Tamsulosin Mylan Generics

Patient Information Leaflet

Tamsulosin Mylan Generics

0.4 mg modified-release hard capsules
(Tamsulosine hydrochloride)
Equivalent 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 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 Tamsulosin Mylan Generics is and what it is used for
2. What you need to know before taking Tamsulosin Mylan Generics
3. How to take Tamsulosin Mylan Generics
4. Possible side effects
5. How to store Tamsulosin Mylan Generics
6. Contents of the pack and other information

1. What Tamsulosin Mylan Generics is and what it is used for
Tamsulosin Mylan Generics contains the active substance tamsulosine hydrochloride, which belongs to a group of medicines called alpha-adrenoreceptor antagonists (alpha-blockers). These medicines are used to reduce muscle contraction in the prostate and urethra. This facilitates the flow of urine through the urethra and helps urination.
Tamsulosin Mylan Generics is used for the treatment of lower urinary tract symptoms due to benign prostatic enlargement, known as benign prostatic hyperplasia (BPH).

2. What you should know before taking Tamsulosin Mylan Generics

Do not take Tamsulosin Mylan Generics:

• if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Allergic reaction to tamsulosin may present as sudden swelling of the hands or feet, difficulty in breathing and/or itching and skin rash, swelling of the lips, tongue or throat (angioedema).
• if you have suffered from dizziness or have lost consciousness due to low blood pressure (e.g. when sitting down or standing up suddenly).
• if you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosin Mylan Generics:

• if you have severe kidney problems.
• if you are scheduled to undergo or are about to undergo eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma).

A condition called "intraoperative floppy iris syndrome" may occur (see section 4, "Possible side effects"). Inform your ophthalmologist if you have previously taken, are currently taking, or plan to take tamsulosin. The specialist may therefore take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with tamsulosin before undergoing eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma).

During treatment
Inform your doctor or pharmacist:

• if you experience dizziness or fainting while using tamsulosin. If these signs of orthostatic hypotension occur, please sit or lie down immediately until symptoms subside.
• if you experience sudden swelling of the hands or feet, swelling of the lips, tongue or throat, difficulty breathing and/or itching and skin rash due to an allergic reaction (angioedema) while using tamsulosin.

You must undergo a medical examination of the prostate or urinary system before taking Tamsulosin Mylan Generics and subsequently at regular intervals.

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

Other medicines and Tamsulosin Mylan Generics
Inform your doctor if you are taking, have recently taken or might take any other medicines.

• Tamsulosin may lower blood pressure if taken together with other alpha-blockers, such as doxazosin, prazosin and indoramin.
• Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting) may affect how quickly tamsulosin is removed from the body.
• Medicines that lower blood pressure, such as verapamil and diltiazem.
• Medicines used to suppress your immune system, such as cyclosporine.
• Antibiotics used to treat infections, such as erythromycin, clarithromycin.
• Medicines used to treat fungal infections, e.g. ketoconazole, itraconazole, fluconazole, voriconazole.
• Medicines used to treat HIV, such as ritonavir, saquinavir.

Please bear in mind that these considerations may also apply to products used in the past or which may be used in the future.

Pregnancy, breastfeeding and fertility
Tamsulosin is not indicated for use in women.
Tamsulosin may cause ejaculation disorders, including ejaculation of semen into the bladder (retrograde ejaculation) and inability to ejaculate (failure to ejaculate).

Driving and use of machines
No studies have been conducted on the effects of tamsulosin on the ability to drive vehicles or operate machinery. However, patients should be warned about the possibility of experiencing dizziness.

3. How to take Tamsulosin Mylan Generics

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 capsule daily, taken after breakfast or the first meal of the day.
The capsule must be swallowed whole.
The capsule must not be crushed or chewed, as this would affect the absorption of the medicine into the body.

If you take more Tamsulosin Mylan Generics than you should
If you have taken more Tamsulosin Mylan Generics than you should, contact your doctor or pharmacist immediately. Symptoms of hypotension may occur, such as dizziness, vertigo, fainting, blurred vision, irregular heartbeat, confusion, or weakness. If any of these symptoms occur, you should sit or lie down.

If you forget to take Tamsulosin Mylan Generics
If you have forgotten to take tamsulosin after the first meal of the day, take it later on the same day after having eaten something. If the day has already passed, simply continue taking your daily capsule as prescribed.
Do not take a double dose to make up for a forgotten capsule.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects:
If you experience any of the following symptoms, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department:
Rare (may affect up to 1 in 1,000 people):

• sudden swelling of the hands or feet, difficulty breathing and/or itching and skin rash, swelling of the lips, tongue or throat (angioedema).

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

• severe widespread skin rash with blisters, peeling of the skin, and bleeding from the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome).
  Not known (frequency cannot be estimated from the available data):
• irregular and abnormally rapid heartbeat (atrial fibrillation)

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

• dizziness,
• ejaculation disorders including inability to ejaculate and ejaculation of semen into the bladder (retrograde ejaculation)

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

• headache,
• an abnormal sensation of heartbeat (palpitations),
• dizziness, especially when sitting down or standing up suddenly (orthostatic hypotension),
• runny or blocked nose (rhinitis),
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• skin rash,
• itching,
• feeling of weakness (asthenia).

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

• fainting.

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

• painful, prolonged, involuntary erection (priapism).

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

• widespread skin inflammation with light red spots with a clear central area, known as erythema multiforme,
• abnormal heart rhythm (arrhythmia),
• increased heart rate (tachycardia),
• shortness of breath (dyspnoea),
• blurred or reduced vision (visual disturbance),
• nosebleed,
• scaly skin rashes (exfoliative dermatitis),
• dry mouth.

In some cases, possible complications have been observed after cataract or glaucoma surgery. During surgery, a condition called "Intraoperative Floppy Iris Syndrome" (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. For further information, see section 2 "Warnings and precautions".
Reporting of suspected adverse reactions
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 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 Tamsulosin Mylan Generics

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Keep the container tightly closed.
Do not use this medicine after the expiry date stated on the label and the box after (EXP).
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Tamsulosin Mylan Generics contains:
The active substance is tamsulosin hydrochloride.
Each modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.
The other excipients are: microcrystalline cellulose, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate and talc.
The capsule body contains gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Tamsulosin Mylan Generics and contents of the pack
Tamsulosin Mylan Generics modified-release capsules have an orange body and olive green cap. The capsules contain granules that are white to off-white in colour.
Blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 or multiple packs of 200 (comprising 2 boxes of 100) modified-release capsules are available, or containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milano, Italy

Manufacturer responsible for batch release:
Synthon Hispania S.L., Castellò 1, Poligono las Salinas - 08830 Sant Boi de Llobregat – Spain
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate - Grange Road, Dublin 13 – Ireland
Generics UK Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komárom, Mylan út. 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Tamsulosin Arcana retard 0.4 mg - Kapseln
Belgium: Tamsulosine Mylan 0.4 mg capsules met gereguleerde afgifte, hard
Finland: Tamsulogen 0.4 mg Säädellysti vapauttava kapseli, kova
Germany: Tamsulosin-dura 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Greece: Tamsulosin/ Mylan καψάκιο ελεγχόμενης αποδέσμευσης, σκληρό 0.4 mg/CAP
Ireland: Tamsulosin 400 micrograms Modified-Release Capsules
Iceland: Tamsulosin Mylan 0.4 mg hylki með breyttan losunarhraða, hörð
Italy: Tamsulosin Mylan Generics
Norway: Tamsulosin Mylan 0.4 mg kapsler med modifisert frisetting, harde
Netherlands: Tamsulosine HCL Retard Mylan 0.4 mg, harde capsules met gereguleerde afgifte
Poland: TAMSUGEN 0.4 mg kapsułki o zmodyfikowanym uwalnianiu, twarde
Portugal: Tansulosina Mylan
United Kingdom: Prosurin XL 400 microgram Capsules
Czech Republic: Tamsulosin HCI Mylan 0.4 mg, tvrdé tobolky s řízeným uvolňováním
Slovakia: Tamsulosin HCI Mylan 0.4 mg
Spain: Tamsulosina Mylan 0.4 mg cápsulas duras de liberación modificada EFG
Hungary: Tamsugen 0.4 retard kemény kapszula

This leaflet was last revised in