Package leaflet: Information for the patient

Tamoptim, 0.4 mg, modified-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 consult 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 adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

What Tamoptim is and what it is used for
Important information before taking Tamoptim
How to take Tamoptim
Possible side effects
How to store Tamoptim
Contents of the pack and other information

1. What Tamoptim is and what it is used for

Tamoptim is used in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia.
These symptoms may include difficulty in passing urine (weak stream), dribbling, urgency, and the need to urinate frequently both during the day and at night.
The active substance in the capsules (tamsulosin – an alpha-adrenergic receptor antagonist) causes relaxation of the smooth muscles of the prostate gland and urethra. This facilitates urine flow through the urethra and improves urination.

2. Important information before taking Tamoptim

When not to take Tamoptim
if the patient is allergic to tamsulosin hydrochloride or to any of the other
components of this medicine (listed in section 6). Allergy to tamsulosin hydrochloride
may manifest as sudden swelling of hands or feet, difficulty breathing and (or) itching
and rash (angioedema).
if the patient has previously experienced dizziness or fainting due to low blood pressure (e.g. when rapidly sitting up from a lying position or standing up).
if the patient has severe liver function impairment.

Warnings and precautions
Please consult your doctor or pharmacist if:
the patient has severe kidney function impairment.
taking Tamoptim causes dizziness or fainting in the patient. In such a case,
the patient should sit or lie down until these symptoms subside.
during treatment with Tamoptim, the patient develops sudden swelling of hands or feet,
difficulty breathing and (or) itching with rash (angioedema) due to an allergic reaction.
the patient is scheduled for surgery or a surgical procedure due to cataract
or increased intraocular pressure (glaucoma), as there may be a risk of intraoperative floppy iris syndrome (see section 4 "Possible side effects").
The ophthalmic surgeon should be informed about current, past or planned use of Tamoptim.
The specialist will then be able to take appropriate precautions when choosing treatment methods and surgical techniques. Please ask your doctor whether it is advisable to delay treatment with this medicine or temporarily discontinue it prior to cataract or glaucoma surgery.
Please consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Children and adolescents
Tamoptim must not be given to children and adolescents under 18 years of age due to lack of efficacy in this age group.

Tamoptim with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
In particular, inform about use of:

diclofenac (a pain-relieving and anti-inflammatory medicine) and warfarin (an anticoagulant), as they may affect the rate at which Tamoptim is eliminated from the body;
medicines that lower blood pressure (such as verapamil and diltiazem);
medicines used to treat HIV infection (such as ritonavir or indinavir);
medicines used to treat fungal infections (such as ketoconazole or itraconazole);
other alpha-1A-adrenolytic medicines (such as doxazosin, indoramin, prazosin or alfuzosin); concomitant use with Tamoptim may lead to decreased blood pressure with dizziness or vertigo.
erythromycin (an antibiotic used to treat infections).

Tamoptim with food and drink
Tamoptim should be taken after the first meal of the day. Taking this medicine on an empty stomach
may increase the number of adverse reactions or their severity.

Pregnancy, breastfeeding and fertility
This medicine is not intended for use in women.

Driving and operating machinery
There is currently no evidence that Tamoptim affects the ability to drive
or operate machinery. However, it should be remembered that the medicine may cause dizziness.

Tamoptim contains sodium
Each modified-release hard capsule contains less than 1 mmol of sodium (23 mg), which
means the medicine is considered "sodium-free".

3. How to use Tamoptim

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The recommended dose is one Tamoptim capsule once daily after the first meal of the day.
The capsule should be taken whole, while standing or sitting (not lying down), with a glass of water.
Do not chew the capsules.
The physician will prescribe the dose adjusted to the patient's needs and will determine the duration of treatment.
Do not change the dose without consulting your doctor.
If you feel that the effect of Tamoptim is too strong or too weak, consult your doctor or pharmacist.
Dose adjustment is not necessary in patients with renal function impairment or mild to moderate hepatic impairment. Tamoptim is contraindicated in patients with severe hepatic impairment (see section 2).

Taking a higher than recommended dose of Tamoptim
If more than the recommended dose is taken, seek immediate advice from a doctor or pharmacist.

Missing a dose of Tamoptim
If a patient forgets to take the capsule after the first meal of the day, they may take it later that day, after a meal. If the dose is missed entirely for the day, take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose.

Stopping treatment with Tamoptim
Do not stop taking Tamoptim without medical advice, as this may cause symptoms to return or worsen.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Serious adverse reactions occur rarely or very rarely. If any of the following symptoms occur,
treatment with this medicine should be stopped immediately and medical advice should be sought,
as treatment may be necessary:

allergic reaction (may occur in fewer than 1 in 1,000 people) with symptoms such as difficulty breathing, itchy rash, swelling of the face, throat or tongue
prolonged and painful penile erection (usually unrelated to sexual activity) – (may occur in fewer than 1 in 10,000 people)
severe skin reaction with symptoms such as blistering and peeling of the skin (known as Stevens-Johnson syndrome, erythema multiforme or toxic epidermal necrolysis) – frequency unknown (frequency cannot be estimated from available data).

The following adverse reactions have also been reported:
Especially when sitting down or standing up

dizziness (common: may occur in fewer than 1 in 10 people)
feeling of weakness (uncommon: may occur in fewer than 1 in 100 people)

If these occur, you should immediately sit or lie down until you feel better.
Common (may occur in fewer than 1 in 10 people)

abnormal ejaculation (ejaculation disorders). This means that semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation), or the amount of semen is reduced or absent (anejaculation). This phenomenon is not harmful to health.

Uncommon (may occur in fewer than 1 in 100 people)

headache
increased heart rate (palpitations)
nasal congestion or runny nose
nausea or vomiting
diarrhoea or constipation
itching or hives, rash, itching, feeling of weakness.

Rare (may occur in fewer than 1 in 1,000 people)

feeling faint.

Very rare (may occur in fewer than 1 in 10,000 people)

during eye surgery due to cataract or high eye pressure (glaucoma), inadequate pupil dilation (the black circle in the center of the eye) may occur, and the iris (colored part of the eye) may become floppy.

Frequency not known (cannot be estimated from available data)

blurred vision or worsening of vision
nosebleeds
dry mouth
irregular heartbeat
difficulty breathing.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tamoptim

This medicine should be stored out of sight and reach of children.
Blister packs:
Store in the original packaging.
Container:
Keep the container tightly closed.
Do not use this medicine after the expiry date stated on the label of the container, blister pack,
and outer packaging following EXP. 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 Tamoptim contains

Active substance: Each modified-release capsule contains the active substance: 0.4 mg tamsulosin hydrochloride.
Other ingredients: microcrystalline cellulose, methacrylic acid–ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc. Capsule shell: gelatin, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Tamoptim looks like and contents of the pack
The capsules are orange-olive green and filled with white or almost white pellets.
The medicine is available in PVC/PE/PVDC/Aluminium blister packs in cardboard boxes or in HDPE bottles with child-resistant PP caps.
Pack sizes:
Blister packs: 30, 60, 90 modified-release capsules
Bottle: 30, 60, 90 modified-release capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw, Poland

Manufacturers
Synthon BV
Microweg 22
NL-6545 CM Nijmegen, The Netherlands
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat, Spain
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Rowa Pharmaceuticals Ltd.
Newton, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For further information on the medicine and its names in the countries of the European Economic Area, please contact
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw, Poland