DUTASTERIDE/TAMSULOSIN VIATRIS 0.5 mg/0.4 mg HARD CAPSULES

2. What you need to know before you take Dutasteride/Tamsulosin Viatris

Do not take Dutasteride/Tamsulosin Viatris

• 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, peanutor any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressurewhich 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 spoken to your doctor.

Warnings and precautions

Talk to 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 to have extra 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, tell your eye specialist that you are taking dutasteride/tamsulosin (or have taken it in the past). Your specialist will need to take special 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, the affected area should be washed 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. Dutasteride/tamsulosin has been shown to decrease sperm count, sperm motility, and semen volume. This may reduce fertility.

• Dutasteride/tamsulosin affects the blood test for PSA (prostate-specific antigen)which is sometimes used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, but must 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 had a higher incidence of a more serious form of prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this serious form of prostate cancer is not clear.

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

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

Using Dutasteride/Tamsulosin Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 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 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 doctorif you are taking any of these medicines.

Taking Dutasteride/Tamsulosin Viatris with food

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

Pregnancy, breastfeeding, and fertility

Women must not takedutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) must 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, sperm motility, and semen volume. This may reduce fertility.

• Consult your doctorif 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 machineryif you are affected in this way.

Dutasteride/Tamsulosin Viatriscontains soybean lecithin, propylene glycol, and sodium

This medicine contains soybean lecithin, which may contain soybean oil. It must not be used in case of peanut or soy allergy.

This medicine contains 299.46 mg of propylene glycol in each capsule, equivalent to 4.27 mg/kg.

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

3. How to take Dutasteride/Tamsulosin Viatris

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you do not take it 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 Viatris than you should

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

If you forget to take Dutasteride/Tamsulosin Viatris

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

Do not stop treatment with Dutasteride/Tamsulosin Viatriswithout advice

Do not stop treatment with Dutasteride/Tamsulosin Viatris 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 rashthat may itch
• hives
• 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 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 have 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 immediatelyif you have these symptoms and stop using dutasteride/tamsulosin.

Common side effects

These may affect up to 1 in 10 patients taking dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*
• reduced sex drive (libido)
• difficulty ejaculating, as well as decreased amount of semen ejaculated*
• breast tenderness or enlargement (gynecomastia)
• dizziness.
• * In a small number of people, some of these side effects may continue after stopping dutasteride/tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 patients:

• 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).
• low blood pressure when standing up
• rapid 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 patients:

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

Very rare side effects

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

• 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 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 of side effects

If you experience any side effects, talk to 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 Medicines Monitoring System for Human Use: 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 Viatris

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 refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of Dutasterida/Tamsulosina Viatris

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

Hard capsule shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Contents of the soft dutasteride capsule:

Propylene glycol monocaprylate, type II

Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Soy lecithin (may contain soybean oil) (see section 2)

Tamsulosin pellets:

Methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion (contains 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)

Potassium hydroxide (E525)

Appearance of the product and container contents

The medication is presented in hard gelatin capsules, oblong, approximately 21.4 mm × 7.4 mm, with a brown body and an orange cap, printed with C001 in black ink.

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

It is available in packs of 7, 30, and 90 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

LABORATORIOS LEÓN FARMA S.A.

C/ La Vallina s/n, Polígono Industrial Navatejera

Villaquilambre 24193 (León)

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Date of the last revision of this leaflet:August 2019.

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