Tamsulosin Kern Pharma 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Kern Pharma 0.4 mg modified-release hard capsules EFG

tamsulosin hydrochloride

Read the 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tamsulosin Kern Pharma is and what it is used for

The active substance in this medicine is tamsulosin. It is a selective antagonist of α 1A/1D adrenergic receptors. It reduces the tone of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it decreases the sensation of urgency.

This medicine is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urinary 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 Kern Pharma

Do not take Tamsulosina Kern Pharma:

• If you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
• Hypersensitivity may present as sudden localized swelling of 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 suffer from dizziness due to a drop in blood pressure when changing position (when sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before starting tamsulosin:

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting may rarely occur during treatment with tamsulosin, as may happen 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 or are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue this medicine prior to such surgery for lens opacity (cataracts) 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.

Other medicines and Tamsulosina Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking tamsulosin together with other medicines 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 also being treated with medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Kern Pharma with food and drink 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.

This section is not relevant, as tamsulosin is intended exclusively for male patients.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not released from the body through the urethra but 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 tools or machinery. However, you should bear in mind that dizziness may occur, in which case you should not perform activities requiring alertness.

3. How to take Tamsulosina Kern Pharma

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

The recommended dose is 1 capsule daily, taken after breakfast or after the first meal of the day. The capsule must be swallowed whole and must not be broken or chewed. Tamsulosina is usually prescribed for long-term use. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.

If you take more Tamsulosina Kern Pharma than you should

Taking too much tamsulosina may lead to an unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of fainting.

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 forget to take Tamsulosina Kern Pharma

If you have forgotten to take tamsulosina as directed, you may take your daily dose later on the same day. If you have missed the dose for a 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 Kern Pharma

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 can cause adverse effects, although not everyone experiences them.

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

• difficulty breathing
• swelling of the face, tongue or throat (angioedema)
• itching and skin rash

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

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

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

• headache
• palpitations (heartbeat faster than normal and noticeable)
• reduction in blood pressure, e.g. when standing up quickly after sitting or lying down, sometimes associated with dizziness (orthostatic hypotension)
• nasal drip or nasal obstruction (rhinitis)
• diarrhoea
• nausea (feeling of discomfort)
• vomiting
• constipation
• feeling of weakness (asthenia)
• skin rash
• itching and hives (urticaria)

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

• fainting and sudden localized swelling of soft tissues of the body (e.g. 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 (prolonged, painful, unwanted erection requiring immediate medical treatment)
• rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, which is an allergic reaction to medicines or other substances called Stevens-Johnson Syndrome.

Frequency not known (cannot be estimated from available data)

• blurred vision
• visual disturbance
• nosebleed (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormally irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea)
• 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 hydrochloride, the pupil may dilate insufficiently and the iris (the coloured, circular part of the eye) may become flaccid during the procedure (see section 2 “Warnings and precautions”).
• dry mouth

In addition to the adverse effects listed above,

• very rapid and uncoordinated contractions of the heart
• irregular heartbeat
• abnormally fast heart rate and difficulty breathing associated with the use of tamsulosin hydrochloride. Since these events are spontaneously reported from post-marketing experience worldwide, the frequency of these events and the role of tamsulosin hydrochloride in their causality cannot be reliably determined.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 Kern Pharma

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister, bottle, and carton 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 collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Tamsulosina Kern Pharma

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

Pellets: Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E-433).

Coating material: Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion*, dibutyl sebacate, polysorbate 80 (E-433), hydrated colloidal silica.

Calcium stearate

Hard gelatin capsule: Iron oxide red (E-172), titanium dioxide (E-171), iron oxide yellow (E-172), iron oxide black (E-172), indigo carmine (E-132), gelatin.

*The dispersion contains 0.7% sodium lauryl sulfate Ph.Eur/NF and 2.3% polysorbate 80 Ph.Eur/NF in solid substance, as emulsifiers.

Appearance of the product and contents of the container

Tamsulosina Kern Pharma consists of hard capsules, approximately 15.6 - 16.2 mm in length, closed, with an opaque orange body and olive green cap. Tamsulosina Kern Pharma is available in PVC/PVdC-Al blisters or HDPE bottles, packed in cardboard boxes.

The PVC/PVdC-aluminum blisters contain 10, 20, 30, 50, 90 or 100 capsules.

The pre-cut single-dose PVC/PVdC-aluminum blisters contain 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1 or 100 x 1 capsules.

The HDPE bottles contain 30, 35, 50, 60, 90, 100, 112 or 200 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, No. 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

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

Denmark – Tamsulosin Liconsa 0.4 mg modified-release capsules, hard

France – Tamsulosine Liconsa LP 0.4 mg, gélule à libération prolongée

Romania – Tamsulosin Liconsa 0.4 mg capsule cu eliberare modificata

Spain – Tamsulosina Kern Pharma 0.4 mg modified-release hard capsules EFG

Portugal – Tansulosina Pharmakern 0.4 mg modified-release hard capsules

Ireland – Tamsulosin Rowa 0.4 mg capsules modified-release hard capsules

Date of the most recent review of this leaflet: May 2024

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/.