Silodosine Doc Generici

Package leaflet: Information for the patient

SILODOSIN DOC 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet
1 What SILODOSIN DOC is and what it is used for

2 What you need to know before taking SILODOSIN DOC
3 How to take SILODOSIN DOC
4 Possible side effects
5 How to store SILODOSIN DOC
6 Contents of the pack and other information

1. What SILODOSINA DOC is and what it is used for

What SILODOSINA DOC is
SILODOSINA DOC belongs to a group of medicines called alpha 1A-adrenoceptor inhibitors.
SILODOSINA DOC 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 SILODOSINA DOC is used for
SILODOSINA DOC 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,
• sensation of not having completely emptied the bladder,
• frequent need to urinate, including during the night.

2. What you need to know before taking SILODOSINA DOC

Do not take SILODOSINA DOC
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 SILODOSINA DOC

• If you are scheduled for eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your
  ophthalmologist that you are currently taking or have previously taken SILODOSINA DOC. 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 SILODOSINA DOC prior to cataract surgery.

• If you have previously fainted or experienced dizziness upon standing up suddenly, inform your doctor before taking SILODOSINA DOC. Dizziness upon standing may occur when taking SILODOSINA DOC, 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 SILODOSINA DOC, as the medicine has not been studied in patients with these conditions.

• If you have kidney problems, consult your doctor. If you have moderate kidney impairment, your doctor will start treatment with SILODOSINA DOC cautiously and possibly with a reduced dose (see section 3 “Dosage”). You must not take SILODOSINA DOC if you have severe kidney disease.

• Since benign enlargement of the prostate and prostate cancer may present with similar symptoms, your doctor will check whether you have prostate cancer before starting treatment with Urorec. Urorec is not a treatment for prostate cancer.

• Treatment with SILODOSINA DOC may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect disappears after discontinuation of SILODOSINA DOC. Inform your doctor if you intend to father children.

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

Other medicines and SILODOSINA DOC
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 SILODOSINA DOC.
• 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 can increase the concentration of SILODOSINA DOC in the blood.
• Medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with SILODOSINA DOC may slightly reduce blood pressure.
• Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of SILODOSINA DOC may be reduced.

Pregnancy and breastfeeding
Pregnancy
Since SILODOSINA DOC is used to treat men with benign enlargement of the prostate, it is not indicated for use in women.

Fertility
SILODOSINA DOC may reduce the amount of semen, temporarily decreasing the chance of fathering a child.

Driving and use of machines
Do not drive or operate machinery if you feel faint, dizzy, or drowsy, or if you experience blurred vision.

SILODOSINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take SILODOSIN DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 8 mg SILODOSIN DOC capsule daily, taken orally.
Take the capsule always with food, 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 impairment, your doctor may prescribe a different dose. For these cases, SILODOSIN DOC 4 mg hard capsules are available.

If you take more SILODOSIN DOC 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 DOC
If you forget to take a dose, 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 missed capsule.

If you stop taking SILODOSIN DOC
If you stop treatment, your symptoms may return.

If you have any questions 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 may become severe.

The most common side effect is a reduction in the amount of semen ejaculated during sexual activity. This effect disappears after stopping treatment with SILODOSIN DOC. Inform your doctor if you wish to have children.

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

SILODOSIN DOC may cause complications during cataract surgery (eye surgery performed to treat 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 DOC.

The possible side effects are listed below:

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

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

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

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

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

• Rapid or irregular heartbeat (so-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

Frequency not known (cannot be estimated from available data)

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

If you feel this medicine is affecting your sexual life, please inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SILODOSIN DOC

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 carton and on the blister
after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the packaging is damaged or shows signs of
tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SILODOSINA DOC contains
SILODOSINA DOC 4 mg hard capsules
The active substance is silodosin. Each capsule contains 4 mg of silodosin.
The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Black printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

SILODOSINA DOC 8 mg hard capsules
The active substance is silodosin. Each capsule contains 8 mg of silodosin.
The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171).
• Black printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of SILODOSINA DOC and pack contents
SILODOSINA DOC 4 mg hard capsules
Yellow, opaque, size 3 hard gelatin capsule, with "4" printed in black ink on the cap.
SILODOSINA DOC 8 mg hard capsules
White, opaque, size 0 hard gelatin capsule, with "8" printed in black ink on the cap.
SILODOSINA DOC is available in packs containing 30 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan – Italy
Manufacturer:
Rontis Hellas Medical and Pharmaceutical Products S.A., P.O Box 3012 Larisa Industrial Area, Larisa - 41004 Greece

This medicinal product is authorised in the European Economic Area Member States under the following names:
Hungary: SILODOSIN DOC
Italy: SILODOSINA DOC