TAMSULOSIN VIATRIS PHARMACEUTICALS 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosin Viatris Pharmaceuticals 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosin allows urine to flow more easily and facilitates urination. It also reduces the feeling 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), dripping, urgency, and frequent need to urinate both at night and during the day.

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

Do not take Tamsulosin Viatris Pharmaceuticals:

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

Warnings and precautions

Consult your doctor before taking Tamsulosin Viatris Pharmaceuticals:

• If you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. Lie down or sit until the symptoms have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo or have undergone eye surgery due to cataracts or glaucoma. A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored part of the eye) may become floppy during surgery. Please inform your ophthalmologist if you have previously taken, are taking, or are going to take Tamsulosin Viatris Pharmaceuticals. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to cataracts or glaucoma.

Regular medical examinations are necessary to monitor the development of the disease for which you are being treated.

You may notice remains of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because it does not work in this population.

Taking Tamsulosin Viatris Pharmaceuticals with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Other medicines may be affected by tamsulosin. These medicines, in turn, may affect the proper functioning of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Other alpha-1A adrenergic receptor blockers. The combination may cause a drop in blood pressure, causing dizziness or fainting.

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

Tamsulosin Viatris Pharmaceuticals with food and drinks

Tamsulosin can be taken independently 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 come out 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.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive and use machines. You should be aware that tamsulosin may cause dizziness and fainting. Only drive or operate machines if you feel well.

3. How to take Tamsulosin Viatris Pharmaceuticals

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis 1 tablet per day. You can take tamsulosin with or without food, preferably at the same time every day.

The tablet must be swallowed whole. It is important that you do not break or chew the tabletas this may affect the proper functioning of tamsulosin.

Tamsulosin is not indicated 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you take more tamsulosin than you should, your blood pressure may drop suddenly. 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 can take your daily dose later that day. If you have missed a dose for one day, 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 abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosin Viatris Pharmaceuticals for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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.

It is rare for serious side effects to occur. Contact your doctor immediatelyif you experience a severe allergic reaction that causes swelling of the face or throat(angioedema).

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

• Dizziness.
• Abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not come out 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 patients):

Headache; palpitations; low blood pressure when standing up, which causes dizziness or fainting (orthostatic hypotension); nasal congestion and irritation (rhinitis); constipation; diarrhea; nausea; vomiting; rash; hives (urticaria); feeling of weakness (asthenia); itching (pruritus).

Rare(may affect up to 1 in 1,000 patients):

• Fainting (syncope)

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

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

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

• Abnormal heart rhythm.
• Irregular heartbeat.
• Faster heartbeat.
• Breathing difficulties.
• Blurred vision.
• Altered vision.
• Nosebleeds (epistaxis).
• Itching, pink to red spots on the skin with a 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 colored part of the eye) may become floppy during surgery. For more information, see section 2, Warnings and precautions.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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. Storing Tamsulosin Viatris Pharmaceuticals

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

Do not use Tamsulosin Viatris Pharmaceuticals after the expiry date which is stated on the carton after “EXP”. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Viatris Pharmaceuticals

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

Appearance of the product and packaging

Tamsulosin Viatris Pharmaceuticals is presented in the form of round, white, prolonged-release tablets with the inscription “T9SL” on one side and “0.4” on the other.

They are available in packs of 10, 18, 20, 28, 30, 50, 60, 90, 98, or 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Netherlands

Or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised 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 comprimidos de liberación prolongada EFG

Date of last revision of this leaflet:January 2014

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