Leaflet: information for the patient

Silodosina ratiopharm 8 mg hard capsules EFG

silodosina

Read 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, consult your doctor or pharmacist.

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

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

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

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

3. How to take Silodosina ratiopharm

4. Possible side effects

5. Storage of Silodosina ratiopharm

6. Contents of the pack and additional information

What is silodosina ratiopharm

Silodosina belongs to a group of medications called 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 relieves your symptoms.

What is silodosina ratiopharm 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 completely emptying the bladder,

• need to urinate more frequently, even at night.

Do not take Silodosina ratiopharm

- if you are allergic to silodosin or 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:

-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 silodosin previously. This is because some patients treated with this type of medication experienced 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 temporarily the treatment with silodosin when you are to undergo cataract surgery.

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

When taking silodosin, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

-If you havesevere liver problems, you should not take silodosin, as it has not been evaluated in this situation.

-If you havekidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will initiate treatment with silodosin with caution and possibly with a lower dose (see section 3 “Dose”). 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 Silodosina ratiopharm. Silodosin is not used to treat prostate cancer.

-Treatment with this medicine may lead to abnormal ejaculation (reduced semen volume 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 administer this medicine to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Concomitant use of Silodosina ratiopharm with other medicines

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

Inform your doctor in 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 medicine.

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

•medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concomitant use with silodosin may lead to a slight decrease in blood pressure.

•medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of Silodosina ratiopharm may be reduced.

Driving and operating machines

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

Silodosina ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule of silodosina 8 mg per day by oral administration.

Take the capsule always accompanied by food, preferably at the same hour 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 presentation silodosina 4 mg hard capsules is 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 feel dizzy or weak, inform your doctor immediately.

If you forgot to take silodosina

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

If you interrupt the treatment with silodosina

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

If you have any other doubt 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 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 discharge 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 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.

PVC/PE/PVdC-Aluminum Blister:

Do not store at a temperature above 30°C.

OPA/Alu/PVC-Aluminum Blister:

This medication does not require special storage conditions.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been improperly handled.

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

Composition of Silodosina ratiopharm 8 mg hard capsules EFG

-The active ingredient is silodosina. Each hard capsule contains 8 mg of silodosina.

-The other excipients are mannitol, pregelatinized cornstarch, sodium fumarate stearate, gelatin, and titanium dioxide (E171). The capsules contain shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Appearance of the product and content of the container

Silodosina ratiopharm 8 mg hard capsules are hard gelatin capsules of size 0, white, opaque, and printed with a “8” in black ink.

They are available in containers of 10, 30, or 90 hard capsules; and in single-dose blister packs of 10x1, 30x1, or 90x1 hard capsules.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B 1st Floor

Alcobendas, 28108 Madrid

Spain

Responsible manufacturer:

TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen

Hungary

Revision date of this prospectus:March 2019

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