Label: Information for the User

Tamsulosin TecniGen 0.4 mg Extended-Release Hard Capsules EFG

Read this label carefully before taking this medicine because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

Tamsulosina TecniGen is used in the treatment of symptoms associated with benign prostatic hyperplasia such as difficulties with urination.

Tamsulosina belongs to a group of medications known as alpha1 receptor blockers that reduces the tension of the prostate and urethral muscles. For this reason, it facilitates the flow of urine through the urethra and facilitates urination.

Do not take Tamsulosina TecniGen:

If you are allergic or have had an allergic reaction to tamsulosina 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 Tamsulosina TecniGen.

There may be a decrease in blood pressure in individual cases during treatment with Tamsulosina TecniGen, resulting in dizziness, Ante the first symptoms of orthostatic hypotension (dizziness and weakness) you should sit or lie down until they have disappeared.

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

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

It is not recommended to start treatment with Tamsulosina TecniGen in patients who have a scheduled eye surgery for cataracts. A syndrome, variant of the small pupil syndrome, called Intraoperative Flaccid Iris Syndrome (IFIS), has been observed in some patients on treatment or previously treated with tamsulosina, which could increase complications during surgery.

If the patient is on treatment with Tamsulosina TecniGen, it would be useful to interrupt it 1 to 2 weeks before surgery.

Other medications and Tamsulosina TecniGen

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

No interactions have been observed when Tamsulosina TecniGen was administered concurrently with atenolol, Enalapril, nifedipine or theophylline. Concurrent administration of cimetidine produces an increase in plasma levels of tamsulosina and concurrent administration with furosemide, produces a decrease; but as the levels achieved remain within the normal range, no change in dosage is necessary. In in vitro studies, none of these medications alters the free fraction of tamsulosina in plasma: diazepam, propranolol, trichloromethiazide, clormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin. Similarly, tamsulosina does not alter the free fraction of diazepam, propranolol, trichloromethiazide and clormadinon.

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

Concurrent administration of other alpha1-adrenergic receptor antagonists may cause hypotensive effects.

Tamsulosina TecniGen with food and beverages

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

Pregnancy, lactation and fertility:

Not applicable. Tamsulosina TecniGen is administered only to males.

Driving and operating machinery:

No data are available on the possibility that tamsulosina may adversely affect the ability to drive and operate machinery. However, Tamsulosina TecniGen may cause dizziness.

Tamsulosina TecniGen contains sodium

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

Follow exactly the administration instructions for this medication 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 it, to avoid interfering with the prolonged release of the active ingredient.

Your doctor will indicate the duration of your treatment with Tamsulosina TecniGen. Do not discontinue treatment beforehand, as this may not have the desired effect.

If you estimate that the action of Tamsulosina TecniGen is too strong or too weak, inform your doctor or pharmacist.

If you have taken more Tamsulosina TecniGen than you should

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

If you forgot to take your daily capsule of Tamsulosina TecniGen

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

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

Do not take a double dose to compensate for the missed dose.

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

The adverse effects of medications are classified as follows:

Very common:Affect more than 1 in 10 patients.

Common:Affect less than 1 in 10 patients, but no more than 1 in 100.

Uncommon:Affect less than 1 in 100 patients, but no more than 1 in 1,000.

Rare:Affect less than 1 in 1,000 patients, but no more than 1 in 10,000.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Nervous system disorders:

Common:Dizziness.

Uncommon:Headache.

Rare:Syncope.

Eye disorders:

Common:Intraoperative Flaccid Iris Syndrome (IFIS, variant of small pupil syndrome)

Cardiac disorders:

Uncommon:Palpitations.

Vascular disorders:

Uncommon:Postural hypotension.

Respiratory, thoracic and mediastinal disorders:

Uncommon:Rhinitis.

Gastrointestinal disorders:

Uncommon:Constipation, diarrhea, nausea, vomiting.

Frequency unknown:Dry mouth.

Skin and subcutaneous tissue disorders:

Uncommon:Exanthema, pruritus, urticaria.

Rare:Angioedema.

Reproductive and breast disorders:

Uncommon:Alterations in ejaculation.

Very rare:Priapism.

General disorders and administration site conditions:

Uncommon:Asthenia.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can alsoreport them directly through the Spanish System for the Pharmacovigilance of Medications for Human Use. Website:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging (carton and blister pack). The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the pharmacy's designated point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

What Tamsulosina TecniGen contains

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

The other components (excipients) are:

Core: sodium alginate, copolymer of methacrylic acid and ethyl acrylate (1:1), dibehenate of glycerol, maltodextrin, sodium lauryl sulfate, macrogol 6000, polisorbate 80, sodium hydroxide, simethicone emulsion, anhydrous colloidal silica, and purified water.

Body and cap of the capsule: gelatin, purified water, red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172).

Appearance of the product and contents of the packaging

Tamsulosina TecniGen is presented in the form of prolonged-release hard capsules. The capsules are orange-colored gelatin and contain 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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) SPAIN

Responsible manufacturer

Atlantic Pharma-Produções Farmacêuticas, S.A.

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

This medicine is authorized in the Member States of the European Union with the following names:

Portugal:Tansulosina Reliva

Hungary:Tamsulosin Pharmacenter

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

This prospectus was reviewed in December 2021

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