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Document: leaflet ASPIRE PHARMA_PL 14048-0250 change

• leaflet ASPIRE PHARMA_PL 14048-0250
• leaflet MAH BRAND_PL 14048-0250

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Package leaflet: Information for the user

Losinate MR 400 microgram modified-release capsule, hard

Tamsulosin hydrochloride

In this leaflet:

1.    What Losinate MR is and what it is used for

2.    What you need to know before you take Losinate MR

3.    How to take Losinate MR

4.    Possible side effects

5.    How to store Losinate MR

6.    Contents of the pack and other information

1.    What Losinate MR is and what it is used for

Losinate MR is an alpha1A-adrenoreceptor blocker.

It relaxes the muscles in the prostate and urinary tract.

Tamsulosin is prescribed to alleviate urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia).

By relaxing the muscle, it enables easier passage of urine and helps urination.

2.    What you need to know before you take Losinate MR

Do not take Losinate MR if you:

•    are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (symptoms may include: swelling of your face and throat (angio-oedema)).

•    have a history of a fall in blood pressure on standing up, which causes dizziness, lightheadedness or fainting.

•    have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losinate MR

•    if you experience dizziness or light-headedness,

especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms have gone.

•    if you suffer from severe kidney problems.

The normal dose of tamsulosin may not have the expected effect when your kidneys are not functioning normally.

•    if you are undergoing eye surgery because of cloudiness of the lens (cataract). An eye condition called Intraoperative Floppy Iris Syndrome may occur (see section 4, Possible side effects), please inform your eye specialist that you are using or have previously used tamsulosin hydrochloride.

The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used.

Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure of the eye (glaucoma).

Before starting therapy with Losinate MR, your doctor should examine you to confirm your symptoms are truly caused by an enlarged prostate.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years because it does not work in this population.

Other medicines and Losinate MR

Other medicines may be affected by tamsulosin.

They, in turn, may affect how well tamsulosin works. Tamsulosin can interact with:

•    diclofenac, a pain killer and anti-inflammatory medicine. This medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin is effective.

•    warfarin, a medicine to prevent blood clotting.

This medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin is effective.

•    another ^-adrenoreceptor blocker.

The combination may lower your blood pressure, causing dizziness or light-headedness.

•    ketoconazole, a medicine to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

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

Losinate MR with food and drink

You should take tamsulosin with a glass of water after breakfast or after your first meal of the day.

Pregnancy, breast-feeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Driving and using machines

There is no information on the effects of tamsulosin on the ability to drive and use machines. You should take into account that tamsulosin may cause dizziness and light-headedness. Only drive or use machines if you feel alright.

3.    How to take Losinate MR

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one capsule per day taken after breakfast or after your first meal of the day.

Swallow the capsule whole with a glass of water, while standing or sitting (not while lying down).

It is important that you do not break or crush the capsule as this may influence how well tamsulosin works.

If you suffer from mild to moderate kidney or liver disease, you can take the usual dose of tamsulosin.

If you take more Losinate MR than you should

Your blood pressure may suddenly drop if you take more tamsulosin than you should. You may experience dizziness, weakness and fainting, vomiting and diarrhoea. Lie down to minimise the effects of low blood pressure and then contact your doctor. Your doctor may give you medicines to restore your blood pressure and fluid level, and may monitor your body function. When necessary your doctor may empty your stomach and give you a laxative to remove any tamsulosin not yet taken up in the blood from your body.

If you forget to take Losinate MR

Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time.

If you stop taking Losinate MR

When treatment with tamsulosin is stopped prematurely, your original complaints may return. Therefore use tamsulosin as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy.

If you have any further questions on 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 everybody gets them.

Serious reactions are rare. Contact your doctor immediately if you experience a serious allergic reaction which causes swelling of the face or throat (angio-oedema). You should not be restarted on Losinate MR (see Section 2, Do not take Losinate MR).

Common side effects

(may affect up to 1 in 10 people)

•    Dizziness, particularly when going to sit or stand up

•    Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon side effects

(may affect up to 1 in 100 people)

•    Headache

•    Feeling your heart beat (palpitations)

•    A fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting (orthostatic hypotension)

•    Swelling and irritation inside the nose (rhinitis)

•    Constipation

•    Diarrhoea

•    Feeling sick (nausea)

•    Vomiting

•    Rash

•    Hives (urticaria)

•    Feeling of weakness (asthenia)

•    Itching

Rare side effects

(may affect up to 1 in 1000 people)

•    Fainting (syncope)

Very rare side effects

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

•    Painful erection (priapism)

•    Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

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

•    Blurred vision

•    Vision loss

•    Nose bleeds (epistaxis)

•    Dry mouth

•    Serious skin rashes (erythema multiforme, dermatitis exfoliative)

•    Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea)

During eye surgery, because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) a condition called 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 surgery.

For more information see Section 2, Warnings and precautions.

Reporting of side effects

If you get other side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via The Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard).

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Losinate MR

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 carton and the blister or container after ‘EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

Store the blisters in the original package.

Keep the container tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Losinate MR contains

•    The active substance is tamsulosin hydrochloride 0.4mg.

•    The other ingredients are:

Capsule: Microcrystalline cellulose, Methacrylic acid-ethyl acrylate copolymer, Polysorbate 80, Sodium laurilsulfate, Triethyl citrate, Talc

Capsule body: Gelatine, Indigotine (E 132), Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E 172), Black iron oxide (E 172)

What Losinate MR looks like and contents of the pack Orange/olive-green modified-release capsule (19.3 x 6.4mm).

The capsules contain white to off-white pellets.

They are supplied in blister packs or containers with 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 and Manufacturer Marketing Authorisation Holder:

Synthon BV,

Microweg 22,

6545 CM Nijmegen,

Netherlands

Manufacturer(s):

Synthon BV,

Microweg 22,

6545 CM Nijmegen,

Netherlands

or

Synthon Hispania S.L.,

Castello,

Polfgono las Salinas,

08830 Sant Boi de Llobregat,

Spain

Distributor:

Aspire Pharma Limited,

Bellamy House,

Winton Road,

Petersfield,

Hampshire,

GU32 3HA,

United Kingdom.

This leaflet was last revised in

04/2016

ASPIRE'

1010097-P9.3    Pharma