Prospect: information for the patient

Silodosina Teva-ratiopharm 8 mg hard capsules EFG

silodosina

Read this prospect carefully before starting to take this medicine, because 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 Teva-ratiopharm and what is it used for

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

3. How to take Silodosina Teva-ratiopharm

4. Possible adverse effects

5. Storage of Silodosina Teva-ratiopharm

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 completely emptying the bladder,

• more frequent need to urinate, even at night.

Do not take Silodosina Teva-ratiopharm

- 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 from iris muscle tone loss (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 it is necessary or not to postpone or interrupt temporarily the silodosina treatment 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 Teva-ratiopharm.

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 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 silodosina, 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 start the treatment with silodosina with caution and possibly with a lower dose (see section 3 “Doses”). If your kidney problems are severe, you should 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 does not treat prostate cancer.

-Treatment with this medication may lead to abnormal ejaculation (reduced semen expulsion 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.

Use of Silodosina Teva-ratiopharm 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 alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during use of thismedication.
• 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 silodosina blood concentrations.
• medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concurrent 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.

Driving and operating machines

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

Silodosina Teva-ratiopharm contains sodium

This medication containsless than 23 mg of sodium (1 mmol) per capsule, which 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 with 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 medicines, this medicine 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 frequent 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 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 imperceptible 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 the 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 medicine.

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 manipulated improperly.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that 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 that you no longer need. By doing so, you will help protect the environment.

Composition of Silodosina Teva-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 contents of the packaging

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

It is available in packaging of 10, 30, or 90 hard capsules; and in single-dose blister packaging of 10x1, 30x1, or 90x1 hard capsules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible manufacturer:

TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen

Hungary

Local representative:

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B 1st Floor

Alcobendas, 28108 Madrid

Spain

Last review date of thisleaflet:March 2019

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