Luracin

Package leaflet: Information for the user

Luracin 6 mg/0.4 mg modified-release tablets

Solifenacin succinate/tamsulosin hydrochloride
Equivalent medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Luracin is and what it is used for

Luracin 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.
Luracin is used in men to treat moderate to severe filling symptoms and voiding symptoms of the lower urinary tract caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Luracin is used for this condition when previous monotherapy treatments have not adequately relieved the symptoms.
An enlarged prostate can cause urinary problems (voiding symptoms) such as hesitancy (difficulty starting urination), difficulty in urinating (weak stream), dribbling, and a sensation of incomplete bladder emptying. At the same time, the bladder is also involved and contracts spontaneously even when you do not intend to empty it. This causes filling symptoms such as changes in bladder sensation, urgency (a sudden, strong need to urinate without prior warning), and the need to urinate more frequently.
Solifenacin reduces involuntary contractions of the bladder and increases the amount of urine the bladder can hold. In this way, it helps delay the 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 taking Luracin

Do not take Luracin 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 Luracin from your body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you;
• you have moderate liver problems AND at the same time are being treated with medicines that may reduce the elimination of Luracin from your body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you;
• you have a serious stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis);
• you have the muscle disease called myasthenia gravis, which causes extreme weakness of certain muscles;
• you have increased eye pressure (glaucoma), with gradual loss of vision;
• you suffer from fainting due to a drop in blood pressure when changing position (sitting down or standing up), known as orthostatic hypotension.

Inform your doctor if you have any of the conditions listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Luracin if:

• you have difficulty passing urine (urinary retention);
• you have obstructions in the digestive system (constipation);
• you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will inform you if this applies to you;
• you have a stomach tear (hiatal hernia) or heartburn and/or are simultaneously taking medicines that cause or worsen oesophagitis;
• you suffer from a type of nervous system 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.
Luracin may affect your blood pressure and may cause dizziness, vertigo, or rarely fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they disappear.
If you are scheduled for, or are on a waiting list for, eye surgery for cataract (clouding of the lens) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or are about to take Luracin. The specialist may then take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily stop treatment with this medicine before undergoing eye surgery for cataract or increased eye pressure (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Luracin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to 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 Luracin is eliminated from the body;
• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase if you are taking two medicines of the same type;
• cholinergics, as they may reduce the effectiveness of Luracin;
• medicines such as metoclopramide and cisapride, which speed up the digestive system, as Luracin may reduce their effectiveness;
• other alpha-blockers, as this may cause an unwanted drop in blood pressure;
• medicines such as bisphosphonates, which may cause or worsen inflammation of the throat (oesophagitis).

Luracin with food and drink
Luracin can be taken with or without food, as preferred.
Pregnancy, breastfeeding and fertility
Luracin is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculation is reduced or absent (anejaculation). This event is harmless.
Driving and using machines
Luracin may cause dizziness, blurred vision, fatigue, and, not commonly, drowsiness. If you experience these side effects, do not drive or operate machinery.

3. How to take Luracin

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken orally. You may take Luracin with or without food, according to your preference. Do not crush or chew the tablet.

If you take more Luracin than you should
If you have taken more tablets than prescribed, or if someone else has accidentally taken your tablets, contact a doctor, pharmacist, or hospital immediately.
In case of overdose, the doctor may administer treatment with activated charcoal. 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, perception of things not present (hallucinations), over-excitement, epileptic seizure (convulsions), breathing difficulties, increased heart rate (tachycardia), inability to completely or partially empty the bladder or urinate (urinary retention), and/or unwanted drop in blood pressure.

If you forget to take Luracin
Take the next dose of Luracin as scheduled. Do not take a double dose to make up for the missed tablet.

If you stop taking Luracin
If you stop treatment with Luracin, your symptoms may return or worsen.
Always consult your doctor if you intend to discontinue treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Luracin can cause side effects, although not everybody gets them.

The most serious side effect observed with uncommon frequency (may affect up to 1 in 100 men) in clinical studies during treatment with solifenacin succinate/hydrochloride tamsulosin is acute urinary retention, which is a sudden inability to urinate. If you think you have this condition, contact your doctor immediately. You may need to stop taking Luracin.

Allergic reactions may occur with Luracin:

• Severe allergic reaction (anaphylactic reaction) may occur at an unknown frequency;
• Uncommon symptoms of allergic reactions may include rash (which may be itchy) or hives;
• Rare symptoms include swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, Luracin must be stopped immediately and must not be used again.

If an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin) occurs, you must contact your doctor immediately and stop using Luracin. Appropriate therapies and/or measures must be taken.

Very common (may affect more than 1 in 10 people)

• Dry mouth.

Common (may affect up to 1 in 10 people)

• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Tiredness (fatigue)
• Abnormal ejaculation (ejaculation disorders). This means that seminal fluid does not exit the body through the urethra but instead enters the bladder (retrograde ejaculation) or that the volume of seminal fluid is reduced or absent (failed ejaculation). This phenomenon is harmless.
• Feeling unwell (nausea)
• Abdominal pain.

Uncommon (may affect up to 1 in 100 people)

• Drowsiness
• Itching
• Urinary tract infection, bladder infection (cystitis)
• Altered taste sensation (dysgeusia)
• Dry eyes
• Dry nose
• Gastro-esophageal reflux disease (acid reflux)
• Dry throat
• Dry skin
• Difficulty in urination
• Fluid accumulation in the lower parts of the legs (edema)
• Headache
• Fast or irregular heartbeat (palpitations)
• Dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis)
• Diarrhea
• Feeling unwell (vomiting)
• Tiredness (asthenia).

Rare (may affect up to 1 in 1,000 people)

• Accumulation of large amounts of hardened feces in the large intestine (fecal impaction), colon obstruction
• Feeling faint (syncope)
• Skin allergy characterized by swelling of tissue just beneath the skin surface (angioedema).

Very rare (may affect up to 1 in 10,000 people)

• Hallucinations, confusion
• Skin allergic reaction (erythema multiforme)
• Prolonged and painful erection (usually not occurring during sexual activity) (priapism)
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from the available data)

• Decreased appetite
• High levels of potassium in the blood (hyperkalemia) which may cause abnormal heart rhythm
• Increased eye pressure (glaucoma)
• Irregular or abnormal heartbeat (QT prolongation, torsade de pointes, atrial fibrillation, arrhythmia)
• Fast heartbeat (tachycardia)
• Shortness of breath (dyspnea)
• During eye surgery for cataract (clouding of the lens) or for increased eye pressure (glaucoma), the pupil (the black circle in the middle of your eye) may dilate poorly. Also, the iris (the colored part of your eye) may become floppy during surgery
• Voice disorders
• Liver disorders
• Muscle weakness
• Kidney disorders
• Visual impairment
• Nosebleeds (epistaxis)
• Delirium
• Intestinal disorders (ileus)
• Abdominal discomfort
• Severe skin allergy leading to skin peeling (exfoliative dermatitis).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luracin

Keep this medicine out of the 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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Luracin Contains

• The active substances are: solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate, equivalent to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.37 mg of tamsulosin.
• The other components are: microcrystalline cellulose; macrogol; anhydrous colloidal silica; magnesium stearate; calcium hydrogen phosphate; silicified microcrystalline cellulose; low-substituted hydroxypropylcellulose; hypromellose; red iron oxide (E172).

Description of the Appearance of Luracin and the Contents of the Pack
Luracin 6 mg/0.4 mg tablets are round (9 mm in diameter), biconvex, red, film-coated,
with "6 04" engraved on one side.
Blister packs in PA/aluminum/PVC/aluminum, packed in cardboard boxes containing 10, 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ecupharma S.r.l. – Via Mazzini, 20 – 20123 Milan, Italy
Responsible Manufacturer for Batch Release
Adamed Pharma S.A. - ul. Marszałka Józefa Piłsudskiego 5 - 95-200 Pabianice - Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Poland: Solifenacin succinate + Tamsulosin hydrochloride Adamed
Austria: Solifenacin + Tamsulosin Adamed
Bulgaria: Urifenacin
Croatia: Tancer 6 mg/0.4 mg tablete s prilagođenim oslobađanjem
France: VECALMYS 6 mg/0.4 mg, comprimé à libération modifiée
Greece: VALIREM
Italy: Luracin
Romania: SOLIFENACIN/TAMSULOZIN ADAMED 6 mg/0.4 mg comprimate cu eliberare modificată
Spain: Solifenacina/Tamsulosina Cinfamed 6 mg/0.4 mg comprimidos de liberación modificada
EFG