TAMSULOSIN NORMON 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin Normon 0.4 mg prolonged-release hard capsules 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 symptoms 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. See section 4.

Contents of the pack:

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

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

Tamsulosin is an alpha-1 adrenoceptor blocker. It relaxes the muscles in the prostate and in the urinary tract.

Tamsulosin is indicated for the relief of urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscle, it allows urine to pass more easily and helps with urination.

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

Do not take Tamsulosin Normon if:

• you are allergicto tamsulosin or any of the other ingredients of this medicine

(listed in section 6) (symptoms may include: swelling of the face or throat(angioedema));

• you have a history of low blood pressure when standing up, which causes

dizziness, feeling of dizziness or fainting;

• you have severe liver problems.

Warnings and precautions:

Consult your doctor or pharmacist before taking Tamsulosin Normon

• if you suffer from dizziness or feeling of dizziness, especially when standing up.

Tamsulosin may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms disappear;

• if you have severe kidney problems. The normal dose of tamsulosin may not

have the expected effect when your kidneys are not working normally.

• if you are going to have eye surgerydue to cataracts.

There is an eye disease called Intraoperative Floppy Iris Syndrome that may occur (see section 4, Possible side effects), please inform your eye specialist that you are taking or have taken tamsulosin hydrochloride. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used.

Ask your doctor if you should postpone or temporarily stop taking this medicine when you are going to have eye surgery for cataracts or increased pressure in the eye (glaucoma).

Before starting treatment with tamsulosin, your doctor should examine you to confirm that the symptoms are actually caused by an enlarged prostate.

Children and adolescents

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

Taking Tamsulosin Normon with other medicines:

Other medicines may be affected by tamsulosin. On the other hand, other medicines may affect the action of tamsulosin. Tamsulosin may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medicine: this medicine may

increase the elimination of tamsulosin from the body, thereby shortening the time that tamsulosin is effective;

• warfarin, a medicine to prevent blood clotting: this medicine may

increase the elimination of tamsulosin from the body, thereby shortening the time that tamsulosin is effective;

• other alpha-1 adrenoceptor blockers.The combination may lower your blood

pressure, causing dizziness or feeling of dizziness.

• Ketoconazole, a medicine to treat skin fungal infections. This medicine may increase the effect of tamsulosin.

Tell your doctor or pharmacistif you are using, have recently used or might use any other medicines.

Tamsulosin Normon with food, drinks and alcohol

Tamsulosin should be taken after breakfast or the first meal of the day with the help of a glass of water.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that the semen is not released through the urethra, but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculation failure). This phenomenon is harmless.

• Driving and using machines

There is no information on the effects of tamsulosin on the ability to drive and use machines. You should be aware that tamsulosin may cause dizziness or feeling of dizziness. Only drive or use machines if you feel well.

Tamsulosin Normon contains sodium

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

3. How to take Tamsulosin Normon

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

The normal doseis one capsule per day taken after breakfastor after your first meal of the day.

Swallow the capsule wholewith a glass of water, sitting or standing (do not lie down). It is important that you do not break or chew the capsuleas this may affect the action of tamsulosin.

If you have mild to moderate kidney or liver disease, you can take the normal dose of tamsulosin.

If you take more Tamsulosin Normon than you should:

Consult your doctor, pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you take more tamsulosin than you should, your blood pressure may drop suddenly. You may feel dizzy, weak and faint, vomit and have diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor may administer medicines to restore your blood pressure and fluid levels, and may monitor your body function. If necessary, your doctor may proceed with gastric lavage and administration of a laxative to eliminate the tamsulosin that has not entered the bloodstream.

If you forget to take Tamsulosin Normon:

Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.

If you stop taking Tamsulosin Normon

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as 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.

Severe reactions are very rare. Contact your doctor immediatelyif you suffer:

• a severe allergic reaction that causes swelling of the face or throat(angioedema). You

should not restart taking tamsulosin (see section 2, Do not take Tamsulosin Normon);

Common side effects(may affect up to 1 in 10 people)

Dizziness, especially when sitting or standing up.

Abnormal ejaculation (ejaculation disorder). This means that the semen is not released through the urethra, but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculation failure). This phenomenon is harmless.

Uncommon side effects(may affect up to 1 in 100 people)

Headache. Feeling the heartbeat (palpitations). Low blood pressure when standing up, which causes dizziness, feeling of dizziness or fainting (orthostatic hypotension). Swelling and irritation inside the nose (rhinitis). Constipation. Diarrhea. Feeling sick (nausea). Vomiting. Rash. Hives (urticaria). Feeling of weakness (asthenia). Itching.

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

Fainting (syncope).

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

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

Side effects of unknown frequency(frequency cannot be estimated from the available data)

Blurred vision, loss of vision, nosebleeds (epistaxis), dry mouth, severe skin rashes (erythema multiforme, exfoliative dermatitis). Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).

During eye surgery due to cataracts or increased pressure in the eye (glaucoma), a condition called Intraoperative Floppy Iris Syndrome may occur: the pupil may not dilate 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 Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Normon

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The first two digits indicate the month and the last four digits the year. The expiry date is the last day of the month indicated.

Store in the original package. Keep the container tightly closed.

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

6. Contents of the pack and other information

Composition of Tamsulosin Normon

The active substance is tamsulosin hydrochloride, 0.4 mg.

The other ingredients are:

Contents of the capsule:Microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Body of the capsule:Gelatin, carmine indigo (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of the product and contents of the pack

Orange/greenish-brown capsules. The capsules contain white or almost white pellets.

Each pack contains 30 capsules.

Marketing authorisation holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

Synthon BV

Microweg, 22, P.O. Box 7071 (Nijmegen)- NL 6545 (THE NETHERLANDS)

or

Synthon Hispania, S.L.

Castello 1, Polígono Las Salinas (Sant Boi de Llobregat)- 08830- Barcelona (SPAIN)

or

Quinta Analitica, S.R.O

Prazska 1486/18c (Prague)-102 00- (CZECH REPUBLIC)

or

GENERICON PHARMA GMBH

Hafnerstrasse, 211

Graz-Austria-A-8054

This leaflet was last revised in January 2021

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

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/68385/P_68385.html