Label: information for the user

Tamsulosin Viatris Pharmaceuticals 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

• Keep this label, 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 you should not give it 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 label.

Tamsulosina relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosina allows urine to pass more easily and facilitates urination. Additionally, it reduces the sensation of urgency.

Tamsulosina 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 a frequent need to urinate both at night and during the day.

Do not take Tamsulosina Viatris Pharmaceuticals:

• If you areallergic (hypersensitive) to tamsulosina or to any of the other componentsof this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• If you have a drop in blood pressure when standing, which causesdizziness or fainting.
• If you havesevere liver problems.

Warnings and precautions

Consult your doctor before starting to take Tamsulosina Viatris Pharmaceuticals:

• If you havedizziness or fainting, especially after getting up. Tamsulosina may lower your blood pressure causing these symptoms. You should lie down or sit until the symptoms have disappeared.
• If you havesevere kidney problems, consult your doctor.
• 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). You may develop a condition called Intraoperative Floppy Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you have previously taken, are taking or have to take Tamsulosina Viatris Pharmaceuticals. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are about to undergo such surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma).

Regular medical check-ups are necessary to monitor the development of the disease you are being treated for.

You may observe remnants of tablets in your stools. 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 medication to children or adolescents under 18 years old because it does not work in this population.

Taking Tamsulosina Viatris Pharmaceuticals with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medication. Other medications may be affected by tamsulosina. These medications, in turn, may affect the proper functioning of tamsulosina. Tamsulosina may interact with:

• Diclofenac, pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Warfarin, medication to prevent blood clotting. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Other alpha-1A adrenergic receptor blockers1A. The combination may produce 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 medications that may decrease the elimination of tamsulosina from your body (e.g. ketoconazole, erythromycin).

Tamsulosina Viatris Pharmaceuticals with food and drinks

Tamsulosina can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

Tamsulosina is not indicated for use in women.

In men, an abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not come out 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 operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The tablet must be swallowedwhole. It is essentialthat you do not break or chew the tabletas this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated for children.

If you take more Tamsulosina Viatris Pharmaceuticals than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you take more tamsulosina 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 forgot to take Tamsulosina Viatris Pharmaceuticals

If you have forgotten to take Tamsulosina Viatris Pharmaceuticals as recommended, you can take your daily dose later in 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 compensate for the missed doses.

If you interrupt treatment with Tamsulosina Viatris Pharmaceuticals

When tamsulosina treatment is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Viatris Pharmaceuticals for the entire time your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

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

It is rare for serious adverse reactions to occur.Contact your doctor immediatelyif you experience asevere allergic reaction that causes swelling of the face or throat(angioedema).

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

• Dizziness.
• An abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not come out 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.

Occasional(may affect up to 1 in 100 patients):

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

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

• Fainting (syncope)

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

• Pain during erection (priapism).
• Severe disease 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.
• Fast heartbeat.
• Difficulty breathing.
• Blurred vision.
• Altered vision.
• Nosebleeds (epistaxis).
• Itching, pink to red spots on the skin with pale centers (erythema multiforme).
• Dermatitis exfoliativa.
• Dry mouth.

During eye surgery, a condition called Flaccid Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid during the 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse 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.

Do not use Tamsulosina Viatris Pharmaceuticals after the expiration date that appears on the packaging after “CAD”. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Store the blister packs in the original packaging to protect them from light.

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

Tamsulosina Viatris Pharmaceuticals Composition

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

Appearance of the product and contents of the package

Tamsulosina Viatris Pharmaceuticals is presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other.

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

Only some package 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

Netherlands

Or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 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:

NetherlandsTamsulosine HCl Retard Mylan 0,4 mg, tablets with prolonged release

FranceTAMSULOSINE Mylan LP 0,4 mg, prolonged-release tablet

PolandOmnitamgen

SpainTamsulosina Viatris Pharmaceuticals 0,4 mg prolonged-release tablets EFG

Last review date of this leaflet:January 2014

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