Apo-tamis

Leaflet attached to the packaging: patient information

Apo-Tamis, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine 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 Apo-Tamis and what is it used for
• 2. Important information before taking Apo-Tamis
• 3. How to take Apo-Tamis
• 4. Possible side effects
• 5. How to store Apo-Tamis
• 6. Contents of the pack and other information

1. What is Apo-Tamis and what is it used for

The active substance of Apo-Tamis is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, it reduces the feeling of urgency to urinate.
Apo-Tamis is used in men for the treatment of symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia (enlargement of the prostate). These symptoms include difficulty urinating (weak stream), urinating in drops, sudden urge to urinate, and increased frequency of urination both at night and during the day.

2. Important information before taking Apo-Tamis

When not to take Apo-Tamis

• if you have been diagnosed with hypersensitivity (allergy) to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash (angioedema).
• if you have severe liver impairment.
• if you have low blood pressure when changing position (sitting or standing), which may cause fainting.

Warnings and precautions

Before starting to take Apo-Tamis, discuss it with your doctor or pharmacist.

• Regular medical check-ups are necessary to monitor the course of the disease.
• During treatment with Apo-Tamis, as with other medicines of this type, fainting may rarely occur. If you experience dizziness or weakness, you should sit or lie down until the symptoms pass.
• If you have severe kidney impairment, tell your doctor.
• If you are going to have cataract surgery or increased intraocular pressure (glaucoma) surgery, inform your doctor that you have taken, are taking, or

are going to take Apo-Tamis. Your doctor may take appropriate precautions considering the medications and surgical techniques used. When preparing for cataract surgery or surgical treatment of increased intraocular pressure (glaucoma), you should ask your doctor if you should postpone or temporarily stop taking the medicine.

• Do not take tamsulosin at the same time as strong CYP3A4 inhibitors in patients with a poor CYP2D6 metabolizer phenotype. Consult your doctor before taking any other medicines.

Children and adolescents

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

Apo-Tamis and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines available without a prescription.

Tell your doctor or pharmacist if you are taking any of the following medicines

Taking tamsulosin with other medicines from the same group (alpha-receptor antagonists, e.g., doxazosin, prazosin, or alfuzosin) may cause undesirable low blood pressure. Inform your doctor about all the medicines you have taken recently that may reduce the excretion of tamsulosin from the body (e.g., ketoconazole, erythromycin). Concomitant use with diclofenac or warfarin may increase the excretion of tamsulosin.

Apo-Tamis with food and drink

Apo-Tamis should be taken after breakfast or after the first meal, washed down with a glass of water.

Pregnancy and breastfeeding

Apo-Tamis is not indicated for use in women.

Fertility

Abnormal ejaculation has been reported during treatment with tamsulosin.

Driving and using machines

Apo-Tamis may cause dizziness. Do not drive vehicles, use tools, or operate machines until you are sure how Apo-Tamis affects you. If you have any doubts, consult your doctor or pharmacist.
If any of the above warnings apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Apo-Tamis.
Apo-Tamis contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".

3. How to take Apo-Tamis

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• The usual dose is one capsule per day.

Apo-Tamis should be taken after breakfast or after the first meal, washed down with a glass of water.
The capsule should be swallowed whole and not chewed or crushed, as this disrupts the ability to release the active substance slowly. However, the capsule can be opened and its contents swallowed without chewing.

Taking more Apo-Tamis than prescribed

If you take more Apo-Tamis than prescribed, you may experience undesirable low blood pressure and rapid heart rate, feeling of fainting. If you have taken too many capsules, contact your doctor as soon as possible.

Missing a dose of Apo-Tamis

If you forget to take a dose of Apo-Tamis as directed, you can take it later that day. If you do not take the capsule on the given day, continue treatment according to the previous dosing schedule. Do not take a double dose to make up for the missed dose (capsule).

Stopping treatment with Apo-Tamis

If you stop treatment with Apo-Tamis too early, the symptoms of the disease may return. Therefore, Apo-Tamis should be taken for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. Before stopping treatment, always consult your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Tamis can cause side effects, although not everybody gets them. The following side effects have been reported during treatment with this medicine:
Common(may affect up to 1 in 10 people):
Dizziness, blurred vision, vision disturbances, abnormal or retrograde ejaculation or ejaculation disorders, low or absent semen during ejaculation (ejaculation failure).
Uncommon(may affect up to 1 in 100 people):
Headache, palpitations (heartbeats felt and faster than usual), dizziness, especially when sitting or standing from a lying position, nasal congestion, gastrointestinal reactions (constipation, diarrhea, nausea, vomiting), allergic reactions (rash, itching, urticaria), weakness.
Rare(may affect up to 1 in 1,000 people):
Fainting and sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash, often due to an allergic reaction (angioedema). Treatment should be stopped immediately. Therapy should be resumed after the skin reactions have subsided and consultation with a doctor.
Very rare(may affect up to 1 in 10,000 people):
Priapism (persistent and painful erection of the penis, which requires immediate treatment). Rash, a disease characterized by inflammation and blistering of the skin and (or) mucous membranes in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome).
If you are going to have eye surgery for cataracts (lens clouding) and have taken or are taking Apo-Tamis, weak pupil dilation and iris floppiness (flaccidity) may occur during the procedure.
Not known(frequency cannot be estimated from the available data):
Abnormal, disturbed heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea), nosebleeds, itchy skin rash, often with blisters resembling small targets (erythema multiforme), a skin disease characterized by intense peeling and redness of the skin (exfoliative dermatitis), dryness in the mouth.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Tamis

• Store in a place out of sight and reach of children.
• Do not store above 30°C.
• Store in the original packaging.

Do not take Apo-Tamis after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month.
The batch number is stated after the abbreviation "Lot".
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 Apo-Tamis contains

• The active substance is tamsulosin hydrochloride. Each prolonged-release capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: Contents of the capsule:sodium alginate, methacrylic acid and ethyl acrylate copolymer (1:1), dibehenic acid glyceride, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone emulsion 30% (simethicone, methylcellulose, sorbic acid), anhydrous colloidal silica. Capsule shell:Body: titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin. Cap: titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin.

What Apo-Tamis looks like and contents of the pack

Orange gelatin capsules No. 2, which contain white or yellowish granules.
Apo-Tamis is available in packs of 30, 90, and 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 02.2022