BITAMSOL 6 mg/0.4 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Bitamsol 6 mg/0.4 mg Modified Release Tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Bitamsol and what is it used for

Bitamsol 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.

Bitamsol is used in men to treat both moderate to severe filling symptoms and emptying symptoms of the lower urinary tract caused by bladder problems and by an enlarged prostate (benign prostatic hyperplasia). Bitamsol is used when previous treatment with monotherapy for this condition did not sufficiently relieve the symptoms.

When the prostate gland enlarges, it can cause urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and a feeling of incomplete emptying of the bladder. 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 (having a strong and sudden desire to urinate without prior warning), and having to urinate more frequently.

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

2. What you need to know before you take Bitamsol

Do not take Bitamsol if:

• you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• you are undergoing renal dialysis.
• you have severe liver disease.
• you have severe kidney disease AND you are being treated with medicines that may decrease the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• you have moderate liver disease AND you are being treated with medicines that may decrease the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• you have a severe stomach or intestinal disorder (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 decrease in blood pressure when changing posture (when sitting or standing up); this is called orthostatic hypotension.

Tell 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 eliminating fluid (urinary retention).
• you have any obstruction of the digestive tract.
• you are at risk of decreased activity of the digestive tract (movements of the stomach and intestine). Your doctor will inform you if this is the case.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or you are taking medicines that may cause or worsen esophagitis.
• you have a certain type of nerve disease (autonomic neuropathy).
• you have severe kidney disease.
• you have moderate liver disease.

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

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

If you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eyes (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use this medicine. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily interrupt taking this medicine when you are going to undergo eye surgery for cataracts or increased pressure in the eyes (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and Bitamsol

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

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

• 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 side effects of both medicines may be intensified if you are taking two medicines of the same type.
• cholinergics, as they may reduce the effect of Bitamsol.
• medicines such as metoclopramide and cisapride, which may speed up the functioning of the digestive tract. Bitamsol may reduce their effect.
• other alpha-blockers, as they may cause an undesired decrease in blood pressure.
• medicines such as bisphosphonates, which may cause or exacerbate inflammation of the esophagus (esophagitis).

Using Bitamsol with food and drinks

Bitamsol can be taken with or without food, according to your preferences.

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 is not released through the urethra, but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

This medicine may cause dizziness, blurred vision, fatigue, and less frequently, drowsiness. If you experience these side effects, do not drive or use machines.

Bitamsol contains sodium

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

3. How to use Bitamsol

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are 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 preferences. Do not crush or chew the tablet.

If you take more Bitamsol than you should

If you have taken more tablets than you were told to, or if someone else has taken 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, your doctor may treat you with activated charcoal; emergency stomach lavage may be useful if performed within one hour of 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, convulsions, difficulty breathing, increased heart rate (tachycardia), inability to empty the bladder completely or partially or to urinate (urinary retention), and/or undesired increase in blood pressure.

If you forget to take Bitamsol

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

If you stop taking Bitamsol

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

If you have any other questions about 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 observed with a frequency of less than 1 in 100 men during treatment with this medicine in clinical studies is acute urinary retention, which is a sudden inability to urinate. If you think you may have this, go to 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 itch) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with Bitamsol should be stopped immediately and definitively.

If you experience an allergic reaction or a severe skin reaction (e.g. formation of blisters and peeling of the skin), you should inform your doctor immediately and stop using this medicine. Treatment and/or measures should be applied.

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

• Dizziness
• Blurred vision
• Dry mouth, indigestion (dyspepsia), constipation, feeling sick (nausea), abdominal pain
• Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra, but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.
• Fatigue

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

• Urinary tract infection, bladder infection (cystitis)
• Sleepiness (somnolence), alteration of taste (dysgeusia), headache
• Dry eyes
• Fast or irregular heartbeat (palpitations)
• Feeling dizzy or weak, especially when standing up (orthostatic hypotension)
• Runny or stuffy nose (rhinitis), dry nose
• Gastroesophageal reflux disease, diarrhea, dry throat, vomiting
• Itching (pruritus), dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema), tiredness (asthenia)

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

• Fainting (syncope)
• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Allergic reaction in the skin that causes swelling in the tissue under the skin surface (angioedema)

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

• Hallucinations, confusion
• Severe 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 the available data)

• Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• Decreased appetite, high levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm
• Rapid decrease in consciousness and general mental function (delirium)
• During eye surgery for cataracts or increased pressure in the eyes (glaucoma), it is possible that the pupil (the black circle in the center of the eye) does not increase in size conveniently. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased pressure in the eyes (glaucoma), vision disturbance
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), fast heart rate (tachycardia)
• Breathing difficulties (dyspnea), voice disorder, nosebleeds (epistaxis)
• Intestinal obstruction (ileus), abdominal discomfort
• Inflammation of the skin that causes redness and peeling in large areas of the body (exfoliative dermatitis)
• Liver disorder
• Muscle weakness
• Kidney disorder

Reporting of side effects

If you experience 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 to the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bitamsol

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 is the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), red iron oxide (E172), magnesium stearate (E470b), macrogol, high molecular weight, anhydrous colloidal silica, titanium dioxide (E171).

Appearance and packaging of the product

Bitamsol 6 mg/0.4 mg modified release tablets are red, round, biconvex, film-coated, and engraved 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 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 modified release tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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

Netherlands

Synthon S.R.O.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands Solifenacinesuccinaat/Tamsulosinehydrochloride Synthon 6 mg/0.4 mg, tabletten met gereguleerde afgifte

Spain Bitamsol 6 mg/0.4 mg comprimidos de liberación modificada 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 last revision of this leaflet:04/2023

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