Patient Information Leaflet (PIL) For Vitaros Cream

vitaros cream1. What Vitaros is and what it is used for

Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of cream.Vitaros is used to treat erectile dysfunction (ED) in men 18 years 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 counseling. After application of Vitaros the onset of erection is within 5 to 30 minutes. 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 Vitaros

Do 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 section 6).
  • 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 recent stroke
  • if your partner is pregnant, breast feeding or of childbearing potential unless you use a condom barrier.Warnings and precautionsTalk 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

    A condom should be used in the following situations:

    • your partner is pregnant or breastfeeding
    • 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 the urine.

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

    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 1 to 2 hours 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 not sure.

    Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of cream. Vitaros should be used as needed to achieve an erection. Each Vitaros AccuDose™ container is for single use only and should be properly discarded after use.

    For an erection: the starting dose should be recommended by a physician.

    Do not adjust your dose yourself. Talk to your doctor who will instruct you on proper technique for administration and accomodation of your dose.

    Do not apply Vitaros more than 2-3 times a week and only once per 24 hour period.

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

    Apply Vitaros to the tip of the penis within 5 to 30 minutes prior to attempting intercourse by following the instructions below:

    1. Wash your hands before applying Vitaros. Remove the AccuDose™ container from the foil pouch by tearing fully down the seal from the middle of the top edge. Remove the AccuDose™ container from the sachet. Save the sachet for discarding the used AccuDose™ container later. Remove the cap from the tip of the container.
    2. Grasp the tip of the penis with one hand and gently manipulate to widen the opening of the penis. Note: if you are not circumcised, first retract and hold the foreskin back prior to widening the opening of the penis.
    3. Hold the barrel of the AccuDose™ container between your fingers and place the tip of the container over the opening of the penis and carefully push down the plunger with your thumb or finger until all the cream is expelled from the AccuDose™ container barrel into the opening and surrounding skin

    Note: do not insert the tip of the AccuDose™ container into the opening of the penis.4. Hold the penis in an upright position for approximately 30 seconds to allow the cream to penetrate. There will likely be some cream that does not fit into the opening of the penis. The amount of extra cream will vary depending on the patient and it is not unusual that half of the dose will remain at the edge of the opening. Do not use a second AccuDose™ to compensate for cream not expelled into the opening of the penis. Any excess cream covering the opening may be rubbed gently into the opening and skin surrounding the application site with the tip of a finger.

    5. Remember each Vitaros dose is good for a single administration only. Replace the cap on the AccuDose™ container and place in the opened foil sachet, fold and discard in accordance with local requirements.

    6. Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.EFFECTS AFTER APPLICATION:

    Vitaros requires between 5 to 30 minutes 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 1 to 2 hours. 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 orgasm or ejaculation. After your erection is over your penis may feel full, warm, and somewhat sensitive to touch. These effects are normal and may last for a few hours.

    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 needed to have foreplay and sexual intercourse, you may need to have your dose increased. Similarly, if an erection lasts 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 your dose.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 the penis.

    Factors which may reduce your erection:

    • anxiety, fatigue, tension, and too much alcohol.
    • urination immediately after application may result in loss of medication.Children and adolescentsVitaros is not indicated for children or men below 18 years of age.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 4 hours. 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 gets them.

      If you get a long-lasting erection of more than 4 hours, contact your doctor immediately.

      Your doctor may reduce your dose of Vitaros or discontinue your treatment.

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

      You:

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

      Your partner:

      • mild vaginal burning or itching, vaginitis

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

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

      You:

      • light-headedness/dizziness
      • prolonged erection for more than 4 hours
      • 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

      Your partner:

      • vulvovaginal 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 Section 2).

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

      Duration of side effects:

      Most effects are short acting and resolve within 1-2 hoursReporting of side effects

      If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

      5. How to store Vitaros

      Keep this medicine out of the sight and reach of children.

      Do not use VITAROS after the expiry date which is stated on the carton, sachet and

      AccuDose™ container label after Exp.

      The expiry date refers to the last day of the month.

      Store in a refrigerator (2°C – 8°C).

      Do not freeze.

      Unopened sachets may be kept out of the refrigerator by the patient, at a temperature below 25°C for up to 3 days prior to use.

      At the end of this period, the product should be discarded if not used.

      Each dispenser is for single use only.

      Once opened, use immediately, discard any unused portion.

      Store in the original sachet in order to protect from light.

      Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.6. Contents of the pack and other information

      What VITAROS contains

      The active substance is Alprostadil

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

      Vitaros is available in unit cartons with four (4) single dose containers.

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

      What VITAROS looks like and contents of the pack

      Vitaros is a white to off-white cream supplied in AccuDose™, a single dose container.

      AccuDose™ is 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.

      Marketing Authorisation Holder

      Takeda UK Ltd
      Building 3
      Glory Park
      Glory Park Avenue
      Wooburn Green
      BUCKS
      HP10 0DF
      United Kingdom

      Manufacturer

      Takeda UK Ltd
      Building 3
      Glory Park
      Glory Park Avenue
      Wooburn Green
      BUCKS
      HP10 0DF

      United KingdomThis medicinal product is authorised in the Member States of the EEA under the following names:

      Vitaros 3mg/g cream

      Germany Vitaros

      ® HEXAL® 300 Mikrogramm/100 mg Creme

      UK Vitaros 3 mg/g cream

      France Vitaros 300 microgrammes, crème

      Spain Virirec 3 mg/g Crema

      Sweden Vitaros 3 mg/g Kräm

      Ireland Vitaros 3 mg/g Cream

      Belgium Vytaros 3 mg/g crème

      Luxembourg Vytaros 3 mg/g crème

      Netherlands Vitaros 300 microgram crème

      This leaflet was last revised in 09/2014.

      Other Sources of Information

      Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk.

      If you are looking to buy Vitaros Cream (you will need a private prescription), please go to www.ukmeds4u.com for your free consultation.

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