a 2.5 mg tablet.
It is not possible to use 5 mg tablets for all dosage recommendations; tadalafil may also be available as 2.5, 10, and 20 mg tablets. Not all strengths may be marketed.
Do not take Tadalafil Stada more than once per day.
When you take Tadalafil Stada 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 Stada may be appropriate for men who have sexual intercourse two or more times per week.
It is important to remember that Tadalafil Stada 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.
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 Stada more than once daily.
If you use too much Tadalafil STADA
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. You may experience the side effects described in section 4.
If you forget to use Tadalafil STADA
Take your dose as soon as you remember but do not take a double dose to make up for a missed tablet. You should not take Tadalafil Stada more often than once a day.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 less common)
- chest pain – do not use nitrates but see a doctor immediately
- prolonged and possibly painful erection after taking Tadalafil Stada (frequency rare). If you get an erection that lasts continuously for more than 4 hours, consult a doctor immediately
- sudden loss of vision (frequency rare).
Other side effects have been reported:
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, 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 fatigue.
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, rash (itchy red small blisters on the skin), bleeding from the penis, presence of blood in the semen, and increased sweating.
Heart attack and stroke have 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 has been reported rarely.
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.
How to store Tadalafil STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton or blister 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
Contents declaration
- The active substance is tadalafil.
One film-coated tablet contains 5 mg tadalafil.
- Other ingredients are:
Tablet core:
Lactose
Croscarmellose sodium
Sodium lauryl sulfate
Hydroxypropyl cellulose
Polysorbate 80
Magnesium stearate
Film coating:
Hypromellose 2910 (E464)
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
Talc (E553b)
Appearance and package sizes of the medicine
Yellow, capsule-shaped, biconvex, film-coated tablet, marked “T5” on one side and plain on the other, with nominal dimensions of 8.2 mm x 4.1 mm.
Packs of 14, 28, or 84 film-coated tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
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61118 Bad Vilbel
Germany
Other manufacturers
Genepharma SA
18:th km Marathonos Avenue, 15351 Pallini Athens
Greece
Combino Pharm (Malta) Ltd.
HF60, Hal Far Industrial Estate, Hal Far BBG3000
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC, Etten-Leur
Netherlands
Local representative
STADA Nordic ApS
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2730 Herlev
Denmark