Tamiron

Patient Information Leaflet

Tamiron, 0.4 mg, prolonged-release capsules, hard
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Tamiron is and what it is used for
2. What you need to know 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 Tamiron is and what it is used for

The active substance in Tamiron is tamsulosin hydrochloride, which belongs to a group of medicines called selective alpha1A/1D-adrenergic receptor antagonists. It reduces the tone of the smooth muscles in the prostate gland and the urethra, allowing easier urine flow through the urethra and facilitating urination. It also reduces the sensation of urgency to urinate.
Tamiron is used in men to treat lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty in urinating (weak urine stream), dribbling of urine, urgency to urinate, and the need to urinate frequently during the night and during the day.

2. Important information before using Tamiron

When not to take Tamiron:

• if the patient is 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 the patient experiences fainting due to low blood pressure upon changing position (when sitting down or standing up).
• in patients with severe hepatic impairment.

Warnings and precautions
Before starting treatment with Tamiron, discuss this with your doctor or pharmacist.

• Regular medical examinations are necessary to monitor the progression of the disease being treated.
• Rarely, during treatment with tamsulosin, as with other drugs in this class, fainting may occur. If early symptoms such as dizziness or weakness are observed, the patient should sit or lie down until symptoms subside.
• Inform your doctor if the patient has severe renal impairment.
• If the patient is scheduled for or has been referred to undergo ophthalmic surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma), inform the ophthalmologist that Tamiron has been previously used, is currently being used, or is planned for use. The ophthalmologist may then take appropriate precautions, including the use of suitable medications and surgical techniques. Ask your doctor whether it is necessary to postpone or temporarily discontinue Tamiron during ophthalmic surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma).

Children and adolescents
Tamiron should not be given to children or adolescents under 18 years of age, as its efficacy has not been demonstrated in this patient group.

Tamiron and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is necessary due to possible interactions—Tamiron may affect the way some other medicines work, and some other medicines may affect the way Tamiron works.

Specifically, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• other medicines from the same class (alpha-1 adrenergic receptor antagonists), e.g. prazosin, alfuzosin. These are medicines used to treat high blood pressure or enlarged prostate gland,
• medicines used to treat gout or pain (diclofenac),
• medicines preventing blood clotting, i.e. anticoagulants (warfarin),
• medicines that may reduce the elimination of tamsulosin hydrochloride from the body (e.g. the antifungal agent ketoconazole or the antibiotic erythromycin).

Tamiron with food and drink
Tamiron should be taken after the first meal of the day. Taking the medicine on an empty stomach may increase the number and severity of adverse effects.

Pregnancy, breastfeeding and fertility
Tamiron is not indicated for use in women.
In short- and long-term clinical trials of tamsulosin, ejaculation disorders were observed. Since the introduction of the medicine, cases of ejaculation disorder, retrograde ejaculation, and absence of ejaculation have been reported.

Driving and operating machinery
There are no data on the effect of tamsulosin on the ability to drive or operate machinery. However, dizziness may occur. In such cases, activities requiring attention should not be performed.

Excipients
Tamiron contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".

3. How to take Tamiron

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.

• Usually one capsule (0.4 mg of tamsulosin hydrochloride) is taken once daily after the first meal of the day.
• Capsules should be taken whole, while standing or sitting (not lying down), with a glass of water.
• Capsules must not be broken, chewed or opened.
• Dose adjustment is not usually required for elderly patients.

The doctor has prescribed a dose tailored to the patient and their condition, and has also specified the duration of treatment. Do not change the prescribed dose without first consulting the doctor.
If the patient feels that the effect of Tamiron is too strong or too weak, they should consult their doctor or pharmacist.

Taking more Tamiron than recommended
Taking too many Tamiron capsules may cause an unwanted drop in blood pressure and increased heart rate accompanied by a feeling of faintness. If an overdose of Tamiron is taken, seek medical advice immediately.

Missing a dose of Tamiron
If a dose of Tamiron is missed at the scheduled time, it can be taken later on the same day. If the patient forgets to take the medicine on a given day, they should take the next capsule at the usual time the following day. Do not take a double dose to make up for a missed dose.

Stopping Tamiron treatment prematurely
If Tamiron treatment is stopped early, symptoms of the disease may return. Therefore, Tamiron should be taken for the full period indicated by the doctor, even after symptoms have improved. Always consult the doctor before stopping the medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must stop taking the medicine immediately and contact your doctor immediately if the patient experiences any of the following serious adverse reactions:

• Sudden localised swelling of soft tissues (e.g. throat or tongue), breathing difficulties and/or itching and rash, often as an allergic reaction (angioedema). May occur in no more than 1 in 1,000 patients.
• Skin rash, skin inflammation and/or inflammation of the mucous membranes of the lips, eyes, mouth, nasal passages or genital organs, and blister formation (Stevens-Johnson syndrome). May occur in no more than 1 in 10,000 patients.
• Priapism (painful, prolonged, unintended erection requiring immediate treatment). May occur in no more than 1 in 10,000 patients.
• Skin rash which may cause blistering and appear as small target-like lesions (a dark centre surrounded by a lighter area and a dark ring around the edge), known as erythema multiforme. Frequency cannot be estimated from the available data.
• Widespread red skin rash with small blisters containing pus (exfoliative dermatitis). Frequency cannot be estimated from the available data.

Other adverse reactions include:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache
• palpitations (heart beats faster than usual, also noticeable)
• low blood pressure, e.g. upon quickly standing up from a sitting or lying position, sometimes associated with dizziness
• nasal congestion or blocked nose (rhinitis)
• constipation
• diarrhoea
• nausea and vomiting
• weakness (asthenia)
• rashes
• itching and urticaria.

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

• fainting.

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

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

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

• visual disturbances and blurred vision
• nosebleeds
• dryness of the mouth.

If the patient requires ophthalmic surgery due to clouding of the eye's lens (cataract) or increased intraocular pressure (glaucoma), and is currently taking or has recently taken Tamiron, there may be difficulty in dilating the pupil and the iris (the coloured part of the eye) may become flaccid during surgery.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tamiron

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature. 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 pack. The expiry date refers to the last day of the stated month.
Medicines must 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.
• Other ingredients are:
  Capsule contents: microcrystalline cellulose, talc, methacrylic acid-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.
  Printing ink: shellac, iron oxide black (E 172).

What Tamiron looks like and contents of the pack
Prolonged-release, hard capsule.
Hard two-part gelatin capsule: opaque olive-green and opaque orange parts, printed with edible black ink showing the letter "D" on the outer part and the digits "53" on the inner part. The capsule contains white or almost white pellets.
Capsule length: 20.4 mm.
Pack sizes:
Blister packs: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 200 and 250 capsules.
Bottle: 10 and 250 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]