Tadalafil 20 Mg By Ranbaxy

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL31750/0131 .

Tadalafil SUN 20 mg film-coated tablets

Tadalafil 20 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tadalafil is and what it is used for
2. What you need to know before you take Tadalafil
3. How to take Tadalafil
4. Possible side effects
5. How to store Tadalafil
6. Contents of the pack and other information

Tadalafil is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). Following sexual stimulation Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil 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.

are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)
are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite (nitrates) used in the treatment of angina pectoris (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
have serious heart disease or have had a heart attack within the last 90 days
have had a stroke within the last 6 months
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”
are taking riociguat. 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). PDE5 inhibitors, such as Tadalafil, have been shown to increase the blood pressure lowering effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Tell your doctor before taking Tadalafil if you have:

a heart problem. Sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
sickle cell anaemia (an abnormality of red blood cells)
multiple myeloma (cancer of the bone marrow)
leukaemia (cancer of the blood cells)
any deformation of your penis
a serious liver problem
a severe kidney problem.

It is not known if Tadalafil is effective in patients who have had:

pelvic surgery
removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).

Contact your doctor immediately and stop taking Tadalafil if you experience:

sudden decrease or loss of vision
decreased or sudden hearing loss. This has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil.

Tadalafil is not intended for use by women.

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

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

Do not take Tadalafil if you are already taking:

Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work.

Tell your doctor or pharmacist if you are already taking:

an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia)
other medicines 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)
protease inhibitors for treatment of AIDS or HIV infection
phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines)
rifampicin, erythromycin, clarithromycin or itraconazole
other treatments for erectile dysfunction.

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to your doctor for further information.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Some men taking Tadalafil 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.

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

Tadalafil tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.

You may take a Tadalafil tablet at least 30 minutes before sexual activity.

Tadalafil may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil more than once a day. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

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 doctor or pharmacist.

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 (frequency uncommon)
chest pain – do not use nitrates but seek immediate medical assistance (frequency uncommon)
priapism, prolonged and possibly painful erection after taking Tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
sudden loss of vision (frequency rare)
sudden decrease or loss of hearing (frequency rare).

Common (may affect up to 1 in 10 people)

headache
back pain
muscle aches
pain in arms and legs
facial flushing
nasal congestion
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
feeling tired.

Rare (may affect up to 1 in 1,000 people)

fainting
seizures and passing memory loss
swelling of the eyelids
red eyes
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.

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.

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.

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 medicine 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.

The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, crospovidone type A, hydroxypropylcellulose (353-658 cps), poloxamer 188, colloidal silica anhydrous, magnesium stearate.
Film-coat: opadry II yellow: lactose monohydrate, hypromellose 2910/15, macrogol 6000, titanium dioxide (E171), iron oxide yellow (E172), talc.

Tadalafil 20 mg is a yellow coloured, 14.30 x 7.95 mm oval shaped, biconvex, film-coated tablet, 5.975 mm thick, debossed with “20” on one side and “S” on the other side.

Tadalafil 20 mg is available in blister packs containing 2, 4, 8, 10, 12, 28, 56, 84 or 98 tablets.

This medicinal product is authorised in the Member States of the EEA under the following names

This leaflet was last revised in 12/2022.