DUTASTERIDE/TAMSULOSIN TEVA-RATIO 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin Teva-ratio 0.5 mg/0.4 mg hard capsules EFG

Dutasteride/Tamsulosin hydrochloride

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dutasteride/Tamsulosin Teva-ratio and what is it used for
2. What you need to know before you take Dutasteride/Tamsulosin Teva-ratio
3. How to take Dutasteride/Tamsulosin Teva-ratio
4. Possible side effects
5. Storage of Dutasteride/Tamsulosin Teva-ratio
6. Contents of the pack and other information

1. What is Dutasteride/Tamsulosin Teva-ratio and what is it used for

Dutasteride/Tamsulosin is used in men to treat an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

Dutasteride/Tamsulosin is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medicines called alpha blockers.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making it easier to urinate and quickly improving symptoms.

2. What you need to know before you take Dutasteride/Tamsulosin Teva-ratio

Do not takeDutasteride/Tamsulosin Teva-ratio:

• if you are a woman (because this medicine is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanut, or any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• if you have severe liver disease.

If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to take dutasteride/tamsulosin.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients who took only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any disease that affects your liver, you may need some additional checks during your treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a while before the operation. Before the operation, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescents should avoid contact with the broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects the PSA serum test (prostate-specific antigen) used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking dutasteride/tamsulosin. Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher incidence of a more serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is not clear.

• Dutasteride/tamsulosin may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions related to taking dutasteride/tamsulosin.

Using dutasteride/tamsulosin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take dutasteride/tamsulosin with these medicines:

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

It is not recommended to take dutasteride/tamsulosin with these medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, which may increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 inhibitors (used to achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
• erythromycin (an antibiotic used to treat infections)
• paroxetine (an antidepressant)
• terbinafine (used to treat fungal infections)
• diclofenac (used to treat pain and inflammation).

Tell your doctor if you are taking any of these medicines.

Taking dutasteride/tamsulosin with food and drink

You should take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women should not take dutasteride/tamsulosin.

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

Dutasteride/tamsulosin has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.

Consult your doctor if a pregnant woman has been in contact with dutasteride/tamsulosin.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which may affect their ability to drive or operate machinery safely.

Do not drive or operate machinery if you are affected in this way.

Dutasteride/Tamsulosin Teva-ratio contains soy lecithin

This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.

Dutasteride/Tamsulosin Teva-ratio contains propylene glycol

This medicine contains 299.46 mg of propylene glycol monocaprylate, type II in each capsule (equivalent to more than 1 mg/kg/day, but less than 50 mg/kg/day of propylene glycol) and traces of propylene glycol in the black ink.

Dutasteride/Tamsulosin Teva-ratio contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Dutasteride/Tamsulosin Teva-ratio

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist.

If you do not take dutasteride/tamsulosin regularly, your PSA levels may be affected. If in doubt, consult your doctor or pharmacist again.

What dose should you take

The recommended dose is one capsule once a day, 30 minutes after the same meal each day.

How to take it

The capsules should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.

If you take moredutasteride/tamsulosinthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takedutasteride/tamsulosin

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

If you stop taking dutasteride/tamsulosin

Do not stop taking dutasteride/tamsulosin without consulting your doctor first.

If you have any other questions about the use of this medicine, 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

Symptoms of an allergic reaction can include:

• skin rash (which may itch)
• hives (like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs

Contact your doctor immediately if you experience any of these symptoms and stop taking this medicine.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful when getting up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

Signs of severe skin reactions can include:

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

Contact your doctor immediately if you have these symptoms and stop using this medicine.

Common side effects

These may affect up to 1 in 10 men:

• impotence (inability to achieve or maintain an erection)*
• reduced sex drive (libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sex*
• breast enlargement and breast tenderness (gynecomastia)
• dizziness

• In a small number of people, some of these side effects may continue after stopping this medicine.

Uncommon side effects

These may affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• fast heart rate (palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or hair growth

Rare side effects

These may affect up to 1 in 1,000 men:

• swelling of the eyelids, face, lips, arms, or legs (angioedema)
• fainting

Very rare side effects

These may affect up to 1 in 10,000 men:

• prolonged and painful erection of the penis (priapism)
• severe skin reactions (Stevens-Johnson syndrome)

Other side effects

Other side effects have been reported in a small number of men, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or rapid heart rate (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Teva-ratio

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store below 30°C.

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 protect the environment.

6. Container contents and additional information

Composition ofDutasteride/Tamsulosine Teva-ratio

The active ingredients are dutasteride and tamsulosine hydrochloride. Each capsule contains 0.5 mg of dutasteride (in a soft capsule) and 0.4 mg of tamsulosine hydrochloride (as modified release pellets).

The other components are:

Hard capsule shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Black ink (shellac, black iron oxide (E172), propylene glycol, ammonia solution, concentrated potassium hydroxide.

Contents of the soft dutasteride capsule:

Propylene glycol monocaprylate, type II (see section 2 "Dutasteride / Tamsulosine Teva-ratio contains propylene glycol")

Butylhydroxytoluene (E321)

Gelatin

Glycerol

Titanium dioxide (E171)

Triglycerides (medium chain)

Lecithin (may contain soybean oil) (see section 2 "Dutasteride / Tamsulosine Teva-ratio contains soy lecithin")

Contents of the tamsulosine pellets:

Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30 percent (contains sodium lauryl sulfate and polysorbate 80, see section 2 "Dutasteride / Tamsulosine Teva-ratio contains sodium")

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Hydrated colloidal silica

Calcium stearate

Appearance of the product and container contents

This medicinal product is presented in hard, oblong capsules, with a brown body and a beige cap, printed with C001 in black ink, approximately 24 mm in length.

Container sizes:

HDPE bottles: 7, 30, 90 and 180 (2 bottles of 90) capsules.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura, 11

Albatros B building, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Laboratorios LEON FARMA, S.A.

Navatejera Industrial Estate

La Vallina, s/n 24193 Navatejera – León

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:Dutasteride/Tamsulosinehydrochloride Teva 0.5 mg/0.4 mg, hard capsules

Belgium:Dutasteride/Tamsulosine Teva 0.5 mg/0.4 mg hard capsules / capsules / Hartkapseln

Denmark:Dutasterid/Tamsulosin-ratiopharm 0.5 mg + 0.4 mg Hartkapseln

Estonia:Dutasteride/Tamsulosine Teva

Spain:Dutasterida/Tamsulosina Teva-ratio 0.5 mg/0.4 mg hard capsules EFG

Finland:Dutasteride/Tamsulosinhydrochlorid ratiopharm 0.5 mg/0.4 mg capsule, hard

France:Dutastéride/Tamsulosine Teva 0.5 mg/0.4 mg capsule

Hungary:Duster Duo 0.5 mg/0.4 mg hard capsules

Iceland:Dutasteride/Tamsulosin Teva

Luxembourg:Dutasterid/Tamsulosin-ratiopharm 0.5 mg + 0.4 mg Hartkapseln

Latvia:Dutasteride/ Tamsulosine Teva 0.5 mg/0.4 mg hard capsules

Poland:DUTATEV

Portugal:Dutasterida + Tansulosina Teva

Slovenia:Dutrex Combo 0.5 mg/0.4 mg hard capsules

Dateof the last revision of this prospectus:July 2019

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es