Dutasteride/tamsulosin Teva-Ratio 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dutasteride/Tamsulosin Teva-ratio is and what it is used for
2. What you need to know before taking Dutasteride/Tamsulosin Teva-ratio
3. How to take Dutasteride/Tamsulosin Teva-ratio
4. Possible adverse effects
5. How to store 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 known as 5-alpha reductase enzyme inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

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

Dutasteride reduces the production of dihydrotestosterone, helping to shrink 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 urination easier and rapidly improving symptoms.

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

Do not take Dutasteride/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, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanuts, or to 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 causes fainting (orthostatic hypotension)
• if you have severe liver disease.

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

Warnings and precautions

Talk to your doctor before starting 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 taking only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood as well as it should.

• Make sure your doctor knows if you have liver problems. If you have any condition affecting your liver, you may need additional monitoring during treatment with dutasteride/tamsulosin.

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

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

• Women, children, and adolescents must avoid contact with broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If skin contact occurs, wash the affected area 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 suspects she might be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.

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

• In a clinical study conducted in men at increased risk of prostate cancer, men who took dutasteride more frequently developed a more serious type of prostate cancer compared to those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is unclear.

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

Talk to your doctor or pharmacist if you have any questions about taking dutasteride/tamsulosin.

Mood changes and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic group (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Taking dutasteride/tamsulosin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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, increasing the risk of adverse effects. Some of these medicines are:

• PDE5 enzyme 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).

Inform 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 must not take dutasteride/tamsulosin.

Pregnant women (or women who might be pregnant) must avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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 suspects she might be pregnant, you must avoid exposing her to your semen.

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

Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which could 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 lecithin from soy

This medicine contains lecithin from soy. It must not be used if you are allergic to peanuts or soy.

Dutasteride/Tamsulosin Teva-ratio contains propylene glycol

This medicine contains 299.46 mg of monocaprylate propylene glycol, type II, in each capsule (equivalent to more than 1 mg/kg/day but less than 50 mg/kg/day of propylene glycol) and trace amounts 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 exactly the instructions for use of this medicine provided by your doctor or pharmacist.

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

What dose should you take

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

How to take it

The capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more dutasteride/tamsulosin than you should

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

If you forget to take dutasteride/tamsulosin

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

If you stop taking dutasteride/tamsulosin

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• rash (which may be itchy)
• hives (such as urticaria)
• 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, rarely, fainting. You should be cautious when standing 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 passed.

Serious skin reactions

Signs of serious skin reactions may include:

• widespread rash with blistering 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.

Frequent adverse effects

These may affect up to 1 in 10 men:

• impotence (inability to achieve or maintain an erection)*

• decreased sex drive (libido)*

• ejaculation disorders, such as reduced amount of semen released during sexual intercourse*

• enlargement of the breast and tenderness (gynecomastia)

• dizziness

• In a small number of people, one or more of these adverse events may continue after stopping this medicine.

Uncommon adverse effects

These may affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth

Rare adverse effects

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

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

Very rare adverse effects

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

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

Other adverse effects

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 outer packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Teva-ratio

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

The other components are:

Hard capsule shell:

Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Gelatin
Black ink (shellac, iron oxide black (E172), propylene glycol, ammonium hydroxide solution, potassium hydroxide concentrate)

Contents of the dutasteride soft capsule:

Propylene glycol monocaprylate, type II (see section 2 “Dutasteride / Tamsulosin Teva-ratio contains propylene glycol”)
Butylhydroxytoluene (E321)
Gelatin
Glycerol
Titanium dioxide (E171)
Medium-chain triglycerides
Lecithin (may contain soybean oil) (see section 2 “Dutasteride / Tamsulosin Teva-ratio contains soybean lecithin”)

Contents of the tamsulosin pellets:

Methacrylic acid copolymer and ethyl acrylate (1:1) dispersion 30% (contains sodium lauryl sulfate and polysorbate 80, see section 2 “Dutasteride / Tamsulosin Teva-ratio contains sodium”)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Calcium stearate

Appearance of the product and pack contents

This medicine is supplied as hard, oblong capsules with a brown body and beige cap, printed with "C001" in black ink, approximately 24 mm in length.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.
C/ Anabel Segura, 11
Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid (Spain)

Manufacturer:

Laboratorios LEON FARMA, S.A.
Polígono Industrial Navatejera
C/ La Vallina, s/n
24193 Navatejera – León
Spain

This medicinal product is authorized in the European Economic Area member states 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 / gélules / 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 kapseli, kova
France: Dutastéride/Tamsulosine Teva 0.5 mg/0.4 mg gélule
Hungary: Duster Duo 0.5 mg/0.4 mg tvrde kapsule
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 cietas kapsulas
Poland: DUTATEV
Portugal: Dutasterida + Tansulosina Teva
Slovenia: Dutrex Combo 0.5 mg/0.4 mg trde kapsule

Date of the latest revision of this leaflet: July 2019

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/84718/P_84718.html