Tamsulosin Eg

Package leaflet: Information for the patient

Tamsulosin EG 0.4 mg modified-release hard capsules

Equivalent medicine
Please read all of 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Tamsulosin EG 0.4 mg is and what it is used for
2. What you need to know before taking Tamsulosin EG 0.4 mg
3. How to take Tamsulosin EG 0.4 mg
4. Possible side effects
5. How to store Tamsulosin EG 0.4 mg
6. Contents of the pack and other information

1. What Tamsulosin EG 0.4 mg is and what it is used for

Tamsulosin is an alpha1A-adrenergic receptor blocker. It relaxes the smooth muscle in the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the smooth muscle, it facilitates urine flow through the urethra and improves urination.

2. What you need to know before taking Tamsulosina EG 0.4 mg

Do NOT take Tamsulosina EG 0.4 mg if:

• you are allergic to tamsulosin or to any of the other ingredients of this medicine listed in section 6 (symptoms may include swelling of the face and throat (angioedema)).
• you have a history of low blood pressure upon standing up, causing dizziness, lightheadedness, or fainting.
• you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsulosina EG 0.4 mg if:

• you experience dizziness or lightheadedness, especially when standing up. Tamsulosina EG 0.4 mg may cause a drop in blood pressure, leading to these symptoms. Sit or lie down until symptoms subside.
• you have severe kidney problems. In case of renal dysfunction, the standard dose of Tamsulosina EG 0.4 mg may not produce the expected effect.
• you develop swelling of the face or throat. These are symptoms of angioedema (see section 2 Do NOT take Tamsulosina EG 0.4 mg). Immediately stop treatment with tamsulosin and consult your doctor. You must not be treated with tamsulosin again.
• you are about to undergo cataract surgery (loss of vision, especially concerning blue colours) or glaucoma surgery (increased eye pressure). During surgery, a condition known as intraoperative floppy iris syndrome (IFIS) may occur if you are currently being treated or have previously been treated with tamsulosin. IFIS may lead to complications during surgery. It is recommended that tamsulosin be discontinued 1–2 weeks prior to surgery. Contact your doctor or surgeon before surgery to discuss your case.

Children
Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosina EG 0.4 mg
Tamsulosin may affect the action of other medicines, and other medicines may affect how tamsulosin works. Tamsulosin may interact with:

• diclofenac, a painkiller and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from your body, thereby shortening the duration of tamsulosin’s effectiveness.
• warfarin, used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from your body, thereby shortening the duration of tamsulosin’s effectiveness.
• medicines used to lower blood pressure, such as verapamil and diltiazem.
• medicines used to treat HIV, such as ritonavir or indinavir.
• medicines used to treat fungal infections, such as ketoconazole or itraconazole.
• another alpha-adrenergic receptor blocker such as doxazosin, indoramin, prazosin or alfuzosin.
  Combination may cause a drop in blood pressure, leading to dizziness or feeling faint.
• erythromycin, an antibiotic used to treat infections.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tamsulosina EG 0.4 mg with food and drink
Take tamsulosin with a glass of water after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
Tamsulosina EG 0.4 mg is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This event is not harmful.

Driving and using machines
There is no information available regarding the effects of tamsulosin on the ability to drive vehicles or operate machinery. Bear in mind that tamsulosin may cause dizziness and a sensation of lightheadedness. Only drive or operate machinery if you feel completely well.

Tamsulosina EG 0.4 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Tamsulosin EG 0.4 mg

Take this medicine exactly as directed by your doctor. 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.
The capsule should be taken while sitting or standing (not lying down) and must be swallowed whole with a glass of water. It is important that you do not break or crush the capsule, as this could affect the effectiveness of Tamsulosin EG 0.4 mg.

If you take more Tamsulosin EG 0.4 mg than you should
If you take more Tamsulosin EG 0.4 mg than prescribed, your blood pressure may drop suddenly, causing dizziness, weakness, or fainting. Lie down to minimize the effects of low blood pressure and contact your doctor immediately. Your doctor may prescribe medications to restore your blood pressure and monitor your organ function. If necessary, your doctor may empty your stomach and give you a laxative to remove any tamsulosin not yet absorbed into the bloodstream.

If you forget to take Tamsulosin EG 0.4 mg
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time. If you have any questions about the use of 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.

Common (may affect up to 1 in 10 people):

• Dizziness
• Abnormal ejaculation (ejaculation disorders). This means that semen is not expelled through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (incomplete ejaculation). This phenomenon is not dangerous.

Uncommon (may affect up to 1 in 100 people):

• Headache
• Awareness of heartbeat (palpitations)
• Drop in blood pressure upon standing, causing dizziness, feeling lightheaded or fainting (orthostatic hypotension)
• Swelling and irritation inside the nose (rhinitis)
• Constipation
• Diarrhoea
• Feeling unwell (nausea)
• Vomiting
• Skin rash
• Itching (pruritus)
• Hives (urticaria)
• Feeling of weakness (asthenia)

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

• Fainting (syncope)
• Severe allergic reaction causing swelling of the face and throat (angioedema): contact your doctor immediately; you must not be treated with tamsulosin again (see section 2 Do NOT take Tamsulosin EG 0.4 mg).

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

• Painful erection (priapism)
• Serious illness characterised by blisters affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from the available data):

• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Nosebleeds (epistaxis)
• Blurred vision or impaired vision
• A condition involving constriction of the pupil, known as Intraoperative Floppy Iris Syndrome (IFIS), during cataract or glaucoma surgery has been reported in association with tamsulosin therapy in the post-marketing period (see also section 2 Warnings and precautions)
• Dry mouth

Other side effects (reported during the post-marketing period):
Abnormal heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), and shortness of breath (dyspnoea) have been reported in association with the use of tamsulosin, in addition to the side effects listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsulosin EG 0.4 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP". The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
Store the blisters in the original packaging to protect the medicine from moisture.
Keep the container tightly closed to protect the medicine from moisture.
Do not dispose of medicines 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 Tamsulosina EG 0.4 mg contains
The active substance is tamsulosin hydrochloride 0.4 mg.
The other components are:
Capsule: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, sodium
lauryl sulfate, triethyl citrate, talc
Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
Description of the appearance of Tamsulosina EG 0.4 mg and package contents
Modified-release capsule of orange/olive green color. The capsules contain granules ranging in color from white to almost white.
Available in blister packs containing 10, 14, 15, 20, 28, 30, 48, 50, 56, 60, 90, 98, 100 or 200 modified-release capsules, or bottles containing 60 or 250 modified-release capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Manufacturers
Synthon Hispania S.L., Castello, 1 – Poligono Las Salinas – Sant Boi de Llobregat (Spain)
STADA Arzneimittel AG, Stadastr. 2-18 – 61118 Bad Vilbel (Germany)
Cosmo S.p.A., Via C. Colombo, 20045 Lainate - Milan, Italy
Eurogenerics N.V., Heizel Esplanade, Heysel b 22, B-1020 Brussels (Belgium)
Lamp San Prospero S.p.A., Via della Pace, 25/A - 41030 San Prospero – Modena, Italy
This medicinal product is authorized in the European Economic Area countries under the following
names:
Ireland: Tamnic 400 micrograms modified-release capsule, hard
Netherlands: Tamsulosine HCI CF 0.4 mg, capsules met gereguleerde afgifte
Denmark: Omnistad
Estonia: Tamsulosin STADA
Germany: Tamsulosin STADA 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Belgium: Tamsulosine EG 0.4 mg capsules met gereguleerde afgifte, hard
Hungary: Urostad 0.4 mg módosított hatóanyagleadású kémeny kapszula
Austria: Tamsulosin „Stada“ retard 0.4 mg – Kapseln
Spain: Tamsulosina STADA 0.4 mg cápsulas duras de liberación modificada EFG
Italy: Tamsulosina EG 0.4 mg capsule rigide a rilascio modificato
Lithuania: Tamsulosin STADA 0.4 mg modifikuoto atpalaidavimo kietos kapsulės
Luxembourg: Tamsulosine EG 0.4 mg gélules à libération modifiée
Latvia: Tamsulosin STADA 0.4 mg ilgstošās darbības cietās kapsulas
United Kingdom: Tabphyn MR Capsules 400 micrograms