Indoramin 20 Mg Tablets
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Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Doralese Tiltab Tablets (called 'Doralese' in this leaflet) contain a medicine called indoramin (as indoramin hydrochloride). This belongs to a group of medicines called 'alpha-blockers' (also called alpha adrenoceptor antagonists).
What Doralese is used for
• Doralese is used to treat a condition where your prostate becomes bigger, called 'benign prostatic hyperplasia' or BPH. The prostate is a gland found underneath the bladder in men. It surrounds the tube (called the urethra) which carries urine from the bladder to the outside of the body
• if the prostate gland becomes bigger, it may squeeze on the urethra and make it hard for you to pass urine. When your prostate grows:
- the flow of your urine may be weaker or you may have to pass urine more often than before
- this can happen during the day or you can find you have to get up more often during the night
- you may have to wait for the flow of your urine to start
- you may find it difficult to stop the flow of your urine completely
• as men get older their prostate grows in size and some men will suffer these symptoms
• Doralese can be used for patients who do not need or want an operation and also for patients waiting for an operation.
How Doralese works
• Doralese relaxes muscles in your bladder, prostate gland and the tube that carries urine from the bladder to the outside of the body
• this will help your urine flow better.
Do not take Doralese
• if you are allergic (hypersensitive) to indoramin or any of the ingredients of Doralese (listed in Section 6)
• if you have heart failure.
Take special care with Doralese
Check with your doctor or pharmacist before taking your medicine if:
• you have liver or kidney problems
• you have Parkinson's disease
• you have epilepsy
• you have ever had depression.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Doralese. You may need to be given another medicine or your dose may need to be lowered.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal preparations. This is because Doralese can affect the way some other medicines work. Also some other medicines can affect the way Doralese works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Monoamine oxidase inhibitors, sometimes called 'MAOIs', used for depression. Do not take Doralese if you are already taking a MAOI
• medicines used for high blood pressure such as water tablets (diuretics) or beta-blockers
• medicines that can lower blood pressure such as water tablets (diuretics), moxisylytes (medicines used for circulation problems) and medicines used for depression, anxiety or to help you sleep
• medicines that may make you sleepy such as pain killers, antidepressants, tablets for your nerves and antihistamines.
Cataract eye surgery patients
If you are due to have eye surgery because of a cataract (cloudiness of the lens):
• Tell your eye specialist before the operation that you are using or have previously used Doralese.
• Doralese and other medicines of the same type (alpha-blockers) may cause problems during the surgery which can be managed if your specialist is told before your operation.
Taking Doralese with food and drink
Do not drink alcohol if Doralese makes you feel drowsy. Alcohol can increase the amount of Doralese that gets from your stomach into your blood stream. This could make you feel more drowsy.
Pregnancy and breast-feeding
Occasionally a doctor may prescribe Doralese for a woman. Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or are breast-feeding.
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Driving and using machines
You may feel sleepy while taking Doralese. If this happens, do not drive or use any tools or machines.
If you feel very sleepy, tell your doctor.
Important information about some of the ingredients of Doralese
Doralese contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
. Keep out of the reach and sight of children.
• Do not use Doralese after the expiry date which is stated on the carton. The expiry date refers to the last day of the month stated.
• Store your tablets below 25°C.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
Always take Doralese exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.
How much to take
• The usual dose is one tablet (20 mg) twice a day.
• The tablet should be swallowed with water.
• Some elderly patients may need just one tablet at night.
• Your doctor may increase your dose to a maximum total daily dose of 100 mg.
• Do not take more than your doctor has recommended.
If you take more Doralese than you should
• If you take more Doralese than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take your Doralese
• If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Doralese
• Do not stop taking Doralese without talking to your doctor. If you stop taking your tablets, your symptoms may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
Like all medicines, Doralese can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
• when you start taking Doralese you may feel sleepy. This will usually go after a few days
• other less common side effects include dry mouth, stuffy nose, weight gain, dizziness, failure to ejaculate, depression, headache and dizziness caused by low blood pressure, which can occur on standing. The dizziness may or may not be accompanied by fainting.
Rare (affects less than 1 in 1,000 people)
• allergic (hypersensitivity) reactions, such as a rash and itching
• Parkinson's disease may get worse.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Doralese contains
• The active ingredient is indoramin (as indoramin hydrochloride).
• Each tablet contains 20 mg of indoramin.
• The other ingredients are:
lactose, magnesium stearate (E572), microcrystalline cellulose, hydroxypropylmethyl cellulose, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), polyethylene glycol 400, polacrilin potassium, butterscotch flavour and carnauba wax.
The film-coating is made of Opadry OY- 3736 and Purified Water.
What Doralese looks like and contents of the pack
• Doralese Tiltab are coated tablets. The special 'Tiltab' design helps you to pick up your tablets more easily.
• They are available in packs of 60 tablets.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW.
This leaflet was last revised in
January 2011
'Doralese', 'Chemidex' and the Chemidex logo are trademarks of Chemidex Pharma Ltd.
'Tiltab' is a trademark of, and used under licence from, the GlaxoSmithKline group of companies.
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