Tamsulosin Normon 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Normon 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Tamsulosin is an alpha1-adrenoceptor blocker. It relaxes the muscles in the prostate and 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 improves urination.

2. What you need to know before taking Tamsulosina Normon

Do not take Tamsulosina Normon if:

• you are allergic to tamsulosin or to any of the components 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 upon standing, causing

dizziness, lightheadedness, or fainting;

• you have severe liver problems.

Warnings and precautions:

Talk to your doctor or pharmacist before starting Tamsulosina Normon

• if you experience dizziness or lightheadedness, especially after standing up.

Tamsulosin may lower your blood pressure, causing these symptoms. You should sit or

lie down until the symptoms resolve;

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

produce the expected effect when your kidneys are not functioning normally.

• if you are scheduled for eye surgery due to clouding of the lens

(cataracts).

There is an eye condition called Intraoperative Floppy Iris Syndrome (IFIS) that may occur (see section 4, Possible side effects). Please inform your eye specialist that you are taking or have previously taken tamsulosin hydrochloride. Your specialist can then take appropriate precautions regarding medication and surgical techniques.

Ask your doctor whether you should delay or temporarily stop taking this medicine before undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

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

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 Normon with other medicines:

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

• diclofenac, an analgesic and anti-inflammatory medicine: this medicine may

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

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

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

• other α1-adrenergic blockers. The combination may lower your blood

pressure, causing dizziness or lightheadedness.

• ketoconazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

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

Tamsulosina Normon with food, drinks and alcohol

Tamsulosin should be taken after breakfast or the first meal of the day, with 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 semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This phenomenon is harmless.

• Driving and using machines

There is no information on the effects of tamsulosin on the ability to drive or operate machinery. You should bear in mind that tamsulosin may cause dizziness or lightheadedness. Only drive or operate machinery if you feel well.

Tamsulosina Normon contains sodium

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

3. How to take Tamsulosin Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

The usual dose is one capsule per day taken after breakfast or after your first meal of the day.

Swallow the capsule whole with a glass of water, while sitting or standing (do not lie down). It is important not to break or chew the capsule, as this may affect the action of tamsulosin.

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

If you take more Tamsulosin Normon than you should:

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

If you take more tamsulosin than prescribed, your blood pressure may drop suddenly. You may experience dizziness, weakness, fainting, vomiting, and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor may give you medications to restore your blood pressure and fluid levels, and may monitor your body functions. If necessary, your doctor may perform gastric lavage and administer a laxative to eliminate any tamsulosin that has not yet been absorbed into the bloodstream.

If you forget to take Tamsulosin Normon:

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

If you stop taking Tamsulosin Normon

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, continue taking tamsulosin for as long as your doctor prescribes, even if your symptoms have improved. Always consult your doctor before stopping 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 reactions are very rare. Contact your doctor immediately if you experience:

• A severe allergic reaction causing swelling of the face or throat (angioedema). You should not restart tamsulosin (see section 2, Do not take Tamsulosina Normon);

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

Dizziness, especially when sitting down or standing up.

Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (failure to ejaculate). This phenomenon is harmless.

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

Headache. Awareness of your heartbeat (palpitations). Drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting (orthostatic hypotension). Nasal swelling and irritation (rhinitis). Constipation. Diarrhea. Feeling sick (nausea). Vomiting. Rash. Hives (urticaria). Feeling of weakness (asthenia). Itching.

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

Fainting (syncope).

Very rare adverse effects (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).

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

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

During eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored 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 type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may 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 Normon

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Tamsulosina Normon

The active substance is tamsulosin hydrochloride, 0.4 mg.

The other components are:

Capsule contents: Microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Capsule shell: Gelatin, indigo carmine (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/olive-green capsules. The capsules contain white or almost white pellets.

Each pack contains 30 capsules.

Marketing Authorization 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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