Silodosin Mylan

Package leaflet: Information for the patient

Silodosin Mylan 4 mg hard capsules, 8 mg hard capsules

Generic Medicine
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Silodosina Mylan is
Silodosina Mylan belongs to a group of medicines called alpha-blockers.
Silodosina Mylan 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 Mylan is used for
Silodosina Mylan is used in adult men for the treatment of urinary symptoms associated with
benign enlargement of the prostate (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 Mylan

Do not take Silodosin Mylan
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 Mylan

• 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 Silodosin Mylan. This is because some patients treated
  with this type of medicine have experienced loss of iris muscle tone (the
  coloured 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 is necessary to postpone or temporarily discontinue treatment with Silodosin
  Mylan in case of cataract surgery.

• If you have previously fainted or experienced dizziness when standing up suddenly, inform your doctor before taking Silodosin Mylan. Dizziness upon standing may occur while taking Silodosin Mylan, 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 symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, do not take Silodosin Mylan, 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 problems, your doctor will start treatment with Silodosin Mylan cautiously and possibly at a reduced dose (see section 3 “Dosage”). You must not take Silodosin Mylan if you have severe kidney disease.

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

• Treatment with Silodosin Mylan may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect disappears after stopping treatment with Silodosin Mylan. 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 Mylan
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 Mylan.
• 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 Silodosin Mylan in the blood.
• medicines used for difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), because concomitant use with Silodosin Mylan may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Mylan may be reduced. Pregnancy and fertility

Pregnancy
Since Silodosin Mylan is used to treat men with benign enlargement of the prostate, it is not intended for use in women.
Fertility
Silodosin Mylan may reduce the amount of semen, temporarily reducing the ability to father a child.
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 Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially 'sodium-free'.

3. How to take Silodosina Mylan

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 Silodosina Mylan 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, Silodosina Mylan 4 mg hard capsules are available.

If you take more Silodosina Mylan 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 Silodosina Mylan
If you have forgotten to take a capsule, you may take it later 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 Silodosina Mylan
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 everyone experiences 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 lead to serious consequences.

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

Dizziness may occur, even when standing up, and occasionally fainting. If you feel weak or dizzy, 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.

Silodosina Mylan may cause complications during cataract surgery (a surgical procedure on the eye 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 Silodosina Mylan.

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 intercourse; 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 tests
• Low blood pressure

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

• Rapid or irregular heartbeat (known as 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 the available data)

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

If you feel that this medicine is affecting your sexual life, 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 http://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 Mylan

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/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 medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Silodosina Mylan contains
Silodosina Mylan 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, glycerol dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Silodosina Mylan 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, glycerol dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of Silodosina Mylan and pack contents
Silodosina Mylan 4 mg hard capsules
Yellow, opaque, hard gelatin capsule, size 3, with "4" printed in black ink on the cap.
.
Silodosina Mylan 8 mg hard capsules
White, opaque, hard gelatin capsule, size 0, with "8" printed in black ink on the cap.
.
4 mg:
Silodosina Mylan is available in packs containing 10, 30 and 100 capsules.
8 mg:
Silodosina Mylan is available in packs containing 30, 50 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A, P.O Box 3012 Larisa Industrial Area 41004,
Larisa, Greece

This medicinal product is authorized in the EEA Member States under the following names:
HU: Silodosin Mylan 4 mg, 8 mg kemény kapszula
ES: Silodosina Mylan cápsulas duras EFG
FR: Silodosine Mylan 4 mg et 8 mg, gélule
IT: Silodosina Mylan
PT: Silodosina Mylan
SK: Silodosin Mylan 4 mg
Silodosin Mylan 8 mg