Tamsulosin Viatris Pharmaceuticals 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina ViatrisPharmaceuticals 0.4 mg modified-release hard capsules EFG

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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tamsulosina Viatris Pharmaceuticals is and what it is used for
2. What you need to know before taking Tamsulosina Viatris Pharmaceuticals
3. How to take Tamsulosina Viatris Pharmaceuticals
4. Possible adverse effects
5. How to store Tamsulosina Viatris Pharmaceuticals
6. Contents of the pack and other information

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

The active substance in this medicine is tamsulosine. It is a selective antagonist of α 1A/1D adrenergic receptors. It reduces the tension of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces the sensation of urgency.

Tamsulosine is used in men to treat lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urine stream), dribbling, urgent need to urinate, and frequent need to urinate both during the day and at night.

2. What you need to know before taking Tamsulosin Viatris Pharmaceuticals

Do not take Tamsulosin Viatris Pharmaceuticals if:

• You are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden localized swelling of soft tissues of the body (e.g. throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• You have severe liver problems.
• You suffer from dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before taking tamsulosin:

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting may rarely occur during treatment with tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms resolve.
• If you have severe kidney problems, consult your doctor.
• If you are undergoing or have undergone eye surgery due to lens opacity (cataracts), please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue this medicine if you are scheduled for surgery due to lens opacity (cataract).

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosin Viatris Pharmaceuticals

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

Taking tamsulosin together with other medicines of the same class (α1-adrenergic receptor antagonists) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are also being treated with medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin Viatris Pharmaceuticals with food and drinks

Tamsulosin should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Tamsulosin is indicated only for use in men.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not expelled through the urethra but enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should bear in mind that dizziness may occur, and in such cases, you should not engage in activities requiring alertness.

3. How to take Tamsulosin Viatris Pharmaceuticals

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one capsule daily, taken after breakfast or the first meal of the day.

The capsule must be swallowed whole and must not be broken or chewed. This medicine is usually prescribed for long periods of time. Effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you take more Tamsulosin Viatris Pharmaceuticals than you should

Taking too much tamsulosin may lead to an unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of faintness. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Tamsulosin Viatris Pharmaceuticals

If you have forgotten to take tamsulosin as recommended, you may take your daily dose later on the same day. If you have missed the dose for one day, simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Viatris Pharmaceuticals

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor has prescribed, even if your symptoms have improved. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

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

Serious adverse effects:

Stop taking this medicine and seek immediate medical help if you experience any of the following symptoms:

• Difficulty breathing
• Swelling of the face, tongue or throat (angioedema)
• Rash and itching

Common (may affect up to 1 in 10 people)

• Dizziness
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead goes into the bladder
• retrograde ejaculation
• or that the volume ejaculated is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• Headache
• Irregular or rapid heartbeat
• Dizziness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose
• Constipation
• Diarrhea
• Nausea (feeling sick)
• Vomiting
• Skin rash
• Itching and hives (urticaria)
• Feeling of weakness

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

• Fainting

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

• Unwanted, prolonged and painful erection (Priapism)
• Severe skin rash, skin inflammation and/or mucous membrane inflammation of the lips, eyes, mouth, nasal passages or genitals, which is an allergic reaction to medicines or other substances known as Stevens-Johnson syndrome.

Frequency not known (cannot be estimated from the available data)

• Nosebleeds
• Blurred vision, visual disturbance
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are undergoing eye surgery due to lens opacity (cataract), and you are currently taking or have previously taken tamsulosin hydrochloride, the pupil may dilate poorly during surgery and the iris (the coloured circular part of the eye) may become floppy (see section 2 “Warnings and precautions”).

Other possible adverse effects:

• very rapid and uncoordinated contractions of the heart
• irregular heartbeat
• abnormally fast heart rate, and cases of breathing difficulty associated with the use of tamsulosin hydrochloride have been reported.

Since these events reported spontaneously come from post-marketing experience worldwide, the frequency of these events and the causal role of tamsulosin hydrochloride cannot be reliably determined.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Viatris Pharmaceuticals

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging, after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on 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 Tamsulosina Viatris Pharmaceuticals

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

Pellets: methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E-433).

Capsule coating: methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent*, dibutyl sebacate, polysorbate 80 (E-433), hydrated colloidal silica.

Calcium stearate.

Hard gelatin capsule: red iron oxide (E-172), titanium dioxide (E-171), yellow iron oxide (E-172), black iron oxide (E-172), indigo carmine – FD&C Blue No. 2 (E-132), gelatin.

*the dispersion contains 0.7% Sodium lauryl sulfate Ph. Eur./NF and 2.3% Polysorbate 80 Ph. Eur./NF in solid substance, as emulsifiers

Appearance of the product and contents of the pack

Tamsulosina Viatris Pharmaceuticals is presented as hard capsules approximately 15.6 – 16.2 mm in length, closed, opaque, with an orange body and olive green cap. Tamsulosina Viatris Pharmaceuticals is packaged in cardboard boxes containing aluminum-PVC/PVDC blisters or HDPE bottles.

Aluminum-PVC/PVDC blisters containing 10, 20, 30, 50, 90 or 100 capsules.

Single-dose perforated aluminum PVC/PVDC blisters containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 or 100 x 1 capsules.

HDPE bottles containing 30, 35, 50, 60, 90, 100, 112 or 200 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Manufacturer Responsible

Laboratorios Liconsa, S.A.
Avda. Miralcampo, No. 7
Pol. Ind. Miralcampo, 19200
Azuqueca de Henares, Guadalajara
Spain

or

Mylan Hungary Kft.
H-2900 Komárom,
Mylan utca 1,
Hungary

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

Germany: Tamsulosin Viatris 0.4 mg Hartkapsel mit veränderter Wirkstofffreisetzung
Belgium: Tamsulosine Viatris Pharma 0,4 mg harde capsules met gereguleerde afgifte
Slovakia: Tamsulosin Viatris 0,4 mg
Spain: Tamsulosina Viatris Pharmaceuticals 0,4 mg cápsulas duras de liberación modificada EFG
Denmark: Tamsulosin Viatris Pharma
Finland: Tamsulosin hydrochloride Viatris
France: Tamsulosine Viatris Santé LP 0,4 mg, gélule à libération prolongée
Ireland: Tamsulosin Viatris 0.4 mg modified release capsules, hard
Iceland: Tamsulosin Viatris Pharma
Italy: Tamsulosina Mylan
Luxembourg: Tamsulosine Viatris Pharma 0,4 mg gélules à libération modifiée
Norway: Tamsulosin Viatris Pharma
Portugal: Tamsulosin hydrochloride Viatris
Netherlands: Tamsulosine HCl Viatris 0,4 mg, harde capsules met gereguleerde afgifte

Date of the most recent review of this leaflet: July 2025.

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