DUTASTERIDE/TAMSULOSIN STADA 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Patient Information Leaflet: Information for the Patient

Dutasteride/Tamsulosin Stada 0.5 mg/0.4 mg hard capsules EFG

dutasteride/tamsulosin hydrochloride

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

• Keep this leaflet, as 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 experience 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 Stada and what is it used for
2. What you need to know before you take Dutasteride/Tamsulosin Stada
3. How to take Dutasteride/Tamsulosin Stada
4. Possible side effects
5. Storage of Dutasteride/Tamsulosin Stada
6. Contents of the pack and further information

1. What is Dutasteride/Tamsulosin Stada 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 inhibitorsand 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 remove it.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate 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 Stada

Do not take Dutasteride/Tamsulosin Stada:

• if you are a woman (as 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 can make 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 take this medicine until you have spoken to your doctor.

Warnings and precautions

Talk to your doctor before taking Dutasteride/Tamsulosin Stada.

• 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 additional monitoring 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, tell your eye specialist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them before). Your specialist will need to take appropriate precautions to avoid complications during the operation.

• Women, children, and adolescentsshould avoid contact with broken dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, wash the affected area immediatelywith water and soap.

• 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 can 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 blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test to check your PSA, tell 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 were more likely to have a 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 pain. If this bothers you, or if you notice lumps in the breastor nipple discharge, talk to your doctor, as these changes can be signs of a serious disease, such as breast cancer.

• Talk to your doctor or pharmacistif you have any questions about taking dutasteride/tamsulosin.

Other medicines and Dutasteride/Tamsulosin Stada

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

Do not take Dutasteride/Tamsulosin Stada with these medicines:

• other alpha blockers (for an 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 can 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 AIDS)
• 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 doctorif you are taking any of these medicines.

Taking Dutasteride/Tamsulosin Stada with food

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 may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and can 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.

• Talk to your doctorif a pregnant woman has come into 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 machineryif you are affected in this way.

Dutasteride/Tamsulosin Stada contains soybean lecithin, propylene glycol, and sodium

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

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

This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Dutasteride/Tamsulosin Stada

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, the control of 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 more Dutasteride/Tamsulosin Stada than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Dutasteride/Tamsulosin Stada

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

Do not stop taking Dutasteride/Tamsulosin Stada without advice

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

If you have any further questions on 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 can itch)
• hives (like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs
• Contact your doctor immediatelyif you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin can 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 passed.

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 immediatelyif you have these symptoms and stop using dutasteride/tamsulosin.

Common side effects

These can affect up to 1 in 10 men taking dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sex*

• breast enlargement and pain (gynecomastia)
• dizziness

• In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

Uncommon side effects

These can affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood through 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 can affect up to 1 in 1,000 men:

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

Very rare side effects

These can 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 frequency is not known (the frequency cannot be estimated from the available data):

• abnormal or rapid heart rhythm (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 side effects

If you experience 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 to the Spanish Medicines Monitoring System: 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 Stada

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

Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dutasterida/Tamsulosina Stada

The active ingredients are dutasteride and tamsulosina hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosina hydrochloride (equivalent to 0.367 mg of tamsulosina).

The other components are:

• Hard capsule shell: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin
• Content of the soft dutasteride capsule: propylene glycol monocaprylate type II, butylhydroxytoluene (E321)
• Soft capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, lecithin (may contain soybean oil) (see section 2)
• Tamsulosina pellets: methacrylic acid-ethyl acrylate copolymer 1:1 dispersion 30 percent (containing sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose, dibutyl sebacate, polysorbate 80, hydrated colloidal silica, calcium stearate
• Black ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520), concentrated ammonia solution (E527), and potassium hydroxide (E525)

See section 2 "Dutasterida/Tamsulosina Stada contains soybean lecithin, propylene glycol, and sodium".

Product Appearance and Container Content

This medication is presented in hard gelatin capsules, oblong, approximately 24.2 mm x 7.7 mm, with a brown body and a beige cap, printed with C001 in black ink.

Each hard capsule contains modified-release pellets of tamsulosina hydrochloride and a soft gelatin capsule with dutasteride.

They are available in packs of 7, 30, 90, and 180 (2 x 90) capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios LEÓN FARMA, SA

C/La Vallina, s/n, Polígono Industrial Navatejera

Villaquilambre-24193 (León)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus:August 2019

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