Patient leaflet - Tadalafil 10 mg film-coated tablets

1. What Tadalafil tablets are and what it is used for

Tadalafil tablets are a treatment for adult men with erection problems (erectile dysfunction). This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Tadalafil tablets contain the active substance tadalafil which belongs to a group of medicines called

phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation Tadalafil tablets works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis.

It is important to note that Tadalafil tablets do not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

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

Do not take Tadalafil tablets if you:

Do not have an erection problem, as this medicine will not provide any benefit to you.
Are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Take medicines called nitrates or nitric oxide donors (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate for the relief of chest pain or heart failure, or nicorandil, molsidomine or sodium nitroprusside), as the combination may lead to a dangerous fall in blood pressure.
Take amyl nitrate also known as “poppers” as recreational drugs, as the combination may lead to a dangerous fall in blood pressure.
Have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels, such as recent heart attack (within the last 90 days) or stroke (within the last 6 months), unstable angina or severe cardiac failure.
Have low blood pressure or
uncontrolled high blood pressure.
Ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
Are taking riociguat or other medicines belonging to a group called guanylate cyclase stimulators. This drug 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 secondary to blood clots).
Have a deformed penis (such as angulation, cavernosal fibrosis or Peyronie’s disease).
Are a woman.
Are under 18 years of age.

Warnings and precautions

Talk to your pharmacist or doctor before taking Tadalafil tablets.

Be aware that sexual activity can put an extra strain on your heart. If you have a heart problem or think you might have a heart problem you should tell your pharmacist or doctor.

It is important to have a check-up with your doctor as soon as possible within the first 6 months of using Tadalafil tablets to ensure that your erection problems are not caused by another serious health condition.

Even if you feel healthy, your erection problems may be linked to other serious health conditions. Erectile dysfunction may be an early sign of:

Heart and blood vessel problems
Diabetes
High blood pressure
Depression

You should discuss your symptoms and these conditions with your doctor if you have not already done so.

Cardiovascular risk factors

Before taking the tablets, in order to ensure this medicine is suitable for you and that you are fit enough to have sex, tell your doctor if you:

Get very breathless or feel any pain in the chest with light or moderate activity (e.g. walking briskly for 20 minutes or climbing two flights of stairs). Your doctor may need to check whether your heart can take the additional strain of having sex;
Have or have ever had any heart disease or heart surgery e.g. valvular heart disease (damaged or diseased heart valve), cardiomyopathy (disease of the heart muscle), arrhythmia (irregular heart beat);
Have high blood pressure that is not controlled;
Have an abnormal or impaired left lower heart chamber;
Have a restriction of the blood flow from the heart e.g. aortic stenosis;
Have Multiple System Atrophy (a rare condition causing severe loss of control of blood pressure due to a shrinkage of muscle or nerve tissue).

Other risk factors

Talk to your doctor before taking Tadalafil tablets if you:

Have ever had an erection that lasted more than 4 hours (called priapism) or have any condition which can cause priapism which includes sickle cell anaemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), or leukaemia (cancer of the blood cells).
Have any deformation of your penis.
Have a serious liver problem.
Have a severe kidney problem.
Take any other medicines listed in this leaflet. Please refer to section 2 ‘Other medicines and Tadalafil tablets'.

Speak your doctor if you have:

Undergone pelvic surgery.
Undergone removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy) as it is not known if Tadalafil tablets will be effective for you.
Known hereditary degenerative retinal disorders such as retinitis pigmentosa (a genetic disorder that causes loss of vision) as it is unknown whether tadalafil is safe for you to use.

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking tadalafil stop taking Tadalafil tablets and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil tablets and contact your doctor immediately.

Children and adolescents

Tadalafil tablets is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil tablets

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

Do not take Tadalafil tablets if you take:

NITRATE medicines (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate) or nitric oxide donors (such as amyl nitrite (“poppers”), nicorandil, molsidomine or sodium nitroprusside). These are often used for the relief of chest pain (angina pectoris), or heart failure. Using Tadalafil tablets with any of these medicines may lead to a dangerous fall in blood pressure.
Riociguat (or other medicines of a group called guanylate cyclase stimulators), 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 due to blood clots).

Some medicines may be affected by Tadalafil tablets or they may affect how well Tadalafil tablets will work. Tell your pharmacist or doctor if you are already taking:

An alpha blocker such as alfuzosin, doxazosin or tamsulosin, which are medicines used to treat urinary problems due to an enlarged prostate (benign prostatic hyperplasia) or occasionally high blood pressure.
Other medicines to treat high blood pressure.
Finasteride (a 5- alpha reductase inhibitor used to treat benign prostatic hyperplasia).
Itraconazole or ketoconazole tablets (medicines to treat fungal infections)
Ritonavir or saquinavir (protease inhibitors for treatment of AIDS or HIV infection).
Phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
Rifampicin, erythromycin or
clarithromycin (antibiotics).
Other treatments for erectile dysfunction.
Theophylline or terbutaline (to treat asthma).
Cimetidine (used to treat heartburn and stomach ulcers).

Package leaflet: Information for the user

Tadalafil

10 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you.

Keep this leaflet. You may need to read it again.
Ask your pharmacist or doctor if you need more information or advice.
If you get any side effects talk to your pharmacist or doctor. This includes any possible side effects not listed in this leaflet. See section 4.
If you have taken Tadalafil tablets as directed (see section 3) and were not able to get or keep an erection hard enough for satisfactory sex, you should talk to your pharmacist or doctor.

Tadalafil tablets with drink and alcohol

Grapefruit juice may affect how well Tadalafil tablets will work and must be avoided. Drinking excessive alcohol can temporarily reduce your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink large amounts of alcohol before sexual activity. Talk to your pharmacist or doctor for further information.

Recreational Drugs

Do not take amyl nitrite (also known as “poppers”) as recreational drugs, as the combination may lead to a dangerous fall in blood pressure.

Avoid the use of Tadalafil tablets with other recreational drugs (including but not limited to nitrous oxide, GHB/GBL, methamphetamines, MDMA/ecstasy, ketamine, flunitrazepam, cannabis, opioids, cocaine, etc.), as it may lead to side effects such as dizziness, decrease of blood pressure, stroke or heart attack, seizures, priapism, and coma.

Pregnancy, breastfeeding and fertility

This medicine should not be used by women

Driving and using machines

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

Tadalafil tablets contains lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Tadalafil tablets contains sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Tadalafil tablets

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

Take one tablet as needed, at least 30 minutes before sexual activity.
Swallow the tablet whole with some water.
Do not take more than 1 tablet a day.

You can get an erection, when sexually stimulated, in 30 minutes and for up to 36 hours after taking one Tadalafil tablet.

The tablets can be taken with or without food.

This medicine is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. Talk to your doctor if you feel you need to take this medicine every day.

It is important to note that Tadalafil tablets does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Remember to relax and be patient. There is no rush. If you are not successful the first time, try to have sex again, but remember you can only take one tablet a day. For most men, Tadalafil tablets will work the first or second time they try it. If it has been some time since you were able to get or keep an erection, it may take several attempts before you are able to achieve an erection. If you feel the effect of Tadalafil tablets is too strong or too weak, talk to your pharmacist or doctor.

Talk to your pharmacist or doctor if you have taken Tadalafil tablets as directed and are still not able to get and keep an erection.

If you take more Tadalafil tablets than you should

Contact your doctor. You may experience side effects described in section 4.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

Allergic reactions including rashes, sudden wheeziness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat (frequency uncommon).
Chest pain - If this occurs before, during or after intercourse, get in a semi-sitting position and try to relax. DO NOT use nitrates to treat chest pain but seek immediate medical assistance (frequency uncommon).
Priapism, a prolonged and possibly painful erection after taking tadalafil lasting longer than 4 hours (frequency rare).
Sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Stevens-Johnson Syndrome (SJS) which is a rare, serious disorder of the skin causing flu-like symptoms and a painful rash that spreads, and blisters.
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
- Headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)

Dizziness, stomachache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)

Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen, and increased sweating.

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

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

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:

Distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tadalafil tablets

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 and blister after ‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil tablets contains

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), Low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose, sodium laurilsulfate , magnesium stearate. Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide, yellow iron oxide, talc.

What Tadalafil tablets look like and contents of the pack

Tadalafil 10 mg is a Yellow, 9.60 mm x 5.20 mm, oval shaped, film-coated tablet, debossed with ‘T10’ on one side and plain on other side.

Tadalafil 10 mg is available in blister packs containing 2, 4, 8 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Northumbria Pharma Ltd.

NETPark,

Thomas Wright Way,

Sedgefield,

Stockton-on-Tees,

TS21 3FD,

Manufacturer

Northumbria Pharma Limited

NETPark Discovery 1,

William Armstrong Way,