Tamsulosin Tecnigen 0.4 mg prolonged-release capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina TecniGen 0.4 mg prolonged-release hard capsules EFG

Read this entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet.

Leaflet contents:

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

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

Tamsulosin TecniGen is used in the treatment of symptoms associated with benign prostatic hyperplasia, such as difficulty urinating.

Tamsulosin belongs to a group of medicines called alpha1-receptor blockers, which reduce the tension of the muscles in the prostate and urethra. For this reason, it facilitates the flow of urine through the urethra and makes urination easier.

2. What you need to know before starting Tamsulosina TecniGen

Do not take Tamsulosina TecniGen:

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

If you have severe hepatic impairment.

Warnings and precautions:

Consult your doctor or pharmacist before taking Tamsulosina TecniGen.

A decrease in blood pressure may occur in individual cases during treatment with Tamsulosina TecniGen, which may result in fainting. At the first symptoms of orthostatic hypotension (dizziness and feeling of weakness), you should sit or lie down until symptoms 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 impairment should be carried out with caution, as this type of patient has not been studied.

Initiation of treatment with Tamsulosina TecniGen is not recommended in patients scheduled for cataract surgery. A syndrome, a variant of the small pupil syndrome, called Intraoperative Floppy Iris Syndrome (IFIS), has been observed in some patients currently or previously treated with tamsulosin, which could increase the risk of complications during surgery.

If the patient is undergoing treatment with Tamsulosina TecniGen, it would be advisable to discontinue it 1 to 2 weeks prior to surgery.

Other medicines and Tamsulosina TecniGen

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

No interactions have been observed when Tamsulosina TecniGen was administered concomitantly with atenolol, enalapril, nifedipine, or theophylline. Concomitant administration of cimetidine causes an increase in plasma levels of tamsulosin, and concomitant administration with furosemide causes a decrease; however, since the levels achieved remain within the normal range, no change in dosage is necessary. In vitro studies have shown that none of these medicines alter the free fraction of tamsulosin in plasma: diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin. Likewise, tamsulosin does not alter the free fraction of diazepam, propranolol, trichlormethiazide, and chlormadinone.

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

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

Tamsulosina TecniGen with food and drinks

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

Pregnancy, breastfeeding and fertility:

Not applicable. Tamsulosina TecniGen is administered only to males.

Driving and use of machines:

There are no available data on the possibility that tamsulosin adversely affects the ability to drive or operate machinery. However, Tamsulosina TecniGen may cause dizziness.

Tamsulosina TecniGen contains sodium

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

3. How to Take Tamsulosina TecniGen

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

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

The capsule must be swallowed whole, without breaking or chewing it, so as not to interfere with the prolonged release of the active substance.

Your doctor will indicate how long your treatment with Tamsulosina TecniGen should last. Do not stop the treatment earlier, as it may not have the intended effect.

If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forgot to take your daily capsule of Tamsulosina TecniGen

If you forgot to take your dose after breakfast or after the first meal of the day, you may take it later during the same day.

If you missed the dose for a whole day, 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 further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Adverse effects of medicines are classified according to the following:

Very common: affects more than 1 in 10 patients.

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

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

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

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

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Nervous system disorders:

Common: dizziness.

Uncommon: headache.

Rare: syncope.

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, diarrhoea, nausea, vomiting.

Frequency not known: dry mouth.

Skin and subcutaneous tissue disorders:

Uncommon: rash, pruritus, urticaria.

Rare: angioedema.

Reproductive system and breast disorders:

Uncommon: ejaculation disorders.

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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

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

5. Storage of Tamsulosin TecniGen

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

Do not store above 30°C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container (carton and blister pack). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the pharmacy's collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

What Tamsulosina TecniGen contains

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

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

Tamsulosina TecniGen is presented as prolonged-release hard capsules. The capsules are orange-colored gelatin capsules containing white or yellowish granules.

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

Not all pack 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 medicine is authorized in the European Union countries under the following names:

Portugal: Tansulosina Reliva
Hungary: Tamsulosin Pharmacenter
Spain: Tamsulosina TecniGen 0.4 mg prolonged-release hard capsules EFG

This leaflet was last reviewed in December 2021

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