Caverject 10microgram powder and solvent for solution for injection vials

Caverject is used in the diagnosis and treatment of erectile dysfunction in men. Caverject works by relaxing muscles in the walls of the blood vessels which increases the flow of blood to the penis. This helps to produce an erection which should normally last up to an hour and is suitable for sexual activity.

Treatment with Caverject does not protect you or your partner from sexually transmitted diseases. Men who are at risk of passing on infections to their partner during sexual activity, should use a condom.

Caverject is not suitable for women.

Other information about Caverject:

Caverject needs to be injected. Your prescriber will show you how to inject this medicine yourself.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Some medicines work best if they are taken at a specific time of day. If someone is giving you this injection, the person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

If you are injecting this medicine yourself, make sure that you have Caverject at the recommended time.

This medicine needs to be injected. Your medical team will train you how to inject the medicine yourself. For more information see the Patient Information Leaflet or contact one of your medical team.

In the case of Caverject:

If you have any concerns about this medicine or about the process of having it you should talk to someone who is involved in your medical care.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

If you are not having any problems with this medicine, you may keep having it until you no longer need it or your prescriber advises you to stop using it.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Caverject:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Caverject is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Caverject can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Caverject has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 men who take Caverject

• penile pain

Common: More than 1 in 100 men who take Caverject

• blocked nose
• bruising or collection of blood under the skin at the injection site
• connective tissue problems such as Peyronie's disease, scarring or formation of nodules on the penis - seek medical advice if your penis becomes bent or if you develop any lumps or scars on the penis
• cough
• feeling dizzy
• flu or flu-like symptoms
• headaches
• pain in the leg, genitals, buttocks, back or stomach
• penile oedema
• prolonged erections - seek immediate medical advice if an erection lasts for more than four hours
• prostate problems
• raised blood pressure
• sinusitis
• skin rash or rashes
• upper respiratory tract infection

Uncommon: More than 1 in 1000 men who take Caverject

• abnormal laboratory test results
• blood in the urine
• circulation problems
• dry mouth
• eye or eyesight problems
• heart problems
• hypesthesia
• injection site problems such as inflammation, infection, bleeding or redness
• itching
• leg cramps
• lowered blood pressure
• nausea
• pelvic pain
• penile and testicular disorders such as feelings of warmth, numbness, irritation, sensitivity, swellings, formation of cysts, narrowing of the opening of the foreskin, painful erection or abnormal ejaculation
• skin neoplasms
• sweating
• urinary problems
• urinary urgency
• urinating more often
• vasodilatation
• weakness

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Caverject:

The following types of medicine may interact with Caverject:

If you are taking Caverject and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Caverject.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Caverject can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Caverject:

Alcohol can interact with certain medicines.

In the case of Caverject:

This medicine must not be taken by women so its effects in pregnancy are not known.

This medicine must not be taken by women so its effects on breast-feeding are not known.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Caverject contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Caverject before, do not have Caverject. Talk to your prescriber, pharmacist or nurse as soon as possible.