SILODOSINA 4 мг Капсулы твердые

Содержание инструкции

1. Silodosina Teva 4 mg hard capsules, 8 mg hard capsules
   1. What is Silodosina Teva and what is it used for
   2. What you need to know before taking Silodosina Teva
   3. How to take Silodosina Teva
   4. Possible side effects
   5. How to store Silodosina Teva
   6. Contents of the pack and other information

Silodosina Teva 4 mg hard capsules, 8 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is Silodosina Teva
Silodosina Teva belongs to a group of medicines called alpha-adrenoceptor inhibitors.
Silodosina Teva is selective for the receptors located in the prostate, bladder and urethra. Through the
blockade of these receptors, the medicine relaxes the smooth muscle of these tissues. This makes it easier to
urinate and relieves the symptoms.

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

• difficulty starting to urinate,
• feeling of not completely emptying the bladder,
• frequent need to urinate, even at night.

2. What you need to know before taking Silodosina Teva

Do not take Silodosina Teva

• if you are allergic to silodosina 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 Silodosina Teva

• If you are to have eye surgery for a clouded lens (cataract surgery), it is important that you immediately inform your ophthalmologist

that you are using or have used in the past Silodosina Teva. This is because some patients treated with
this type of medicine have experienced a 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 that will be used. Ask your doctor if it is
necessary to postpone or temporarily interrupt treatment with Silodosina Teva in
case of cataract surgery.

• If you have fainted or felt dizzy when getting up suddenly in the past, tell your doctor before taking Silodosina Teva. Taking Silodosina Teva may cause dizzinesswhen standing up and, occasionally, fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. In such cases, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also section “Driving and operating machinery”).
• If you have severe liver problems, you should not take Silodosina Teva, because the medicine has not been studied in patients with these conditions.
• If you have kidney problems, ask your doctor for advice. If you have moderate kidney problems, your doctor will start treatment with Silodosina Teva with caution and possibly with a reduced dose (see section 3 “How to take Silodosina Teva”). If you have a severe kidney disease, you should not take Silodosina Teva.
• Since an enlarged benign prostate and prostate cancer can present the same symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosina Teva. Silodosina Teva is not a treatment for prostate cancer.
• Treatment with Silodosina Teva may lead to abnormal ejaculation (reduced amount of semen released during sexual intercourse), which may temporarily impair male fertility. This effect disappears after stopping treatment with Silodosina Teva. Tell your doctor if you want to have children.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is no
indication for this age group.

Other medicines and Silodosina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 Silodosina Teva.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used againstHIV/AIDS infection(such as ritonavir) or medicines used after a transplant toprevent organ rejection(such as cyclosporine), because these medicines can increase the concentration of Silodosina Teva in the blood.
• medicines used if you have problems getting or maintaining an erection(such as sildenafil or tadalafil), because concomitant use with Silodosina Teva may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of Silodosina Teva may be reduced.

Driving and operating machinery
Do not drive or operate machinery if you feel faint, dizzy or sleepy, or if your vision is
blurred.

Silodosina 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 Silodosina Teva

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is one Silodosina Teva 8 mg capsule daily by oral route.
Take the capsule always with a meal, preferably at the same time each day. Do not crush or
chew the capsule, but 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 these cases is
available Silodosina Teva 4 mg hard capsules.

If you take more Silodosina 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,
inform your doctor immediately.

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

If you stop taking Silodosina Teva
If you stop the treatment, the symptoms may reappear.
If you have any doubts about 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 notice any of the following allergic reactions: swelling of the
face or throat, difficulty breathing, feeling faint, skin itching or hives, because the
consequences can become serious.
The most common side effect is a reduction in the amount of semen emitted during sexual
activity. This effect disappears after stopping treatment with Silodosina Teva. Tell your
doctor if you wish to have children.
Dizzinessmay occur, even when getting up, and, occasionally, fainting.
If you feel weak or dizzy, sit or lie down immediately until the
symptoms disappear. If you feel dizzy when standing up or in case of fainting, tell your doctor as
soon as possible.
Silodosina Teva may cause complications during a cataract operation(surgical
procedure on the eye performed to correct lens opacity, see the section “Warnings and
precautions”).
It is important that you immediately inform your ophthalmologist if you are using or have used Silodosina Teva in
the past.
The possible side effects are listed below:

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

• Abnormal ejaculation (reduction or absence of semen emission during sexual activity, see section “Warnings and precautions”)

Common (may affect up to 1 in 10 people)

• Dizziness, even when getting up (see also above, in this paragraph)
• Runny or blocked nose
• Diarrhea

Uncommon (may affect up to 1 in 100 people)

• Decreased libido
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• Fast heartbeat
• Symptoms of an allergic reaction affecting the skin, such as rash, itching, hives and drug-induced rash
• Abnormal liver function tests
• Hypotension

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

• Fast 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 available data)

• Flag pupil during cataract surgery (see also above, in this paragraph)

If you think there are effects on your sex life, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 Silodosina Teva

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 package and on the blister after Exp.
The expiry date refers to the last day of that month.
PVC/PE/PVdC/Aluminum blisters:
Do not store at temperatures above 30°C.
OPA/Alu/PVC-aluminum blisters:
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the package is damaged or if it shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Silodosina Teva contains
Silodosina Teva 4 mg

• The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.
• The other ingredients are mannitol, pregelatinized maize starch, sodium stearylfumarate, 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 ingredient is silodosin. Each capsule contains 8 mg of silodosin.
• The other ingredients are mannitol, pregelatinized maize starch, sodium stearylfumarate, 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: Hard gelatin capsule, ivory, opaque, size 2, with the
inscription “4” in black ink.
Silodosina Teva 8 mg hard capsules: Hard gelatin capsule, white, opaque, size 0, with the
inscription “8” in black ink.
Silodosina Teva is available in packs of 10 hard capsules, 30 hard capsules, 90 hard capsules.
Silodosina Teva is available in blister packs for unit doses of 10 x 1 hard capsules, 30 x 1
hard capsules, 90 x 1 hard capsules.
Not all pack sizes may be marketed.

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

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