Patient leaflet - Tamsumac 0.4 mg prolonged-release capsules hard
1. What Tamsumac is and what it is used for
The active ingredient in Tamsumac is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra
and aids urination.
In the prostate gland,
bladder and urethra there are specialised cells containing alpha -receptors that cause
1A
the muscles in the urethra to tighten. Tamsumac is an alpha -adrenoceptor blocker, which reduces
1A
the action of these specialised cells and relaxes the muscles making it easier to pass water.
Tamsumac 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 symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.
2. What you need to know before you take Tamsumac
Do not take Tamsumac:
Ÿ If you are allergic (hypersensitive) to
tamsulosin or any of the other ingredients of Tamsumac (listed in section 6).
Ÿ if you have a severe liver condition. Ÿ if you have ever fainted or felt dizzy
when suddenly sitting or standing up. Dizziness can sometimes occur when taking Tamsumac, particularly if you are also taking other alpha - blockers. If you
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do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.
Warnings and precautions
Tamsumac 0.4 mg prolonged release capsules, hard
- 6.
Contents of the pack and other
information
- 5. How to store Tamsumac
- 4. Possible side effects
- 3. How to take Tamsumac
- 2.
What you need to know before you take
Tamsumac
- 1. What Tamsumac is and what it is used for What is in this leaflet
Ÿ 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.
Ÿ 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.
Ÿ If you have any further questions, ask
your doctor or pharmacist.
Ÿ Keep this leaflet. You may need to read it
again
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Package Leaflet: Information for the user
tamsulosin hydrochloride
The recommended dose is 1 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, Tamsumac is prescribed for long periods of time. The effects on the bladder and on urination are maintained during long-term treatment with Tamsumac.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ʻsodium-free’
3. How to take Tamsumac
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Ÿ If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma). Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin. 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 to increased pressure in the eye (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescent under 18 years because it does not work in this population.
Other medicines and Tamsumac
- Taking Tamsumac together with other medicines from the same class (α -1 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 Tamsumac from the body (for example, ketoconazole, erythromycin). Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Tamsumac with food and drink
Tamsumac must be taken after breakfast or the first meal of the day.
Pregnancy, breast-feeding and fertility
Tamsumac is not indicated for use in women.
In men, abnormal ejaculation has been reported (ejaculation
disorder). This means that
semen does not leave the
body via the urethra, but
instead goes into the bladder
(retrograde ejaculation) or
ejaculate volume is reduced
or absent (ejaculatory failure). This phenomenon is harmless.
Driving and using machines
There is no evidence that Tamsumac 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.
If you take more Tamsumac than you should
Taking too much Tamsumac 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 Tamsumac.
If you forget to take Tamsumac
You may take your daily Tamsumac later the same day if you have forgotten to take it as recommended. If you have missed a day, just Ÿ Blurred vision or impaired vision Ÿ Nose bleeds
Ÿ Dry mouth
Ÿ Serious skin rashes (erythema
multiforme, dermatitis exfoliative) Ÿ Abnormal irregular heart rhythm (atrial
fibrillation, arrhythmia, tachycardia), Ÿ Difficult breathing (dyspnoea). Ÿ If you are undergoing eye surgery because
of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) and are already taking or have previously taken Tamsumac, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.
continue to take your daily capsule as prescribed. Never take a double dose to make up for a forgotten capsule.
If you stop taking Tamsumac
When treatment with Tamsumac is stopped prematurely, your original complaints may return. Therefore take Tamsumac 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 (may affect up to 1 in 10 people) Ÿ Dizziness, particularly when going to sit
or stand up.
Ÿ 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 ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.
Uncommon (may affect up to 1 in 100 people)
Ÿ Headache Palpitations (the heart beats
more rapidly than
normal and it is also noticeable)
Ÿ Reduced blood pressure
e.g. when getting up quickly from a seating or lying position sometimes associated with dizziness.
Ÿ Runny or blocked nose (rhinitis). Ÿ Diarrhoea.
Ÿ Feeling sick and vomiting.
Ÿ Constipation.
Ÿ Weakness (asthenia).
Ÿ Rashes, itching and hives (urticaria).
Rare (may affect upto 1 in 1,000 people) Ÿ Faintiness 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 (may affect up to 1 in 10,000 people)
Ÿ Priapism (painful prolonged unwanted
erection for which immediate medical treatment is required).
Ÿ 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 from the available data)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 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 Tamsumac
Keep this medicine out of the sight and reach of children
Tamsumac does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the blister pack and on the carton after EXP. 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 Tamsumac contains
Ÿ The active substance is tamsulosin hydrochloride.
Ÿ The other ingredients
are Polysorbate 80,
Methacrylic acid
copolymer dispersion,
Triacetin, Sodium lauryl
sulfate, Purified water,
Microcrystalline cellulose and Calcium stearate. These all help to make the granules which are in the capsule Ÿ The capsule shell contains FD & C Blue 2
(E 132), Iron oxide black (E 172), Iron oxide red (E 172), Iron oxide yellow (E 172), Titanium dioxide (E 171), Gelatin, Purified water, Sodium lauryl sulfate; Printing ink is Shellac (E904), Dehydrated alcohol, Isopropyl alcohol, Butyl alcohol, Propylene glycol, Strong ammonia solution, Black iron oxide (E172), Potassium hydroxide and Purified water.
What Tamsumac looks like and contents of the pack
Tamsumac capsules are Olive green opaque / Orange opaque, Size "2", hard gelatin capsules, containing free flowing white to off white spheroids with "CL 23" on cap and "0.4" on the body imprinted with black ink.
The capsules are packaged in Clear PVC/PE/PVdC – Aluminium Blister.
The capsules are supplied in blister packs of 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue, Wynyard, Billingham, TS22 5TB
United Kingdom
PL 34771/0170