Silodosin Teva

Patient Information Leaflet

Silodosin Teva 4 mg Hard Capsules, 8 mg Hard Capsules

Equivalent Medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Silodosin Teva is
Silodosin Teva belongs to a group of medicines called alpha-adrenoceptor blockers.
Silodosin Teva is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, the medicine causes relaxation of the smooth muscle in these tissues. This makes urination easier and relieves symptoms.

What Silodosin Teva is used for
Silodosin Teva is used in adult men for the treatment of urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia), such as:

• difficulty starting to urinate,
• feeling of not having completely emptied the bladder,
• frequent need to urinate, including during the night.

2. What you need to know before taking Silodosin Teva

Do not take Silodosin Teva

• 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 Silodosin Teva

• If you are scheduled to undergo eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently using or have previously used Silodosin Teva. This is because some patients treated with this type of medicine have experienced loss of iris muscle tone (the colored circular part of the eye) during such surgery. The ophthalmologist will take appropriate precautions regarding the medicines and surgical techniques to be used. Ask your doctor whether it may be necessary to postpone or temporarily discontinue treatment with Silodosin Teva prior to cataract surgery.

• If you have previously fainted or experienced dizziness upon standing up suddenly, inform your doctor before taking Silodosin Teva. Dizziness when standing up may occur while taking Silodosin Teva, and occasionally fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, you must not take Silodosin Teva, as the medicine has not been studied in patients with this condition.

• If you have kidney problems, consult your doctor. If you have moderate kidney problems, your doctor will start treatment with Silodosin Teva cautiously and may prescribe a reduced dose (see section 3 “How to take Silodosin Teva”). You must not take Silodosin Teva if you have severe kidney disease.

• Since benign enlargement of the prostate and prostate cancer may cause similar symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosin Teva. Silodosin Teva is not a treatment for prostate cancer.

• Treatment with Silodosin Teva may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily impair male fertility. This effect disappears after stopping treatment with Silodosin Teva. Inform your doctor if you wish to have children.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as there is no indication for use in this age group.
Other medicines and Silodosin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially medicines called alpha-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with Silodosin Teva.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used to treat HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), because these medicines may increase the concentration of Silodosin Teva in the blood.
• medicines used for erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodosin Teva may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Teva may be reduced.

Driving and use of machines
Do not drive or operate machinery if you feel faint, dizzy, or drowsy, or if you have blurred vision.
Silodosin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Silodosin Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 8 mg Silodosin Teva capsule daily, taken orally.
Take the capsule always with a meal, preferably at the same time each day. Do not crush 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 these cases, Silodosin Teva 4 mg hard capsules are available.

If you take more Silodosin Teva than you should
If you have taken more than one capsule, inform your doctor as soon as possible. If you feel dizzy or weak, contact your doctor immediately.

If you forget to take Silodosin Teva
If you have forgotten to take a capsule, you may take it later on the same day. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten capsule.

If you stop taking Silodosin Teva
If you stop treatment, your symptoms may return.

If you have any doubts about how to use this medicine, consult 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 notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives, as these could become severe.

The most common side effect is a reduced amount of semen released during sexual intercourse. This effect disappears after stopping treatment with Silodosin Teva. Inform your doctor if you intend to have children.

Dizziness, even when standing up, and occasionally fainting may occur.
If you feel weak or experience dizziness, sit or lie down immediately until symptoms subside. If you experience dizziness upon standing or episodes of fainting, inform your doctor as soon as possible.

Silodosin Teva may cause complications during a cataract surgery (eye surgery performed to correct clouding of the lens; see section “Warnings and precautions”).
It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken Silodosin Teva.

The possible side effects are listed below:

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

• Abnormal ejaculation (reduced or absent semen emission during sexual intercourse; see section “Warnings and precautions”)

Common (may affect up to 1 in 10 people)

• Dizziness, even when standing up (see also above in this section)
• Runny or stuffy nose
• Diarrhoea

Uncommon (may affect up to 1 in 100 people)

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergic reactions such as rash, itching, hives, and drug-induced skin eruptions
• Abnormal liver function test results
• Hypotension

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

• Rapid or irregular heartbeat (called palpitations)
• Fainting/loss of consciousness

Very rare (may affect up to 1 in 10,000 people)

• Other allergic reactions with swelling of the face or throat

Not known (frequency cannot be estimated from the available data)

• Intraoperative floppy iris syndrome during cataract surgery (see also above in this section)

If you feel there are effects on your sexual life, inform your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system available at:
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silodosin Teva

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 that month.
PVC/PE/PVdC/Aluminium blisters:
Do not store above 30°C.
OPA/Alu/PVC-Aluminium blisters:
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Silodosina Teva contains
Silodosina Teva 4 mg

• The active substance is silodosin. Each capsule contains 4 mg of silodosin.
• The other components are mannitol, pregelatinized maize starch, sodium stearoyl fumarate, gelatin, titanium dioxide (E171), yellow iron oxide (E172). The capsules also contain shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

Silodosina Teva 8 mg

• The active substance is silodosin. Each capsule contains 8 mg of silodosin.
• The other components are mannitol, pregelatinized maize starch, sodium stearoyl fumarate, gelatin and titanium dioxide (E171). The capsules also contain shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Silodosina Teva and contents of the pack
Silodosina Teva 4 mg hard capsules: Ivory, opaque, size 2 hard gelatin capsules, printed with the number "4" in black ink.
Silodosina Teva 8 mg hard capsules: White, opaque, size 0 hard gelatin capsules, printed with the number "8" in black ink.
Silodosina Teva is available in packs of 10 hard capsules, 30 hard capsules, 90 hard capsules.
Silodosina Teva is also available in unit dose blister packs of 10 x 1 hard capsules, 30 x 1 hard capsules, 90 x 1 hard capsules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen 4042
Hungary