Tamsulosina normon 0,4 mg capsulas duras de liberacion modificada efg

Leaflet: information for the user

Tamsulosin NORMON 0.4 mg modified-release hard capsules EFG

Tamsulosin, hydrochloride

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

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

2. What you need to know before you start taking Tamsulosin Normon

3. How to take Tamsulosin Normon

4. Possible side effects

5. Storage of Tamsulosin Normon

6. Contents of the pack and additional information

Tamsulosina is an alpha1-adrenoreceptor blocker. It relaxes the muscles in the prostate and the urinary tract.

Tamsulosina is indicated to alleviate urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscle, it allows for easier urine flow and aids in urination.

Do not take Tamsulosina Normon if:

• you areallergicto tamsulosina or any of the components of this medication

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

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

dizziness, lightheadedness, or fainting;

• you havesevere liver problems.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tamsulosina NORMON

• if you sufferdizziness or lightheadedness, especially after standing up.

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

• if you havesevere kidney problems. The normal dose of tamsulosina may not have the expected effect when your kidneys do not function normally.

This may result in reduced efficacy of the medication.

• if you are to undergoeye surgerydue to a cloudy lens (cataract).

(There is a condition 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 hydrochloride tamsulosina previously. Your 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 medication when undergoing eye surgery for a cloudy lens (cataract) or increased eye pressure (glaucoma).

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

Children and adolescents

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

Taking Tamsulosina Normon with other medications:

Other medications may be affected by tamsulosina. Conversely, other medications may affect the action of tamsulosina. Tamsulosina may interact with:

• diclofenac, analgesic and anti-inflammatory medication: this medication may

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

• warfarin, medication to prevent blood coagulation: this medication may

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

• other α1-adrenoreceptor blockers.The combination may lower your blood pressure, causing dizziness or lightheadedness.

This may result in reduced efficacy of the medication.

• ketoconazole, medication to treat fungal skin infections. This medication may increase the effect of tamsulosina.

Inform your doctor or pharmacistif you are using, have used recently, or will have to use any other medication.

Tamsulosina Normon with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory failure). This phenomenon is harmless.

• Driving and operating machinery

No information is available on the effects of tamsulosina on the ability to drive and operate

machines. You should be aware that tamsulosina may cause dizziness or lightheadedness. Only drive or operate machines if you feel well.

Tamsulosina Normon contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Theusual doseis one capsule per day takenafter breakfastor after your first meal of the day.

Swallow the capsulewholewith a glass of water, sitting or standing (do not lie down). It is essential thatyou do not break or chew the capsuleas this may affect the action of tamsulosina.

If you have mild to moderate kidney or liver disease, you may take the usual dose of tamsulosina.

If you take more Tamsulosina Normon than you should:

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

If you take more tamsulosina than you should, your blood pressure may drop suddenly. You may experience dizziness, weakness, and fainting, vomiting, and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor may administer medications to restore your blood pressure and fluid levels, and may monitor your bodily function. If necessary, your doctor may proceed with gastric lavage and administration of a laxative to eliminate the tamsulosina that has not entered the bloodstream.

If you forgot to take Tamsulosina Normon:

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

Ifyou interrupt treatment with Tamsulosina Normon

When tamsulosina treatment is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosina for the entire time your doctor prescribes, even if your symptoms have disappeared. Consult your doctor at all times if you decide to discontinue treatment.

If you have any other doubts 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.

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

• A severe allergic reaction that causes swelling of the face or throat(angioedema). Do not

resume using tamsulosina (see section 2, Do not take Tamsulosina Normon);

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

Dizziness, especially when sitting or standing up.

Abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but goes to 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, 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 weak (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)

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

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

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

During eye surgery due to opacity of the lens (cataracts) or increased pressure in the eye (glaucoma) may occur a disease called Iris Flaccid Syndrome: the pupil may dilate slightly and the iris (the colored circular part of the eye) may become flaccid during surgery. (For more information see section 2, Warnings and precautions).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them

directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side 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 this medication 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 in the original packaging. Keep the packaging perfectly closed.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Tamsulosina Normon Composition

The active ingredient is hydrochloride of tamsulosin, 0.4 mg.

The other components are:

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

Capsule body: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 content of the packaging

Orange/green olive-colored capsules. The capsules contain white or almost white pellets.

Each package contains 30 capsules.

Marketing Authorization Holder

NORMON LABORATORIES, S.A.

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

Responsible for Manufacturing

NORMON LABORATORIES, S.A.

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

or

Synthon BV

Microweg, 22, P.O. Box 7071 (Nijmegen)- NL 6545 (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 revised in January 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/