VITAROS 3 MG / G CREAM ALPROSTADIL 3 MG / G CREAM - patient leaflet, side effects, dosage | Patient info (2024)

Vitaros® 3 mg/g cream

(alprostadil)

1. what vitaros is and what it is used for

Vitaros is available in two dosage strengths of 200and 300mcg alprostadil in 100mg of cream. Vitaros is used to treat erectile dysfunction (ED) in men 18years of age or older. ED is the inability to attain or maintain an erection sufficient for sexual intercourse. There are several causes of ED including medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, and hormonal problems. Often ED is due to more than one cause. Treatments for ED include switching medications, if you are taking a medication that causes ED, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow to the penis, penile implants and psychological counselling. After application of Vitaros the onset of erection is within 5to 30minutes. You should not stop taking any prescription medications, unless told to do so by your doctor.

2. what you need to know before you use vitarosdo not use vitaros if you have underlying disorders such as drop in blood pressure when going from a lying/sitting to a standing position, history of a heart attack, and syncope (dizziness)

• if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section6)
• if you have a condition that might result in a long-lasting erection or a condition such as sickle cell anaemia or trait, thrombocythemia, polycythemia, multiple myeloma, or leukaemia
• if you have an abnormally formed penis
• if you have an inflammation or infection of the penis
• if you are prone to a venous thrombosis
• if you have a hyperviscosity syndrome which could result in a long-lasting erection
• if you have been told not to have sex for health reasons such as heart problems or a recentstroke
• if your partner is pregnant, breast-feeding or of childbearing potential unless you use a condom barrier.

Warnings and precautions

Talk to your doctor or pharmacist before using Vitaros if you have a history of the following local effects that have been observed with the use of Vitaros:

• Prolonged erections lasting >4 hours (priapism)
• Symptomatic hypotension (dizziness)
• Hepatic and/or renal insufficiency, a lowered dose due to impaired metabolism may be required
• Fainting

Acondom should be used in the following situations:

• Your partner is pregnant or breast-feeding
• Your partner is of childbearing potential
• To prevent sexually transmitted diseases
• During oral sex and anal sex

Only latex condoms have been studied. It is not known if condoms made of other materials may be damaged.

Other medicines and Vitaros

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

The use of Vitaros with other drugs used to treat Erectile Dysfunction have not been studied. Therefore, if you are taking other drugs for ED, do not combine with Vitaros as there could be signs including dizziness, fainting and prolonged erections. Vitaros has not been tested for use with penile implants or smooth muscle relaxants such as papaverine; drugs used to induce erections such as alpha blocking drugs (e.g. intracavernosal phentolamine, thymoxamine). There is a risk of priapism (painful prolonged abnormal erection) when used in combination.

Although not studied, it is possible that Vitaros may have less of an effect when taken in combination with treatments for high blood pressure, decongestants and appetite suppressants.

If you are taking drugs to prevent blood clots, do not take Vitaros as there may be an increased risk for bleeding or blood found in theurine.

In combination with high blood pressure medication, Vitaros use may increase symptoms of dizziness and fainting, especially in the elderly.

Pregnancy and breast-feeding and fertility

There are no data on the use of Vitaros in pregnant women. Pregnant women should not be exposed to Vitaros.

It is not recommended to use Vitaros while breast-feeding.

It is not known whether Vitaros has an effect on human male fertility.

Driving and using machines

Vitaros may make you feel dizzy or faint. Do not drive or operate machinery within 1to 2hours after administration.

3. How to use Vitaros

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are notsure.

The onset of effect is within 5to 30minutes after administration. The duration of effect is approximately 1to 2hours. But, the actual duration can vary from patient to patients.

It is recommended to urinate before applying the drug. After removing the cap, apply all the contents of Vitaros into the opening at the tip of the penis, 5to 30minutes before attempting intercourse by following the instructionsbelow:

Wash your hands before applying Vitaros. Remove the AccuDose container (see Fig. 1) from the sachet by tearing fully down the seal from the middle of the top edge. Save the sachet for discarding the used AccuDose containerlater.

2.

4.

5.

6.

Fig. 4

Fig. 5

Gently move any excess cream inside the opening

Fig. 6

Bring the content of the AccuDose container to room temperature by rolling the container between your hands (see Fig. 2). This step can be avoided if the sachet was removed from the refrigerator earlier (within the time limits stated in Section 5How to store Vitaros) and the contents have already reached room temperature.

Hold the penis in an upright position for approximately 30seconds to allow the cream to penetrate. There will likely be some cream that does not initially fit into the opening at the tip of the penis. Any excess cream covering the opening at the tip of the penis should be gently moved into the opening with the tip of a finger (see Fig. 6). Do not use a second AccuDose to compensate for cream not expelled into the opening at the tip of the penis. Do not urinate immediately after application, due to the risk that drug could come out before the effect takesplace.

If you use more Vitaros than you should

Overdose with Vitaros requiring treatment has not been reported. Overdose with Vitaros may result in a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolonged erection lasting longer than 4hours. This can result in permanent worsening of erectile function. Call your doctor promptly if you suffer with any of these effects.

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

4. possible side effects

Like all medicines, Vitaros can cause side effects, although not everybody getsthem.

If you get a long-lasting erection of more than 4hours, contact your doctor immediately. Your doctor may reduce your dose of Vitaros and discontinue your treatment.

Common side effects (may affect more than 1in 10patients):

You:

• mild to moderate local aching, burning or pain and redness of thepenis
• rash
• genital pruritus
• penile oedema
• inflammation of the glans penis (balanitis)
• penile tingling, throbbing numbness, burning
• mild vagin*l burning or itching, vaginitis

This effect may be due to the drug or to the act of vagin*l penetration. Using a water-based lubricant can help to make vagin*l penetration easier.

Uncommon but potentially serious side effects (may affect up to 1in 100patients):

You:

• light-headedness/diz­ziness
• prolonged erection for more than 4hours
• fainting
• low blood pressure or rapid pulse
• pain at the application site or in extremity
• urethral stenosis
• increase in sensitivity
• penile itching
• genital rash
• scrotal pain
• fullness in genitals
• lack of sensation to penis
• urinary tract inflammation
• vulvovagin*l pruritus

*Increased sexual/physical activity in combination with Vitaros may increase the risk of heart attack or stroke in patients with underlying disease/risk factors (see Section2).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Duration of side effects:

Most effects are short acting and resolve within 1–2hours

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: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 vitaros

• Keep out of the sight and reach of children.
• Do not use Vitaros after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of themonth.
• Store in a refrigerator (2oC– 8oC).
• Do not freeze.
• Unopened sachets may be kept out of the refrigerator by the patient, at a temperature up to 25oC for up to 3days prior to use. At the end of this period, the product should be discarded if notused.
• Store in the original sachet in order to protect fromlight.
• Each dispenser is for single use only.
• Once opened, use immediately, discard any unused portion.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat vitaros containsthe active substance is alprostadil.

Each single dose container contains 300micrograms of alprostadil in 100mg of cream (3mg/g).

The other ingredients are purified water; ethanol, anhydrous; ethyl laurate; hydroxypropyl guar gum; dodecyl-2-(N,N-dimethylamino)-propionate hydrochloride; potassium dihydrogen phosphate; sodium hydroxide, for pH adjustment and phosphoric acid, for pH adjustment.

What Vitaros looks like and contents of the pack

Vitaros is a white to off-white cream supplied in AccuDoseTM, a single dose container. AccuDoseTMis a container consisting of a plunger, barrel and protective cap. Each container is provided in a protective sachet. The sachets are composed of aluminium foil/laminate. The container components are composed of polypropylene and polyethylene.

Vitaros is available in unit cartons with four (4) single dose containers. Each single container contains 100mgcream.

Manufactured by

Bracco s.p.a., Via Caduti di Marcinelle, 13– 20134Milan,Italy.

Dompe farmaceutici s.p.a., Via Campo di Pile snc, 67100L'Aquila, Italy. Ferring GmbH, Wittland 11, 24109Kiel, Germany.

Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS98ER.

Repackaged by MPT Pharma Ltd.

PL: 33532/0690

Leaflet dated 14thFebruary 2019

Leaflet coded XXXXXXXXXX

POM

Vitaros®and AccudoseTMare registered trademarks of Ferring International CenterS.A.

Other Sources of Information

Detailed information on this medicine is available on the MHRA website:

EFFECTS AFTER APPLICATION:

Vitaros requires between 5to 30minutes to begin working before you can have sexual intercourse. After administration you can engage in foreplay, which helps arousal and the process of developing an erection. An effective dose of Vitaros should produce an erection sufficient for sexual intercourse. The duration of the effect is approximately 1to 2hours. However, the actual duration will vary from patient to patient and the dose of the drug. Vitaros may not create an erection comparable to those you experienced when you were younger. Some patients may experience some mild pain, a burning sensation, and aching in the penis or groin area. Also, your erection may continue for a time after org*sm or ejacul*tion. After your erection is over your penis may feel full, warm, and somewhat sensitive to the touch. These effects are normal and may last for a fewhours.

ADDITIONAL INFORMATION AND PRACTICAL TIPS:

You and your doctor will determine the appropriate dose of Vitaros. If your erection cannot be maintained for the time need to have foreplay and sexual intercourse, you may need to have your dose increased. Similarly, if an erection last longer than desired or if the side effects are not well tolerated you may need your dose reduced. Call your doctor if you suspect that you may require an adjustment of yourdose.

Factors that may enhance your erection:

• Being well rested.
• Sexual foreplay with your partner or self-stimulation while sitting or lying after application of Vitaros.
• Pelvic exercises such as tightening and releasing your pelvic and buttock muscles. These are the muscles you use to stop urination.
• Various positions that may favour and not restrict blood flow to thepenis.
• Anxiety, fatigue, tension, and too much alcohol.
• Urination immediately after application may result in loss of medication.

To request a copy of this leaflet in Braille, large print or audio please call 01922745645and ask for the Regulatory Department.

Alprostadil 3 mg/g cream

3. How to use Alprostadil

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are notsure.

1. what alprostadil is and what it is used for

Alprostadil is available in two dosage strengths of 200and 300mcg alprostadil in 100mg of cream. Alprostadil is used to treat erectile dysfunction (ED) in men 18years of age or older. ED is the inability to attain or maintain an erection sufficient for sexual intercourse. There are several causes of ED including medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, and hormonal problems. Often ED is due to more than one cause. Treatments for ED include switching medications, if you are taking a medication that causes ED, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow to the penis, penile implants and psychological counselling. After application of Alprostadil the onset of erection is within 5to 30minutes. You should not stop taking any prescription medications, unless told to do so by your doctor.

2. what you need to know before you use alprostadild* not use alprostadil if you have underlying disorders such as drop in blood pressure when going from a lying/sitting to a standing position, history of a heart attack, and syncope (dizziness)

• if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section6)
• if you have a condition that might result in a long-lasting erection or a condition such as sickle cell anaemia or trait, thrombocythemia, polycythemia, multiple myeloma, or leukaemia
• if you have an abnormally formed penis
• if you have an inflammation or infection of the penis
• if you are prone to a venous thrombosis
• if you have a hyperviscosity syndrome which could result in a long-lasting erection
• if you have been told not to have sex for health reasons such as heart problems or a recentstroke
• if your partner is pregnant, breast-feeding or of childbearing potential unless you use a condom barrier.

Warnings and precautions

Talk to your doctor or pharmacist before using Alprostadil if you have a history of the following local effects that have been observed with the use of Alprostadil:

• Prolonged erections lasting >4 hours (priapism)
• Symptomatic hypotension (dizziness)
• Hepatic and/or renal insufficiency, a lowered dose due to impaired metabolism may be required
• Fainting

Acondom should be used in the following situations:

• Your partner is pregnant or breast-feeding
• Your partner is of childbearing potential To prevent sexually transmitted diseases During oral sex and analsex

Only latex condoms have been studied. It is not known if condoms made of other materials may be damaged.

Other medicines and Alprostadil

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

The use of Alprostadil with other drugs used to treat Erectile Dysfunction have not been studied. Therefore, if you are taking other drugs for ED, do not combine with Alprostadil as there could be signs including dizziness, fainting and prolonged erections. Alprostadil has not been tested for use with penile implants or smooth muscle relaxants such as papaverine; drugs used to induce erections such as alpha blocking drugs (e.g. intracavernosal phentolamine, thymoxamine). There is a risk of priapism (painful prolonged abnormal erection) when used in combination.

Although not studied, it is possible that Alprostadil may have less of an effect when taken in combination with treatments for high blood pressure, decongestants and appetite suppressants.

If you are taking drugs to prevent blood clots, do not take Alprostadil as there may be an increased risk for bleeding or blood found in theurine.

In combination with high blood pressure medication, Alprostadil use may increase symptoms of dizziness and fainting, especially in the elderly.

Pregnancy and breast-feeding and fertility

There are no data on the use of Alprostadil in pregnant women. Pregnant women should not be exposed to Alprostadil.

It is not recommended to use Alprostadil while breast-feeding.

It is not known whether Alprostadil has an effect on human male fertility.

Driving and using machines

Alprostadil may make you feel dizzy or faint. Do not drive or operate machinery within 1to 2hours after administration.

The onset of effect is within 5to 30minutes after administration. The duration of effect is approximately 1to 2hours. But, the actual duration can vary from patient to patients.

It is recommended to urinate before applying the drug. After removing the cap, apply all the contents of Alprostadil into the opening at the tip of the penis, 5to 30minutes before attempting intercourse by following the instructionsbelow:

Wash your hands before applying Alprostadil. Remove the AccuDose container (see Fig. 1) from the sachet by tearing fully down the seal from the middle of the top edge. Save the sachet for discarding the used AccuDose containerlater.

2.

4.

Gently squeeze to widen the opening

6.

Fig. 6

Gently move any excess cream inside the opening

Bring the content of the AccuDose container to room temperature by rolling the container between your hands (see Fig. 2). This step can be avoided if the sachet was removed from the refrigerator earlier (within the time limits stated in Section 5How to store Alprostadil) and the contents have already reached room temperature.

Hold the penis in an upright position for approximately 30seconds to allow the cream to penetrate. There will likely be some cream that does not initially fit into the opening at the tip of the penis. Any excess cream covering the opening at the tip of the penis should be gently moved into the opening with the tip of a finger (see Fig. 6). Do not use a second AccuDose to compensate for cream not expelled into the opening at the tip of the penis. Do not urinate immediately after application, due to the risk that drug could come out before the effect takesplace.

7.Remember each Alprostadil dose is suitable for a single administration only. Replace the cap on the tip of the AccuDose container and place in the opened foil sachet, fold and discard in accordance with local requirements.

If you use more Alprostadil than you should

Overdose with Alprostadil requiring treatment has not been reported. Overdose with Alprostadil may result in a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolonged erection lasting longer than 4hours. This can result in permanent worsening of erectile function. Call your doctor promptly if you suffer with any of these effects.

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

4. possible side effects

Like all medicines, Alprostadil can cause side effects, although not everybody getsthem.

If you get a long-lasting erection of more than 4hours, contact your doctor immediately. Your doctor may reduce your dose of Alprostadil and discontinue your treatment.

Common side effects (may affect more than 1in 10patients):

You:

• mild to moderate local aching, burning or pain and redness of thepenis
• rash
• genital pruritus
• penile oedema
• inflammation of the glans penis (balanitis)
• penile tingling, throbbing numbness, burning
• mild vagin*l burning or itching, vaginitis

This effect may be due to the drug or to the act of vagin*l penetration. Using a water-based lubricant can help to make vagin*l penetration easier.

Uncommon but potentially serious side effects (may affect up to 1in 100patients):

You:

• light-headedness/diz­ziness
• prolonged erection for more than 4hours
• fainting
• low blood pressure or rapid pulse
• pain at the application site or in extremity
• urethral stenosis
• increase in sensitivity
• penile itching
• genital rash
• scrotal pain
• fullness in genitals
• lack of sensation to penis
• urinary tract inflammation
• vulvovagin*l pruritus

*Increased sexual/physical activity in combination with Alprostadil may increase the risk of heart attack or stroke in patients with underlying disease/risk factors (see Section2).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Duration of side effects:

Most effects are short acting and resolve within 1–2hours

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: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 alprostadil

• Keep out of the sight and reach of children.
• Do not use Alprostadil after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of themonth.
• Store in a refrigerator (2oC– 8oC).
• Do not freeze.
• Unopened sachets may be kept out of the refrigerator by the patient, at a temperature up to 25oC for up to 3days prior to use. At the end of this period, the product should be discarded if notused.
• Store in the original sachet in order to protect fromlight.
• Each dispenser is for single use only.
• Once opened, use immediately, discard any unused portion.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat alprostadil containsthe active substance is alprostadil.

Each single dose container contains 300micrograms of alprostadil in 100mg of cream (3mg/g).

The other ingredients are purified water; ethanol, anhydrous; ethyl laurate; hydroxypropyl guar gum; dodecyl-2-(N,N-dimethylamino)-propionate hydrochloride; potassium dihydrogen phosphate; sodium hydroxide, for pH adjustment and phosphoric acid, for pH adjustment.

What Alprostadil looks like and contents of the pack

Alprostadil is a white to off-white cream supplied in AccuDoseTM, a single dose container. AccuDoseTMis a container consisting of a plunger, barrel and protective cap. Each container is provided in a protective sachet. The sachets are composed of aluminium foil/laminate. The container components are composed of polypropylene and polyethylene.

Alprostadil is available in unit cartons with four (4) single dose containers. Each single container contains 100mgcream.

Manufactured by

Bracco s.p.a., Via Caduti di Marcinelle, 13– 20134Milan,Italy.

Dompe farmaceutici s.p.a., Via Campo di Pile snc, 67100L'Aquila, Italy. Ferring GmbH, Wittland 11, 24109Kiel, Germany.

Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS98ER.

Repackaged by MPT Pharma Ltd.

PL: 33532/0690

Leaflet dated 14thFebruary 2019

Leaflet coded XXXXXXXXXX

POM

Vitaros®and AccudoseTMare registered trademarks of Ferring International CenterS.A.

Other Sources of Information

Detailed information on this medicine is available on the MHRA website:

EFFECTS AFTER APPLICATION:

Alprostadil requires between 5to 30minutes to begin working before you can have sexual intercourse. After administration you can engage in foreplay, which helps arousal and the process of developing an erection. An effective dose of Alprostadil should produce an erection sufficient for sexual intercourse. The duration of the effect is approximately 1to 2hours. However, the actual duration will vary from patient to patient and the dose of the drug. Alprostadil may not create an erection comparable to those you experienced when you were younger. Some patients may experience some mild pain, a burning sensation, and aching in the penis or groin area. Also, your erection may continue for a time after org*sm or ejacul*tion. After your erection is over your penis may feel full, warm, and somewhat sensitive to the touch. These effects are normal and may last for a fewhours.

ADDITIONAL INFORMATION AND PRACTICAL TIPS:

You and your doctor will determine the appropriate dose of Alprostadil. If your erection cannot be maintained for the time need to have foreplay and sexual intercourse, you may need to have your dose increased. Similarly, if an erection last longer than desired or if the side effects are not well tolerated you may need your dose reduced. Call your doctor if you suspect that you may require an adjustment of yourdose.

Factors that may enhance your erection:

• Being well rested.
• Sexual foreplay with your partner or self-stimulation while sitting or lying after application of Alprostadil.
• Pelvic exercises such as tightening and releasing your pelvic and buttock muscles. These are the muscles you use to stop urination.
• Various positions that may favour and not restrict blood flow to thepenis.
• Anxiety, fatigue, tension, and too much alcohol.
• Urination immediately after application may result in loss of medication.