Tamsulosin Aurovitas 0.4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Aurovitas 0.4 mg prolonged-release hard capsules EFG

Tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as yours, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance of Tamsulosin Aurovitas is tamsulosin. It is a selective antagonist of α1A/1D adrenergic receptors. It reduces the tension of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak urine stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

2. What you need to know before taking Tamsulosina Aurovitas

Do not take Tamsulosina Aurovitas

• if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of soft tissues in the body (e.g., throat or tongue), difficulty breathing and/or itching and skin rash (angioedema),
• if you have severe liver problems,
• if you suffer from dizziness due to a drop in blood pressure when changing posture (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take tamsulosin.

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting may rarely occur during treatment with tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are scheduled for eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist if you have previously taken, are currently taking, or plan to take tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor on whether you should delay or temporarily discontinue this medicine if undergoing surgery due to lens opacity (cataract) or increased eye pressure (glaucoma).

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 Aurovitas with other medicines

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

Taking tamsulosin together with other medicines of the same class (α1-adrenergic receptor antagonists) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are being treated simultaneously with medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Aurovitas with food and drink

Take the medicine after the first meal of the day.

Pregnancy and breastfeeding

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 goes into the bladder (retrograde ejaculation), or that the volume ejaculated is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should be aware that dizziness may occur, and in such a case, you should not perform activities requiring concentration.

Tamsulosina Aurovitas contains sodium

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

3. How to take Tamsulosina Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose is 1 capsule daily, to be taken after breakfast or the first meal of the day.

The capsule must be swallowed whole and must not be broken or chewed. Tamsulosina 0.4 mg is usually prescribed for long-term use.

The effects on the bladder and urination are maintained during long-term treatment with tamsulosina 0.4 mg.

If you take more Tamsulosina Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

Taking too many tamsulosina capsules may lead to an undesirable drop in blood pressure and an increased heart rate, with a feeling of faintness. Contact your doctor immediately if you have taken too many tamsulosina capsules.

If you forget to take Tamsulosina Aurovitas

If you have forgotten to take tamsulosina as recommended, you may take your daily dose later on the same day. If you have forgotten the dose for a whole day, you may simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for missed doses.

If you stop taking Tamsulosina Aurovitas

If treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take tamsulosina for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue 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 may cause adverse effects, although not everyone experiences them.

Stop taking your medicine and seek immediate medical attention if you experience any of the following allergic reactions:

• Difficulty breathing.
• Swelling of the face, tongue, or throat (angioedema).
• Itching and skin rash.

Common (may affect up to 1 in 10 people):

• Dizziness, especially when sitting down or standing up.
• Abnormal ejaculation (ejaculatory disorder). This means that semen does not exit through the urethra but goes into the bladder (retrograde ejaculation), or the volume of ejaculated semen is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Palpitations (heart beating faster than normal and noticeably).
• Drop in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness.
• Runny or stuffy nose (rhinitis).
• Constipation.
• Diarrhea.
• Nausea and vomiting.
• Weakness (asthenia).
• Skin rash.
• Itching and hives (urticaria).

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

• Fainting and sudden localized swelling of soft body tissues (such as the throat or tongue).
• Breathing difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).

Very rare (may affect up to 1 in 10,000 people):

• Priapism (unwanted, prolonged, and painful erection requiring immediate medical treatment).
• Skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from available data):

• Blurred vision.
• Visual disturbance.
• Nosebleed (epistaxis).
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during surgery.
• Dry mouth

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 Aurovitas

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

This medicine does not require any special storage conditions.

Keep in the original packaging to protect it from moisture.

Do not use this medicine after the expiry date stated on the carton, blister pack, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Aurovitas

• The active substance is tamsulosin hydrochloride. Each prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components (excipients) are:

Capsule contents: Microcrystalline cellulose, talc, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triacetin, and calcium stearate.

Capsule shell: Indigo carmine (E 132), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin.

Printing ink: Shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

Nature of the product and pack contents

Prolonged-release hard capsule.

Olive green/opaque orange hard gelatin capsules of size “1EL”, filled with white to off-white granules, printed in edible black ink with “D” on the cap and “53” on the body.

Tamsulosina Aurovitas is available in:

PVC/PE/PVDC/Aluminium blisters: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 200 hard capsules.

Round white opaque high-density polyethylene (HDPE) bottles with white opaque polypropylene closure: 10 and 250 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19, Venda Nova

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

France: TAMSULOSINE ARROW LP 0.4 mg, prolonged-release capsule
Germany: Tamsulosin Aurobindo 0.4 mg Retardkapseln
Malta: Tamsulosin Aurobindo 0.4 mg prolonged-release capsules
Italy: Tamsulosina Aurobindo 400 microgrammi capsule rigide a rilascio prolungato
Netherlands: Tamsulosine HCl Aurobindo 0.4 mg, capsules with controlled release, hard
Poland: Tamsulosin Aurovitas
Portugal: Tansulosina Aurovitas
Spain: Tamsulosina Aurovitas 0.4 mg prolonged-release hard capsules EFG

Date of the most recent review of this leaflet: February 2019

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