Prospect: information for the patient

Bitamsol 6 mg/0.4 mg modified-release EFG tablets

solifenacin succinate/tamsulosin hydrochloride

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

Bitamsol is a combination of two different medications called solifenacina and tamsulosina in a single tablet. Solifenacina belongs to a group of medications known as anticholinergics and tamsulosina belongs to a group of medications known as 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 problems related to the bladder and by the enlargement of the prostate (benign prostatic hyperplasia). Bitamsol is used when previous treatment with monotherapy for this condition did not alleviate symptoms sufficiently.

When the prostate becomes enlarged, urinary problems (emptying symptoms) such as delayed urination (difficulty initiating urination), reduced urine flow (weak stream), dripping, and sensation of incomplete bladder emptying may appear. 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.

Solifenacina reduces involuntary bladder contractions and increases the amount of urine that the bladder can store. Therefore, you can expect to wait longer before having to go to the bathroom. Tamsulosina allows urine to pass more easily through the urethra and facilitates urination.

Do not use Bitamsol if:

• You are allergic to solifenacin or tamsulosin or any of the other components of this medication (listed in section 6).
• You are undergoing renal dialysis.
• You have a severe liver disease.
• You have a severe kidney disease and, at the same time, are being treated with medications that can reduce the elimination of this medication from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• You have a moderate liver disease and, at the same time, are being treated with medications that can reduce the elimination of this medication from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• You have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• You have a muscle disease 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 position (sitting or standing); this is called 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 eliminating liquid (urinary retention).
• You have any obstruction of the digestive system.
• You have a risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• You have a hiatal hernia or heartburn and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.
• You have a certain type of nervous disease (autonomic neuropathy).
• You have a severe kidney disease.
• You have a moderate liver disease.

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

This medication 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 scheduled to undergo 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 medication.The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should or should not postpone or interrupt temporarily the use of this medication when undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Bitamsol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Medications such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine that reduce the rate at which Bitamsol is eliminated from the body.
• Other anticholinergic medications, as the effects and adverse effects of both medications can be intensified if you are taking two medications of the same type.
• Cholinergic medications, as they can reduce the effect of Bitamsol.
• Medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. Bitamsol may reduce their effect.
• Other alpha-blockers, as they can cause an undesirable decrease in blood pressure.
• Medications such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Use of Bitamsol with food and drinks

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

Pregnancy, breastfeeding, and fertility

This medication is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

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

Bitamsol contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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, according to your preference. 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 by mistake, contact your doctor, pharmacist, or hospital immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

In case of overdose, your doctor may treat you with activated charcoal; emergency gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.

The symptoms of overdose may include: dry mouth, dizziness, and blurred vision, seeing things that are not there (hallucinations), over-excitement, convulsions, 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 forgot to takeBitamsol

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

If you interrupt treatment with 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most serious side effect that has been observed with a low frequency (which may affect up to 1 in 100 men) during treatment with this medicine in clinical studies is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing it, go to your doctor immediately. You may need to stop taking Solifenacina succinato/tamsulosina hydrochloride.

Solifenacina succinato/tamsulosina hydrochloride may cause allergic reactions:

• Less common signs of allergic reactions may include skin rash (which may cause itching) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported in rare cases with tamsulosina and in very rare cases with solifenacina. In the event of angioedema, treatment with Bitamsol should be discontinued immediately and definitively.

If you experience an allergic crisis or a severe skin reaction (for example, blistering and peeling of the skin), you should inform your doctor immediately, and stop using this medicine. Appropriate 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, nausea, abdominal pain
• Abnormal ejaculation (ejaculatory disorder). This means that semen does not release through the urethra, but rather into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless
• Fatigue

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

• Urinary tract infection, bladder infection (cystitis)
• Drowsiness, alteration of the sense of taste (dysgeusia), headache
• Dry eyes
• Irregular or rapid heartbeat (palpitations)
• Sensation of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny nose or nasal obstruction (rhinitis), nasal dryness
• Gastroesophageal reflux disease (GERD), diarrhea, sore throat, vomiting
• Itching (pruritus), dry skin
• Difficulty urinating
• Swelling of the legs (edema), fatigue (asthenia)

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

• Sensation of fainting (syncope)
• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Allergy 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
• Skin rash, inflammation, and blistering on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome), skin allergy (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• Decreased appetite, elevated potassium levels in the blood (hyperkalemia) that may cause irregular heartbeat
• Rapid decrease in consciousness and general mental function (delirium)
• During eye surgery for cataracts or increased eye pressure (glaucoma), it is possible that the pupil (the black circle in the center of the eye) will not dilate sufficiently. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased eye pressure (glaucoma), altered vision
• Irregular or abnormal heartbeat (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heartbeat (tachycardia)
• Difficulty breathing (dyspnea), voice disorder, nasal bleeding (epistaxis)
• Intestinal obstruction (ileus), abdominal discomfort
• Dermatitis exfoliativa: inflammation of the skin that causes redness and peeling on large areas of the body
• Liver disorder
• Muscle weakness
• Renal disorder

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Bitamsol

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

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS Q PHARMA S.L.

C/ Moratín, nº 15, Entlo. Oficinas 6-7

03008 Alicante

Spain

Responsible for manufacturing

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

Republic of Czech

This medicinal product is authorized in the member states of the European Economic Area with the following names:

NetherlandsSolifenacin succinate/Tamsulosin hydrochloride Synthon 6 mg/0.4 mg, tablets with modified release

SpainBitamsol 6 mg/0.4 mg modified-release tablets EFG

GreeceVesolitam (6+0.4) mg/tab

CroatiaYolatin 6 mg/0.4 mg tablets with modified release

HungaryÖrgunderin 6 mg/0.4 mg modified-release tablets

IcelandSoltamcin

Date of the last review of this leaflet:04/2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/.