Solifenacin Succinate/tamsulosin Hydrochloride, 6 mg/0.4 mg modified-release tablets - Patient leaflet, side effects, dosage

1. What Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets is and what it is used for

Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets 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. Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract which are caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). This medicine is used when previous treatment with a monoproduct for this condition did not relieve symptoms effectively.

As the prostate grows, it can lead to urinary problems (voiding symptoms) such as hesitancy (difficulty to start urinating), difficulty urinating (poor stream), dribbling and feeling of incomplete bladder emptying. At the same time, the bladder is also affected and contracts spontaneously at times you do not want to void. This causes storage symptoms such as changes in bladder sensation, urgency (having a strong, sudden desire to urinate without prior warning), and having to urinate more frequently.

Solifenacin reduces the undesired contractions of your bladder and increases the amount of urine that your bladder can hold. Therefore, you can wait longer before you have to go to the toilet. Tamsulosin enables urine to pass more readily through the urethra and facilitates urination.

2. What you need to know before you take Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets

Do not take Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets if you:

• are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• are undergoing kidney dialysis.
• have a severe liver disease.
• suffer from severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have informed you if this is the case.
• suffer from moderate liver disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have informed you if this is the case.
• have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis).
• suffer from a muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
• suffer from increased pressure in the eyes (glaucoma), with gradual loss of eye sight.
• suffer from fainting due to reduced blood pressure when changing posture (going to sit up or stand up); this is called orthostatic hypotension.

Tell your doctor if you think that any of these conditions apply to you. Warnings and precautions

Talk to your doctor or pharmacist before using Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets if you:

• have an inability to pass water (urinary retention).
• have some obstruction of the digestive system.

• are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is

  the case.

  • have a stomach tear (hiatus hernia) or heartburn and/or if, at the same time, you are taking medicines that can cause or worsen oesophagitis.
  • suffer from a certain type of nervous disease (autonomic neuropathy).
  • suffer from severe kidney disease.
  • suffer from moderate liver disease.

Periodic medical examinations are necessary to monitor the development of the condition you are being treated for. This medicine can affect your blood pressure which can make you feel dizzy, light headed or rarely can make you faint (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they disappear.

If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eyes (glaucoma), please inform your eye specialist that you have previously taken, are taking or are planning to take Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma). Children and adolescents

Do not give this medicine to children and adolescents. Other medicines and Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

It is especially important to inform your doctor if you are using:

• medicines like ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine which decrease the rate at which Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets is removed from the body.
• other anticholinergic medicines, as effects and side effects of both medications can be increased if you are taking two medicines of the same type.
• cholinergics, as they can reduce the effect of Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified- release tablets.
• medicines like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets can reduce their effect.
• other alpha-blockers (used to lower blood pressure), as this may cause an unwanted decrease in blood pressure.
• medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis). Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets with food and drink

Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets can be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets is not indicated for use in women. In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Driving and using machines

This medicine might cause dizziness, blurred vision, tiredness and, uncommonly, sleepiness. If you get any of these side effects, do not drive or operate machinery.

3. How to take Solifenacin succinate/Tamsulosin hydro-chloride 6 mg/0.4 mg modified-release tablets

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken by mouth. It can be taken with or without food, according to your preference. Do not crush or chew the tablet.

If you take more Solifenacin succinate/Tamsulosin hydro-chloride 6 mg/0.4 mg modified-release tablets 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 immediately for advice.

In case of an overdose your doctor may treat you with activated charcoal; emergency stomach washout may be useful if performed within 1 hour of overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness, and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, increased 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 Solifenacin succinate/Tamsulosin

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hydrochloride 6 mg/0.4 mg modified-release tablets

Take your next tablet of Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets as normal. Do not take a double dose to make up for a forgotten tablet. If you stop taking Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets

If you stop taking this medicine, your original complaints may return or worsen. Always consult your doctor, if you are considering stopping the 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 uncommonly (may affect up to 1 in 100 men) been observed 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, see a doctor straight away. You may need to stop taking this medicine.

Allergic reactions could occur with Solifenacin succinate/ Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets:

• uncommon signs of allergic reactions can include skin rash (which can 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 on tamsulosin and very rarely with solifenacin. If angioedema occurs, this medicine should be stopped immediately and not started again.

If you experience an allergic attack, or a severe skin reaction (such as blistering and peeling of the skin), you must inform your doctor immediately, and stop taking this medicine. Appropriate therapy and/or measures should be taken.

Other side effects:

Common (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 does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure) This phenomenon is harmless.
• feeling sick (nausea)
• abdominal pain

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

• sleepiness (somnolence)
• itching (pruritus)
• rash
• urinary tract infection, bladder infection (cystitis)
• impaired sense of taste (dysgeusia)
• dry eyes
• dry nose
• reflux disease (gastro-oesophageal reflux)
• dry throat
• dry skin
• difficulty in passing urine
• accumulation of fluid in the lower legs (peripheral oedema)
• headache
• fast or uneven heartbeat (palpitations)
• feeling dizzy or weak especially when you stand up (orthostatic hypotension)
• runny or blocked nose (rhinitis)
• diarrhoea
• being sick (vomiting)
• tiredness (asthenia)

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

• lodging of a large amount of hardened stool in the large intestine (faecal impaction)
• feeling faint (syncope)
• skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin (angioedema)

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

• hallucinations, confusion
• allergic skin reaction (Erythema multiforme)
• long-lasting 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 breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness)
• decreased appetite

• high levels of blood potassium (hyperkalaemia) which can cause

  abnormal heart rhythm

  • increased pressure in the eyes (glaucoma)
  • irregular or unusual heart beat (QT prolongation, Torsade de Pointes, atrial fibrillation, arrhythmia)
  • faster heartbeat (tachycardia)
  • shortness of breath (dyspnoea)
  • during an operation of the eye for cloudiness of the lens (cataract) or for increased pressure in the eye (glaucoma) the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery.
  • voice disorder
  • liver disorder
  • muscle weakness
  • kidney disorder
  • impaired vision
  • nose bleeds (epistaxis)
  • psychiatric disorders like confusion (delirium)
  • abdominal discomfort

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Solifenacin succinate/Tamsulosin hydro-chloride 6 mg/0.4 mg modified-release tablets

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 or blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Solifenacin succinate/Tamsulosin hydrochloride 6 mg/ 0.4 mg modified-release tablets contains

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified- release tablet contains 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride.
• The other ingredients are: Cellulose, microcrystalline (E460); Macrogol, high molecular mass; Silica, colloidal anhydrous (E551); Magnesium stearate (E470b); Calcium hydrogen phosphate (E341); Silicified Microcrystalline Cellulose (Prosolv SMCC HD90); Hydroxypropyl cellulose, low-substituted (E463). Film-coating: Opadry 03F45072 Red; (HPMC 2910/Hypromellose 6MPas; Macrogol/PEG 8000; Iron Oxide Red (E172). What Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets looks like and contents of the pack

Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets are round, biconvex, red, film-coated tablets, debossed with “6 04” on one side and have a 9 mm diameter.

Solifenacin succinate/Tamsulosin hydrochloride 6 mg/0.4 mg modified-release tablets is supplied in carton box containing PA/Aluminium/PVC/Aluminium blister or in PA/Aluminium/ PVC/ Aluminium unit- dose perforated blisters.

Pack size of 30, 90 or 100 tablets (in blisters)

Pack size of 30 x 1, 90 x 1 or 100 x 1 tablets (in unit-dose perforated blisters) Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer. Marketing Authorisation Holder

Altair Science Limited

78 Wembley Park Drive,

Wembley Middlesex,

HA9 8HB,

United Kingdom

Manufacturer

Adamed Pharma S.A

ul. Marszałka Józefa Piłsudskiego

5, Pabianice, 95-200

Poland

This leaflet was last revised in February 2025

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