Prospect: information for the patient

Silodosina Stada 8 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Silodosina Stada

3. How to take Silodosina Stada

4. Possible adverse effects

5. Storage of Silodosina Stada

6. Contents of the package and additional information

What is silodosina

Silodosina belongs to a group of medications known as alpha 1A adrenergic receptor blockers.

Silodosina 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 alleviates your symptoms.

What is silodosina used for

Silodosina is used in adult males to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination,

• feeling of not fully emptying the bladder,

• more frequent need to urinate, even at night.

Do not take silodosina

if you are allergic to silodosina or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you are to undergo eye surgery for cataract turbidity (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used silodosina previously. This is because some patients treated with this type of medication have suffered a loss of iris muscle tone (the circular colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions regarding medical and surgical techniques. Ask your doctor if you need to postpone or interrupt silodosina treatment temporarily when undergoing cataract surgery.

• If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking silodosina.

When taking silodosina, dizziness and, occasionally, fainting may occur when standing up, especially when starting treatment or taking other medications 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 operating machines”).

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

• If you have kidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will initiate treatment with silodosina with caution and possibly with a lower dose (see section 3 “How to take Silodosina Stada”). If your kidney problems are severe, do not take this medication.

• 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 silodosina. Silodosina is not used to treat prostate cancer.

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

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Concomitant use of silodosina with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctorin particular if you take:

• blood pressure-lowering medications(especially alpha 1 blockers, such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during use of this medication.

• antifungal medications(such as ketoconazole or itraconazole),medications used for HIV/AIDS infection(such as ritonavir) ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase silodosina blood concentrations.

• medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concomitant use with silodosina may lead to a slight decrease in blood pressure.
• epilepsy medications or rifampicin(a medication used to treat tuberculosis), as the effect of silodosina may be reduced.

Pregnancy and fertility

Pregnancy

This medication is not used in women, as silodosina is used to treat benign prostatic hyperplasia in men.

Fertility

Silodosina may reduce semen volume, which may temporarily affect the ability to father a child.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, dizziness, or somnolence or have blurred vision.

This medication contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosina capsule per day taken orally.

Take the capsule always accompanied by food, preferably at the same time every 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 a different dose. For this purpose, the 4 mg silodosina hard capsules are available.

If you take more silodosina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 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 silodosina

You can take the capsule later the same day if you forget 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 compensate for the missed capsule.

If you interrupt treatment with silodosina

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be severe: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or urticaria.

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

You may experiencedizziness, including dizziness when standing up, and, occasionally,fainting.

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

Silodosinamay cause complications duringcataract surgery(eye surgery for clouding of the crystalline lens; see section “Warnings and precautions”).

It is essential that youinform your ophthalmologist immediatelyif you are using or have previously usedsilodosina.

The possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or inappreciable 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 secretion or obstruction

• Diarrhea

Uncommon side 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 allergy symptoms, such as rash, itching, urticaria, and drug-induced rash

• Abnormal liver function test results

• Low blood pressure

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

• Rapid 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

Unknown frequency (the frequency cannot be estimated from the available data)

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

Inform your doctor if you notice that your sexual relations are affected.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Do not use this medication if you observe that it is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Silodosina Stada 8 mg hard capsules EFG

• The active ingredient is silodosina. Each capsule contains 8 mg of silodosina.
• The other components are:
• Content of the capsule: manitol (E421), pregelatinized cornstarch, sodium laurilsulfate, dibehenato of glycerol (E471).
• Capsule coating: gelatine; 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 content of the container

Silodosina Stada 8 mg hard capsules EFG:

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

Silodosina Stada is presented in cardboard boxes containing 10, 30, 50, and 100 hard capsules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Last review date of this leaflet: February 2019

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/