Tamsulosin Alter 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Alter 0,4 mg modified-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. Do not pass it on to other people, even if they have the same symptoms as yours, because it may harm them.

# # - If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

# # Contents of this leaflet

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

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

The active substance of Tamsulosin Alter is tamsulosin. It is a selective antagonist of alpha1A/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. It also reduces the sensation of urgency.

Tamsulosin Alter 0.4 mg is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia), such as: difficulty urinating (weak urine stream), dribbling, urgency, and frequent need to urinate both during the night and during the day.

2. What you need to know before taking Tamsulosina Alter

Do not take Tamsulosina Alter

- If you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Allergic symptoms may include 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 position (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Tamsulosina Alter.

- Periodic medical examinations are necessary to monitor the progression of the condition being treated.

- Although rarely, the use of Tamsulosina Alter may cause fainting. If you experience dizziness or feel weak, you should sit or lie down until symptoms disappear.

- If you have severe kidney problems, consult your doctor.

- If you are scheduled for, or are undergoing, eye surgery due to cataracts (clouding of the lens) or increased eye pressure (glaucoma), please inform your ophthalmologist if you are currently taking, have previously taken, or are considering taking Tamsulosina Alter. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily stop taking this medicine prior to undergoing surgery for cataracts or glaucoma.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Taking Tamsulosina Alter with other medicines

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

Taking Tamsulosina Alter together with other medicines of the same class (alpha-1 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 Alter with food and drink

Tamsulosina Alter should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding and fertility

Tamsulosina Alter is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen is not expelled through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and use of machines

There is no evidence that Tamsulosina Alter affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness may occur, in which case you should not perform activities requiring attention.

3. How to take Tamsulosina Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule per day, taken after breakfast or the first meal of the day. The capsule must be swallowed whole and must not be broken or chewed. Tamsulosina Alter is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with this medicine.

If you take more Tamsulosina Alter than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20 immediately, stating the name of the medicine and the amount ingested.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Taking too many capsules of Tamsulosina Alter may lead to an undesirable drop in blood pressure and an increased heart rate, accompanied by a feeling of fainting.

If you forget to take Tamsulosina Alter

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

If you have missed 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 forgotten doses.

If you stop taking Tamsulosina Alter

If treatment with Tamsulosina Alter is stopped prematurely, your original symptoms may return. Therefore, take this medicine for as long as your doctor has prescribed, even if your symptoms have improved. 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.

• Frequent (may affect up to 1 in 10 people)

- Dizziness, especially when sitting down or standing up.

- Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead goes into the bladder (retrograde ejaculation), or that 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 rate faster than normal and noticeably felt), reduction in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, runny or blocked nose (rhinitis), diarrhoea, nausea, vomiting, constipation, 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 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 (undesired, prolonged and painful erection requiring immediate medical treatment).

- Skin rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

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

- Blurred vision

- Vision disturbance

- Nosebleed (epistaxis)

- Severe skin rashes (erythema multiforme, exfoliative dermatitis)

- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea)

- If you are undergoing eye surgery due to clouding of the lens (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken this medicine, during surgery the pupil may show poor dilation and the iris (coloured circular part of the eye) may become floppy.

- 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 may also report them directly via the Spanish Pharmacovigilance System for 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 Alter

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please 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 Alter

• The active substance is tamsulosin hydrochloride. Each modified-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are sodium alginate (E401), methylacrylic acid-ethyl acrylate copolymer (1:1) (methacrylic acid copolymer type C), glyceryl dibehenate, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80 (E433), sodium hydroxide (E524), simeticone 30% emulsion, and anhydrous colloidal silica.

The capsule shell components are gelatin, iron oxide red (E172), iron oxide yellow (E172), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Tamsulosina Alter is presented as modified-release hard capsules. The capsules are orange in colour and contain white or yellowish granules. Each pack contains 30 capsules.

Marketing Authorization Holder

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Manufacturer

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

or

Bluepharma - Indústria Farmacêutica S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal

Date of the most recent revision of this leaflet: July 2017.

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