Tamsulosin Medical Vallei

Package Leaflet: Information for the Patient

Tamsulosin Medical Valley, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tamsulosin Medical Valley and what is it used for
• 2. Important information before taking Tamsulosin Medical Valley
• 3. How to take Tamsulosin Medical Valley
• 4. Possible side effects
• 5. How to store Tamsulosin Medical Valley
• 6. Contents of the pack and other information

1. What is Tamsulosin Medical Valley and what is it used for

The active substance of Tamsulosin Medical Valley is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. It reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of urgency to urinate.
Tamsulosin Medical Valley is used in men for the treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include difficulty urinating (weak stream), urinating in drops, urgency to urinate, and increased frequency of urination both at night and during the day.

2. Important information before taking Tamsulosin Medical Valley

When not to take Tamsulosin Medical Valley:

• If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest as sudden, localized swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• If you have severe liver function disorders
• If you experience fainting due to low blood pressure when changing position from lying down to sitting or standing.

Warnings and precautions

Before starting treatment with Tamsulosin Medical Valley, discuss it with your doctor or pharmacist.

• Regular medical check-ups are necessary to determine the progression of the disease being treated.
• As with other medicines in this group, fainting may rarely occur during treatment with Tamsulosin Medical Valley. If symptoms such as dizziness or weakness occur, sit or lie down until they pass.
• Tell your doctor if you have severe kidney function disorders.
• If you are scheduled for eye surgery for cataracts, inform your ophthalmologist that you are taking, have taken, or are planning to take Tamsulosin Medical Valley. The doctor will then be able to take appropriate precautions during treatment and surgery. Ask your doctor if you should stop taking this medicine or temporarily discontinue it in connection with cataract surgery.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age, as it is not effective in this patient group.

Tamsulosin Medical Valley and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Taking Tamsulosin Medical Valley with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may result in unintended low blood pressure.
It is especially important to tell your doctor if you are taking medicines that may reduce the elimination of Tamsulosin Medical Valley from the body (e.g., ketoconazole, erythromycin).

Tamsulosin Medical Valley with food and drink

Take the medicine after breakfast or after the first meal of the day.

Pregnancy, breastfeeding, and fertility

This does not apply, as Tamsulosin Medical Valley is intended for use in men only.
There have been reports of abnormal ejaculation in men (ejaculation disorders). This means that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or does not occur. These symptoms are not harmful to the patient.

Driving and using machines

There is no data on the effect of Tamsulosin Medical Valley on the ability to drive or operate machinery. However, be aware of the possibility of dizziness. In such cases, do not perform tasks that require concentration and attention.

3. How to take Tamsulosin Medical Valley

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one capsule per day, taken after breakfast or after the first meal of the day. Swallow the capsule whole, do not chew or crush it.
Tamsulosin Medical Valley is usually prescribed for long-term use.
The effect on the bladder and urination persists during long-term treatment with Tamsulosin Medical Valley.

If you take more Tamsulosin Medical Valley than you should

Taking too many Tamsulosin Medical Valley capsules may lead to unintended low blood pressure and increased heart rate with a feeling of weakness. If you have taken too many Tamsulosin Medical Valley capsules, contact your doctor immediately.

If you forget to take Tamsulosin Medical Valley

If you miss a dose of Tamsulosin Medical Valley at the recommended time, you can take it later that day. If you forget to take the medicine on a given day, take the next capsule at the usual time the next day. Do not take a double dose to make up for a missed dose.

Stopping treatment with Tamsulosin Medical Valley

If treatment with Tamsulosin Medical Valley is stopped earlier than recommended, the symptoms of the disease may recur. Therefore, take Tamsulosin Medical Valley for as long as your doctor has prescribed, even if the symptoms have disappeared. Stopping treatment should always be discussed with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosin Medical Valley can cause side effects, although not everybody gets them.
Stop taking the 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 rash

Common (may affect up to 1 in 10 people)

• dizziness
• abnormal ejaculation (ejaculation disorders). This means that semen does not flow through the urethra but instead flows back into the bladder.
• retrograde ejaculation
• reduced or absent ejaculation. This phenomenon is not harmful.

Uncommon (may affect up to 1 in 100 people)

• headache
• rapid or irregular heartbeat
• dizziness, especially when standing up quickly from a lying or sitting position (orthostatic dizziness)
• runny nose or stuffy nose (rhinitis)
• constipation
• diarrhea
• nausea (vomiting)
• vomiting
• rash
• itching and hives
• feeling of weakness

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

• fainting

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

• painful, prolonged, and unwanted erection (priapism)
• severe rash and inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals, which is an allergic reaction to medicines or other substances, known as Stevens-Johnson syndrome.

Not known (frequency cannot be estimated from the available data)

• nosebleeds
• vision disturbances and blurred vision
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are scheduled for cataract surgery and are taking or have taken tamsulosin hydrochloride, the pupil may not dilate properly, and the iris may become floppy during surgery.
In addition to the side effects listed above, the following have also been reported in connection with tamsulosin:

• very rapid, uncoordinated heart contractions
• irregular heartbeat
• abnormally rapid pulse
• difficulty breathing

Since these reports come from spontaneous reports from around the world after the marketing of tamsulosin, it is not possible to reliably determine the frequency of these events and the role of tamsulosin hydrochloride in their occurrence.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsulosin Medical Valley

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the blister, bottle, or carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tamsulosin Medical Valley contains

Each capsule contains 0.4 mg of tamsulosin hydrochloride.
The other ingredients are:
Pellets: Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% (type A)*, microcrystalline cellulose (type 105), dibutyl sebacate, polysorbate 80
Pellet coating: Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% (type A)*, dibutyl sebacate, polysorbate 80, colloidal silicon dioxide, hydrated
Calcium stearate
Capsule shell: Red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), indigo carmine (E 132), gelatin
* The dispersion contains 0.7% sodium lauryl sulfate (Ph. Eur.) and 2.3% Polysorbate 80 (Ph. Eur.) in solid form as an emulsifier.

What Tamsulosin Medical Valley looks like and contents of the pack

Tamsulosin Medical Valley is available in the form of hard capsules, approximately 15.6-16.2 mm in length, with an opaque orange body and an olive-green cap.
Tamsulosin Medical Valley is packaged in PVC/PVDC/Aluminum blisters or HDPE bottles, placed in a cardboard box.
PVC/PVDC/Aluminum blisters contain 10, 20, 30, 50, 90, or 100 capsules.
Perforated single-dose blisters of PVC/PVDC/Aluminum contain 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90, or 100 x 1 capsules.
HDPE bottles contain 30, 35, 50, 60, 90, 100, 112, or 200 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

Manufacturer

LABORATORIOS LICONSA S.A.
Avda. Miralcampo, Nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

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

Denmark
Tamsulosin Medical Valley
Netherlands
Tamsulosine HCl Xiromed 0.4 mg, hard capsules with modified release
Germany
Tamsaxiro 0.4 mg Hartkapsel mit veränderter Wirkstofffreisetzung
Norway
Tamsulosin Medical Valley
Poland
Tamsulosin Medical Valley

Date of last revision of the leaflet: