Silodosin Stada 4 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Silodosin Stada 4 mg Hard Capsules EFG

Read this entire 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 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 effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Silodosin Stada is and what it is used for

What silodosin is

Silodosin belongs to a group of medicines called alpha-1A 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 during the night.

2. What you need to know before taking Silodosin Stada

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

Talk to your doctor or pharmacist before taking this medicine:

• 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 medication 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 standing up suddenly, inform your doctor before taking silodosin.

When taking silodosin, dizziness may occur upon standing, and occasionally fainting, especially when starting treatment or if you are taking other medications 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 such cases.

• If you have kidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start treatment with silodosin cautiously and may prescribe a lower dose (see section 3 “How to take Silodosin Stada”). If your kidney problems are severe, you should not take this medicine.

• 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.

• Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen released during sexual intercourse), which may temporarily affect male fertility. This effect reverses after stopping 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:

• 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 when used together with 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 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.

Pregnancy and fertility

Pregnancy

This medicine is not used in women, as silodosin is indicated for the treatment of men with benign prostatic enlargement.

Fertility

Silodosin may reduce the amount of semen, and therefore may temporarily affect the ability to father a child.

Driving and use of machines

Do not drive or operate machinery if you feel faint, dizzy, or drowsy, or if you have blurred vision.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially “sodium-free”.

3. How to take Silodosin Stada

Follow exactly the instructions for use of this medicine provided 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.

Take the capsule always 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 problems, your doctor may prescribe you a different dose. For this purpose, the 4 mg silodosin hard capsule formulation is 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 capsule later the same day if you forgot to take it earlier. If it is almost time for the 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 gets 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 ejaculated 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 due to 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 (a reduced or negligible amount of semen is ejaculated 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 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 heartbeats (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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Silodosin Stada

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 after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Do not use this medicine if you notice it is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Stada 4 mg hard capsules EFG

• The active substance is silodosin. Each capsule contains 4 mg of silodosin.
• The other components are:
  • Capsule contents: mannitol (E421), pregelatinized starch (corn), sodium lauryl sulfate, glyceryl dibehenate (E471).
  • Capsule shell: gelatin; titanium dioxide (E171); yellow iron oxide (E172).
  • Printing ink, black: shellac (E904); propylene glycol (E1520); concentrated ammonia solution (E527); black iron oxide (E172); potassium hydroxide (E525).

Appearance of the medicine and contents of the pack

Silodosin Stada 4 mg hard capsules EFG:

Yellow, opaque, gelatin hard capsules, size 3, marked on the cap in black ink with “4”.

Silodosin Stada is available in cardboard boxes containing 10, 30, 50 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Rontis Hellas S.A., Medical and Pharmaceutical Products

Larisa Industrial Area, P.O. Box 3012, Larisa, 41004

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel

Germany

Date of the most recent revision of this leaflet: February 2019

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/