TAMISPRAS 6 mg + 0.4 Mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. TamisPras DUO, 6 mg + 0,4 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the package leaflet:
3. What is TamisPras DUO and what is it used for
4. Important information before taking TamisPras DUO
   1. When not to take TamisPras DUO:
   2. Warnings and precautions
   3. Children and adolescents
   4. TamisPras DUO with other medicines
   5. TamisPras DUO with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. TamisPras DUO contains sodium
5. How to take TamisPras DUO
   1. If you take more TamisPras DUO than you should
   2. If you forget to take TamisPras DUO
   3. If you stop taking TamisPras DUO
6. Possible side effects
   1. Reporting side effects
7. How to store TamisPras DUO
8. Contents of the pack and other information
   1. What TamisPras DUO contains
   2. What TamisPras DUO looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. Marketing authorisation holder:
   5. Manufacturer:
   6. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the package leaflet: 12/2024

Package Leaflet: Information for the User

TamisPras DUO, 6 mg + 0,4 mg, prolonged-release tablets

Solifenacin succinate + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult your doctor or pharmacist.
This medicine has been prescribed to you by your doctor. 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 package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What is TamisPras DUO and what is it used for

TamisPras DUO is a combination of two different medicines, solifenacin and tamsulosin, in one tablet. Solifenacin belongs to a group of medicines called anticholinergics, and tamsulosin belongs to a group of medicines called alpha-blockers.
TamisPras DUO is used in men to treat moderate to severe symptoms of benign prostatic hyperplasia (BPH), which is a non-cancerous enlargement of the prostate gland. The symptoms can include difficulty starting to urinate, weak urine flow, frequent urination, or waking up at night to urinate.
TamisPras DUO works by relaxing the muscles in the prostate and bladder, making it easier to urinate.

2. Important information before taking TamisPras DUO

When not to take TamisPras DUO:

if you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
if you have severe kidney disease or are on dialysis.
if you have severe liver disease.
if you have a history of certain eye problems (such as narrow-angle glaucoma).
if you have a history of certain heart problems (such as slow heart rate or low blood pressure).
if you are taking certain medicines that can interact with TamisPras DUO (such as ketoconazole, erythromycin, or ritonavir).
if you have a history of certain neurological disorders (such as Parkinson's disease or multiple system atrophy).
if you have a history of certain psychiatric disorders (such as depression or anxiety).
Tell your doctor if you have any of these conditions.

Warnings and precautions

Before taking TamisPras DUO, tell your doctor if you have:
any kidney or liver problems.
any heart problems (such as high blood pressure or heart failure).
any neurological disorders (such as Parkinson's disease or multiple system atrophy).
any psychiatric disorders (such as depression or anxiety).
any history of seizures or epilepsy.
any history of narrow-angle glaucoma.
Tell your doctor if you are taking any other medicines, including those bought without a prescription.

Children and adolescents

Do not give TamisPras DUO to children or adolescents under 18 years old.

TamisPras DUO with other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including those bought without a prescription.
Some medicines can interact with TamisPras DUO, such as:
ketoconazole, erythromycin, or ritonavir (which can increase the levels of solifenacin in your blood).
other anticholinergic medicines (which can increase the risk of side effects).
cholinergic medicines (which can decrease the effectiveness of TamisPras DUO).
metoclopramide or cisapride (which can increase the risk of side effects).
other alpha-blockers (which can increase the risk of low blood pressure).
bisphosphonates (which can increase the risk of side effects).

TamisPras DUO with food and drink

You can take TamisPras DUO with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Do not take TamisPras DUO if you are pregnant or breastfeeding.
TamisPras DUO may affect fertility in men. If you are planning to father a child, tell your doctor.

Driving and using machines

TamisPras DUO may cause dizziness, blurred vision, or fatigue. Do not drive or operate machinery if you experience these side effects.

TamisPras DUO contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take TamisPras DUO

Always take TamisPras DUO exactly as your doctor or pharmacist has told you.
The recommended dose is one tablet per day, taken orally.
You can take TamisPras DUO with or without food, as you prefer.
Do not crush or chew the tablet.

If you take more TamisPras DUO than you should

If you take more tablets than your doctor has prescribed, or if someone else takes your tablets, contact your doctor, pharmacist, or hospital immediately.
In case of overdose, your doctor may give you activated charcoal or perform gastric lavage if it is done within 1 hour of overdose. Do not induce vomiting.

If you forget to take TamisPras DUO

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

If you stop taking TamisPras DUO

If you stop taking TamisPras DUO, your symptoms may come back or get worse.
Always consult your doctor before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TamisPras DUO can cause side effects, although not everybody gets them.
The most serious side effect is acute urinary retention, which is a sudden inability to urinate. If you experience this, contact your doctor immediately.
Other side effects include:
Common side effects(may affect up to 1 in 10 people)
dizziness
blurred vision
dry mouth, nausea, constipation, abdominal pain
abnormal ejaculation (such as retrograde ejaculation). This means that semen does not come out of the penis, but instead goes into the bladder.
fatigue (tiredness)
Uncommon side effects(may affect up to 1 in 100 people)
urinary tract infection, cystitis (inflammation of the bladder)
sleepiness (somnolence), taste disturbances (dysgeusia), headache
dry eyes
rapid or irregular heartbeat (palpitations)
dizziness or weakness, especially when standing up (orthostatic hypotension)
runny nose or stuffy nose (rhinitis), dry nose
gastroesophageal reflux disease (GERD), diarrhea, dry throat, nausea (vomiting)
itching (pruritus)
difficulty urinating
swelling of the feet or ankles (edema), fatigue (asthenia)
Rare side effects(may affect up to 1 in 1,000 people)
fainting (syncope)
constipation, intestinal obstruction (ileus)
allergic reactions, such as hives or itching (urticaria)
Very rare side effects(may affect up to 1 in 10,000 people)
hallucinations, disorientation
severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis
prolonged and painful erection (priapism)
Frequency not known(cannot be estimated from the available data)
anaphylaxis (a severe allergic reaction)
decreased appetite, high levels of potassium in the blood (hyperkalemia), which can cause irregular heartbeat
delirium (a state of confusion and altered consciousness)
inflammation of the liver (hepatitis)
yellowing of the skin and eyes (jaundice)
seizures (fits)
increased heart rate (tachycardia)
shortness of breath, difficulty speaking, nosebleeds (epistaxis)
intestinal obstruction (ileus), abdominal discomfort
liver problems (elevated liver enzymes)
skin reactions, such as rash or itching (urticaria)
muscle weakness (myasthenia)
kidney problems (elevated creatinine levels)

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
You can also report side effects directly to the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TamisPras DUO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store the blisters below 25°C.
Store the bottles below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What TamisPras DUO contains

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each prolonged-release tablet contains 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), hypromellose (E 464), red iron oxide (E 172), magnesium stearate (E 470b), macrogol, silica colloidal anhydrous, titanium dioxide (E 171).

What TamisPras DUO looks like and contents of the pack

TamisPras DUO, 6 mg + 0.4 mg, prolonged-release tablets are red, round, biconvex, film-coated tablets with the inscription "T7S" on one side.
TamisPras DUO is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 prolonged-release tablets in a cardboard box or in perforated unit dose blisters containing 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 100 x 1, or 200 x 1 prolonged-release tablet and in HDPE bottles containing 200 prolonged-release tablets, closed with a child-resistant polypropylene cap, with 2 g of desiccant, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer:

Synthon Hispania S.L.
C/ Castelló 1
08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon s.r.o.
Brněnská 32/čp. 597
678 01 Blansko
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands:
Solifenacinesuccinaat/Tamsulosine HCl Aurobindo 6mg/0,4mg, tabletten met gereguleerde afgifte
Belgium:
Solifenacine/Tamsulosine AB 6 mg/0,4 mg tabletten met gereguleerde afgifte/ comprimés à libération modifiée/ Tabletten mit veränderter Wirkstofffreisetzung
Spain:
Solifenacina/Tamsulosina 6 mg/0,4 mg comprimidos de liberacion modificada EFG
Poland:
TamisPras DUO
Portugal:
Solifenacina + Tansulosina Generis

Date of last revision of the package leaflet: 12/2024