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.
-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.
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:
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:
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:
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:
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)
Less common side effects (may affect up to 1 in 100 men)
Rare side effects (may affect up to 1 in 1,000 men)
Very rare side effects (may affect up to 1 in 10,000 men)
Frequency not known (cannot be estimated from available data)
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
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/.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.