Bitamsol 6 mg/0.4 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bitamsol 6 mg/0,4 mg modified release tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Bitamsol is and what it is used for
2. What you need to know before taking Bitamsol
3. How to take Bitamsol
4. Possible side effects
5. How to store Bitamsol
6. Contents of the pack and other information

1. What Bitamsol is and what it is used for

Bitamsol is a combination of two different medicines called solifenacin and tamsulosin in a single tablet. Solifenacin belongs to a group of medicines known as anticholinergics, and tamsulosin belongs to a group of medicines known as alpha-blockers.

Bitamsol is used in men to treat both moderate to severe filling symptoms and lower urinary tract voiding symptoms caused by bladder problems and by enlargement of the prostate (benign prostatic hyperplasia). Bitamsol is used when prior treatment with monotherapy for this condition has not adequately relieved symptoms.

When the prostate gland enlarges, urinary problems (voiding symptoms) may occur, such as delayed urination (difficulty starting to pass urine), reduced urine flow (weak stream), dribbling, and a sensation of incomplete bladder emptying. At the same time, the bladder is also affected and contracts spontaneously at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (a sudden, strong need to urinate without warning), and increased frequency of urination.

Solifenacin reduces involuntary contractions of the bladder and increases the amount of urine that your bladder can hold. Therefore, you can wait longer before needing to go to the toilet. Tamsulosin allows urine to pass more easily through the urethra and improves urination.

2. What you need to know before taking Bitamsol

Do not use Bitamsol if:

• you are allergic to solifenacin or tamsulosin or to any of the other components of this medicine (listed in section 6).
• you are undergoing renal dialysis.
• you have severe liver disease.
• you have severe renal impairment AND at the same time are being treated with medicines that may reduce the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• you have moderate liver disease AND at the same time are being treated with medicines that may reduce the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you have a muscle disorder called myasthenia gravis, which can cause extreme weakness of certain muscles.
• you have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• you experience fainting due to a drop in blood pressure when changing position (sitting or standing up); this is known as orthostatic hypotension.

Inform your doctor if you think you have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bitamsol if:

• you have difficulty passing urine (urinary retention).
• you have any obstruction of the gastrointestinal tract.
• you are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• you have a diaphragmatic hernia (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen oesophagitis.
• you suffer from a certain type of nerve disorder (autonomic neuropathy).
• you have severe renal impairment.
• you have moderate liver disease.

Regular medical check-ups are necessary to monitor the progression of the condition for which you are being treated.

This medicine may affect blood pressure, which could cause dizziness, lightheadedness, or rarely fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they resolve.

If you are undergoing or have scheduled eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use this medicine. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily interrupt taking this medicine when undergoing eye surgery for lens opacity (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children or adolescents.

Other medicines and Bitamsol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking:

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the rate at which Bitamsol is eliminated from the body.
• other anticholinergic medicines, as the effects and adverse effects of both medicines may be intensified when taking two medicines of the same type.
• cholinergics, as they may reduce the effect of Bitamsol.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Bitamsol may reduce their effect.
• other alpha-blockers, as they may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Use of Bitamsol with food and drink

Bitamsol may be taken with or without food, according to your preference.

Pregnancy, breastfeeding, and fertility

This medicine is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

This medicine may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. If you experience these adverse effects, do not drive or operate machinery.

Bitamsol contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to use Bitamsol

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken orally. It can be taken with or without food, depending on your preference. Do not crush or chew the tablet.

If you take more Bitamsol than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, your doctor may treat you with activated charcoal; emergency gastric lavage may be helpful if performed within one 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), over-excitability, seizures, difficulty breathing, increased heart rate (tachycardia), inability to completely or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

If you forget to take Bitamsol

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

If you stop using Bitamsol

If you stop taking Bitamsol, your original symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most serious adverse effect observed infrequently (affecting up to 1 in 100 men) during clinical studies with this medicine is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing this, contact your doctor immediately. You may need to stop taking solifenacin succinate/tamsulosin hydrochloride.

Solifenacin succinate/tamsulosin hydrochloride may cause allergic reactions:

• 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. In case of angioedema, treatment with Bitamsol must be immediately and permanently discontinued.

If you experience an allergic crisis or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor immediately and stop using this medicine. Appropriate treatment and/or measures should be applied.

Frequent adverse effects (may affect up to 1 in 10 men)

• Dizziness
• Blurred vision
• Dry mouth, indigestion (dyspepsia), constipation, feeling of dizziness (nausea), abdominal pain
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but goes into the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless
• Fatigue

Uncommon adverse effects (may affect up to 1 in 100 men)

• Urinary tract infection, bladder infection (cystitis)
• Sleepiness (somnolence), altered sense of taste (dysgeusia), headache
• Dry eyes
• Rapid or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis), dry nose
• Reflux disease (gastroesophageal reflux), diarrhea, dry throat, vomiting
• Itching (pruritus), dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema), tiredness (asthenia)

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

• Feeling of fainting (syncope)
• Accumulation of hardened stool in the large intestine (fecal impaction)
• Skin allergy causing swelling in the tissue beneath the skin surface (angioedema)

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

• Hallucinations, confusion
• Skin rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome), allergic skin reaction (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• Decreased appetite, elevated blood potassium levels (hyperkalemia) which may cause abnormal heart rhythm
• Rapid decline in consciousness and overall mental function (delirium)
• During eye surgery for lens clouding (cataracts) or increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may not dilate properly. In addition, the iris (the colored part of the eye) may become floppy during surgery, increased eye pressure (glaucoma), vision disturbances
• Irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia), fast heart rate (tachycardia)
• Breathing difficulty (dyspnea), voice disorder, nosebleed (epistaxis)
• Intestinal obstruction (ileus), abdominal discomfort
• Skin inflammation causing redness and peeling over large areas of the body (exfoliative dermatitis)
• Liver disorder
• Muscle weakness
• Kidney disorder

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bitamsol

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bitamsol

• The active substances are solifenacin succinate and tamsulosin hydrochloride.
• The other components are calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), red iron oxide (E172), magnesium stearate (E470b), macrogol high molecular weight, colloidal anhydrous silica, titanium dioxide (E171).

Appearance of the product and contents of the pack

Bitamsol 6 mg/0.4 mg modified-release tablets are red, round, biconvex, film-coated tablets printed with "T7S" on one side.

Bitamsol 6 mg/0.4 mg modified-release tablets are available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release tablets, or in single-dose perforated 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 modified-release tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

LABORATORIOS Q PHARMA S.L.
C/ Moratín, nº 15, Entlo. Oficinas 6-7
03008 Alicante
Spain

Manufacturer

Synthon Hispania S.L.
C/ Castelló, nº1
Sant Boi de Llobregat
08830 Barcelona
Spain

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon S.R.O.
Brnenská 32/cp. 597
678 01 Blansko
Czech Republic

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

Netherlands: Solifenacinesuccinaat/Tamsulosinehydrochloride Synthon 6 mg/0.4 mg, tabletten met gereguleerde afgifte
Spain: Bitamsol 6 mg/0.4 mg modified-release tablets EFG
Greece: Vesolitam (6+0.4) mg/tab
Croatia: Yolatin 6 mg/0.4 mg tablete s prilagodenim oslobadanjem
Hungary: Örgunderin 6 mg/0.4 mg módosított hatóanyagleadású tabletta
Iceland: Soltamcin

Date of the most recent review of this leaflet: 04/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.