Tamur

Package Leaflet: Information for the Patient

Tamur, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tamur and what is it used for

Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. Tamsulosin reduces the tension of the prostate and urethra.
Tamsulosin is used to relieve the symptoms of benign prostatic hyperplasia (enlargement of the prostate).
By relaxing the muscles, it makes it easier to urinate.

2. Important information before taking Tamur

When not to take Tamur:

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (symptoms may include: facial and throat swelling(angioedema));
• if you have had a history of low blood pressure when standing up, causing dizziness, fainting or lightheadedness;
• if you have severe liver disease.

Warnings and precautions

Before starting treatment with Tamur, you should discuss it with your doctor:

• if you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower your blood pressure, which can cause these symptoms. In this case, you should sit or lie down and stay in this position until the symptoms go away;
• if you have severe kidney disease. The usual dose of tamsulosin may not be effective in patients with impaired kidney function.
• if you are planning to have eye surgery for cataracts or glaucoma. A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4. Possible side effects). You should inform your ophthalmologist if you have taken or are taking tamsulosin. Your doctor will be able to take appropriate precautions regarding treatment and surgical techniques. You should ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or glaucoma treatment.

Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are indeed caused by an enlarged prostate.

Children and adolescents

Tamur should not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Tamur and other medicines

Tamsulosin may affect the action of other medicines, and some other medicines may affect the action of tamsulosin. Therefore, it is important to tell your doctor if you are taking:

• blood pressure-lowering medicines (e.g. verapamil and diltiazem);
• medicines used to treat HIV infection (e.g. ritonavir or indinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• blood-thinning medicines (warfarin);
• anti-inflammatory medicines (e.g. diclofenac);
• medicines used to treat infections (e.g. erythromycin, clarithromycin);
• medicines that weaken the immune system (e.g. cyclosporin).

Tell your doctor or pharmacistabout all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.

Tamur with food and drink

Tamsulosin should be taken with a glass of water, after breakfast or after the first meal.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.
There have been reports of ejaculation disorders in men. This means that semen does not flow through the urethra, but instead flows back into the bladder (retrograde ejaculation) or there is a decrease in the volume of ejaculated semen or its absence (absence of ejaculation).

Driving and using machines

There is no data on the effect of tamsulosin on the ability to drive and use machines. However, patients should take into account that tamsulosin may cause dizziness or lightheadedness. The patient may drive or operate machinery only if they feel well.

Tamur contains sodium

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

3. How to take Tamur

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.
The recommended doseis one capsule once a day after breakfastor after the first meal.
The capsule should be taken with a glass of water, standing or sitting (not lying down), and swallowed whole. It is important not to break or crush the capsule, as this may alter the proper action of tamsulosin.
If you have mild to moderate kidney or liver disease, you may take the usual dose of tamsulosin.

Taking more than the recommended dose of Tamur

After taking more than the recommended dose of Tamur, a sudden drop in blood pressure may occur. The patient may experience dizziness, weakness, and fainting, vomiting, and diarrhea. To reduce the symptoms of low blood pressure, you should lie down and then contact your doctor. Your doctor may give you medicines to restore blood pressure to normal values and monitor your vital functions. If necessary, your doctor may recommend gastric lavage and give you laxatives to remove the part of the medicine that has not yet been absorbed from the digestive system into the blood.

Missing a dose of Tamur

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Tamur

If treatment is stopped prematurely, the symptoms of the disease may return. Therefore, you should take tamsulosin for as long as your doctor has prescribed, even if the symptoms of the disease 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, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediatelyif you experience:

• rare side effects (occurring in less than 1 in 1,000 patients): sudden swelling of the hands, feet, mouth, tongue, or throat, causing difficulty breathing and (or) itching and rash, caused by an allergic reaction (angioedema)
• very rare side effects (occurring in less than 1 in 10,000 patients): rash, redness, blistering, and peeling of the skin and (or) mucous membranes of the lips, eyes, mouth, nose, or genitals (Stevens-Johnson syndrome)
• side effects with unknown frequency (frequency cannot be estimated from available data): severe redness and peeling of the skin (erythema multiforme).

Common side effects(occurring in less than 1 in 10 patients):
dizziness, ejaculation disorders, retrograde ejaculation, absence of ejaculation
Uncommon side effects(occurring in less than 1 in 100 patients):
headache, palpitations (heartbeat felt and faster than usual), low blood pressure felt, for example, when changing position from lying to standing, and sometimes causing dizziness, lightheadedness, or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhea, nausea, vomiting, rash, itching rash (hives), feeling of weakness (asthenia), itching
Rare side effects(occurring in less than 1 in 1,000 patients):
fainting
Very rare side effects(occurring in less than 1 in 10,000 patients):
prolonged and painful erection (priapism)
Frequency not known(frequency cannot be estimated from available data):
blurred vision, loss of vision, nosebleeds, dry mouth.
During eye surgery for cataracts or glaucoma, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate well, and the iris (the colored part of the eye) may become floppy. For more information, see section 2. "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Tamur

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and container after: EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Store the blisters in the original packaging.
Keep the container tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tamur contains

• The active substance is 0.4 mg of tamsulosin hydrochloride.
• Excipients: capsule contents: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion: polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Pellet coating:methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion: polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell - cap: indigo carmine (E132), iron oxide black (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin.
Capsule shell - body:iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin.

What Tamur looks like and contents of the pack

Tamur is orange/olive-green capsules containing white or almost white pellets.
Pack sizes: 30, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Synthon Hispania S.L.
Calle Castelló no 1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6, 00-728 Warsaw
tel. 22 364 61 01

Date of last revision of the leaflet: