SILODOSIN STADA 8 mg HARD CAPSULES

2. What you need to know before you take Silodosin Stada

Do not take silodosin

if you are allergic to silodosin or 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 going to have eye surgery for cataracts, it is important that you inform your ophthalmologist immediately that you are using or have previously used silodosin. This is because some patients treated with this type of medicine have suffered a loss of muscle tone in the iris (the colored part of the eye) during this type of surgery. The ophthalmologist may then take appropriate precautions regarding the medical and surgical techniques to be used. Ask your doctor if it is necessary to postpone or temporarily interrupt treatment with silodosin when you are going to undergo cataract surgery.

• If you have ever fainted or felt dizzy when standing up, inform your doctor before taking silodosin.

When taking silodosin, dizziness and, occasionally, fainting may occur when standing up, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also the section "Driving and using machines").

• If you have severe liver problems, you should not take silodosin, as it has not been evaluated in this situation.

• If you have kidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will start treatment with silodosin with caution and possibly with 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 prostatic hyperplasia 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 used to treat prostate cancer.

• Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen expelled during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping treatment with silodosin. Inform your doctor if you are planning to have children.

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 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor in particular if you are taking:

• medicines that lower blood pressure(especially alpha-1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines will increase during use of this medicine.

• antifungal medicines(such as ketoconazole or itraconazole), medicines used for HIV/AIDS(such as ritonavir), or medicines used after transplants to prevent organ rejection(such as cyclosporine), as these medicines may increase blood levels of silodosin.

• medicines used to treat erection problems(such as sildenafil or tadalafil), as 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 used to treat men with benign prostatic hyperplasia.

Fertility

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

Driving and using machines

Do not drive or use machines if you feel faint, dizzy, or sleepy, or

have blurred vision.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Silodosin Stada

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosin capsule per day, 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.

Patient with kidney problems

If you have moderate kidney problems, your doctor may prescribe a different dose. For this purpose, the 4 mg silodosin hard capsules are available.

If you take more Silodosin Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. If you feel dizzy or weak, inform your doctor immediately.

If you forget to take Silodosin Stada

You can take the capsule later the same day if you forget to take it before. 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 missed capsule.

If you stop taking Silodosin Stada

If you stop treatment, it is possible that the symptoms will reappear.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you experience any of the following allergic reactions, as their consequences could be serious: swelling of the face or throat, difficulty breathing, feeling of fainting, itching of the skin, or hives.

The most common side effect is a reduction in the amount of semen expelled during sexual intercourse. This effect disappears after stopping treatment with silodosin. Inform your doctor if you are planning to have children.

Dizziness, including dizziness when standing up, and, occasionally, fainting may occur.

If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear. If you experience dizziness when standing up or fainting, inform your doctor as soon as possible.

Silodosin may cause complications during cataract surgery (eye surgery for cataracts; see section "Warnings and precautions").

It is important that you inform your ophthalmologist immediately if you are using or have previously used silodosin.

Other possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or negligible amount of semen is expelled during sexual intercourse; see section "Warnings and precautions")

Common side effects (may affect up to 1 in 10 people)

• Dizziness, including dizziness when standing up (see also above in this section)
• Nasal congestion or obstruction
• Diarrhea

Uncommon side effects (may affect up to 1 in 100 people)

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• Increased heart rate
• Symptoms of an allergic reaction affecting the skin, such as rash, itching, hives, and drug-induced rash

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

• Fast or irregular heartbeats (called palpitations)
• Fainting/Loss of consciousness

Very rare side 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 the available data)

• Flaccid pupil during cataract surgery (see also above in this section)

Tell your doctor if you notice that your sexual intercourse is affected.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after "EXP". The expiry date is the last day of the month shown.

Store in the original package to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Silodosin Stada 8 mg hard capsules EFG

• The active substance is silodosin. Each capsule contains 8 mg of silodosin.
• The other ingredients are:
• Contents of the capsule:mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, dibehenate (E471).
• Capsule shell:gelatin; titanium dioxide (E171).
• Printing ink, black:shellac (E904); propylene glycol (E1520); concentrated ammonia solution (E527); iron oxide black (E172); potassium hydroxide (E525).

Appearance of the product and pack contents

Silodosin Stada 8 mg hard capsules EFG:

Hard gelatin capsule, opaque, white, size 0, marked on the cap in black ink with "8".

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last 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/