Prospecto: information for the patient

Tamsulosina Viatris 0.4 mg modified-release hard capsules EFG

tamsulosin hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Tamsulosina Viatris and what is it used for

2.What you need to know before starting to take Tamsulosina Viatris

3.How to take Tamsulosina Viatris

4.Possible adverse effects

5.Storage of Tamsulosina Viatris

6.Contents of the pack and additional information

Tamsulosina Viatris contains the active ingredient tamsulosin hydrochloride and belongs to a group of medicines called alpha-adrenergic antagonists (alpha 1A receptor blockers).These medicines are used to reduce the tension of the muscles of the prostate and urethra.This facilitates the flow of urine through the urethra and helps to urinate.

Tamsulosina Viatris is used for the treatment of symptoms of the lower urinary tract caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH).

Do not take Tamsulosina Viatris:

• If you are allergic to tamsulosina or any of the other ingredients in this medication (listed in section 6). An allergy to tamsulosina may manifest as sudden swelling of the hands or feet, difficulty breathing and/or skin itching and rash (angioedema), swelling of the lips, tongue, or throat.
• If you experience dizziness or weakness due to low blood pressure (for example, when sitting or standing up).
• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Viatris:

• If you have severe kidney problems.
• If you are about to undergo or have undergone eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma).

A condition called Intraoperative Floppy Iris Syndrome (see section 4, “Possible side effects”) may occur. Please inform your ophthalmologist if you have previously taken, are currently taking, or will need to take tamsulosina. The specialist will then be able to take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma).

During treatment

Talk to your doctor or pharmacist:

• If you experience dizziness or fainting while using tamsulosina. If you experience the previous symptoms caused by orthostatic hypotension, please sit or lie down immediately until the symptoms disappear.
• If you experience sudden swelling of the hands or feet, swelling of the lips, tongue, or throat, difficulty breathing and/or skin itching and rash, caused by an allergic reaction (angioedema) while using tamsulosina.

Your doctor should examine your prostate or urinary system before taking tamsulosina and regularly afterwards.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old, as it does not work in this population.

Taking Tamsulosina Viatris with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

• The use of tamsulosina with other alpha 1A blockers, such as doxazosina, prazosina, and indoramina, may cause a decrease in blood pressure.
• Diclofenaco (an analgesic anti-inflammatory) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosina from the body.
• Medications that lower blood pressure, such as verapamilo and diltiazem.
• Medications used to suppress your immune system, such as ciclosporina.
• Antibiotics to treat infections, such as eritromicina, claritromicina.
• Medications to treat fungal infections, such as ketoconazol, itraconazol, fluconazol, voriconazol.
• Medications used to treat HIV (AIDS) such as ritonavir, saquinavir.

Be aware that interactions may also occur with medications used in the past or used once tamsulosina administration has been completed.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

Tamsulosina may cause ejaculation disorders, including retrograde ejaculation (ejaculation of semen into the urinary bladder) and inability to ejaculate (ejaculatory insufficiency).

Driving and operating machinery

No studies have been conducted on the effects of tamsulosina on the ability to drive or operate machinery. However, patients should be aware that they may experience dizziness.

Tamsulosina Viatris contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one capsule per day after breakfast or the first meal of the day.

The capsule should be swallowed whole.

Do not break or chew the capsule, as this may affect how the medication is absorbed by your body.

If you take more Tamsulosina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you take more Tamsulosina Viatris than you should, you may experience symptoms of low blood pressure, such as dizziness, drowsiness, fainting, blurred vision, irregular heartbeats, confusion, or weakness. If you experience any of these symptoms, sit or lie down.

If you forgot to takeTamsulosina Viatris

If you forgot to take your daily capsule of tamsulosina after the first meal of the day, you can take it on the same day after eating. If you have missed a dose one day, simply continue taking your daily capsule as prescribed.

Do not take a double dose to compensate for missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following symptoms, stop taking this medicine and immediately inform your doctor or visit the nearest hospital:

Rare(may affect up to 1 in 1,000 people)

• Swelling of the hands or feet, difficulty breathing, and/or skin itching and rash, swelling of the lips, tongue, or throat (angioedema).

Very rare(may affect up to 1 in 10,000 people)

• Generalized rash with blisters, skin peeling, bleeding of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from available data)

• Irregular and abnormal heartbeats (atrial fibrillation).

Other possible side effects:

Common(may affect up to 1 in 10 people)

• Dizziness.
• Sexual function disorders, including the inability to ejaculate and retrograde ejaculation (ejaculation of semen into the urinary bladder).

Uncommon(may affect up to 1 in 100 people)

• Headache.
• Irregular heartbeats (palpitations).
• Dizziness, especially when standing up or sitting down (orthostatic hypotension).
• Nasal congestion or secretion (rhinitis).
• Constipation.
• Diarrhea.
• Nausea.
• Vomiting.
• Rash.
• Itching (pruritus).
• Weakness (asthenia).

Rare(may affect up to 1 in 1,000 people)

• Fainting (syncope) or sudden and transient loss of consciousness.

Very rare(may affect up to 1 in 10,000 people)

• Unwanted, prolonged, and painful erection (priapism).

Frequency not known(cannot be estimated from available data)

• Severe skin inflammation, with pale red patches, known as erythema multiforme.
• Abnormal heart rhythm (arrhythmia).
• Accelerated heart rate (tachycardia).
• Difficulty breathing (dyspnea).
• Blurred or reduced vision (visual disturbances).
• Nasal bleeding.
• Scaly skin rash (dermatitis exfoliativa).
• Dry mouth.

In some cases, possible complications have been observed in relation to cataract or glaucoma surgery. During eye surgery, a condition called Flaccid Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris may become flaccid during the surgery. For more information, see section 2. “Warnings and precautions”.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging.

Keep the packaging perfectly closed.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofTamsulosina Viatris

-The active ingredient is tamsulosin hydrochloride. Each modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.

-The other components (excipients) are: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate dispersion 30 percent (1:1), poloxamer 80, sodium lauryl sulfate, triethyl citrate, and talc.

The capsule coating contains: gelatin, indigo carmine (E-132), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172).

Appearance of the product and contents of the package

Tamsulosina Viatrisis presented in the form of capsules with an orange body and a green olive cap, containing white or off-white spheres.

It is presented in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200, and in multi-packs of 200, which include 2 packages of 100 modified-release capsules each, or in bottles containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 modified-release capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Synthon Hispania S.L.

Castelló, 1

Polígono las Salinas

08830 - Sant Boi de Llobregat

Spain

Or

Mylan Hungary Kft

H-2900 Komárom

Mylan út. 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyTamsulosin-dura 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

AustriaTamsulosin Arcana retard 0.4 mg - Kapseln

BelgiumTamsulosine Mylan 0.4 mg capsules metgereguleerdeafgifte, hard

SlovakiaTamsulosin HCI Mylan 0.4 mg

SpainTamsulosina Viatris 0.4 mg hard capsules with modified-release EFG

FinlandTamsulogen 0.4 mgSäädellysti vapauttava kapseli, kova

GreeceTamsulosin/Mylanκαψ?κιοελεγχ?μενηςαποδ?σμευσης,σκληρ?0.4 mg/CAP

IrelandTamsulosin 400 micrograms Modified-Release Capsules

IcelandTamsulosinMylan0,4 mghylki með breyttan losunarhraða, hörð

ItalyTamsulosin Mylan Generics

NorwayTamsulosin Mylan 0.4 mg kapslermed modifisert frisetting, harde

NetherlandsTamsulosine HCL Retard Mylan 0.4 mg,harde capsules met gereguleerde afgifte

PolandTAMSUGEN 0.4 mgkapsulkio zmodyfikowanym uwalnianiu, twarde

PortugalTansulosina Mylan

Czech RepublicTamsulosin HCI Mylan0,4 mg,tvrdé tobolky s rízeným uvolnováním

Date of the last review of this leaflet:November 2020

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/