Tamiron

Leaflet accompanying the packaging: information for the user

Tamiron, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

Read the 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 to you by a doctor. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tamiron and what is it used for

The active substance of Tamiron is tamsulosin hydrochloride, which belongs to the group of selective alpha-1A/1D adrenergic receptor antagonists. It reduces the tension of the smooth muscles of the prostate and urethra, making it easier for urine to flow through the urethra and facilitating urination. Additionally, it reduces the feeling of pressure on the bladder. Tamiron is used in men to treat symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms may include difficulty urinating (weak urine flow), urinating in drops, pressure on the bladder, and the need to urinate frequently at night and during the day.

2. Important information before taking Tamiron

When not to take Tamiron:

• if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden, localized itching of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• if you experience fainting due to low blood pressure when changing position (when sitting or standing up).
• in patients with severe liver function disorders.

Warnings and precautions

Before starting to take Tamiron, discuss it with your doctor or pharmacist.

• periodic medical examinations are necessary to monitor the progression of the disease being treated.
• rarely, during tamsulosin treatment, as with other drugs in this group, fainting may occur. If you experience initial symptoms of dizziness or weakness, you should sit or lie down until these symptoms pass.
• you should inform your doctor if you have severe kidney function disorders.
• if you are being prepared for or have been scheduled for eye surgery due to cataracts or increased eye pressure (glaucoma), you should inform the ophthalmologist that you have taken Tamiron, are currently taking it, or plan to take it. The ophthalmologist may then take appropriate precautions in the form of appropriate medications and surgical techniques. You should ask your doctor about the need to postpone or temporarily stop taking the medicine during eye surgery due to cataracts or increased eye pressure (glaucoma).

Children and adolescents

The medicine should not be given to children or adolescents under 18 years of age, as it has no effect in this patient group.

Tamiron and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is necessary because Tamiron may affect the way some other medicines work, and some other medicines may affect the way Tamiron works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines from the same group (alpha-1 adrenergic receptor antagonists), such as prazosin, alfuzosin. These are medicines used to treat high blood pressure or enlarged prostate,
• medicines used to treat gout or pain (diclofenac),
• blood-thinning medicines, i.e., anticoagulants (warfarin),
• medicines that may reduce the excretion of tamsulosin hydrochloride from the body (e.g., the antifungal medicine ketokonazole or the antibiotic erythromycin).

Tamiron with food and drink

The medicine should be taken after the first meal of the day. Taking the medicine on an empty stomach may increase the number and severity of side effects.

Pregnancy, breastfeeding, and fertility

Tamiron is not indicated for use in women. In short- and long-term clinical trials, tamsulosin has been associated with ejaculation disorders. After the marketing of the medicine, cases of ejaculation disorder, retrograde ejaculation, and absence of ejaculation have been reported.

Driving and using machines

There are no data on the effects of tamsulosin on the ability to drive or use machines. However, you should be aware of the possibility of dizziness. In this case, do not perform tasks that require attention.

Excipients

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Tamiron

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• the usual dose is one capsule (0.4 mg of tamsulosin hydrochloride) per day, after the first meal of the day.
• the capsules should be swallowed whole, standing or sitting (not lying down), with a glass of water.
• the capsules should not be broken, chewed, or crushed.
• no dose adjustment is necessary for elderly patients.

Your doctor has prescribed a dose tailored to you and your condition, also determining the duration of treatment. Do not change the prescribed dose without consulting your doctor first. If you feel that the effect of Tamiron is too strong or too weak, you should consult your doctor or pharmacist.

Taking more than the recommended dose of Tamiron

Taking too many Tamiron capsules may cause unwanted low blood pressure and increased heart rate with a feeling of fainting. If you have taken too much Tamiron, contact your doctor immediately.

Missing a dose of Tamiron

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

Stopping treatment with Tamiron

If you stop taking Tamiron prematurely, the symptoms of the disease may return. Therefore, you should take Tamiron for the period prescribed by your doctor, even after the symptoms have disappeared. Before stopping the medicine, you should always consult 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, Tamiron can cause side effects, although not everybody gets them. Stop taking the medicine and contact your doctor immediatelyif you experience any of the following serious side effects:

• sudden localized swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema). This may occur in less than 1 in 1,000 patients.
• rash, skin inflammation, and/or inflammation of the mucous membranes of the lips, eyes, mouth, respiratory tract, or genitals, and the formation of blisters on them (Stevens-Johnson syndrome). This may occur in less than 1 in 10,000 patients.
• priapism (painful, prolonged, unwanted erection that requires immediate treatment). This may occur in less than 1 in 10,000 patients.
• skin rash that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around the edge) called erythema multiforme. The frequency cannot be estimated from the available data.
• widespread red skin rash with small blisters containing pus (exfoliative dermatitis). The frequency cannot be estimated from the available data.

Other side effects include:
Common (may affect up to 1 in 10 patients)

• dizziness, especially when sitting or standing up
• ejaculation disorders
• absence of ejaculation
• retrograde ejaculation. This means that semen does not come out through the urethra but instead goes into the bladder. This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 patients)

• headache
• palpitations (heart beats faster than usual, which is also noticeable)
• low blood pressure, e.g., when standing up quickly from a sitting or lying position, sometimes associated with dizziness
• runny nose or blocked nose (inflammation of the nasal mucosa)
• constipation
• diarrhea
• nausea and vomiting
• weakness (asthenia)
• rash
• itching and hives.

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

• fainting.

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

• heart rhythm disorders (atrial fibrillation, arrhythmia, tachycardia)
• breathing difficulties (dyspnea).

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

• vision disorders and blurred vision
• nasal bleeding
• dry mouth.

If you need to undergo eye surgery due to cataracts or increased eye pressure (glaucoma) and are taking or have recently taken Tamiron, there may be a problem with dilating the pupil, and the iris may become floppy during the procedure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to 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 Tamiron

Keep the medicine out of the sight and reach of children. There are no special storage instructions for the medicine. Store in the original packaging to protect from moisture. Do not use this medicine after the expiry date stated on the carton, label, or blister. The expiry date refers to the last day of the month. 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 Tamiron contains

• The active substance is tamsulosin hydrochloride. Each prolonged-release capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: Capsule ingredients: microcrystalline cellulose, talc, methacrylic acid, and ethyl acrylate copolymer (1:1) dispersion 30%, triacetin, calcium stearate. Capsule shell: indigo carmine (E 132), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate. Ink: shellac, iron oxide black (E 172).

What Tamiron looks like and contents of the pack

Prolonged-release hard capsule. The hard gelatin capsule consists of two parts: a non-transparent olive-green and a non-transparent orange part, with a black edible ink print in the form of the letter "D" on the outer part and the number "53" on the inner part. The capsules contain white or off-white pellets. The length of the capsule is 20.4 mm. Pack sizes: Blister: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 200, and 250 capsules. Container: 10 and 250 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:17.02.2021