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 Cialis Together 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

1. What Cialis Together tablets are and what they are used for
2. What you need to know before you take Cialis Together tablets
3. How to take Cialis Together tablets
4. Possible side effects
5. How to store Cialis Together tablets
6. Contents of the pack and other information

• 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 in this medicine (listed in section 6)
• take any 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 nitrite 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
• have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”
• take riociguat or other medicines belonging to a group called guanylate cyclase stimulators.
  These medicines are 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

Talk to your pharmacist or doctor before taking Cialis Together tablets.

Sexual activity can put 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 Cialis Together 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 Cialis Together 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 Cialis Together 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), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow)
• take any other medicines listed in this leaflet.
  Please refer to section 2 ‘Other medicines and Cialis Together tablets’
• have any deformation of your penis
• have a serious liver problem
• have a severe kidney problem

Speak to your doctor if you have:

• undergone pelvic surgery or 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 Cialis Together 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, stop taking Cialis Together 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 Cialis Together tablets and contact your doctor immediately.

Cialis Together tablets are not intended for use by children and adolescents under the age of 18.

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

• 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 Cialis Together 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 Cialis Together tablets or they may affect how well Cialis Together 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 to treat benign prostatic hyperplasia)
• Itraconazole or ketoconazole (medicines to treat fungal infections)
• Rifampicin, erythromycin or clarithromycin (antibiotics)
• Ritonavir or saquinavir (protease inhibitors for treatment of AIDS or HIV infection)
• Phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines)
• other treatments for erectile dysfunction
• Theophylline (to treat asthma)
• Cimetidine (used to treat heartburn and stomach ulcers)

Grapefruit juice may affect how well Cialis Together 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

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 Cialis Together 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.

This medicine should not be used by women.

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

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

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

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

• an allergic reaction: this occurs uncommonly.
  Symptoms include sudden wheeziness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, rashes
• chest pains: this occurs uncommonly. 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. Seek immediate medical help
• persistent and sometimes painful erection lasting longer than 4 hours: this occurs rarely
• a sudden decrease or loss of vision: this occurs rarely
• 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 (may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach ache, 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 (may affect up to 1 in 1000 people)

• 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 Cialis Together tablets. 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 Cialis Together tablets that were not seen in clinical trials. These include:

• 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 Cialis Together tablets. Diarrhoea has been reported more frequently in men over 65 years of age taking Cialis Together tablets.

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 the Yellow Card Scheme at: 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.

• The active substance is tadalafil. Each tablet contains 10mg of tadalafil.
• The other ingredients are:
  Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
  Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

Cialis Together tablets are a light yellow film-coated tablet in the shape of an almond and have “C 10” marked on one side.

Cialis Together tablets are available in blister packs containing 2, 4 or 8 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: