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Package leaflet: Information for the patient

Avolve 0.5 mg soft capsules


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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Avolve is and what it’s used for

2. What you need to know before you take Avolve

3. How to take Avolve

4. Possible side effects

How to store Avolve

6. Contents of the pack and other information

What is Avolve and what it is used for

Avolve is used to treat men with an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors.

As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention). This requires immediate medical treatment. In some situations surgery is necessary to remove or reduce the size of the prostate gland. Avolve lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery.

Avolve may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

What you need to know before you take Avolve

Do not take Avolve:

- if you’re allergic)to dutasteride, other 5-alpha reductase inhibitors,soya, peanutor to any of the other ingredients of this medicine (listed in section 6).

- if you have a severe liver disease.

If you think any of these apply to you, don’t take this medicine until you have checked with your doctor.

This medicine is for men only.It must not be taken by women, children or adolescents.

Warnings and precautions

Talk to your doctor before takingAvolve

Contact you doctor or pharmacist if you have any questions about taking Avolve.

Other medicines and Avolve

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

Some medicines can react with Avolve and may make it more likely that you’ll have side-effects. These medicines include:

Tell your doctor if you are taking any of these medicines. Your dose of Avolve may need to be reduced.

Avolve with food and drink

Avolve can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women who are pregnant (or may be) must not handle leaking capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male baby. This is a particular risk in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Avolve. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Avolve has been shown to reduce sperm count, semen volume and sperm movement. Therefore male fertility may be reduced.

Contact your doctor for advice if a pregnant woman has come into contact with dutasteride.

Driving and using machines

Avolve is unlikely to affect your ability to drive or operate machinery.

Avolve contains lecithin from soya

This medicine contains lecithin from soya, which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

How to take Avolve

Always take Avolve exactly as your doctor or pharmacist has told you to. If you do not take it regularly the monitoring of your PSA levels may be affected. Check with your doctor or pharmacist if you are not sure.

How much to take

If you take more Avolvethan you should

Contact your doctor or pharmacist for advice if you take too many Avolve capsules.

If you forget to take Avolve

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

Don’t stop Avolve without advice

Don’t stop taking Avolve without talking to your doctor first. It may take up to 6 months or more for you to notice an effect.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The signs of allergic reactions can include:

Contact you doctor immediately if you get any of these symptoms, and stop using Avolve.

Common side effects

These may affect up to 1 in 10 men taking Avolve:

Uncommon side effects

These may affect up to 1 in 100 men taking Avolve:

Not known side effects

The frequency cannot be estimated from the available data:

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Avolve

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

Don’t store Avolve above 30°C.

Do not use this medicineafter the expiry date which is stated on the carton or the foil blister strip. 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 Avolve contains

The active substance is dutasteride.Each soft capsule contains 0.5 mg dutasteride.

The other ingredients are:

What Avolve looks like and contents of the pack

Avolve soft capsules are oblong opaque, yellow, soft gelatin capsules marked with GX CE2. They are available in packs of 10, 30, 50, 60 and 90 capsules. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

To be completed nationally

Marketing Authorisation Holder:

{Name and address}





GlaxoSmithKline Pharmaceuticals S.A.

Ul. Grunwaldzka 189

60-322 Poznan


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

Avolve - Spain, Sweden

Avodart - Germany

This leaflet was last approved in 29 October 2015.

To be completed nationally