Xilapro 8 mg hard capsules EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Xilapro 8 mg hard capsules EFG
Silodosin
Read all of this leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Xilapro is and what it is used for
- What you need to know before taking Xilapro
- How to take Xilapro
- Possible side effects
- How to store Xilapro
- Contents of the pack and other information
1. What Xilapro is and what it is used for
What is silodosin
Silodosin belongs to a group of medicines called alpha-adrenergic receptor blockers.
Silodosin is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle in these tissues. This makes it easier for you to urinate and relieves your symptoms.
What silodosin is used for
Silodosin is used in adult men to treat urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia, BPH), such as:
- difficulty starting urination,
- feeling of incomplete bladder emptying,
- increased need to urinate, including at night.
2. What you need to know before starting to take Xilapro
Do not take silodosin
if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medicine:
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If you are scheduled for eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken silodosin. This is because some patients treated with this type of medicine have experienced loss of muscular tone in the iris (the colored circular part of the eye) during this type of surgery. The ophthalmologist can then take appropriate precautions regarding the medical and surgical techniques to be used. Ask your doctor whether it is necessary to delay or temporarily interrupt treatment with silodosin prior to cataract surgery.
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If you have ever fainted or felt dizzy upon standing up suddenly, inform your doctor before taking silodosin.
When taking silodosin, dizziness and, occasionally, fainting may occur upon standing, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).
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If you have severe liver problems, you must not take silodosin, as it has not been evaluated in this condition.
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If you have kidney problems, consult your doctor.
If your kidney problems are moderate, your doctor will start treatment with silodosin cautiously and possibly at a lower dose (see section 3 “How to take Xilapro”). If your kidney problems are severe, you must not take this medicine.
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Since benign enlargement of the prostate and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not effective for treating prostate cancer.
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Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen ejaculated during sexual intercourse), which may temporarily affect male fertility. This effect resolves after discontinuation of silodosin treatment. Inform your doctor if you are planning to have children.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as there are no relevant indications for this age group.
Taking silodosin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are taking:
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Medicines that lower blood pressure (especially alpha1-blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines increases during treatment with this medicine.
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Antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of silodosin.
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Medicines used to treat difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), as their concomitant use with silodosin may lead to a slight decrease in blood pressure.
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Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as the effect of silodosin may be reduced.
Pregnancy and breastfeeding
Silodosin is not indicated for use in women.
Fertility
Silodosin may reduce the amount of semen and temporarily affect your ability to father a child. If you intend to have a child, consult your doctor or pharmacist before using this medicine.
Driving and use of machines
Do not drive or operate machinery if you feel faint, dizzy, or drowsy, or if you have blurred vision.
Xilapro contains Sodium
This medicine contains less than 23 mg of sodium (1 mmol) per hard capsule; this is essentially “sodium-free”.
3. How to take Xilapro
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 recommended dose is one 8 mg silodosin capsule daily, taken orally.
Always take the capsule with food, preferably at the same time each day. Do not break or chew the capsule; swallow it whole, preferably with a glass of water.
Patients with kidney problems
If you have moderate kidney impairment, your doctor may prescribe a different dose. For this purpose, silodosin 4 mg hard capsules are available.
If you take more silodosin than you should
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 experience dizziness or feel weak, inform your doctor immediately.
If you forget to take silodosin
You may take the missed capsule later the same day if you forgot to take it earlier. If it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for the forgotten capsule.
If you stop taking silodosin
If you stop treatment, your symptoms may return.
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.
Contact your doctor immediately if you experience any of the following allergic reactions, as they may have serious consequences: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives.
The most common adverse effect is a reduction in the amount of semen released during sexual intercourse. This effect disappears after stopping treatment with silodosin. Inform your doctor if you are planning to have children.
Dizziness, including dizziness upon standing, and occasionally fainting, may occur.
If you feel weak or dizzy, sit or lie down immediately until symptoms subside. If you experience dizziness upon standing or fainting, inform your doctor as soon as possible.
Silodosin may cause complications during cataract surgery (eye surgery for lens clouding; see section "Warnings and precautions").
It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken silodosin.
The possible adverse effects are listed below:
Very common adverse effects (may affect more than 1 in 10 people)
- Abnormal ejaculation (reduced or minimal semen release during sexual intercourse; see section "Warnings and precautions")
Common adverse effects (may affect up to 1 in 10 people)
- Dizziness, including dizziness upon standing (see also above in this section)
- Nasal discharge or nasal congestion
- Diarrhea
Uncommon adverse effects (may affect up to 1 in 100 people)
- Loss of sexual desire
- Nausea
- Dry mouth
- Difficulty achieving or maintaining an erection
- Increased heart rate
- Skin allergic reaction symptoms such as rash, pruritus, urticaria, and drug-induced rash
- Abnormal liver function test results
- Low blood pressure
Rare adverse effects (may affect up to 1 in 1,000 people)
- Fast or irregular heartbeat (called palpitations)
- Fainting/Loss of consciousness
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Other allergic reactions with swelling of the face or throat
Frequency not known (frequency cannot be estimated from available data)
- Floppy iris during cataract surgery (see also above in this section)
Inform your doctor if you notice that your sexual activity is affected.
Reporting of adverse effects
If you experience any type of 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Xilapro
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.
PVC/PE/PVdC-Al blisters: Do not store above 30°C.
OPA/Alu/PVC-Aluminium blisters: This medicine does not require any special storage conditions.
Do not use this medicine if it appears damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Xilapro.
- The active substance is silodosin. Each capsule contains 8 mg of silodosin.
- The other components are mannitol (E421), pregelatinized starch (derived from maize), sodium fumarate stearate, gelatin, titanium dioxide (E171). The capsules also contain shellac, propylene glycol, black iron oxide and potassium hydroxide.
Appearance of the product and contents of the pack
Xilapro 8 mg hard capsules: white, opaque, size 0 gelatin capsules, marked with a "8" in black ink.
Xilapro is available in packs of 30 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adventia Pharma, S.L.
Calle Viera y Clavijo, 30, 2º
35002 Las Palmas de Gran Canaria (Spain)
Local representative:
Atika Pharma, S.L.
Calle Viera y Clavijo, 30, 2º
35002 Las Palmas de Gran Canaria (Spain)
Manufacturer
TEVA Gyógyszergyár Zrt.
Pallagi út 13
Debrecen, 4042
Hungary
Date of the most recent revision of this leaflet: October 2023
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/