Antunes

Package leaflet: Information for the user

ANTUNES 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you start 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, tell your doctor or pharmacist. See Section 4.

Contents of this leaflet:

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

1. What ANTUNES is and what it is used for

ANTUNES contains tamsulosin as the active substance, an alpha-adrenergic receptor blocker
that relaxes the smooth muscle of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by prostate enlargement
(benign prostatic hyperplasia).

2. What you should know before taking ANTUNES

Do not take ANTUNES if:

• you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
• you suffer from low blood pressure upon changing from a lying to a standing position (orthostatic hypotension);
• you have severe liver problems (hepatic insufficiency).

Warnings and precautions:
Talk to your doctor or pharmacist before taking ANTUNES:

• if you experience dizziness or weakness, especially after standing up. Tamsulosin may lower blood pressure, causing these symptoms. In such cases, you should sit or lie down until symptoms disappear;
• if you have severe kidney problems;
• if you are scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). You may develop a condition affecting the eyes called intraoperative floppy iris syndrome (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken tamsulosin hydrochloride. In this case, the specialist may take appropriate precautions regarding the drug and surgical techniques to be used. Ask your doctor whether you should postpone or temporarily discontinue taking this medicine before undergoing surgery for cataract or glaucoma.

Children and Adolescents
ANTUNES is not indicated for children or adolescents under 18 years of age.
Other medicines and ANTUNES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tamsulosin may affect the action of other medicines, and these, in turn, may affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are taking:

• cimetidine, used for stomach disorders;
• furosemide, used to increase urine production;
• ketoconazole, used for fungal infections (mycoses);
• paroxetine, used for depression;
• warfarin, used to delay blood clotting;
• diclofenac, an anti-inflammatory drug.
  Taking ANTUNES together with other medicines belonging to the same class (α1-adrenergic receptor antagonists) may cause a drop in blood pressure.

ANTUNES with food and drinks
You should take tamsulosin with a glass of water after breakfast or after the first meal of the day.
Pregnancy, breastfeeding and fertility
ANTUNES is not indicated for use in women.
In men, ejaculation abnormalities (ejaculation disorders) have been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculation is reduced or absent (inadequate ejaculation).
Driving and using machines
No studies on the ability to drive vehicles or operate machinery have been conducted. You should bear in mind that this medicine may cause dizziness; therefore, drive or operate machinery only if you feel well.
ANTUNES contains sodium.
ANTUNES contains 1.1 mg of sodium per capsule. Please take this into account if you are on a sodium-controlled diet.

3. How to take ANTUNES

Take this medicinal product exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule per day, taken after breakfast or after the first
meal of the day.
Swallow the capsule whole.
It is important not to break or crush the capsule, so as not to interfere with the release of tamsulosin.
If you take more ANTUNES than you should
If you take more tamsulosin than prescribed, you may experience severe hypotension (reduction in blood
pressure).
If you forget to take ANTUNES
Do not take a double dose to make up for a missed dose. Simply take the next dose at the usual time.
If you stop taking ANTUNES
Always consult your doctor if you are considering stopping the treatment.
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 gets them.
Do not take ANTUNES and contact your doctor immediately if you experience any of the following side effects:

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

• Dizziness
• Ejaculation disorders

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

• Headache
• Awareness of your heartbeat (palpitations)
• Drop in blood pressure when moving from lying down to standing (orthostatic hypotension)
• Nasal congestion (rhinitis)
• Constipation
• Diarrhea
• *Nausea
• Vomiting
• Skin rash
• *Hives
• Feeling of weakness (asthenia)
• Itching

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

• Sudden swelling of the lips, face, tongue or throat which may cause difficulty breathing and/or itching, rash, due to an allergic reaction (angioedema)
• Fainting (syncope)

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

• Pain during erection (priapism)
• Severe skin and/or mucous membrane reaction caused by the medicine (Stevens-Johnson syndrome)

Side effects not known (frequency cannot be estimated from available data)

• Blurred vision
• Visual impairment
• Epistaxis (nosebleed)
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Ejaculation disorder, retrograde ejaculation, failure to ejaculate

During eye surgery due to lens opacity (cataract), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate sufficiently and the iris (the coloured circular part of the eye) may flutter during surgery. For further information, please refer to section 2, Warnings and precautions.

• Irregular abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea)

Reporting of side effects
If you get any side effects, 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ANTUNES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after 'Exp'.
The expiry date refers to the last day of that month.
Store the blisters in the original packaging. Keep the container tightly closed.
Do not dispose of any medicine 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 ANTUNES contains
The active substance is tamsulosin hydrochloride.
Each capsule contains 0.4 mg of tamsulosin.
The other components are: sodium alginate; methylacrylic acid-ethyl acrylate copolymer (1:1); glyceryl dibehenate; maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simethicone; anhydrous colloidal silica.
The other components of the capsule shell are: gelatin; purified water; red iron oxide (E172); titanium dioxide (E171); yellow iron oxide (E172).

Description of the appearance of ANTUNES and contents of the pack
Modified-release hard capsules.
They are supplied in packs with PVC/Al blister thermoformed strips in printed cardboard boxes, containing 20 capsules.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia
Italy

Manufacturer
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)
Italy