Blobax 6 mg/0.4 mg modified-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Blobax 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, 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 these effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Blobax is and what it is used for

Blobax 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.

Blobax is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract caused by bladder problems and by enlargement of the prostate (benign prostatic hyperplasia). Blobax is used when previous treatment with monotherapy for this condition has not provided adequate symptom relief.

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 storage symptoms such as changes in bladder sensation, urgency (a sudden and strong need to urinate without prior 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 bathroom. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2. What you need to know before starting to take Blobax

Do not take Blobax 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 kidney disease AND at the same time are being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (for example, 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 solifenacin/tamsulosin from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• you have a serious stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you have a muscle disorder called myasthenia gravis, which may 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 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 starting to use solifenacin/tamsulosin if:

• you have difficulty passing urine (urinary retention).
• you have any obstruction of the gastrointestinal tract.
• you are at risk of reduced gastrointestinal motility (stomago and intestinal movements). Your doctor will inform you if this applies to you.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or are simultaneously taking medications that may cause or worsen esophagitis.
• you suffer from a certain type of nerve disorder (autonomic neuropathy).
• you have severe kidney 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 can cause dizziness, lightheadedness, or rarely, fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they subside.

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 solifenacin/tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily stop taking this medicine prior to undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children and adolescents.

Other medicines and Blobax

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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/tamsulosin is eliminated from the body.
• other anticholinergic medicines, since the effects and adverse reactions of both medicines may be intensified if you are taking two medicines of the same type.
• cholinergics, since 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, since they may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Blobax with food, beverages, and alcohol

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 is not expelled 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 use of machines

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

3. How to take Blobax

Follow exactly the instructions for use of this medicine as 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 Blobax 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, 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.

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.

If you forget to take Blobax

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

If you stop taking Blobax

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 (affecting up to 1 in 100 men) during clinical studies with solifenacin/tamsulosin 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/tamsulosin.

Solifenacin/tamsulosin 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 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 attack or a severe skin reaction (for example, 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.

Common side 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 ejaculated volume 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)
• Taste disturbance (dysgeusia)
• Dry eyes
• Nasal dryness
• Reflux disease (gastroesophageal reflux)
• Throat dryness
• 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
• Fatigue (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 available data)

• Decreased appetite
• Elevated blood potassium levels (hyperkalaemia), which may cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolongation of QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heart rate (tachycardia)
• Breathing difficulty (dyspnea)
• During eye surgery for lens clouding (cataract) or due to increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may fail to 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Blobax

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

Do not use this medicine after the expiry date which is stated after EXP on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the container and additional information

Composition of Blobax The active substances are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.

The other components are microcrystalline cellulose, high molecular weight polyethylene glycol, anhydrous colloidal silicon dioxide, magnesium stearate, anhydrous calcium hydrogen phosphate, silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silicon dioxide), low-substituted hydroxypropylcellulose, and coating material: hypromellose, polyethylene glycol, and iron oxide red (E172).

Appearance of the product and contents of the pack

Solifenacin/tamsulosin tablets are modified-release film-coated tablets. They are round, 9 mm in diameter, biconvex, red tablets, marked with «6 04» on one side.

The tablets are available in packs with PA/aluminum/PVC/aluminum blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice, Poland

or

Atlantic Pharma – Produções Farmacêuticas S.A.,

Rua da Tapada Grande, nº 2, Abrunheira,

2710 – 089 Sintra, Portugal

or

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria,

2565-187 Dois Portos, Portugal

Date of the most recent review of this leaflet: October 2022

Other sources of information

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