Tamoptim

Package Leaflet: Information for the Patient

Tamoptim, 0.4 mg, modified-release capsules, hard
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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given 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 Tamoptim and what is it used for
• 2. Important information before taking Tamoptim
• 3. How to take Tamoptim
• 4. Possible side effects
• 5. How to store Tamoptim
• 6. Contents of the pack and other information

1. What is Tamoptim and what is it used for

Tamoptim is used to treat the symptoms of benign prostatic hyperplasia (enlargement of the prostate gland).
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-1A adrenergic receptor antagonist) relaxes the smooth muscles of the prostate and bladder neck, making it easier to urinate.

2. Important information before taking Tamoptim

When not to take Tamoptim

if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Allergic reactions to tamsulosin hydrochloride may be severe and include sudden swelling of the hands or feet, difficulty breathing, and itching or rash (angioedema).
if you have ever had a severe drop in blood pressure (e.g., when standing up from a lying or sitting position).
if you have severe liver problems.

Warnings and precautions

Tell your doctor or pharmacist if you have:
severe kidney problems.
experienced dizziness or fainting while taking Tamoptim. If this happens, sit or lie down until the symptoms go away.
experienced a severe allergic reaction (such as sudden swelling of the hands or feet, difficulty breathing, and itching or rash) while taking Tamoptim.
are going to have eye surgery (e.g., cataract or glaucoma surgery), as there is a risk of a condition called "floppy iris syndrome" (see section 4 "Possible side effects").
Tell your eye doctor that you are taking or have taken Tamoptim. Your doctor will take precautions during the operation.
Ask your doctor if you should delay taking Tamoptim or stop taking it temporarily before having cataract or glaucoma surgery.
Children and adolescents
Tamoptim should not be given to children and adolescents under 18 years of age, as there is no experience with its use in this age group.

Tamoptim with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those you have bought without a prescription.
Particularly, tell your doctor or pharmacist if you are taking:
diclofenac (a painkiller and anti-inflammatory) and warfarin (a blood thinner), as they may affect the way Tamoptim is removed from the body.
medicines that lower blood pressure (such as verapamil and diltiazem).
medicines used to treat HIV (such as ritonavir or indinavir).
medicines used to treat fungal infections (such as ketoconazole or itraconazole).
other alpha-1A adrenergic receptor antagonists (such as doxazosin, indoramin, prazosin, or alfuzosin), as taking them with Tamoptim may cause a drop in blood pressure, leading to dizziness or fainting.
erythromycin (an antibiotic used to treat infections).

Tamoptim with food and drink

Tamoptim should be taken after the first meal of the day. Taking it on an empty stomach may increase the risk of side effects or make them worse.

Pregnancy, breastfeeding, and fertility

Tamoptim is not intended for use in women.

Driving and using machines

There is no evidence that Tamoptim affects the ability to drive or use machines. However, you should be aware that Tamoptim may cause dizziness.
Tamoptim contains sodium.
Each modified-release capsule contains less than 1 mmol of sodium (23 mg), which means that the medicine is essentially "sodium-free".

3. How to take Tamoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one Tamoptim capsule once a day, after the first meal of the day.
Swallow the capsule whole, standing or sitting (not lying down), with a glass of water.
Do not chew the capsule.
Your doctor will prescribe the dose that is right for you and will tell you how long to take the medicine.
Do not change the dose without talking to your doctor.
If you feel that the effect of Tamoptim is too strong or too weak, talk to your doctor or pharmacist.
No dose adjustment is necessary for patients with kidney problems or mild to moderate liver problems. However, Tamoptim should not be taken by patients with severe liver problems (see section 2).

What to do if you take more Tamoptim than you should

If you have taken more Tamoptim than you should, tell your doctor or pharmacist immediately.

What to do if you forget to take Tamoptim

If you forget to take a capsule after the first meal of the day, you can take it later that day, after a meal. If you do not take the capsule at all, take it the next day at the usual time. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Tamoptim

Do not stop taking Tamoptim without talking to your doctor first, as this may cause your symptoms to come back or get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamoptim can cause side effects, although not everybody gets them.

Severe side effects are rare or very rare. If you experience any of the following symptoms, stop taking Tamoptim and tell your doctor immediately, as you may need treatment:

• allergic reaction (may occur in less than 1 in 1000 people) with symptoms such as difficulty breathing, itching, swelling of the face, throat, or tongue
• prolonged and painful erection (usually unrelated to sexual activity) - (may occur in less 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 not known (cannot be estimated from the available data)

The following side effects have also been reported:

Especially when standing up or sitting down

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

If you experience these symptoms, sit or lie down until you feel better.
Common(may occur in less than 1 in 10 people)

• abnormal ejaculation (ejaculation disorders). This means that semen does not come out of the body through the urethra, but instead goes into the bladder (retrograde ejaculation) or the amount of semen is reduced or absent (ejaculatory failure). This is not harmful to health.

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

• headache
• rapid heartbeat (palpitations)
• runny nose or nasal congestion
• nausea or vomiting
• diarrhea or constipation
• itching or hives, rash, itching, feeling of weakness.

Rare(may occur in less than 1 in 1000 people)

• feeling of fainting.

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

• during eye surgery (e.g., cataract or glaucoma surgery), there is a risk of a condition called "floppy iris syndrome", where the iris (the colored part of the eye) becomes floppy.

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

• blurred vision or decreased vision
• nosebleeds
• dry mouth
• irregular heartbeat
• breathing difficulties.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. You can also report side effects 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 Tamoptim

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

• - Active substance.Each modified-release capsule contains the active substance: 0.4 mg tamsulosin hydrochloride.
• Other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc. Capsule shell: gelatin, indigo carmine (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, filled with white or almost white pellets.
Tamoptim is available in PVC/PE/PVDC/Aluminum blister packs in a cardboard box or HDPE containers with a child-resistant PP cap.
Pack sizes:
Blister packs: 30, 60, 90 modified-release capsules
Container: 30, 60, 90 modified-release capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer
Synthon BV
Microweg 22
NL-6545 CM Nijmegen, 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
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 more information about this medicine and its authorized names in the European Economic Area, contact

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Date of last revision of the leaflet:January 2020