Hytrin Bph 1mg Tablets
PATIENT INFORMATION LEAFLET 075-0307-APIL
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Read all of this leaflet carefully before you start taking this medicine.
Please keep this leaflet. You may need to read It again.
If you have any further questions, ask y This medicine has been prescribed tor you. on to others. It may harm them, even if their symptoms are
Always take Hytrin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For high blood pressure (hypertension)
the same as yours.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Hytrin is and what it is used for Jefore you take Hytrin Tablets How to use Hytrin Tablets Possible Side Effects How to Store Hytrin Tablets Further Information
If you are taking Hytrin lor the first time or if you have not taken Hytrin in the last week:
It is important that you take the correct Hytrin Tablet at the correct time.
You should begin taking tablets from the strip marked HYTRIN STARTER PACK.
All tablets from this strip should be taken at bedtime.
The name of your medicine is Hytrin Tablets. Hytrin Tablets contains the active ingredient terazosin.
Terazosin belongs to a group of medicines called alpha blockers.
Hytrin is used to treat high blood pressure.
Hytrin is also used for the treatment of a condition called benign prostatic hyperplasia (BPH) which affects the prostate and is common in older men. This condition stops the flow of urine from the bladder and can lead to symptoms such as a weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water.
Hytrin can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms.
2. BEFORE YOU TAKE HYTRIN TABLETS Do not take Hytrin if you:
• are allergic to terazosin, arty of the following drugs: alfuzosin, indoramin, prazosin, tamsulosin, doxazosin, or to any of the other ingredients contained in this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or tnroat with difficulty in swallowing or breathing).
Start taking your Hytrin Tablets at Day 1 marked START on the strip. This is a white tablet and you should take it by mouth just before going to bed.
You will notice that from Day 8 onwards, the tablets are yellow. This is to show that the tablets contain a different dose of Hytrin from the white tablets.
Continue to take one tablet each day before you go to bed until you reach Day 14.
When you have finished the STARTER PACK, the next tablet that you take should come from the strip which is marked with the days of the week. See diagram below;
Take special care with Hytrin if you:
• have ever fallen over or fainfed while passing water.
If any of the above apply to you, or if you are not sure, please tell your doctor before taking Hytrin.
Taking with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines without a prescription.
It is especially important to tell your doctor if you are taking;
• other medicines to treat high blood pressure including ACE inhibitors and water tablets (diuretics)'
• medicines for erectile dysfunction (e.g. Cialis, Viagra, Levitra). Some patients who take alpha-blockertherapy for the treatment of high blood pressure or prostate enlargement may ermerience dizziness or light-headedness which may be caused by row blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blockers before you start drugs for erectile dysfunction.
If you are going to have a general anaesthetic, you should tell the doctor or dentist in charge that you are taking Hytrin.
Ifyou are undergoing eye surgery because of cataract (cloudiness ofthe tens) please inform your eye specialist before the operation that you are using or have previously, used Hytrin. This is because Hytrin may cause complications during the surgery which can be managed if your specialist is prepared in advance.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding, please tell your doctor before taking Hytrin.
Driving and operating machinery.
It is important to avoid driving, using machinery or carrying out hazardous tasks for 12 hours after taking your first tablef of each different strength (i.e. the tablets taken on days 1,8 and 22 of your starter pack), as dizziness, light-headedness or drowsiness may occur.
Important information about some of the ingredients of Hytrin Tablets.
Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Hytrin Tablets contain lactose, a type of sugar
This strip is marked with the days of the week to help you remember if you have taken your tablet. For instance, if you start taking tablets from this strip on a Wednesday, take one tablet from a space marked Wednesday. Continue taking one tablet each day following the arrows on the strip until there are no tablets left.
You should take your tablets at the same time each day at bedtime. If you are unsure about when to take your tablets, you should consult your doctor for advice.
II you have taken Hytrin Tablets using a Starter Pack and you are cnntinuinn with your next nack:
When you have finished your starter pack, your doctor may give you more tablets.
Depending on your response to Hytrin, your doctor will decide which strength of tablet you need. You may be given a new pack of Hytrin Tablets containing either 2 mg (yellow tablets), 5 mg (tan tablets) or 10 mg (blue tablets).
Whichever strength you have will be in a pack containing 2 strips of 14 tablets marked with the days ofthe week, as shown below:
nuui VIEWSM7 TOttUMT IWW.1 MTCBMY WNI ^
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HITRIN“ take one tablet ejuch day +
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. .LK-JHSTCUJraY13hD BWJL *][?I1AH
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Start the new strip by taking a tablet from the space marked with the correct day of the week e.g. If you are starting on a Wednesday, take your first tablet from a space marked Wednesday.
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0 AMDIPHARM | |
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PRODUCT NAME: |
Hytrin 1, 2, 5 & lOmg |
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PIP CODE: |
075-0307LF-AM01 |
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COMPONENT: |
Leaflet |
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SIZE: |
165 x 267 |
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MARKET: |
UK |
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PRODUCT SITE: |
TBC |
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SCALE: |
loots |
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COLOURS: |
Black |
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DATE: |
07/08/2013 |
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FONT SIZE: |
8 pt |
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VERSION NO: |
1 |
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AMENDED BY: |
AMCo |
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PROJECT: |
CNC |
REGULATORY AUTHORITY APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.
Continue taking one tablet each day following the arrows on the strip until there are no tablets left.
You should take your tablets at the same time each day e.g. bedtime. Ifyou are unsure about when to takeyourlablets, you should consult your doctor for advice.
You should continue to take yourfablets unless your doctor tells you not to. Do not stop just because you feel better.
Far Benign Prostatic Hyperplasia (BPH)
At first you will be given a starter pack.
It is important that you start with the strip marked STARTER PACK 1 and that you take one tablet each day in the order shown on the strip.
This is so that you take the weakest (white) tablets for the first week, stronger (yellow) tablets in weeks 2 and 3 and the strongest (tan) tablets in the 4th week.
You should take your tablets at the same time each day at bedtime.
When you have finished your starter pack, your doctor will give you more tablets.
Depending on your response to Hytrin, your doctor will decide which strength of tablet is best for you.
You should continue to take yourfablets unless your doctortells you not to. Do not stop just because you feel better.
If you take more tablets than you should
Ifyou take more Hytrin than you should, (more than one tablet in one day) contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.
If you forget to take Hytrin
If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.
If you have not taken a tablet for several days you should NOT continue using the same tablets but return to your doctor for a new starter pack.
Like all medicines, Hytrin can cause side effects, although not everybody gets them.
If you notice;
• Itching or skin rashes;
• Swelling of your face, lips or throat;
• Difficulty in breathing or wheeziness.
Stop taking tne medicine and seek medical advice immediately. These may be signs of an allergic reaction.
When taking Hytrin tablets for the first time or when starting to take higher dose tablets dizziness, light-headedness or fainting may occur. These effects may also occur when standing up quickly from a lying or sitting position.
Ifyou are affected by this, you should lie down until you feel better then you should sit for a few minutes before standing again to revent these effects returning.
hese side effects usually go away and should not return once you have become used to taking yourfablets.
The most common side effects of Hytrin are:
• weakness, dizziness;
• a fast or uneven heartbeat;
• feeling sick;
• swelling of the hands and feet;
• sleepiness;
• blocked nose;
• blurred vision.
Other, less frequent side-eflects of Hytrin are:
• back pain, neck pain, shoulder pain;
• pains in hands and feet, pins and needles;
• headache;
• increased heart rate, irregular heart rate;
• low blood pressure (hypotension) which can cause dizziness or faintness on standing;
• swelling, flushing;
• weight gain;
• nervousness, depression anxiety;
• shortness of breath or difficulty breathing;
• decreased sex-drive, erectile dysfunction, persistent and painful erection;
• vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly on standing);
• chest pains;
• facial swelling;
• stomach pain, indigestion;
• being sick, constipation, diarrhoea, wind;
• dry mouth;
• inflammation or pains in joints or muscles;
• difficulty sleeping;
• bronchitis (inflammation of the lungs);
• nose bleeds, sore throat, blocked nose, cough;
• flu-like symptoms;
• skin rashes and itching;
• sweating;
• vision problems and conjunctivitis;
• ringing in the ears;
• increased frequency of passing water, urinary infection, lack of bladder control.
Some patients have experienced unexpected bruising and their blood taking longer than usual to clot after a cut to the skin.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
5. HOW TO STORE HYTRIN TABLETS
Do not take Hytrin afterthe expiry date shown on the package. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist now to dispose of medicines no longer required. These measures will help to protect the environment.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
6. FURTHER INFORMATION What Hytrin contains
Hytrin tablets come in 4 strengths and colours containing either 1 mg (white), 2 mg (yellow), 5 mg (tan) or 10 mg (blue), of the active ingredientterazosin as terazosin monohydrochloride dihydrate.
The other ingredients are: lactose, maize starch, purified talc magnesium stearate, and either no colour (1 mg tablet) aye yellow E104, (2 mg tablet), dye iron oxide burnt sienna E172, (5 mg tablet) or dye blue E132 (10 mg tablet).
What Hytrin looks like and the contents of the packs
Hytrin tablets are round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other and are either; white (1 mg), yellow (2 mg), tan (5 mg) or blue (10 mg)
They are available in 5 different packs;
• The hypertension starter pack containing seven 1 mg (white) tablets and twenty-one 2 mg (yellow) tablets (4 weeks treatment).
• The BPH starter pack containing seven 1 mg (white) tablets, fourteen 2 mg (yellow) tablets and seven 5 mg (tan) tablets (4 weeks treatment).
• The 2 mg, 5 mg and 10 mg tablet packs each containing 28 tablets (4 weeks treatment).
Marketing Authorisation holder and Manufacturer responsible for batch release
Amdipharm UK Limited,
Regency House,
Miles Gray Road,
Basildon,
EssexSS14 3AF.
Date of leaflet August 2013
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