Sildenafil
Package leaflet: Information for the user
Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
Sildenafil
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.
What is in this leaflet
- What Sildenafil is and what it is used for
- What you need to know before you take Sildenafil
- How to take Sildenafil
- Possible side effects
- How to store Sildenafil
- Contents of the pack and other information
1. What Sildenafil is and what it is used for
Sildenafil contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil will only help you to get an erection if you are sexually stimulated. Sildenafil is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
2. What you need to know before you take Sildenafil Do not take Sildenafil:
- If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.
- If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
- If you 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 sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
- If you have a severe heart or liver problem.
- If you have recently had a stroke or a heart attack, or if you have low blood pressure.
- If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
- If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION)
Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil. Tell your doctor:
- If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow)
- If you have a deformity of your penis or Peyronie’s Disease.
- If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.
- If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
- If you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.
You should not use Sildenafil with any other oral or local treatments for erectile dysfunction. You should not use Sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors. You should not take Sildenafil if you do not have erectile dysfunction. You should not take Sildenafil if you are a woman.
Special considerations for patients with kidney or liver problems: You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.
Children and adolescents
Sildenafil should not be given to individuals under the age of 18.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines containing sacubitril/ valsartan, used to treat heart failure. Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor or pharmacist that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.
You should not take Sildenafil if you are taking medicines called nitrates as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).
You should not take Sildenafil if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure. Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil.
Some patients who take alpha- blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil. In order to reduce the chance that these symptoms might happen , you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.
Sildenafil with food, drink and alcohol
Sildenafil can be taken with or without food. However, you may find that Sildenafil takes longer to start working if you take it with a heavy meal.
Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.
Pregnancy, breast-feeding and fertility
Sildenafil is not indicated for use by women
Driving and using machines
Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil before you drive or use machinery.
Sildenafil contains lactose
Sildenafil film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.
Sildenafil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially ‘sodium-free’.
3. How to take Sildenafil
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.
You should not take Sildenafil more than once a day.
Do not take Sildenafil film-coated tablets in combination with Sildenafil orodispersible tablets.
You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil takes longer to work if you take it with a heavy meal.
If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
If you take more Sildenafil than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more tablets than your doctor tells you to.
Contact your doctor if you take more tablets than you should. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported in association with the use of Sildenafil are usually mild to moderate and of a short duration.
If you experience any of the following serious side effects stop taking Sildenafil and seek medical help immediately:
- An allergic reaction this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
- Chest pains (this occurs uncommonly) If this occurs during or after intercourse:
- Get in a semi-sitting position and try to relax
- Do not use nitrates to treat your chest pain
- Prolonged and sometimes painful erections -this occurs rarely (may affect up to 1 in 1,000 people) If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
- A sudden decrease or loss of vision - this occurs rarely
- Serious skin reactions -this occurs rarely
- Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
- Seizures or fits- this occurs rarely Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain,seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil.
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 the Yellow Card Scheme 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 Sildenafil
Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
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 Sildenafil contains
- The active substance is sildenafil. Each film-coated tablet contains 25 mg Sildenafil (as sildenafil citrate). Each film-coated tablet contains 50 mg Sildenafil (as sildenafil citrate). Each film-coated tablet contains 100 mg Sildenafil (as sildenafil citrate).
- The other ingredients are Tablet core: Calcium hydrogen phosphate, cellulose microcrystalline, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate. Tablet coat: Lactose monohydrate, hypromellose 15cP, titanium dioxide (E171), triacetin
What Sildenafil looks like and contents of the pack
Film-coated tablet Sildenafil 25 mg film-coated tablets White to off-white, round (7.1 mm diameter), biconvex film-coated tablets debossed with “SL” on one side and 25 on the other side.
Sildenafil 50 mg film-coated tablets White to off-white, round (9.6 mm diameter), biconvex film-coated tablets debossed with “SL” on one side and 50 on the other side.
Sildenafil 100 mg film-coated tablets White to off-white, round (11.2 mm diameter), biconvex film-coated tablets debossed with “SL” on one side and 100 on the other side.
Sildenafil film-coated tablets are available in blisters and HDPE bottle packs.
Blister pack:
25 mg: 2, 4, 8, 12 & 24 film- coated tablets
50 mg & 100 mg: 1, 2, 4, 8, 12 & 24 film-coated tablets
HDPE pack:
50 mg: 30, 1000 film-coated tablets
100 mg: 30, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000 Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 06/2022.
Package leaflet: Information for the user
TADALAFIL
10 mg and 20 mg Film-Coated Tablets tadalafil
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.
What is in this leaflet
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
1. What Tadalafil is and what it is used for
The name of your medicine is Tadalafil 10 mg and 20 mg film-coated Tablets (referred to as Tadalafil in this leaflet).
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.
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 (see section 3).
2. What you need to know before you take Tadalafil
Do not take Tadalafil 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 nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“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 recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- 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. 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 hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
- 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).
If you experience sudden decrease or loss of vision, stop taking Tadalafil 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 and contact your doctor immediately.
Tadalafil is not intended for use by women.
Children and adolescents
Tadalafil is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines available without prescription and herbal medicines.
Do not take Tadalafil if you are already taking nitrates.
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.
- riociguat.
- a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
- medicines such as ketoconazole tablets (to treat fungal infections) and 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.
Tadalafil with drink and alcohol
Information on the effect of alcohol is 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.
Fertility
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.
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 contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Tadalafil
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. If the effect of this dose is too weak your doctor may increase the dose to 20 mg.
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.
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.
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.
If you take more Tadalafil 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 doctor or pharmacist.
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 (frequency uncommon)
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon)
- priapism, a 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).
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, 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 (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:
- 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, pharmacist or nurse. 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.
5. How to store Tadalafil
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 contains
- The active substance is tadalafil. Each 10 mg tablet contains 10 mg of tadalafil. Each 20 mg tablet contains 20 mg of tadalafil.
The other ingredients are lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, povidone K-25, magnesium stearate, colloidal silicone dioxide and sodium laurilsulfate.
The tablet coating contains hypromellose, macrogol, titanium dioxide (E171), talc and yellow iron oxide (E172).
What Tadalafil looks like and contents of the pack
Tadalafil 10 mg: Yellow to light yellow, round shaped, bevelled edged, film coated tablet, debossed with ‘338’ on one side and plain on the other side.
Tadalafil 20 mg: Yellow to light yellow, oval shaped, bevelled edged, film coated tablet, debossed with ‘L 339’ on one side and plain on the other side.
Tadalafil 10 mg Tablets are available in blister packs of 4 film-coated tablets.
Tadalafil 20 mg Tablets are available in blister packs of 4 and 56 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR UK
Manufacturer
Waymade Plc, Josselin Road, Burnt Mills Industrial Estate, Basildon, Essex, SS13 1QF UK
This leaflet was last revised in November 2019
PL 06464/3092 Tadalafil 10 mg Film-Coated Tablets
PL 06464/3093 Tadalafil 20 mg Film-Coated Tablets
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: info@waymade.co.uk