TAMSULOSIN VIATRIS 0.4 mg MODIFIED-RELEASE HARD CAPSULES

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

Do not take Tamsulosin Viatris:

• If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergy to tamsulosin may be expressed 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 have dizziness or weakness due to low blood pressure (e.g. when sitting or standing up).
• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before taking Tamsulosin Viatris:

• If you have severe kidney problems.
• If you are going to undergo or have undergone eye surgery due to cataracts 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 taking or are going to take tamsulosin. The specialist will then be able to take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medicine if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

During treatment

Talk to your doctor or pharmacist:

• If you experience dizziness or fainting during the use of tamsulosin. If you experience the above symptoms caused by orthostatic hypotension, please sit or lie down immediately until the symptoms disappear.
• 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 (angioedema) caused by an allergic reaction during the use of tamsulosin.

Your doctor should examine your prostate or urinary system before taking tamsulosin and regularly thereafter.

Children and adolescents

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

Taking Tamsulosin Viatris with other medicines

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

• The use of tamsulosin with other alpha-1A blocking medicines may cause a decrease in blood pressure, such as doxazosin, prazosin, and indoramin.
• Diclofenac (an anti-inflammatory pain reliever) 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 cyclosporin.
• Antibiotics to treat infections, such as erythromycin, clarithromycin.
• Medicines to treat fungal infections, such as ketoconazole, itraconazole, fluconazole, voriconazole.
• Medicines used to treat HIV (AIDS), such as ritonavir, saquinavir.

Note that interactions may also occur with medicines used in the past or used after tamsulosin administration has ended.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

Tamsulosin may cause ejaculation disorders, including semen ejaculation into 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 use machines. However, patients should be aware that they may experience dizziness.

Tamsulosin Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Tamsulosin Viatris

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

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

The capsule should be swallowed whole.

Do not break or chew the capsule, as this may affect the way the medicine gets into your body.

If you take more Tamsulosin Viatris than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you take more Tamsulosin Viatris than you should, you may experience symptoms of low blood pressure, such as dizziness, drowsiness, 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 Tamsulosin Viatris

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

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

If you have any other questions about 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.

Serious side effects:

If you get any of the following symptoms, stop taking this medicine and tell your doctor immediately 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, skin peeling, bleeding from the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome).

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

• Irregular and abnormal heartbeats (atrial fibrillation).

Other possible side effects:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Headache.
• Irregular heartbeats (palpitations).
• Dizziness, especially when standing up suddenly (orthostatic hypotension).
• Nasal congestion or runny nose (rhinitis).
• Constipation.
• Diarrhea.
• Feeling sick (nausea).
• Being sick (vomiting).
• Skin rash.
• Itching (pruritus).
• Feeling weak (asthenia).

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

• Fainting (syncope or loss of consciousness).

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

• Prolonged and painful erection (priapism).

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

• Severe skin inflammation with pale red spots, known as erythema multiforme.
• Abnormal heart rhythm (arrhythmia).
• Fast heart rate (tachycardia).
• Difficulty breathing (dyspnea).
• Blurred or reduced vision (vision disorders).
• Nosebleeds.
• Scaly skin rashes (exfoliative dermatitis).
• Dry mouth.

In some cases, possible complications have been observed in relation to cataract or glaucoma surgery. During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate properly 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance 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. Storage of Tamsulosin Viatris

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

Store in the original package.

Keep the package tightly closed.

Do not use this medicine after the expiry date which is stated on the packaging after CAD or EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. 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

• The active substance is tamsulosin hydrochloride. Each modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients (excipients) are: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.

The capsule shell 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 and packaging

Tamsulosin Viatris is presented in the form of hard capsules with an orange body and an olive green cap, containing white or off-white spheres.

It is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200, and in multi-packs of 200, which include 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.

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 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

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:

Germany Tamsulosin-dura 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Austria Tamsulosin Arcana retard 0.4 mg - Kapseln

Belgium Tamsulosine Mylan 0.4 mg capsules met gereguleerde afgifte, hard

Slovakia Tamsulosin HCI Mylan 0.4 mg

Spain Tamsulosina Viatris 0.4 mg cápsulas duras de liberación modificada 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 kapsler med modifisert frisetting, harde

Netherlands Tamsulosine HCL Retard Mylan 0.4 mg, harde capsules met gereguleerde afgifte

Poland TAMSUGEN 0.4 mg kapsulki o zmodyfikowanym uwalnianiu, twarde

Portugal Tansulosina Mylan

Czech Republic Tamsulosin HCI Mylan 0.4 mg, tvrdé tobolky s rízeným uvolnováním

Date of last revision of this leaflet:November 2020

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