What Tadalafil Orion is and what it is used for
Tadalafil Orion contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Orion 5 mg is 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 has been shown to significantly improve the ability to have a hard and erect penis, sufficient for sexual intercourse. Tadalafil 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 will not help. It is important to remember that tadalafil 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 improves blood flow and relaxes the muscles in 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 Orion 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 using Tadalafil Orion
Do not use Tadalafil Orion
Do not take Tadalafil Orion if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking medicines containing organic nitrates or nitric oxide donors such as amyl nitrite. These medicines (“nitrates”) are used to treat angina (chest pain). Tadalafil Orion 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 Orion, 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 before taking Tadalafil Orion.
Keep in mind that sexual intercourse poses a possible risk to 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 Orion for benign prostatic hyperplasia. Tadalafil Orion 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 Orion 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 Orion 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 Orion and contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Children and young people
Other medicines and Tadalafil Orion
Always tell your doctor if you are taking, have recently taken, or might take any other medicines. Do not take Tadalafil Orion if you are already taking nitrates.
Some medicines can be affected by Tadalafil Orion or affect how well Tadalafil Orion 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 to treat high blood pressure.
- 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 Orion with drink and alcohol
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 by some of the men taking Tadalafil Orion 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 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 Orion contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Tadalafil Orion contains sodium
How to use Tadalafil Orion
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Tadalafil Orion 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 Orion, 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 Orion works for you. You will then be prescribed another product containing tadalafil 2.5 mg.
Do not take Tadalafil Orion more than once per day.
When you take Tadalafil Orion 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 Orion may be suitable for men who have sexual intercourse two or more times per week.
It is important to remember that Tadalafil Orion 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 Orion more than once daily.
If you have used too much Tadalafil Orion
Contact your doctor. You may experience the side effects described in section 4.
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.
If you forget to use Tadalafil Orion
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 Orion more often than once a day.
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 (frequency less common).
- priapism, prolonged and possibly painful erection after taking Tadalafil Orion (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, 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, rash (itchy red small blisters on the skin), bleeding from the penis, presence of blood in semen, and increased sweating.
Heart attack and stroke have been reported rarely in men taking Tadalafil Orion. 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 more rare side effects, which were not observed in clinical trials, have been reported by men taking Tadalafil Orion. These are:
- migraine, facial swelling, severe allergic reaction causing swelling of the face or 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 Orion. Diarrhea has been reported more often in men over 65 years of age taking Tadalafil Orion.
How to store Tadalafil Orion
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, on the blister pack, or on the can label 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 film-coated tablet contains 5 mg of tadalafil.
- Other ingredients are Tablet core: copovidone, macrogol glycerol hydroxy stearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, magnesium stearate film coating: hypromellose, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172), triacetin.
Appearance and package sizes of the medicine
Light yellow, oval film-coated tablet marked “5” on one side and “TL” on the other side.
Tadalafil Orion film-coated tablets are packed in blister packs of transparent PVC/PVdC and aluminum foil and HDPE cans.
Blister packs: 4, 8, 12, 14, 28, 30, 56, 84 and 90 film-coated tablets.
Cans: 100 and 250 film-coated tablets
Marketing Authorisation Holder
Orion Indie 1
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD
Orion Corporation Orion Pharma
Orion Intie 1
Orion Corporation Orion Pharma
Generis Farmacêutica SA
Rua João de Deus, no. 19
Venda Nova, 2700-487 Amadora
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd, email@example.com