Tasoltrip 6 mg/0.4 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TASOLTRIP 6 mg/0.4 mg modified-release tablets EFG

solifenacin succinate/tamsulosin hydrochloride

Read the entire leaflet carefully before you start using 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.

Contents of the leaflet

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

1. What Tasoltrip is and what it is used for

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

Tasoltrip is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract caused by conditions related to the bladder and by enlargement of the prostate (benign prostatic hyperplasia). Tasoltrip is used when prior treatment with monotherapy for this condition did not adequately relieve 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 leads to storage symptoms such as changes in bladder sensation, urgency (a sudden and strong need to pass urine without warning), and increased frequency of urination.

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

2. What you need to know before using Tasoltrip

Do not use Tasoltrip if:

• you are allergic to solifenacin or tamsulosin, or to 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 renal disease AND, at the same time, are being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this applies.
• you have moderate liver disease AND, at the same time, are being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this applies.
• 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 suffer from fainting due to a drop in blood pressure when changing posture (when 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 using Tasoltrip if:

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

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

Solifenacin/tamsulosin may affect blood pressure, which could cause dizziness, lightheadedness, or rarely, fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they have passed.

If you are scheduled for or planning eye surgery due to clouding of the lens (cataracts) or increased pressure in the eye (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 treatment with this medicine prior to undergoing eye surgery for lens clouding (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Use of Tasoltrip with other medicines

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 solifenacin succinate/tamsulosin hydrochloride is eliminated from the body.
• other anticholinergic medicines, since the effects and side effects of both medicines may be intensified when taking two medicines of the same type.
• cholinergics, as they may reduce the effect of solifenacin/tamsulosin.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Solifenacin/tamsulosin 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 esophagus (esophagitis).

Use of Tasoltrip with food and drinks

Solifenacin/tamsulosin may be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility

Solifenacin/tamsulosin 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 that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and use of machines

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

Tasoltrip contains croscarmellose sodium

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

3. How to use Tasoltrip

Follow exactly the instructions for administration 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 Tasoltrip 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, contact your doctor or pharmacist immediately 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 useful 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 Tasoltrip

Take your next solifenacin/tamsulosin tablet as usual. Do not take a double dose to make up for missed doses.

If you stop taking Tasoltrip

If you stop taking solifenacin/tamsulosin, 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 (which may affect up to 1 in 100 men) during clinical studies with solifenacin/tamsulosin is acute urinary retention, characterized by a sudden inability to urinate. If you think you may be experiencing this, seek immediate medical attention. You may need to stop taking this medicine.

Solifenacin/tamsulosin may cause allergic reactions:

• Uncommon signs of allergic reactions may include rash (which may be itchy) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with solifenacin/tamsulosin must be permanently and immediately discontinued.

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

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

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculated semen is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
• Feeling of dizziness (nausea)
• Abdominal pain

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

• Somnolence
• Itching (pruritus)
• Urinary tract infection, bladder infection (cystitis)
• Disturbance of taste sensation (dysgeusia)
• Dry eyes
• Nasal dryness
• Reflux disease (gastroesophageal reflux)
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema)
• Headache
• Rapid or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis)
• Diarrhea
• Vomiting
• Tiredness (asthenia)

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

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

Frequency not known (cannot be estimated from the available data)

• Decreased appetite
• Elevated blood potassium levels (hyperkalemia), which may cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heart rate (tachycardia)
• Difficulty breathing (dyspnea)
• 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.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Vision disturbance
• Nosebleed (epistaxis)

Reporting of adverse effects

If you experience any 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 Tasoltrip

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 after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Tasoltrip

• The active substances are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.
• The other components are calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, hypromellose, iron oxide red (E172), magnesium stearate, high molecular weight polyethylene glycol, polyethylene glycol, anhydrous colloidal silica, titanium dioxide (E171).

Appearance of the product and contents of the pack

Tasoltrip coated tablets are red, round, biconvex, marked with “T7S” on one side and unmarked on the other.

Tasoltrip tablets are available in packs containing 30 tablets in blisters made of oPA/Al/PVC/Al aluminum.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets-Els Fogars

Sector 2, Ctra. C-244, km. 22

08777 Sant Quintí de Mediona,

Barcelona – Spain

Manufacturer

o

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Date of the last revision of this leaflet: August 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/