Patient leaflet - Tamsulosin Ascend 400 mcg modified-release capsule, hard

1. What Tamsulosin Ascend is and what it is used for

The active ingredient in Tamsulosin Ascend is tamsulosin hydrochloride. This is a selective α 1A/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

Tamsulosin 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. Before you take Tamsulosin Ascend

Do not take Tamsulosin Ascend

if you are allergic (hypersensitive) to tamsulosin
hydrochloride or to any of the other ingredients in this medicine.
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 Tamsulosin Ascend

because periodic medical examinations are necessary to
monitor the development of the condition you are being treated for.
because rarely, fainting can occur during the use of this
medicine, 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.
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 this medicine. 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 in the eye (glaucoma).
Children
Do not give this medicine to children or adolescent under 18 years because it does not work in this population.
Other medicines and Tamsulosin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking tamsulosin together with other medicines from the same class (alpha1-adrenoceptor blockers) 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 this medicine from the body (for example, ketoconazole, erythromycin).
Taking Tamsulosin Ascend with food and drink
Tamsulosin Ascend must be taken after breakfast or the first meal of the day.
Pregnancy, lactation and fertility
Pregnancy and lactation
Tamsulosin is not indicated for use in women, therefore information on pregnancy and lactation is not relevant.
Fertility
Difficulties with ejaculation have been reported in association with tamsulosin use (see section 4).
Driving and using machines
There is no evidence that this medicine affects the ability to drive or 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.

3. HOW TO TAKE Tamsulosin Ascend

Always take tamsulosin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dosage 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

Tamsulosin is usually prescribed for long-term treatment. The effects on bladder and urination are achieved with this medicine over a long period of time.

If you take more Tamsulosin Ascend than you should

Taking too many Tamsulosin Ascend 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 tamsulosin.

If you forget to take Tamsulosin Ascend

You may take your daily tamsulosin 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. Never take a double dose to make up for the forgotten capsule.

If you stop taking Tamsulosin Ascend

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 product, 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.
PT XXXX
Abnormal ejaculation. The latter means that semen
does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.

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 from the available data)

Blurred vision
Impaired vision
Nasal bleeding
Serious skin reactions (erythema multiforme,
exfoliative dermatitis)
Abnormal irregular heart rhythm (atrial fibrillation,
arrhythmia, tachycardia), difficult breathing (dyspnoea).
If you are undergoing eye surgery because of cloudiness
of the lens (cataract) or due to increased eye pressure (glaucoma) and are already taking or have previously taken this medicine, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.
Dry mouth

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Y e l l o w C a r d S c h e m e a t : http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE Tamsulosin Ascend

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister pack and on the carton after EXP (month and year). The expiry date refers to the last day of that month.

Store in the original package.

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.

This medicinal product does not require any special storage conditions.

6. FURTHER INFORMATION

What Tamsulosin Ascend contains

The active substance is Tamsulosin hydrochloride. Each capsule contains 0.4 mg Tamsulosin (as hydrochloride).

The other ingredients are:

Capsule fill: Microcrystalline Cellulose (GR 101), Talc, Methacrylic Acid – Ethyl Acrylate Copolymer (1:1) Dispersion 30 percent (contains sodium lauril sulfate and polysorbate 80) Calcium

, Triacetin, Hypromellose and Stearate.

Capsule shell: Gelatin, FD and C Blue 2 (E132), Iron oxide Red (E172), Iron oxide yellow (E172) and Titanium dioxide (E171).

Printing ink: Shellac (E904), Propylene glycol (E1520), Ammonia Solution Concentrated (E527), Potassium hydroxide (E525) and Black iron oxide (E172)

What Tamsulosin Ascend looks like and contents of the pack

White to off white pellets filled in hard gelatin capsule size “1” Olive green opaque cap & orange opaque body imprinted with “TAM” on cap & “0.4 mg” on body in black ink.

Tamsulosin Ascend 0.4 mg capsules are available in OPA/ALU/PVC-Aluminium Blister Pack containing 10's, 20's, 30's, 50's, 60's, 90's, 100's, 200's hard capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ascend Laboratories (UK) Limited

Elsley Court 20-22

Great Titchfield Street

London, W1W 8BE

United Kingdom

Tel: 0800 047 0073

Manufacturer