Tamsulosin Viatris Pharmaceuticals 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Viatris Pharmaceuticals 0.4 mg prolonged-release tablets 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

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 Tamsulosin Viatris Pharmaceuticals is and what it is used for

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing these muscles, tamsulosin allows urine to pass more easily and facilitates urination. In addition, it reduces the sensation of urgency.

Tamsulosin is used in men to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

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

Do not take Tamsulosina Viatris Pharmaceuticals:

• If you are allergic (hypersensitive) to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of soft body tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• If you have a drop in blood pressure upon standing that causes dizziness or fainting.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor before starting Tamsulosina Viatris Pharmaceuticals:

• If you experience dizziness or fainting, especially after standing up. Tamsulosin may lower blood pressure, causing these symptoms. You should lie down or sit until symptoms have resolved.
• If you have severe kidney problems, consult your doctor.
• If you are undergoing or have undergone eye surgery due to lens opacity (cataracts) or increased eye pressure (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 are scheduled to take Tamsulosina Viatris Pharmaceuticals. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily stop taking this medicine if you are scheduled for surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma).

Periodic medical examinations are necessary to monitor the progression of the condition for which you are being treated.

You may notice tablet remnants in your stools. Since the active ingredient has already been released from the tablet, there is no risk of reduced effectiveness.

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 Pharmaceuticals with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Other medicines may affect tamsulosin, and conversely, tamsulosin may affect how well other medicines work. Tamsulosin may interact with:

• Diclofenac, an analgesic and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Other alpha1A-adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness or fainting.

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

Tamsulosina Viatris Pharmaceuticals with food and drinks

Tamsulosin may be taken regardless of meals.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory failure). This phenomenon is not harmful.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should be aware that tamsulosin may cause dizziness or fainting. Only drive or operate machinery if you feel well.

3. How to take Tamsulosin Viatris Pharmaceuticals

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day. You may take tamsulosin with or without food, preferably at the same time each day.

The tablet should be swallowed whole. It is important not to break or chew the tablet, as this may affect the proper functioning of tamsulosin.

Tamsulosin is not indicated for use in children.

If you take more Tamsulosin Viatris Pharmaceuticals than you should

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

If you take more tamsulosin than prescribed, your blood pressure may suddenly decrease. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and consult your doctor.

If you forget to take Tamsulosin Viatris Pharmaceuticals

If you have forgotten to take Tamsulosin Viatris Pharmaceuticals as recommended, you may take your daily dose later on the same day. If you have missed a day's dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Viatris Pharmaceuticals

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosin Viatris Pharmaceuticals for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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 reactions are rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).

Common (may affect up to 1 in 10 people):

• Dizziness.
• Abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculation failure). This phenomenon is not harmful.

Uncommon (may affect up to 1 in 100 people):

Headache; noticeable heartbeat (palpitations); drop in blood pressure when standing up, causing dizziness or fainting (orthostatic hypotension); nasal swelling and irritation (rhinitis); constipation; diarrhoea; nausea; vomiting; rash; hives (urticaria); feeling of weakness (asthenia); itching (pruritus).

Rare (may affect up to 1 in 1000 people):

• Fainting (syncope)

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

• Painful erection (priapism).
• Serious illness with blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

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

• Abnormal heart rhythm.
• Irregular heartbeat.
• Faster heartbeat.
• Breathing difficulty.
• Blurred vision.
• Altered vision.
• Nosebleeds (epistaxis).
• Itching, pink to red skin spots with pale center (erythema multiforme).
• Skin inflammation (exfoliative dermatitis).
• Dry mouth.

During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For further information, see section 2. Warnings and precautions.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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.

Do not use Tamsulosin Viatris Pharmaceuticals after the expiry date stated on the packaging after "EXP". The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the stated month.

Store the blisters in the original packaging to protect them from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist 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

• The active substance is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other components are:
  Inner tablet core: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E-172), magnesium stearate.
  Outer tablet coating: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and pack contents

Tamsulosina Viatris Pharmaceuticals is presented as round, white, prolonged-release tablets, marked with "T9SL" on one side and "0.4" on the other.

Available in packs containing 10, 18, 20, 28, 30, 50, 60, 90, 98 or 100 prolonged-release tablets.

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 trading as 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

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Or

Mylan Hungary Kft.
Mylan utca 1
H-2900, Komárom
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 under the following names:

Netherlands: Tamsulosine HCl Retard Mylan 0.4 mg, tabletten met verlengde afgifte
France: TAMSULOSINE Mylan LP 0.4 mg, comprimé à libération prolongée
Poland: Omnitamgen
Spain: Tamsulosina Viatris Pharmaceuticals 0.4 mg prolonged-release tablets EFG

Date of the most recent revision of this leaflet: January 2014

Detailed and up-to-date 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/