TAMSULOSIN TECNIGEN 0.4 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin TecniGen 0.4 mg prolonged-release hard capsules EFG

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Contents of the package leaflet:

1. What is Tamsulosin TecniGen and what is it used for
2. What you need to know before taking Tamsulosin TecniGen
3. How to take Tamsulosin TecniGen
4. Possible side effects
5. Storage of TecniGen
6. Package contents and additional information

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

Tamsulosin TecniGen is used to treat the symptoms of benign prostatic hyperplasia, such as difficulties with urination.

Tamsulosin belongs to a group of medications called alpha-1 blockers, which reduce the tension of the prostate and urethra muscles. This facilitates the flow of urine through the urethra and makes urination easier.

2. What you need to know before taking Tamsulosin TecniGen

Do not take Tamsulosin TecniGen:

If you are allergic or have had an allergic reaction to tamsulosin or any of the other components of this medication, as listed in section 6.1.

If you have severe liver failure.

Warnings and precautions:

Consult your doctor or pharmacist before taking Tamsulosin TecniGen.

A decrease in blood pressure may occur in individual cases during treatment with Tamsulosin TecniGen, which may cause dizziness and fainting. If you experience the first symptoms of orthostatic hypotension (dizziness and weakness), sit or lie down until they disappear.

Before starting treatment with Tamsulosin TecniGen, the patient should be examined to rule out other conditions that may cause the same symptoms as benign prostatic hyperplasia.

Treatment in patients with severe renal impairment should be carried out with caution, as this type of patient has not been studied.

It is not recommended to start treatment with Tamsulosin TecniGen in patients who have a scheduled cataract surgery. A syndrome, a variant of the small pupil syndrome, called Intraoperative Floppy Iris Syndrome (IFIS), has been observed in some patients being treated or previously treated with tamsulosin, which could increase complications during surgery.

If the patient is being treated with Tamsulosin TecniGen, it would be useful to interrupt it 1 to 2 weeks before surgery.

Other medications and Tamsulosin TecniGen

Tell your doctor or pharmacist if you are using, have recently used, or may need to use other medications.

No interactions have been observed when Tamsulosin TecniGen was administered together with atenolol, Enalapril, nifedipine, or theophylline. The concomitant administration of cimetidine produces an increase in tamsulosin plasma levels, and concomitant administration with furosemide produces a decrease; however, as the levels reached remain within the normal range, no change in dosage is necessary. In vitro studies, none of these medications alter the free fraction of tamsulosin in plasma: diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin. Similarly, tamsulosin does not alter the free fraction of diazepam, propranolol, trichlormethiazide, and chlormadinone.

During in vitro studies with hepatic microsomal fractions (representative of metabolism linked to the cytochrome P450 enzyme system), no interactions have been observed at the level of hepatic metabolism with any of these medications: amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, on the other hand, may increase the elimination of tamsulosin from the body.

The concomitant administration of other alpha-1 adrenergic receptor antagonists may cause hypotensive effects.

Tamsulosin TecniGen with food and beverages

It is recommended to take Tamsulosin TecniGen after breakfast or after the first meal of the day. The absorption of tamsulosin is reduced by a recent meal. The uniformity of absorption can be improved if patients take Tamsulosin TecniGen always after the same meal.

Pregnancy, lactation, and fertility:

This does not apply. Tamsulosin TecniGen is administered only to males.

Driving and using machines:

There are no available data on whether tamsulosin can adversely affect the ability to drive and use machines. However, Tamsulosin TecniGen may cause dizziness.

Tamsulosin TecniGen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; that is, it is essentially "sodium-free".

3. How to take Tamsulosin TecniGen

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

The recommended dose is one capsule per day, taken after breakfast or after the first meal of the day, with a glass of water. It should be administered orally.

The capsule should be swallowed whole, without breaking or chewing, to avoid interfering with the prolonged release of the active ingredient.

Your doctor will indicate the duration of your treatment with Tamsulosin TecniGen. Do not stop treatment before, as it may not have the expected effect.

If you think the effect of Tamsulosin TecniGen is too strong or too weak, inform your doctor or pharmacist.

If you have taken more Tamsulosin TecniGen than you should

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

If you forgot to take your daily Tamsulosin TecniGen capsule

If you have forgotten to take your medication after breakfast or the first meal of the day, you can take it during the same day.

In case you have missed a dose one day, you can simply continue taking your daily capsule as prescribed.

Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Medication side effects are classified as follows:

Very common:affect more than 1 in 10 patients.

Common:affect less than 1 in 10 patients, but more than 1 in 100.

Uncommon:affect less than 1 in 100 patients, but more than 1 in 1,000.

Rare:affect less than 1 in 1,000 patients, but more than 1 in 10,000.

Very rare:affect less than 1 in 10,000 patients, including isolated cases.

Like all medications, this medication can cause side effects, although not everyone experiences them.

Nervous system disorders:

Common:dizziness.

Uncommon:headache.

Rare:fainting.

Eye disorders:

Common:Intraoperative Floppy Iris Syndrome (IFIS, a variant of the small pupil syndrome).

Cardiac disorders:

Uncommon:palpitations.

Vascular disorders:

Uncommon:postural hypotension.

Respiratory disorders:

Uncommon:rhinitis.

Gastrointestinal disorders:

Uncommon:constipation, diarrhea, nausea, vomiting.

Frequency not known:dry mouth.

Skin and subcutaneous tissue disorders:

Uncommon:exanthema, pruritus, urticaria.

Rare:angioedema.

Reproductive system and breast disorders:

Uncommon:ejaculation disorders.

Very rare:priapism.

General disorders and administration site conditions:

Uncommon:asthenia.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tamsulosin TecniGen

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

Do not store above 30°C.

Store in the original package.

Do not use this medication after the expiration date stated on the package (carton and blister). The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packages and medications you no longer need to the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

What Tamsulosin TecniGen contains

The active ingredient is tamsulosin. Each capsule contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

The other ingredients (excipients) are:

Core: sodium alginate, methacrylic acid-ethyl acrylate copolymer (1:1), dibehenoyl glycerol, maltodextrin, laurilsulfate sodium, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone emulsion, anhydrous colloidal silica, and purified water.

Capsule body and cap: gelatin, purified water, red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172).

Appearance of the product and package contents

Tamsulosin TecniGen is presented in the form of prolonged-release hard capsules. The capsules are orange gelatin capsules containing white or yellowish granules.

Each package contains 10 or 30 capsules in a PVC + PVDC/ALU blister or 100 capsules in an HDPE bottle with a PP cap.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Atlantic Pharma-Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra (Portugal)

This medication is authorized in the European Union member states under the following names:

Portugal:Tansulosina Reliva

Hungary:Tamsulosin Pharmacenter

Spain:Tamsulosina TecniGen 0.4mg prolonged-release hard capsules EFG

This package leaflet was revised in December 2021

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