CONTIFLO XL 400 MICROGRAMS CAPSULES
Active substance(s): TAMSULOSIN HYDROCHLORIDE
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Package leaflet: Information for the user
Contiflo XL 400 micrograms capsules
Tamsulosin Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, 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 to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Contiflo XL is and what it is used for
2. What you need to know before you take Contiflo XL
3. How to take Contiflo XL
4. Possible side effects
5. How to store Contiflo XL
6. Contents of the pack and other information
1. What Contiflo XL is and what it is used for
The active ingredient in Contiflo XL is tamsulosin. This is a selective α1A/1D-adrenoceptor antagonist. It
reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more
readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge.
Contiflo XL is used in men for the treatment of the complaints of the lower urinary tract associated
with an enlarged prostatic gland (benign prostatic hyperplasia) These complaints may include
difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well
as during the day.
2. What you need to know before you take Contiflo XL
Do not take Contiflo XL:
- if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine
(listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the
body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).
- if you suffer from severe liver problems.
- if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or
stand up).
Warnings and precautions
Talk to your doctor or pharmacist before taking Contiflo XL.
- Periodic medical examinations are necessary to monitor the development of the condition you are
being treated for.
- Rarely, fainting can occur during the use of Contiflo XL as with other medicinal products of this
type.
At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.
- if you suffer from severe kidney problems, tell your doctor.
- if you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens
(cataract), please inform your eye specialist that you have previously used, are using , or are
planning to use Contiflo XL. 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.
Children
Do not give this medicine to children or adolescent under 18 years because it does not work in this
population.
Other medicines and Contiflo XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Taking Contiflo XL together with other medicines from the same class (α1-adrenoceptor
antagonists) may cause an unwanted decrease in blood pressure.
It is especially important to inform your doctor if you are being treated at the same time with
medicines that may decrease the removal of Contiflo XL from the body (for example, ketoconazole,
erythromycin).
Contiflo XL with food, drink or alcohol
Contiflo XL must be taken after breakfast or the first meal of the day.
Pregnancy, breast-feeding and fertility
This section is not relevant, because Contiflo XL is not indicated for use in women.
Impaired sexual functions in males have been reported with Contiflo XL.
If you stop taking Contiflo XL
When treatment with Contiflo XL is stopped prematurely, your original complaints may return.
Therefore use Contiflo XL 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.
Common (less than 1 in 10, more than 1 in 100 (1-10%)):
Dizziness, particularly when going to sit or stand up.
Ejaculation disorders.
Retrograde ejaculation; this means that semen does not leave the body via the urethra, but instead
goes into the bladder. This phenomenon is harmless.
Ejaculation failure.
Uncommon (more than 1 in 1000, less than 1 in 100 (0,1-1%)):
Headache, palpitations (the heart beats more rapidly than normal and it is also noticeable), reduced
blood pressure e.g. when getting up quickly from a seating or lying position sometimes associated
with dizziness; runny or blocked nose (rhinitis), diarrhoea, feeling sick and vomiting, constipation,
weakness (asthenia), rashes, itching and hives (urticaria).
Rare (more than 1 in 10,000, less than 1 in 1000 (0,01-0,1%)):
Faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult
breathing and / or itching and rash, often as an allergic reaction (angioedema).
Very rare (less than 1 in 10,000 (<0,01%):
Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth,
nasal passages or genitals (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated based on available data)
Vision blurred, visual impairment
Nose bleed
Severe condition of the skin that may affect the mouth and other parts of the body
Skin disease
Dry mouth
Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing
(dyspnoea).
If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already
taking or have previously taken Contiflo XL, the pupil may dilate poorly and the iris (the coloured
circular part of the eye) may become floppy during the procedure.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: 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 Contiflo XL
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Contiflo XL contains
The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400
micrograms of tamsulosin hydrochloride.
The other ingredients are: capsule contents: cellulose microcrystalline PH101, magnesium
stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin,
titanium dioxide (E171), purified talc.
Capsule body: gelatine, sunset yellow, ponceau 4R (E124), quinoline yellow (E104), brilliant blue
(E133), titanium dioxide (E171).
Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122),
titanium dioxide (E171).
Printing ink: shellac, black Iron oxide (E172), potassium Hydroxide.
What Contiflo XL looks like and contents of the pack
3. How to take Contiflo XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The dosage is one capsule per day to be taken after breakfast or the first meal of
each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Contiflo
XL is prescribed for long periods of time. The effects on the bladder and on urination are maintained
during long-term treatment with Contiflo XL.
If you take more Contiflo XL than you should
Taking too many capsules of Contiflo XL may lead to an unwanted decrease in blood pressure and an
increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken
too much Contiflo XL.
If you forget to take Contiflo XL
You may take your daily Contiflo XL later the same day if you have forgotten to take it as
recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Do
not take a double dose to make up for a forgotten capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia, S.A.
124, Fabricii Street, Zip Code 400632,
Cluj Napoca, Cluj
Romania
This leaflet was last revised in September 2016
5132261 - LIT CONTIFLO XL CAP 400 MCG, MARKET : UK-R, Size : 140 x 420 mm (SINGLE FOLD), SPIL-DWS : 03.09.16vs,
OLD CODE : 5119439, ITF CODE : 05132261
Color : 286 U / Black
Swis721 Cn BT-9pt
Contiflo XL contains sunset yellow, azorubine and ponceau 4R
Allergic reactions may occur due to the presence of colouring agents used in this product: sunset
yellow (E110), azorubine (E122) and ponceau 4R (E124).
Contiflo XL 400 micrograms prolonged release capsules comprise of Brown cap/Orange body of
size '2´ imprinted with 'R' on cap and ´TSN400' on body in black edible ink containing white to offwhite granules.
Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules.
5132261
Driving and using machines
There is no evidence that Contiflo XL affects the ability to drive or to operate machinery or equipment.
However, you should bear in mind that dizziness can occur, in which case you should not undertake
activities that require attentiveness.
Contiflo XL 400 micrograms capsules
Tamsulosin Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, 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 to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Contiflo XL is and what it is used for
2. What you need to know before you take Contiflo XL
3. How to take Contiflo XL
4. Possible side effects
5. How to store Contiflo XL
6. Contents of the pack and other information
1. What Contiflo XL is and what it is used for
The active ingredient in Contiflo XL is tamsulosin. This is a selective α1A/1D-adrenoceptor antagonist. It
reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more
readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge.
Contiflo XL is used in men for the treatment of the complaints of the lower urinary tract associated
with an enlarged prostatic gland (benign prostatic hyperplasia) These complaints may include
difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well
as during the day.
2. What you need to know before you take Contiflo XL
Do not take Contiflo XL:
- if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine
(listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the
body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).
- if you suffer from severe liver problems.
- if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or
stand up).
Warnings and precautions
Talk to your doctor or pharmacist before taking Contiflo XL.
- Periodic medical examinations are necessary to monitor the development of the condition you are
being treated for.
- Rarely, fainting can occur during the use of Contiflo XL as with other medicinal products of this
type.
At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.
- if you suffer from severe kidney problems, tell your doctor.
- if you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens
(cataract), please inform your eye specialist that you have previously used, are using , or are
planning to use Contiflo XL. 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.
Children
Do not give this medicine to children or adolescent under 18 years because it does not work in this
population.
Other medicines and Contiflo XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Taking Contiflo XL together with other medicines from the same class (α1-adrenoceptor
antagonists) may cause an unwanted decrease in blood pressure.
It is especially important to inform your doctor if you are being treated at the same time with
medicines that may decrease the removal of Contiflo XL from the body (for example, ketoconazole,
erythromycin).
Contiflo XL with food, drink or alcohol
Contiflo XL must be taken after breakfast or the first meal of the day.
Pregnancy, breast-feeding and fertility
This section is not relevant, because Contiflo XL is not indicated for use in women.
Impaired sexual functions in males have been reported with Contiflo XL.
If you stop taking Contiflo XL
When treatment with Contiflo XL is stopped prematurely, your original complaints may return.
Therefore use Contiflo XL 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.
Common (less than 1 in 10, more than 1 in 100 (1-10%)):
Dizziness, particularly when going to sit or stand up.
Ejaculation disorders.
Retrograde ejaculation; this means that semen does not leave the body via the urethra, but instead
goes into the bladder. This phenomenon is harmless.
Ejaculation failure.
Uncommon (more than 1 in 1000, less than 1 in 100 (0,1-1%)):
Headache, palpitations (the heart beats more rapidly than normal and it is also noticeable), reduced
blood pressure e.g. when getting up quickly from a seating or lying position sometimes associated
with dizziness; runny or blocked nose (rhinitis), diarrhoea, feeling sick and vomiting, constipation,
weakness (asthenia), rashes, itching and hives (urticaria).
Rare (more than 1 in 10,000, less than 1 in 1000 (0,01-0,1%)):
Faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult
breathing and / or itching and rash, often as an allergic reaction (angioedema).
Very rare (less than 1 in 10,000 (<0,01%):
Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth,
nasal passages or genitals (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated based on available data)
Vision blurred, visual impairment
Nose bleed
Severe condition of the skin that may affect the mouth and other parts of the body
Skin disease
Dry mouth
Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing
(dyspnoea).
If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already
taking or have previously taken Contiflo XL, the pupil may dilate poorly and the iris (the coloured
circular part of the eye) may become floppy during the procedure.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: 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 Contiflo XL
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Contiflo XL contains
The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400
micrograms of tamsulosin hydrochloride.
The other ingredients are: capsule contents: cellulose microcrystalline PH101, magnesium
stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin,
titanium dioxide (E171), purified talc.
Capsule body: gelatine, sunset yellow, ponceau 4R (E124), quinoline yellow (E104), brilliant blue
(E133), titanium dioxide (E171).
Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122),
titanium dioxide (E171).
Printing ink: shellac, black Iron oxide (E172), potassium Hydroxide.
What Contiflo XL looks like and contents of the pack
3. How to take Contiflo XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The dosage is one capsule per day to be taken after breakfast or the first meal of
each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Contiflo
XL is prescribed for long periods of time. The effects on the bladder and on urination are maintained
during long-term treatment with Contiflo XL.
If you take more Contiflo XL than you should
Taking too many capsules of Contiflo XL may lead to an unwanted decrease in blood pressure and an
increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken
too much Contiflo XL.
If you forget to take Contiflo XL
You may take your daily Contiflo XL later the same day if you have forgotten to take it as
recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Do
not take a double dose to make up for a forgotten capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia, S.A.
124, Fabricii Street, Zip Code 400632,
Cluj Napoca, Cluj
Romania
This leaflet was last revised in September 2016
5132261 - LIT CONTIFLO XL CAP 400 MCG, MARKET : UK-R, Size : 140 x 420 mm (SINGLE FOLD), SPIL-DWS : 03.09.16vs,
OLD CODE : 5119439, ITF CODE : 05132261
Color : 286 U / Black
Swis721 Cn BT-9pt
Contiflo XL contains sunset yellow, azorubine and ponceau 4R
Allergic reactions may occur due to the presence of colouring agents used in this product: sunset
yellow (E110), azorubine (E122) and ponceau 4R (E124).
Contiflo XL 400 micrograms prolonged release capsules comprise of Brown cap/Orange body of
size '2´ imprinted with 'R' on cap and ´TSN400' on body in black edible ink containing white to offwhite granules.
Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules.
5132261
Driving and using machines
There is no evidence that Contiflo XL affects the ability to drive or to operate machinery or equipment.
However, you should bear in mind that dizziness can occur, in which case you should not undertake
activities that require attentiveness.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
