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    Agreement for car sales

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    DK_H_0936_001_FinalPL

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    Agreement for car sales

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    15 views3 pages

    DK H 0936 001 FinalPL

    Uploaded by

    Olumide Frankie Olulana
    Agreement for car sales

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    Package leaflet: Information for the patient

    Prostacure 0.4 mg prolonged-release capsules, hard


    tamsulosin hydrochloride

    Read all of this leaflet carefully before you start using this medicine because it contains
    important information for you.
    - Keep this leaflet. You may need to read it again.
    - If you have further questions, please ask your doctor or pharmacist.
    - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
    even if their signs of illness are the same as yours.
    - If you get any side effects, talk your doctor or pharmacist.This includes any possible side effects
    not listed in this leaflet.

    What is in this leaflet


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

    1. What Prostacure is and what it is used for

    Prostacure is used in the treatment of functional symptoms of benign prostatic hyperplasia, such as
    difficult urination.
    The active ingredient of Prostacure is tamsulosin. Tamsulosin is an alpha 1 -receptor blocker which
    reduces the tension in muscles of prostate and urethra. Thus an easier flow of urine through the urethra
    and urination are facilitated.

    2. What do you need to know before you use Prostacure

    Do not use Prostacure,


    - if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section
    6)
    - if you suffer orthostatic hypotension
    - if you suffer from severe hepatic insufficiency.

    Warnings and precautions


    Talk to your doctor or pharmacist before taking Prostacure
    - if you suffer from orthostatic hypotension (dizziness caused by low blood pressure after sitting
    or standing up)
    - if you take other alpha1-receptor blockers
    - if you from suffer severe renal insufficiency.

    If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye
    specialist before the operation that you are using or have previously used Prostacure. This is because
    Prostacure may cause complications during the surgery which can be managed if your specialist is
    prepared in advance.

    Prostacure with food and drink


    Prostacure should be taken after breakfast or after the first meal of the day with a glass of water.

    Children

    pilen-tamsulosin 0.4 mg -03-2013 1/3


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

    Pregnancy, breast-feeding and fertility

    Prostacure is not indicated for use in woman.


    Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported.

    Driving and using machines


    No data is available on whether tamsulosin adversely affects the ability to drive or operate machines.
    However, in this respect patients should be aware of the fact that Prostacure may cause dizziness

    Other medicines and Prostacure


    Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use
    any other medicines.
    Concomitant use of tamsulosin with other alpha 1 -receptor blockers (prazosin, alfuzosin) may cause
    hypotension. Diclofenac (an anti-inflammatory painkiller) and warfarin (use to thin blood) may effect
    the way that Prostacure is handled by your body.

    3. How to use Prostacure

    Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
    or pharmacist if you are not sure.
    The recommended dose is one capsule per day.

    Prostacure should be taken after breakfast or after the first meal of the day with a glass of water.
    The capsule should be swallowed whole while sitting or standing (not in lying position). The capsule
    should not be broken or chewed as this will interfere with the modified release of the active ingredient.
    The capsule can, however, be opened and the content can be swallowed without chewing.

    If you have the impression that the effect of Prostacure is too strong or too weak, talk to your doctor
    or pharmacist.

    If you take more Prostacure than you should


    If you have taken more Prostacure than the doctor prescribed, contact your doctor or a hospital.

    If you forget to take Prostacure


    If you forget to take the medicine after breakfast, you can take it later the same day. You should skip
    the dose if you do not notice forgetting it until the following day.

    4. Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them. The
    following adverse effects have been reported during the use of Prostacure :

    Common: may affect up to 1 in 10 people


    Dizziness, ejaculation disorders.

    Uncommon: may affect up to 1 in 100 people


    Headache, palpitations, dizziness especially when sitting down or standing up from the lying position,
    rhinitis, gastrointestinal reactions (constipation, diarrhoea, nausea, vomiting), allergic reactions (skin
    rash, pruritus, urticaria), weakness.

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


    Fainting, angioedema.
    pilen-tamsulosin 0.4 mg -03-2013 2/3
    Very rare: may affect up to 1 in 10,000 people
    Stevens-Johnson syndrome, priapism (persistent and painful erection).

    Not known: frequency cannot be estimated from the available data


    Vision blurred, visual impairment, irregular heart beat (atrial fibrillation, arrhytmia), increased hart
    rate (tachycardia), shortness of breath (dyspnoea), nosebleed (epistaxis), inflammation of skin
    (erythema multiforme, dermatitis exfoliative), ejaculation disorder, retrograde ejaculation, ejaculation
    failure.

    If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
    in this leaflet.

    5. How to store Prostacure

    Keep this medicine out of the sight and reach of children.


    Store in the original package.
    Do not store above 30 °C.
    Do not use this medicine after the expiry date which is stated on the blister and on the carton after
    “EXP”.. The expiry date refers to the last day of that month.

    6. Contents of the pack and other information

    What Prostacure contains


    - The active substance is tamsulosin hydrochloride.
    Each prolonged-release capsule contains 0.4 mg of tamsulosin hydrochloride.

    - The other ingredients are


    Capsule contents: sodium alginate, methacrylic acid – ethyl acrylate copolymer (1:1), glycerol
    dibehenate, maltodextrin, sodium laurilsulphate, macrogol 6000, polysorbate 80, sodium
    hydroxide, simeticone emulsion (simeticone, methylcellulose, sorbic acid), colloidal anhydrous
    silica.
    Capsule shell: gelatine, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide
    (E172).

    What Prostacure looks like and contents of the pack


    Orange no 2 gelatin capsule which contains white or yellowish granules
    Prostacure is available in blister packs with 20, 50, 100 capsules.

    Not all pack sizes may be marketed.

    Marketing Authorisation Holder and Manufacturer

    <To be completed nationally>

    <This medicinal product is authorised in the Member States of the EEA under the following
    names:>

    Germany Prostacure 0,4 mg Hartkapseln, retardiert


    Denmark Prostacure 0.4 mg depotkapsler, hard

    This leaflet was last revised in { }.

    pilen-tamsulosin 0.4 mg -03-2013 3/3

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