Tamsulosin Viatris 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Viatris 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tamsulosin Viatris contains the active substance tamsulosin hydrochloride and belongs to a group of medicines called alpha-adrenergic antagonists (alpha1A-receptor blockers). These medicines are used to reduce the tension of the muscles in the prostate and the urethra. This facilitates the flow of urine through the urethra and helps urination.

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

2. What you need to know before taking Tamsulosina Viatris

Do not take Tamsulosina Viatris:

• If you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Allergic reaction to tamsulosin may present as sudden swelling of the hands or feet, difficulty breathing and/or itching and skin rash (angioedema), swelling of the lips, tongue, or throat.
• If you suffer from dizziness or weakness due to low blood pressure (for example, when sitting down or standing up).
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting Tamsulosina Viatris:

• If you have severe kidney problems.
• If you are undergoing or have undergone eye surgery due to cataracts (clouding of the lens) or increased pressure in the eye (glaucoma).

A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, “Possible side effects”). Please inform your ophthalmologist if you have previously taken, are currently taking, or need to take tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily discontinue this medicine if you are scheduled for surgery due to cataracts or increased eye pressure (glaucoma).

During treatment

Talk to your doctor or pharmacist:

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

Your doctor should examine your prostate or urinary system before starting tamsulosin and periodically thereafter.

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.

Taking Tamsulosina Viatris with other medicines

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

• Using tamsulosin together with other alpha-1A blockers may cause a drop in blood pressure, such as with doxazosin, prazosin, and indoramine.
• Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosin from the body.
• Medicines that lower blood pressure, such as verapamil and diltiazem.
• Medicines used to suppress your immune system, such as cyclosporine.
• Antibiotics used to treat infections, such as erythromycin, clarithromycin.
• Medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole, voriconazole.
• Medicines used to treat HIV (AIDS), such as ritonavir, saquinavir.

Please note that interactions may also occur with medicines previously used or medicines taken after stopping tamsulosin.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

Tamsulosin may cause ejaculation disorders, including semen entering the urinary bladder (retrograde ejaculation) and inability to ejaculate (ejaculatory failure).

Driving and using machines

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

Tamsulosina Viatris contains sodium

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

3. How to take Tamsulosina Viatris

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

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

The capsule must be swallowed whole.

Do not break or chew the capsule, as this may affect how the medicine is delivered into your body.

If you take more Tamsulosina Viatris than you should

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, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and 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, lightheadedness, fainting, blurred vision, irregular heartbeat, confusion, or weakness. If you experience any of these symptoms, you should sit or lie down.

If you forget to take Tamsulosina Viatris

If you forget to take your daily tamsulosin capsule after the first meal of the day, you may take it the same day after the meal. If you have missed a day’s dose, simply continue taking your daily capsule as prescribed.

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

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

Serious adverse effects:

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

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

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

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

• Widespread rash with blisters, peeling of the skin, bleeding from 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 adverse effects:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Headache.
• Irregular heartbeat (palpitations).
• Dizziness, especially when suddenly sitting or standing up (orthostatic hypotension).
• Nasal discharge or congestion (rhinitis).
• Constipation.
• Diarrhea.
• Feeling sick (nausea).
• Malaise (vomiting).
• Skin rash.
• Itching (pruritus).
• Feeling of weakness (asthenia).

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

• Syncope (fainting or sudden, temporary 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 spots, known as erythema multiforme.
• Abnormal heart rhythm (arrhythmia).
• Rapid heartbeat (tachycardia).
• Difficulty breathing (dyspnea).
• Blurred or reduced vision (visual disturbances).
• Nosebleeds.
• Scaly skin rashes (exfoliative dermatitis).
• Dry mouth.

In some cases, possible complications related to cataract or glaucoma surgery have been observed. During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may show poor dilation and the iris (the circular colored part of the eye) may become floppy during surgery. For more information, see section 2, "Warnings and precautions".

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

Keep this medicine out of sight and reach of children.

Store in the original container.

Keep the container tightly closed.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Viatris

• The active substance is tamsulosin hydrochloride. Each modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components (excipients) are: microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer dispersion 30 percent (1:1), polysorbate 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 pack

Tamsulosina Viatris is presented as capsules with an orange body and olive green cap, containing white or almost white spheres.

It is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 capsules, and in multi-packs of 200, consisting of 2 packs 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 certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

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

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 (EEA) under the following names:

Germany Tamsulosin-dura 0.4 mg modified-release hard capsules
Austria Tamsulosin Arcana retard 0.4 mg - Kapseln
Belgium Tamsulosine Mylan 0.4 mg capsules with prolonged release, hard
Slovakia Tamsulosin HCI Mylan 0.4 mg
Spain Tamsulosina Viatris 0.4 mg modified-release hard capsules EFG
Finland Tamsulogen 0.4 mg Säädellysti vapauttava kapseli, kova
Greece Tamsulosin/Mylan καψ?κιο ελεγχ?μενης αποδ?σμευσης, σκληρ? 0.4 mg/CAP
Ireland Tamsulosin 400 micrograms Modified-Release Capsules
Iceland Tamsulosin Mylan 0.4 mg hylki með breyttan losunarhraða, hörð
Italy Tamsulosin Mylan Generics
Norway Tamsulosin Mylan 0.4 mg capsules with modified release, hard
Netherlands Tamsulosine HCL Retard Mylan 0.4 mg, harde capsules met gereguleerde afgifte
Poland TAMSUGEN 0.4 mg capsules with modified release, hard
Portugal Tansulosina Mylan
Czech Republic Tamsulosin HCI Mylan 0.4 mg, tvrdé tobolky s řízeným uvolňováním

Date of the most recent review of this leaflet: November 2020

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/