Silodosin Sandoz 8 mg hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Silodosin Sandoz 8 mg hard capsules EFG
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 must not give it to other people, even if they have the same symptoms as you, because it could 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.
Leaflet contents:
- What Silodosin Sandoz is and what it is used for
- What you need to know before taking Silodosin Sandoz
- How to take Silodosin Sandoz
- Possible adverse effects
- How to store Silodosin Sandoz
- Contents of the pack and other information
1. What Silodosin Sandoz is and what it is used for
What silodosin is
Silodosin belongs to a group of medicines known as alpha1A-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 to urinate,
- feeling that the bladder is not completely emptied,
- increased need to urinate, including during the night.
2. What you need to know before taking Silodosin Sandoz
Do not take Silodosin Sandoz:
- if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Silodosin Sandoz:
-
If you are scheduled to undergo eye surgery for 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 iris muscle tone (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 undergoing cataract surgery.
-
If you have ever fainted or felt dizzy upon suddenly standing up, 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 subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).
-
If you have severe liver problems, you should not take silodosin, as it has not been evaluated in this condition.
-
If you have kidney problems, consult your doctor.
If you have moderate kidney problems, your doctor will start treatment with silodosin cautiously and may prescribe a lower dose (see section 3).
If you have severe kidney problems, you should not take silodosin.
- Since benign enlargement of the prostate and prostate cancer can cause similar symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not effective for treating prostate cancer.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there are no relevant indications for this age group.
Taking Silodosin Sandoz with other medicines
Tell 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:
- 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 is increased during use of silodosin,
- 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,
- 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,
- medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as the effect of silodosin may be reduced.
Fertility
Treatment with silodosin may lead to abnormal ejaculation (reduction in the amount of semen released during sexual intercourse), which may temporarily affect male fertility. This effect reverses after stopping treatment with silodosin. Inform your doctor if you are planning to have children.
Driving and use of machines
Do not drive or operate machinery if you feel weak, dizzy, or drowsy, or if you have blurred vision.
Silodosin Sandoz contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.
3. How to take Silodosin Sandoz
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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, the 4 mg silodosin 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 medication 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 may cause adverse effects, although not everyone experiences 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, please inform your doctor as soon as possible.
Silodosin may cause complications during cataract surgery (eye surgery due to clouding of the lens; 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 negligible amount of semen released during sexual intercourse; see section “Fertility”)
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 appetite
- 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 any changes in your sexual activity.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Silodosin Sandoz
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light. Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Silodosin Sandoz
- The active substance is silodosin.
- Silodosin Sandoz 8 mg: each hard capsule contains 8 mg of silodosin.
- The other components are:
Capsule contents: mannitol (E421), pregelatinized corn starch, sodium lauryl sulfate (E487), magnesium stearate (E470b).
Capsule composition: titanium dioxide (E171), gelatin (E441).
Printing ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525).
Nature of the product and contents of the pack
White hard capsules printed with an “S” on the cap and an “8” on the body, containing a white or almost white fine powder.
Approximate length: 21.7 mm.
Silodosin Sandoz is packaged in PVC/PVDC-aluminum blisters.
Pack sizes
Blister pack: 30 hard capsules.
Unit dose blister pack: 10x1 and 30x1 hard capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Noucor Health S.A.
Avda. Camí Reial, 51-57
08184 Palau-solità i Plegamans
Barcelona, Spain
Lek Pharmaceuticals d.d.
Verovskova Ulica 57,
1526 Ljubljana,
Slovenia
This medicinal product is authorized in the European Economic Area member states under the following names:
Slovenia: Silodozin Sandoz 8 mg trde kapsule
France: SILODOSINE SANDOZ 8 mg, gélule
Italy: Silodosina Sandoz
Netherlands: Silodosine Sandoz 8 mg, harde capsules
Portugal: Silodosina Sandoz
Date of the most recent review of this package leaflet: April 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/