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Package leaflet: Information for the patient

Avolve 0.5 mg soft capsules

Dutasteride

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, pharmacist or nurse.

• 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.

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

6. Contents of the pack and other information

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).

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

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin, experienced heart failure than patients taking only dustasteride or only an alpha blocker. Heart failure means your heart does not pump blood as well as it should.

• Make sure your doctor knows about liver problems. If you have had any illness affecting your liver, you may need some additional check-ups while you are taking Avolve.

• Women, children and adolescents must not handle leaking Avolve capsules, because the active ingredient can be absorbed through the skin. Wash the affected area immediately with soap and water if there is any contact with the skin.

• 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 as dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility. This could reduce your fertility.

• Avolve affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and can still use the test to detect prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking Avolve. Men taking Avolve should have their PSA tested regularly.

• In a clinical study of men at increased risk of prostate cancer, men taking Avolve had a serious form of prostate cancer more often than men who did not take Avolve. The effect of Avolve on this serious form of prostate cancer is not clear.

• Avolve may cause breast enlargement and tenderness. If this becomes troublesome, or if you notice breast lumps or nipple discharge you should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.

 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:

• verapamil or diltiazem (for high blood pressure)

• ritonavir or indinavir (for HIV)

• itraconazole or ketaconazole (for fungal infections)

• nefazodone (an antidepressant)

• alpha-blockers (for enlarged prostate or high blood pressure).

 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.

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

• The recommended dose is one capsule (0.5 mg) taken once a day. Swallow the capsules whole with water. Do not chew or break open the capsule. Contact with the contents of the capsules may make your mouth or throat sore.

• Avolve is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Avolve for 6 months or more before it begins to have an effect. Keep taking Avolve for as long as your doctor tells you.

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:

• skin rash (which can be itchy)

• hives (like a nettle rash)

• swelling of the eyelids, face, lips, arms or legs.

 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:

• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Avolve.

• decreased sex drive (libido), this may continue after you stop taking Avolve.

• difficulty with ejaculation^*, this may continue after you stop taking Avolve.

• breast enlargement or tenderness (gynecomastia)

• dizziness when taken with tamsulosin.

Uncommon side effects

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

• heart failure (heart becomes less efficient at pumping blood around the body. You may have symptoms such as shortness of breath, extreme tiredness and swelling in your ankles and legs)

• hair loss (usually from the body) or hair growth

Not known side effects

The frequency cannot be estimated from the available data:

• depressed mood

• pain and swelling in your testicles

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:

• inside the capsule: mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321).

• capsule shell: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), triglycerides (medium chain), lecithin (may contain soya oil).

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}

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Manufacturer:

GlaxoSmithKline Pharmaceuticals S.A.

Ul. Grunwaldzka 189

60-322 Poznan

Poland

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