ANTUNES 0.4 MG Kapsułka twarda o przedłużonym uwalnianiu

Treść ulotki

1. ANTUNES 0.4 mg modified-release hard capsules
   1. What is ANTUNES and what is it 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

ANTUNES 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before using 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 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 you take 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 is ANTUNES and what is it used for

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

2. What you need to know before taking ANTUNES

Do not take ANTUNES if:

• you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• you suffer from low blood pressure when changing from a lying to an upright 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 can lower blood pressure, causing these symptoms. In this case, you should sit or lie down until the symptoms disappear;
• If you suffer from severe kidney problems;
• If you are going to undergo surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma). A condition affecting the eyes called iris flag syndrome may occur (see section 4, Possible side effects); Inform your ophthalmologist if you are using or have used tamsulosin hydrochloride in the past. In this case, the specialist may take appropriate precautions regarding the medication and surgical techniques to be applied. Ask your doctor if you should postpone or temporarily interrupt taking this medicine before undergoing surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma).

Children and Adolescents
ANTUNES is not indicated in children or adolescents under 18 years of age.

Other medicines and ANTUNES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tamsulosin can affect the action of other medicines and these, in turn, can affect the action
of tamsulosin. Therefore, it is important to inform your doctor if you are taking:

• cimetidine, used for stomach problems;
• furosemide, used to increase urine production;
• ketoconazole, used for fungal infections (infections caused by fungi);
• paroxetine, used for depression
• warfarin, used to delay blood clotting
• diclofenac, an anti-inflammatory. Taking ANTUNES with other medicines belonging to the same class (alpha 1 adrenergic receptor antagonists) may cause a decrease in blood pressure.

ANTUNES with food and drink
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 in women.
In men, abnormalities in ejaculation (ejaculation disorders) have been reported. This means that the
semen does not come out through the urethra but through the bladder (retrograde ejaculation) or that the volume
of ejaculate is reduced or absent (insufficient ejaculation).

Driving and using machines
Studies on the ability to drive and use machines have not been conducted. You should consider that this medicine may cause dizziness, therefore drive or use machines only if you
feel well.

ANTUNES contains sodium.
ANTUNES contains 1.1 mg of sodium per capsule. L take this into account if you are following a diet
controlled for sodium content.

3. How to take ANTUNES

Take this medicine following always exactly the instructions of the doctor or pharmacist. If you have
doubts consult the doctor or pharmacist.
The recommended doseis one capsule a day to be taken after breakfast or after the first
meal of the day.
Swallow the capsule whole.
It is important that you do not break or crush the capsule, in order not to interfere with the release of tamsulosin.

If you take more ANTUNES than you should
If you take more tamsulosin than you should you may have severe hypotension (reduction of 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 think of stopping the therapy.
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 everyone gets them.
Do not take ANTUNES and contact your doctor immediately if you experience the following 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
• Feeling of being aware of the heartbeat (palpitations)
• Lowering of blood pressure when moving from a horizontal to an upright position (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):
• Sudden swelling of the lips, face, tongue or throat which can 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)

• Pain during erection (priapism).
• Severe skin and/or mucous membrane reaction induced by the drug (Stevens-Johnson Syndrome). Side effects not known (frequency cannot be estimated based on available data)
• Blurred vision
• Impaired vision
• Epistaxis (nosebleed)
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Ejaculation disorder, retrograde ejaculation, absent ejaculation During an ophthalmic surgical intervention due to opacification of the lens (cataract) a condition called Iris Flag Syndrome (IFIS) may occur: the pupil may dilate insufficiently and the iris (the colored circular part of the eye) may undulate during the procedure. For further information, see section 2, Warnings and precautions
• Abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia). shortness of breath (dyspnea) Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.qov.itfit/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 which is 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 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 ANTUNES contains
The active ingredient is tamsulosin hydrochloride.
Each capsule contains 0.4 mg of tamsulosin.
The other ingredients are: sodium alginate; methylacrylic acid-ethyl acrylate copolymer (1:1); Glycerol dibehenate; maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simethicone; colloidal anhydrous 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 blister packs of thermo-sealed PVC/Al, in lithographed cardboard boxes, 20 capsules.

Marketing Authorisation 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