What is Tadalafil used for?

Patient Info Service - information for patients

1. What Tadalafil Mylan is and what it is used for

Tadalafil Mylan is used to treat adult men with erectile dysfunction. This occurs when a man cannot get or maintain a hard, erect penis for sexual activity. Tadalafil showed marked improvement in getting a hard, erect penis for sexual activity.

Tadalafil Mylan contains the active substance tadalafil and belongs to a group of medicines called "phosphodiesterase 5 inhibitors". After sexual stimulation, Tadalafil Mylan helps relax the blood vessels in your penis, allowing blood to flow into your penis. The result is an improved erection. Tadalafil Mylan will not help you if you do not have erectile dysfunction.

It is important to note that without sexual stimulation, tadalafil will not work. Foreplay in partnership may be necessary, just as if you had not taken an erectile dysfunction medicine.

2. What you need to know before you take Tadalafil Mylan.

Do not take Tadalafil Mylan if you:

- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

  • are taking any form of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina (a type of “heart pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrates or are unsure, talk to your doctor.

  • have severe heart disease or have had a heart attack in the past 90 days.

  • have had a stroke in the past 6 months.

  • have low or uncontrolled high blood pressure.

  • have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), this disorder is described as "stroke of the eye".

  • Take riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs in addition to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to increase the blood pressure lowering effects of this medicine. If you are taking riociguat or are unsure, talk to your doctor.

Warnings and Precautions

Talk to your doctor before taking Tadalafil Mylan.

Please note that sexual activity carries a potential risk for patients with heart disease because it puts a strain on your heart. If you have heart disease you should tell your doctor.

Talk to your doctor before taking the tablets if you have:

  • Sickle cell anemia (changes in red blood cells)

  • multiple myeloma (bone marrow cancer)

  • Leukemia (cancer of the blood cells)

  • a deformation (deformation) of your penis

  • severe liver disease

  • severe kidney disease

It is not known whether tadalafil will be effective in patients who have:

  • an operation in the pelvic area

  • a complete removal of the prostate or parts of it that has severed prostate nerves (non-nerve-sparing technique)

If you experience any sudden decrease or loss of vision, stop taking Tadalafil Mylan and contact a doctor immediately.

Tadalafil Mylan should not be used by women.

Children and adolescents

Tadalafil Mylan is not for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Mylan

Tell your doctor if you are taking, have recently taken, or may take any other medicines.

Do not take Tadalafil Mylan if you are already using nitrates.

Some medicines could be affected by Tadalafil Mylan, or they could affect how well Tadalafil Mylan works. Tell your doctor or pharmacist if you are already taking the following medicines:

  • Alpha blockers (used to treat high blood pressure or urinary tract problems due to a benign enlarged prostate)

  • other medicines to treat high blood pressure

  • Riociguat

  • 5-alpha reductase inhibitors (used to treat benign enlarged prostate)

  • Medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors (used to treat AIDS or HIV disease)

  • Phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines)

  • Rifampicin, erythromycin, clarithromycin or itraconazole

  • other medicines to treat erectile dysfunction

Tadalafil Mylan with drink and alcohol

Grapefruit juice may affect how well Tadalafil Mylan works and should therefore be taken with caution. Talk to your doctor for more information.

Drinking alcohol can temporarily lower your blood pressure. If you have taken Tadalafil Mylan or if you plan to take Tadalafil Mylan, avoid excessive drinking (blood alcohol levels of 0.8 ‰ and more) as this may increase the risk of dizziness when standing up.

Fertility

Treated dogs showed a decrease in sperm production in the testes. A decrease in sperm has been seen in some men. It is unlikely that this will lead to a reduction in fertility.

Driving and using machines

Some men who took tadalafil in clinical trials have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Mylan contains lactose

Therefore, please only take this medicine after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Tadalafil Mylan contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

3. How to take Tadalafil Mylan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dosage is too little, your doctor may increase the dosage to 20 mg. Tadalafil Mylan is for oral use.

You should take tadalafil at least 30 minutes before sexual activity.

Tadalafil can work for up to 36 hours after taking the tablet.

Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 mg and 20 mg are intended to be taken before expected sexual activity and daily use for long periods is not recommended.

Tadalafil Mylan tablets are for men only. Swallow the whole tablet with a little water. You can take the tablets with or without food.

If you take more Tadalafil Mylan than you should

Let your doctor know. You may experience side effects as described in section 4.

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

4. What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them. These are usually mild to moderate in severity.

Stop treatment and call a doctor immediately if you notice any of the following side effects:

  • allergic reactions including skin rashes (frequency uncommon).

  • Chest pain - do not use nitrates; get medical attention immediately (frequency uncommon).

  • Priapism, a prolonged and possibly painful erection, may occur after taking tadalafil (frequency rare). If you have an erection that lasts for more than 4 hours, contact your doctor immediately.

  • sudden loss of vision (frequency rare).

Other side effects have been reported:

Often (may affect 1 to 10 people in 100):

  • Headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion, and indigestion.

Occasionally (may affect 1 to 10 people in 1,000):

  • Dizziness, stomach pain, malaise, nausea (vomiting), reflux, blurred vision, eye pain, shortness of breath, blood in the urine, prolonged erection, palpitations, fast heart rate, high blood pressure, low blood pressure, nosebleed, ringing in the ear, swelling of the hands, or feet Ankles and feeling tired.

Rare (may affect 1 to 10 people in 10,000):

  • Fainting, seizures and temporary memory loss, swelling of the eyelids, red eyes, sudden partial or complete hearing loss, hives (itchy red bumps on the surface of the skin), penile bleeding, blood in the semen and increased sweating.

Heart attack and stroke have been reported rarely in patients taking tadalafil. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent deterioration, or loss of vision in one or both eyes have rarely been reported.

Some more rare side effectsnot seen in clinical trials have been reported in men taking tadalafil. These include:

  • Migraines, swelling of the face, severe allergic reactions causing swelling of the face or neck, severe reddening of the skin, some conditions that affect the flow of blood to the eye, irregular heartbeat, tightness of the heart (angina pectoris), and sudden death.

Dizziness as a side effect has been seen more frequently in men over 75 years of age after taking tadalafil. Diarrhea has been seen more frequently in men over 65 years of age after taking tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

These medicinal products do not require any special storage conditions.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

6. Contents of the pack and other information

What Tadalafil Mylan contains

- The active ingredient is tadalafil. Each tablet contains 10 mg of tadalafil.

- The other ingredients are:

Tablet core: lactose monohydrate (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose, povidone (K-25), croscarmellose sodium, magnesium stearate, sodium dodecyl sulfate, colloidal anhydrous silicon dioxide.

Film coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), iron (III) hydroxide oxide x H2O (E 172), triacetin.

What Tadalafil Mylan looks like and contents of the pack

Tadalafil Mylan 10 mg is a light yellow, round, biconvex, film-coated tablet, debossed with “M” on one side of the tablet and “TL3” on the other side.

Tadalafil Mylan 10 mg is available in blister packs of 4, 12 and 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharmaceutic entrepreneur

Mylan S.A.S.

117 Allée des Parcs

69800 Saint-Priest

France

Manufacturer

McDermott Laboratories Ltd. t / a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

For more information about the medicine, please contact the local representative of the Marketing Authorization Holder.

Germany

Mylan Healthcare GmbH

Tel: + 49 800 0700 800

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/ available.

This leaflet was last revised in July 2019.