5 mg, 10 mg, 20 mg film-coated tablets
tadalafil
What Tadalafil Sandoz is and what it is used for
Tadalafil Sandoz contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Sandoz 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 Sandoz has been shown to significantly improve the ability to have a hard, erect penis, sufficient for sexual intercourse.
- Tadalafil Sandoz 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 Sandoz will not help. It is important to remember that Tadalafil Sandoz 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 Sandoz 5 mg is used to treat adult men with urinary tract symptoms associated with a common 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 Sandoz improves blood flow and causes the muscles in the prostate and bladder to relax, 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 Sandoz 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 taking Tadalafil Sandoz
Do not take Tadalafil Sandoz 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 Sandoz, 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 Sandoz.
Keep in mind that sexual intercourse poses a possible risk to patients with heart disease because it
strains the heart more than usual. If you have heart problems, tell your doctor.
If you are being treated for benign prostatic hyperplasia with Tadalafil Sandoz 5 mg: 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 Sandoz for benign prostatic hyperplasia. Tadalafil Sandoz 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 Sandoz 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 Sandoz 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 Sandoz and contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Tadalafil Sandoz is not intended for use by women.
Children and young people
Tadalafil Sandoz is not intended for use by children and adolescents under 18 years of age.
Other medicines and Tadalafil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Sandoz if you are already taking nitrates.
Some medicines can be affected by Tadalafil Sandoz or affect how well Tadalafil Sandoz 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
- for the treatment of AIDS or HIV infection
- phenobarbital, phenytoin and carbamazepine (antiepileptic drugs)
- rifampicin, erythromycin, clarithromycin, or itraconazole
- other treatments for erectile dysfunction.
Tadalafil Sandoz with drink and alcohol
For information on the effect of alcohol, see section 3. Grapefruit juice can affect how well Tadalafil Sandoz will work and should be taken with caution. Talk to your doctor for more information.
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 Sandoz in clinical studies. 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 Sandoz contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Tadalafil Sandoz
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Tadalafil Sandoz tablets are taken by mouth and are intended for men only. Swallow the tablet whole with a little water. Tadalafil Sandoz 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 necessary with 10 mg or 20 mg film-coated tablets: 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 Sandoz tablets are taken by mouth. You can take a Tadalafil Sandoz up to 30 minutes before sexual intercourse. The effect of Tadalafil Sandoz can last up to 36 hours after tablet intake. Tadalafil Sandoz 10 mg and 20 mg is intended for use before expected sexual intercourse and is not recommended for continuous use every day.
- Daily dosage with 2.5 mg or 5 mg film-coated tablets: The recommended dose is one 5 mg tablet a day, taken at approximately the same time each day. The doctor may change the dose from one to 2.5 mg depending on how you react to Tadalafil Sandoz. Dose one is then given as a 2.5 mg tablet.When you take Tadalafil Sandoz 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 Sandoz may be appropriate for men who are expected to have sexual intercourse two or more times per week.
Do not take Tadalafil Sandoz more than once a day.
It is important to remember that Tadalafil Sandoz 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 Sandoz, avoid consuming large amounts of alcohol (0.8 per thousand 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 Sandoz more than once a day.
If you have taken too much Tadalafil Sandoz
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. You may experience the side effects described in section 4.
If you forget to take Tadalafil Sandoz
If you have daily dosing of Tadalafil Sandoz, take your dose as soon as you remember but do not take a double dose to make up for a missed dose . You should not take Tadalafil Sandoz 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 uncommon, may affect up to 1 in 100 users)
- chest pain – do not use nitrates but see a doctor immediately (frequency less common, may affect up to 1 in 100 users)
- priapism, prolonged and possibly painful erection after taking Tadalafil Sandoz (frequency rare, may affect up to 1 in 1,000 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:
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 the 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 has been reported in rare cases.
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 Sandoz
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 household waste. Question
pharmacists 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 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:
Ocher or yellow-coloured, 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:
Ocher or yellow-coloured, 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:
Ocher 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 aluminium/OPA/aluminium/PVC blisters or PVC/Aclar/PVC-aluminium blisters or PVC/Aclar/PVdC/PVC/aluminium blisters in a carton.
Package sizes:
5 mg: 14×1, 28×1 and 84×1 film-coated tablets.
10 mg: 4×1, 12×1, 24×1, 36×1 and 48×1 film-coated tablets.
20 mg: 2×1, 4×1, 5×1, 8×1, 10×1, 12×1, 24×1, 36×1, 48×1 and 56×1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
TEVA PHARMA, SLU, Polígono Industrial Malpica, C/C, nº4, 50016, Zaragoza, Spain