TAMSULOSIN Aurovitas 0.4 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take 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 local swelling of the soft tissues of the body (e.g., throat or tongue), difficulty breathing and/or itching and skin rash (angioedema),
• if you have severe liver problems,
• if you have dizziness due to a drop in blood pressure when changing posture (sitting or standing).

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosin.

• Regular medical examinations are necessary to monitor the development of the disease being treated.
• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you have taken, are taking, or plan to take tamsulosin. The specialist can then take the appropriate precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo such an operation due to a cataract or increased pressure in the eye (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

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

Taking tamsulosin with other medicines of the same group (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 at the same time with medicines that may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Aurovitas with food and drinks

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 (alteration of ejaculation) has been reported. This means that semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (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, in which case you should not perform activities that require concentration.

Tamsulosina Aurovitas contains sodium

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

3. How to take Tamsulosina Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The capsule should be swallowed whole and not broken or chewed. Normally, tamsulosin 0.4 mg is prescribed for long periods of time.

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

If you take more Tamsulosina Aurovitas than you should

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

Taking too many tamsulosin capsules can lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of fainting. Consult your doctor immediately if you have taken too many tamsulosin capsules.

If you forget to take Tamsulosina Aurovitas

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

If you stop taking Tamsulosina Aurovitas

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking your medicine and seek medical attention immediately, if you have 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 or standing.
• Abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

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

• Headache.
• Palpitations (the heartbeat is faster than normal and also perceptible).
• Drop in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness.
• Nasal congestion or runny nose (rhinitis).
• Constipation.
• Diarrhea.
• Feeling of nausea and vomiting.
• Weakness (asthenia).
• Skin rash.
• Itching and hives (urticaria).

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

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

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

• Priapism (undesirable, prolonged, and painful erection that requires immediate medical treatment).
• Severe 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 the available data):

• Blurred vision.
• Visual disturbance.
• Nosebleeds (epistaxis).
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have taken tamsulosin, during the operation, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid.
• Dry mouth

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tamsulosina Aurovitas

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

This medicine does not require special storage conditions.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton, blister, and label of the bottle after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients (excipients) are:

Contents of the capsule: Microcrystalline cellulose, talc, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triacetin, and calcium stearate.

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

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

Appearance of the product and contents of the pack

Prolonged-release hard capsule.

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

Tamsulosina Aurovitas is available in:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida 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 medicine is authorized in the Member States of the European Economic Area under the following names:

France: TAMSULOSINE ARROW LP 0.4 mg, prolonged-release capsules

Germany: Tamsulosin Aurobindo 0.4 mg prolonged-release capsules

Malta: Tamsulosin Aurobindo 0.4 mg prolonged-release capsules

Italy: Tamsulosina Aurobindo 400 micrograms prolonged-release hard capsules

Netherlands: Tamsulosine HCl Aurobindo 0.4 mg, prolonged-release capsules, hard

Poland: Tamsulosin Aurovitas

Portugal: Tansulosina Aurovitas

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

Date of last revision of this leaflet:February 2019

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