Tamsulosin medical valley

Package leaflet: Information for the patient

Tamsulosin Medical Valley, 0.4 mg, modified-release capsules, hard
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform 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 in Tamsulosin Medical Valley is tamsulosin. Tamsulosin is a selective
alpha-adrenergic receptor antagonist. It reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. In addition,
tamsulosin reduces the sensation of urgency to urinate.
Tamsulosin Medical Valley is used in men for the treatment of lower urinary tract symptoms
associated with enlargement of the prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling after urination, urgency to urinate, and increased frequency of urination both during the day and at night.

2. Important information before using Tamsulosin Medical Valley

When not to take Tamsulosin Medical Valley:

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

Warnings and precautions
Before starting treatment with Tamsulosin Medical Valley, please discuss this with your doctor or pharmacist.

• Regular medical check-ups are necessary to monitor the progression of the disease being treated.
• As with other medicines in this class, fainting may rarely occur during treatment with Tamsulosin Medical Valley. If symptoms such as dizziness or weakness occur, the patient should sit or lie down until symptoms subside.
• Inform your doctor if the patient has severe kidney function disorders.
• If the patient is scheduled for surgery or is being prepared for a surgical procedure due to cataract (clouding of the eye lens), inform the ophthalmologist that the patient is currently taking, has previously taken, or plans to take Tamsulosin Medical Valley. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. Please consult your doctor whether to delay starting this medicine or temporarily discontinue it prior to cataract removal surgery.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age, as it has not been shown to be effective in this patient group.

Tamsulosin Medical Valley with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Tamsulosin Medical Valley with other medicines from the same group (alpha-adrenergic receptor antagonists) may lead to unintended lowering of arterial blood pressure.
It is especially important to inform your doctor if the patient is 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
Not applicable, as Tamsulosin Medical Valley is intended for use in men only.
Cases of abnormal ejaculation in men (ejaculation disorders) have been reported. This means that semen does not exit through the urethra but instead flows backward into the urinary bladder (retrograde ejaculation), or the volume of ejaculate is reduced or ejaculation does not occur. These symptoms are not harmful to the patient.

Driving and using machines
There are no data available on the effect of Tamsulosin Medical Valley on the ability to drive or operate machinery. However, dizziness may occur. In such a case, activities requiring concentration and attention should not be performed.

3. How to take Tamsulosin Medical Valley

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one tablet per day, taken after breakfast or after the first meal of the day.
The capsule should be swallowed whole; do not chew or crush it.
Tamsulosin Medical Valley is usually prescribed for long-term use.
The effect on the urinary bladder and urination is maintained during prolonged treatment
with Tamsulosin Medical Valley.
Taking more Tamsulosin Medical Valley than recommended
Taking too many capsules of Tamsulosin Medical Valley may lead to an undesirable
decrease in blood pressure and increased heart rate with a feeling of weakness. If too many
capsules of Tamsulosin Medical Valley have been taken, contact a doctor immediately.
Missing a dose of Tamsulosin Medical Valley
If a dose of Tamsulosin Medical Valley has been missed at the scheduled time, the dose may be taken
later on the same day. If the patient has forgotten to take the medicine on a given day, they should take
the next capsule the following day at the usual time. 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, symptoms of the
disease may recur. Therefore, Tamsulosin Medical Valley should be taken for as long as directed by
the attending physician, even if symptoms have subsided. Any decision to discontinue treatment should
always be discussed with a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and immediate medical help sought if the patient experiences 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 exit through the urethra but flows backward into the bladder.
• retrograde ejaculation
• reduced ejaculate volume or absence of ejaculation (ejaculation disorder). This phenomenon is not harmful.

Uncommon (may affect up to 1 in 100 people)

• headache
• fast or irregular heartbeat
• dizziness, especially when rising quickly from a lying or sitting position (orthostatic dizziness)
• nasal congestion or runny nose (nasal mucosal inflammation)
• constipation
• diarrhoea
• nausea
• vomiting
• rash
• itching and urticaria
• 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 inflammatory reaction with blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals, representing an allergic reaction to medicines or other substances, known as Stevens-Johnson syndrome.

Unknown (frequency cannot be estimated from available data)

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

If the patient is scheduled for eye lens surgery due to cataract and is currently taking or has previously taken tamsulosin hydrochloride, the pupil may fail to dilate properly and the iris (the coloured, circular part of the eyeball) may become flaccid during the procedure.

In addition to the adverse reactions listed above, the following have also been reported with the use of tamsulosin:

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

Since reports of the above events are derived globally from spontaneous post-marketing reports following the introduction of tamsulosin, the frequency of these events and the role of tamsulosin hydrochloride in their occurrence cannot be reliably determined.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the 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
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tamsulosin Medical Valley

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

6. Contents of the package and other information

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

What Tamsulosin Medical Valley looks like and contents of the pack
Tamsulosin Medical Valley is a hard capsule approximately 15.6–16.2 mm in length, with an opaque orange body and olive-green cap.
Tamsulosin Medical Valley is packed in blisters made of PVC/PVDC/Aluminium or in HDPE bottles, placed in a cardboard box.
PVC/PVDC/Aluminium blisters contain 10, 20, 30, 50, 90 or 100 capsules.
Single-dose perforated blisters made of PVC/PVDC/Aluminium 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 Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

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

This medicinal product is authorised in the European Economic Area under the following names:
Denmark Tamsulosin Medical Valley
Netherlands Tamsulosine HCl Xiromed 0.4 mg, harde capsules met gereguleerde afgifte
Germany Tamsaxiro 0.4 mg Hartkapsel mit veränderter Wirkstofffreisetzung
Norway Tamsulosin Medical Valley
Poland Tamsulosin Medical Valley