Morvesin 400 Microgram Sr Capsules
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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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 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. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Morvesin is and what it is used for
2. What you need to know before you take Morvesin
3. How to take Morvesin
4. Possible side effects
5. How to store Morvesin
6. Contents of the pack and other information
The active substance of Morvesin is tamsulosin. This is an alpha-1-receptor blocker that reduces the ability to contract the muscles in the prostate and urethra. As a result, the urethra, which runs through the prostate, is less constricted so that urinating is easier. In addition, it diminishes sensations of urge.
Morvesin is used by men for the treatment of complaints in the lower urinary tract that occur in benign prostate enlargement. These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.
Do not take Morvesin
• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Morvesin.
• If you have a serious liver problems if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up).
Warnings and precautions
• Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.
• If you suffer from a serious kidney problems.
• In rare cases during the use of Morvesin, fainting may occur on sitting up straight or standing. If you start to feel dizzy or weak you must lie down or sit down until it has passed.
• Before therapy with Morvesin is initiated, you should be evaluated by your doctor in order to exclude the presence of other conditions which can cause the same symptoms as benign (harmless) prostate enlargement. Your doctor will likely to examine your prostate gland manually (done by hands) to detect abnormalities and may measure a chemical substance produced by the prostate (prostate specific antigen, PSA) in your blood before treatment and at regular intervals afterwards.
• In rare occasions, severe allergic reaction with swelling of the face, lips, tongue and throat which may cause difficulty in breathing, speaking or swallowing (angio-oedema) may occur. If this happens, you should stop taking
Morvesin immediately and contact your doctor.
• If you are undergoing or have been scheduled for eye surgery because of cataract (cloudiness of the lens) or increased pressure in the eye (glaucoma), please inform your eye specialist before the operation that you are using or have previously used, are using, or are planning to use tamsulosin. This is because Morvesin may cause complications during the surgery which can be managed if your specialist is prepared in advance
Consult your doctor if the above-mentioned warning is applicable to you, or has been in the past.
Children
Do not give this medicine to children or adolescent under 18 years because it does not work in this population.
Other medicines and Morvesin
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking:
• Medicines that lower your blood pressure such as verapamil and diltiazem.
• Medicines to treat HIV such as ritonavir or indinavir.
• Medicines to treat a fungal infection such as ketaconazole or itraconazole.
• Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin.
• Erythromycin, an antibiotic used to treat infections.
Taking Morvesin with food and drink
You should take the capsule after breakfast, or the first meal of the day.
Pregnancy, breast-feeding and fertility
Morvesin is not intended for use by 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 evidence that Morvesin affects the ability to drive or to operate machinery or equipment. You should take into account the possibility that Morvesin may cause dizziness. In that case you should not drive vehicles and/or operate machinery that requires concentration.
Always take Morvesin exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The usual recommended dose is one capsule per day taken orally. Take the capsule after breakfast, or the first meal of the day. Swallow the capsule whole with some water while standing or sitting (not lying down). Do not chew or break the capsule.
Usually, Morvesin is prescribed for long periods of time. The effects on the bladder and on urination are maintained during long-term treatment with Morvesin.
Follow these instructions unless otherwise indicated by your doctor. Remember to take your medication. Your doctor will indicate the duration of your treatment with Morvesin.
If you take more Morvesin than you should
If you take more Morvesin than you should, consult your doctor or pharmacist or go to the local hospital accident and emergency department immediately and take this leaflet and any other remaining capsules.
Symptoms of Morvesin overdose may include dizziness, fainting and headache.
If you forget to take Morvesin
If you forget to take your daily Morvesin after breakfast or first meal of the day, you can take it later the same day after another meal. If you miss a whole day, just continue to take your normal daily dose the next day after breakfast or first meal of the day. Do not take a double dose to make up for the dose that you missed.
If you stop taking Morvesin
If the treatment with Morvesin is stopped earlier than recommended, then the original symptoms may return. For this reason, use Morvesin for the duration of your treatment, as recommended by your doctor even though your symptoms may, have disappeared.
Always consult your doctor if you are considering to stop taking the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Keep out of the sight and reach of children.
Store below 30°C.
Do not use Morvesin after the expiry date which is stated on the carton box after EXP: The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Morvesin can cause side effects, although not everybody gets them.
Contact your doctor or hospital immediately if you notice any of the following rare serious side effects (it may be an allergic reaction):
rash, itching, inflamed or reddened skin (especially affecting the whole body); swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing (angio-oedema).
The following side effects have been reported during the use of Tamsulosin Hydrochloride:
Common (may affect up to 1 in 10 people)
• dizziness, abnormal ejaculation.
Uncommon (may affect up to 1 in 100 people)
• headache
• feeling your heart beat
• orthostatic hypotension (experience dizziness caused by low blood pressure after sitting or standing up)
• runny or blocked nose (rhinitis)
• feeling sick and being sick, diarrhoea and constipation
• allergic reactions such as skin rash, itching and local inflammation
• weakness.
Rare (may affect up to 1 in 1,000 people)
• fainting
• generalized hives
Very rare (may affect up to 1 in 10,000 people)
• priapism (persistent and painful erection of the penis without sexual stimulus which requires immediate medical attention)
• serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
Not known (Frequency cannot be estimated from the available data)
Vision blurred, visual impairment, bleeding from the nose, rash, inflammation and blistering of the skin (erythema multiforme, dermatitis exfoliative), irregular heart beat, faster heart beat, shortness of breath, dry mouth.
If you may undergo a cataract or glaucoma surgery while you are taking or have taken tamsulosin, your pupil may not correctly dilate and the iris (the coloured part of the eye) may become floppy (see also
section “Take special care with Morvesin”.
What Morvesin contains
The active substance is tamsulosin hydrochloride.
Each capsules contains 0.4 mg tamsulosin hydrochloride.
The other ingredients are:
Content of the capsules: microcrystalline cellulose (E460), Polyacrylate, Metacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium laurilsulfate, talc (E553b), colloidal anhydrous silica (E551).
The capsule shell contains gelatine (E441), patent blue V (E131), titanium dioxide (E171), yellow red and black iron oxide (E172).
What Morvesin looks like and contents of the pack
Morvesin are light green/yellow capsules. The capsules contain white to slightly yellowish pellets.
Morvesin is packed in blisters.
The capsules may be packed in the following pack sizes:
Carton box with blister(s) containing: 10, 20, 28, 30, 50, 56, 60, 90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovskova 57,
1526 Ljubljana,
Slovenia
or
Salutas Pharma GmbH,
Otto von Guericke Allee 1,
39179 Barleben,
Germany
or
LekS.A.,
Ul. Domaniewska 50C,
02-672 Warzawa,
Poland.
This leaflet is last revised in 03/2014
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