Erectile Dysfunction

The recommended dose is one 10 mg tablet taken at least 30 minutes prior to anticipated sexual activity.

Cialis Together 10 mg tablets are not recommended for continuous daily use. Men who use this product frequently (i.e.at least twice weekly) should consult their doctor to discuss whether a once daily regimen with the lowest doses of tadalafil would be more suitable.

Cialis Together may be taken with or without food.

The maximum dosing frequency is once per day.

Most men will achieve an erection the first or second time they use Cialis Together. However, patients should be advised that they may need to take Cialis Together a number of times on different occasions (a maximum of one 10 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity. If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a doctor.

• Hypersensitivity to the active substance or to any of the excipients of this medicine.

• Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, tadalafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite also known as “ poppers” , nicorandil or molsidomine) or nitrates in any form is therefore contraindicated.

• Cialis Together must not be used in men with cardiac disease for whom sexual activity is inadvisable.

• Cialis Together is contraindicated in the following groups of patients with cardiovascular disease, who were not included in clinical trials:

- patients with myocardial infarction within the last 90 days,

- patients with unstable angina or angina occurring during sexual intercourse,

- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension,

- patients with a stroke within the last 6 months.

• Cialis Together is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.

• Cialis Together should not be used in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease).

• Cialis Together is not indicated for use by women.

• Cialis Together is not intended for men without erectile dysfunction.

• Cialis Together is not intended for men under 18 years of age.

Uncommon (up to 1 in 100 people)

• allergic reactions including rashes.

• chest pain - do not use nitrates but seek immediate medical assistance.

Rare (up to 1 in 1,000 people)

• Priapism, a prolonged and possibly painful erection after taking tadalafil. If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

• sudden loss of vision. Not Known

• distorted, dimmed, blurred central vision or sudden decrease of vision

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

Other side effects have been reported:

Common (up to 1 in 10 people)

• headache

• back pain

• muscle aches

• pain in arms and legs

• facial flushing

• nasal congestion

• indigestion

Uncommon (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

• feeling tired

Rare (up to 1 in 1,000 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

• 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:

• 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

• sudden cardiac death

Not Known

• distorted, dimmed, blurred central vision or sudden decrease of vision

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.

See other products under erectile dysfunction.

https://www.medicines.org.uk/emc/files/pil.14803.pdf