DUTASTERIDE/TAMSULOSIN Aurovitas 0.5 mg/0.4 mg Hard Capsules

Introduction

Patient Information Leaflet

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

Dutasteride/Tamsulosin Hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Leaflet

1. What is Dutasteride/Tamsulosin Aurovitas and what is it used for
2. What you need to know before taking Dutasteride/Tamsulosin Aurovitas
3. How to take Dutasteride/Tamsulosin Aurovitas
4. Possible side effects
5. Storage of Dutasteride/Tamsulosin Aurovitas
6. Package contents and additional information

1. What is Dutasteride/Tamsulosin Aurovitas 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 excessive production of a hormone called dihydrotestosterone.

This medication is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications called alpha blockers.

As the prostate grows, it can cause urinary problems such as difficulty in urinating and frequent need to urinate. It can also cause the urine flow to be weaker. 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 acts by relaxing the muscles of the prostate, making it easier to urinate and quickly improving symptoms.

2. What you need to know before taking Dutasteride/Tamsulosin Aurovitas

Do not take dutasteride/tamsulosin:

• If you are a woman (because this medication 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, or any of the other components of this medication (listed in section 6).
• If you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• If you have a severe liver disease.

• If you think you are in any of these situations, do not take this medication until you have consulted your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• In some clinical studies, there were more patients taking dutasteride and another medication 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 had any disease that affects your liver, you may need 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 previously). Your specialist will need to take appropriate precautions to avoid complications during the operation.

• Women, children, and adolescents should 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, the affected area should be washed immediately with 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 fertility.

• This medication affects the PSA blood test (prostate-specific antigen) used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, although they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking this medication. Men being treated with this medication 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 serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is unclear.

• This medication 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 can be signs of a serious disease, such as male breast cancer.

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

Using dutasteride/tamsulosin with other medications

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

Do not take dutasteride/tamsulosin with these medications:

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

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

• Ketoconazole (used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin, which can increase the risk of side effects. Some of these medications 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 (for fungal infections).
• Diclofenac (used to treat pain and inflammation).

• Tell your doctor if you are taking any of these medications.

Taking dutasteride/tamsulosin with food, drinks, and alcohol

You should take this medication 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 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. Therefore, it may reduce male fertility.

• Consult your doctor if a pregnant woman has come into contact with dutasteride/tamsulosin.

Driving and using machines

Some people may experience dizziness during treatment with this medication, which can affect their ability to drive or operate machinery safely.

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

This medication contains orange yellow S (E110) and sodium

This medication can cause allergic reactions because it contains orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Dutasteride/Tamsulosina Aurovitas

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you do not take this medication 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 taken 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 than 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 medication and the amount ingested.

If you forget to take Dutasteride/Tamsulosina Aurovitas

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/Tamsulosina Aurovitas without consulting your doctor

Do not stop taking this medication without consulting your doctor first.

If you have any other questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction can include:

• Rash (which can 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 medication.

Dizziness, lightheadedness, and fainting

This medication 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 medication affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

The 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 medication.

Common side effects(may affect up to 1 in 10 men)

• Impotence (inability to achieve or maintain an erection)*.
• Decreased libido*.
• Difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse*.
• Enlargement of the breast or tenderness (gynecomastia).
• Dizziness.
  • *In a small number of people, some of these events may continue after stopping this medication.

Uncommon side effects(may 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).
• Decreased blood pressure when standing up.
• Abnormally fast heart rate (palpitations).
• Constipation, diarrhea, vomiting, nausea.
• Weakness or loss of strength.
• Headache.
• Itching, stuffy or runny nose (rhinitis).
• Rash, hives, itching.
• Hair loss (usually from the body) or excessive hair growth.

Rare side effects(may affect up to 1 in 1,000 men)

• Swelling of the eyelids, face, lips, arms, or legs (angioedema).
• Fainting.

Very rare side effects(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 occurred in a small number of men, but their 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dutasteride/Tamsulosin Aurovitas

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

Do not use this medication after the expiration date stated on the packaging and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dutasterida/Tamsulosina Aurovitas

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

• The other components are:

Composition of the hard capsule shell:

Cap :hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), orange yellow S (E110), and red iron oxide (E172).

Body: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), black iron oxide (E172), and red iron oxide (E172).

Content of soft dutasteride capsule:

Monocaprylocaprylate glycerol (Type-I) and butylhydroxytoluene (E321).

Soft capsule shell: gelatin (160 bloom), glycerol, titanium dioxide (E171), and yellow iron oxide (E172).

Tamsulosin hydrochloride pellets:microcrystalline cellulose (Grade-101), talc, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30 percent (contains 0.7% sodium lauryl sulfate and 2.3% polysorbate 80), triacetin, and calcium stearate.

Black printing ink:shellac (E904), black iron oxide (E172), and potassium hydroxide.

Appearance of the Product and Container Content

Hard capsules, size “00”, with an opaque orange cap marked with “DTT” in black ink and an opaque brown body marked with “0.5/0.4” in black ink. The size is approximately 23.5 mm.

Each capsule contains a soft gelatin dutasteride capsule, oblong, opaque, yellowish in color, containing a clear to pale yellow viscous oil and tamsulosin hydrochloride pellets, white to off-white in color.

Dutasterida/Tamsulosina Aurobindo is available in blister packs and HDPE bottles.

Container sizes:

Blister:7, 30, 50, and 90 hard capsules.

HDPE bottle:30, 90, and 500 hard capsules.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Germany: Dutasterid/Tamsulosin PUREN 0.5 mg/0.4 mg Hartkapseln

Belgium: Dutasteride/Tamsulosine HCl AB 0.5 mg/0.4 mg, harde capsules

Spain: Dutasterida/Tamsulosina Aurovitas 0.5 mg/0.4 mg cápsulas duras EFG

France: Dutastéride/Tamsulosine Arrow 0.5 mg/0.4 mg, gélule

Czech Republic: Dutasterid/Tamsulosin Aurovitas

Netherlands: Dutasteride/Tamsulosine HCl Aurobindo 0.5/0.4 mg, harde capsules

Portugal: Dutasterida + Tansulosina Aurovitas

Romania: Dutasterida/Tamsulosin Aurobindo 0.5 mg/0.4 mg capsule

Date of the Last Revision of this Leaflet:June 2019

Detailed 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)