TAMSULOSIN CINFAMED 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

tamsulosina cinfamed 0.4 mg modified-release hard capsules EFG

tamsulosina hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is tamsulosina cinfamed and what is it used for
2. What you need to know before taking tamsulosina cinfamed
3. How to take tamsulosina cinfamed
4. Possible side effects
5. Storage of tamsulosina cinfamed
6. Package Contents and Additional Information

1. What is tamsulosina cinfamed and what is it used for

The active ingredient is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

tamsulosina cinfamed is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before taking tamsulosina cinfamed

Do not take tamsulosina cinfamed

• if you are allergic to tamsulosin or any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden local swelling of the body's soft tissues (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 position (sitting or standing up).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take tamsulosina cinfamed

• Regular medical examinations are necessary to monitor the development of the disease being treated.
• Rarely, fainting can 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 or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you have taken tamsulosin previously, are taking it, or are thinking of taking it. The specialist can then take the necessary 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 surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and Adolescents

Do not administer this medication to children or adolescents under 18 years of age, as it does not work in this population.

Other Medications and tamsulosina cinfamed

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

Taking tamsulosin with other medications of the same group (alpha1 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 medications that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking tamsulosina cinfamed with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that semen is not released through the urethra, but instead 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 tools or machines. However, you should be aware that dizziness can occur, in which case you should not perform activities that require attention.

3. How to Take tamsulosina cinfamed

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The dose is one capsule per day and should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Normally, tamsulosin is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If You Take More tamsulosina cinfamed Than You Should

Taking too much tamsulosin can lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of fainting. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take tamsulosina cinfamed

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

If You Interrupt Treatment with tamsulosina cinfamed

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin for the entire time 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Frequent (may affect up to 1 in 10 patients):

Dizziness, especially when sitting or standing up.

Abnormal ejaculation (altered ejaculation). This means that semen is not released through the urethra, but instead 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 patients):

Headache, palpitations (the heartbeat is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria).

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

Fainting and sudden local swelling of the body's soft tissues (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 patients):

Priapism (undesirable, prolonged, and painful erection that requires immediate medical treatment). Skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

Frequency Not Known (cannot be estimated from available data):

• Blurred vision
• Visual disturbance
• Nosebleed (epistaxis)
• Severe skin eruptions (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 previously, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid.
• Dry mouth

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of tamsulosina cinfamed

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

Store below 25°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of tamsulosina cinfamed

• The active ingredient is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are:

Contents of the capsule:microcrystalline cellulose, hypromellose, ethylcellulose dispersion type B, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion at 30%, triethyl citrate, glycerol monostearate 40-55, and polysorbate 80.

Capsule shell:gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and indigotine - FD&C Blue 2 (E-132).

Printing ink:Shellac, black iron oxide (E-172), propylene glycol (E-1520), and ammonium hydroxide (E-527).

Appearance of the Product and Package Contents

Hard gelatin capsules with an orange body and green cap, marked with the codes "0.4 mg" and "BY7", respectively.

Unit-dose blister packs of PVC/PVDC-aluminum containing 5 or 10 capsules each; cardboard boxes containing 30 capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Package Leaflet: September 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86197/P_86197.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86197/P_86197.html