Tamsudil Plus 6 mg/0.4 mg. 30 tablets

1. What Tamsudil Plus is and what it is used for

Tamsudil Plus is a combination of two different medicines called 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.

Tamsudil Plus is used in men to treat both moderate to severe storage symptoms and lower urinary tract symptoms caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia (BPH)). This medicine is used when previous treatment with a product containing only one of the ingredients for this condition has not effectively relieved the symptoms.

As the prostate grows, this can lead to problems with urination (voiding symptoms) such as hesitancy (difficulty starting to urinate), difficulty urinating (weak stream), dribbling and a feeling of incomplete emptying of the bladder. At the same time, the bladder is also affected and contracts spontaneously when you do not want to urinate. This leads to symptoms of storage such as changes in bladder sensitivity, urgency (having a strong, sudden urge to urinate without warning) and the need to urinate more frequently.

Solifenacin reduces the involuntary contractions of your bladder and increases the amount of urine your bladder can hold. You may therefore wait longer before going to the toilet. Tamsulosin allows urine to pass more easily through the urethra and makes it easier to urinate.

2. What you need to know before you take Tamsulosin Plus

Do NOT take Tamsulosin Plus:

if you are allergic to solifenacin or tamsulosin, or any of the other ingredients of this medicine (listed in section 6); if you are on kidney dialysis;

if you have severe liver disease;

if you suffer from severe kidney disease AND IF at the same time you are being treated with medicines that may reduce the removal of Tamsudil Plus from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case;

if you suffer from moderate liver disease AND IF at the same time you are being treated with medicines that may reduce the removal of Tamsudil Plus from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case;

if you have severe stomach or intestinal disease (including toxic megacolon - a complication associated with ulcerative colitis);

if you suffer from a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles;

if you have increased pressure in the eye (glaucoma) with gradual loss of vision;

if you suffer from fainting due to low blood pressure when you change your position (when sitting or standing) - this is called orthostatic hypotension.

Tell your doctor if you think any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsudil Plus if:

you are unable to urinate (urinary retention);

you have any obstruction (blockage) in your digestive system;

you are at risk of slowing down the activity of your digestive system (stomach and intestinal movements). Your doctor will inform you if this is the case;

you have a stomach problem (hiatal hernia) or heartburn and/or if you are taking medicines at the same time that can cause or worsen oesophagitis;

you have a certain type of nerve disease (autonomic neuropathy);

you suffer from severe kidney disease;

you have moderate liver disease.

Periodic medical check-ups are necessary to monitor the progress of the disease for which you are being treated

This medicine may affect your blood pressure, which may make you feel dizzy, light-headed or in rare cases faint (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they disappear.

If you are undergoing or are scheduled to have eye surgery for clouding of the lens (cataract) or increased pressure in the eye (glaucoma), please inform your eye doctor that you have taken or are taking or plan to use Tamsudil Plus. This way, the specialist can take the necessary precautions in relation to the treatment and the surgical techniques to be used. Talk to your doctor about whether or not you should delay or temporarily stop taking this medicine until you have surgery for clouding of the lens (cataract) or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Tamsudil Plus

You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking:

medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem and paroxetine, which reduce the rate at which Tamsudil Plus is removed from the body;

other anticholinergic medicines, because the effects and side effects of both medicines may be increased if you take two medicines of the same type;

cholinergics, because they may reduce the effect of Tamsudil Plus;

medicines such as metoclopramide and cisapride, which cause the digestive system to speed up. Tamsudil Plus may reduce their effect;

other alpha-blockers, because this may lead to an unwanted decrease in blood pressure;

medicines such as bisphosphonates, which may cause or worsen inflammation of the gullet (esophagitis).

Tamsudil Plus with food and drink

Tamsudil Plus can be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

Tamsudil Plus is not indicated for use in women.

Abnormal ejaculation (ejaculation disorders) has been reported in men. This means that the seminal fluid is not released from the body through the urethra, but instead goes into the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (no ejaculation). This phenomenon is harmless.

Driving and using machines

This medicine may cause dizziness, blurred vision, tiredness and, rarely, drowsiness. If you experience any of these side effects, do not drive or use machines.

3. How to take Tamsudil Plus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The maximum daily dose is one tablet containing 6 mg solifenacin and 0.4 mg tamsulosin, taken by mouth. The medicine can be taken with or without food, according to your preference. Do not crush or chew the tablet.

If you take more Tamsudil Plus than you should

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately.

In case of overdose, your doctor may give you activated charcoal; immediate gastric lavage may be beneficial if done within 1 hour of the overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness and blurred vision, seeing things that are not there (hallucinations), excessive excitability, fits (convulsions), difficulty breathing, fast heart rate (tachycardia), inability to completely or partially empty the bladder or pass urine (urinary retention) and/or an unwanted decrease in blood pressure.

If you forget to take Tamsudil Plus

Take your next Tamsudil Plus tablet as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Tamsudil Plus

If you stop taking this medicine, your original complaints may return or get worse. Always consult your doctor if you plan to stop treatment.

If you have any further questions on 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.

The most serious side effect that has been seen uncommonly (may affect up to 1 in 100 men) during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical studies is acute urinary retention, which is a sudden inability to pass urine. If you think you may have this, consult a doctor immediately. You may need to stop taking this medicine.

Allergic reactions that can occur with Tamsudil Plus:

Uncommon signs of allergic reactions may include skin rash (which may be itchy) or hives (urticaria);

Rare symptoms include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, this medicine should be stopped immediately and not restarted.

If you experience an allergic reaction or severe skin reaction (e.g. blistering and peeling of the skin), you should inform your doctor immediately and stop using this medicine. Appropriate therapy and/or measures should be taken.

Other side effects

Common side effects (may affect up to 1 in 10 men)

dry mouth;

constipation;

indigestion (dyspepsia);

dizziness;

blurred vision;

tiredness (fatigue);

abnormal ejaculation (ejaculation disorder). This means that semen is not released from the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (anejaculation). This phenomenon is harmless;

nausea;

abdominal pain.

Other uncommon side effects (may affect up to 1 in 100 men)

sleepiness (somnolence);

itching (pruritus);

rash;

urinary tract infection, bladder infection (cystitis);

taste disturbance (dysgeusia);

dry eyes;

dry nose;

reflux disease (gastro-oesophageal reflux);

dry throat;

dry skin;

difficulty passing urine;

fluid retention in the lower limbs (peripheral oedema);

headache;

fast or irregular heartbeat (palpitations);

feeling dizzy or weak, especially when standing up (orthostatic hypotension);

runny or blocked nose (rhinitis);

diarrhoea;

vomiting;

tiredness (asthenia).

Rare side effects (may affect up to 1 in 1,000 men)

accumulation of large amounts of hardened stool in the large intestine (faecal impaction) fainting (syncope);

skin allergy that causes swelling of the tissues just under the skin surface (angioedema).

Very rare side effects (may affect up to 1 in 10,000 men)

hallucinations, confusion;

allergic skin reactions (erythema multiforme);

prolonged and painful erection (usually not during sexual activity) (priapism);

inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from the available data)

anaphylactic reaction (sudden, severe allergic reaction with difficulty breathing, swelling, dizziness

ness, fast heart rate, sweating and loss of consciousness;

decreased appetite;

high levels of potassium in the blood (hyperkalemia), which can cause changes in the heart rhythm;

increased pressure inside the eye (glaucoma);

irregular or abnormal heart rhythm (QT prolongation, life-threatening heart rhythm disorder (Torsade de Pointes), atrial fibrillation, arrhythmia);

fast heart rate (tachycardia);

shortness of breath (dyspnoea);

during eye surgery for clouding of the lens (cataract) or for increased pressure inside the eye (glaucoma), the pupil (the black circle in the middle of your eye) may not increase in size to the required size. In addition, the iris (the colored part of the eye) may dilate during the surgery;

voice impairment;

liver damage;

muscle weakness;

kidney damage;

impaired vision;

nosebleeds (epistaxis);

mental disorders such as confusion (delirium);

abdominal discomfort.

5. How to store Tamsudil Plus

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tamsudil Plus contains

Active substances: solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride.

Other ingredients: high molecular weight macrogol; colloidal anhydrous silica (E551); magnesium stearate (E470b); calcium hydrogen phosphate (E341); microcrystalline cellulose (E460); partially substituted hydroxypropylcellulose (E463); hypromellose (E464); red iron oxide (E172); macrogol; butylhydroxytoluene (E321).

What Tamsudil Plus looks like and contents of the pack

Tamsudil Plus 6 mg/0.4 mg modified-release tablets are round, biconvex, red film-coated tablets debossed with "6 04" on one side and with a diameter of 9 mm.

Tamsudil Plus is available in cartons containing PA/aluminium/RUS/aluminium blisters or PA/aluminium/RUS/aluminium perforated unit dose blisters.

Packs of 30, 50, 90 or 100 tablets (in blisters).

Packs of 30 x 1, 50 x 1, 90 x 1 or 100 x 1 tablets (in perforated unit dose blisters).

Not all pack sizes may be marketed.