Trasidrex
PATIENT INFORMATION LEAFLET TRASIDREX®TABLETS
(oxprenolol hydrochloride and cyclopenthiazide)
Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Trasidrex®Tablets are and what they are used for
2. Before you take Trasidrex®Tablets
3. How to take Trasidrex®Tablets
4. Possible side effects
5. How to store Trasidrex®Tablets
6. Further information
1. What Trasidrex®Tablets are and what they are used for
Trasidrex®Tablets belong to a group of medicines called diuretics. They make the kidneys remove water from the body. Trasidrex tablets also contain a class of medicines called beta-blockers, which help to slow the heart beat and relax blood vessels.
Trasidrex®Tablets are used to treat high blood pressure.
2. Before you take Trasidrex®Tablets
DO NOT take Trasidrex®Tablets if you:
• know that you are allergic to oxprenolol, cyclopenthiazide, other diuretics or sulphonamides or any of the other ingredients of Trasidrex®Tablets (see section 6 of this leaflet)
• have a serious heart, liver or kidney disorder (your doctor will advise you)
• have gout (painful joints, especially the big toe) or kidney stones
• suffer from low blood pressure
• raised blood pressure during pregnancy
• have high levels of potassium in your blood have (hyperkalaemia) or high levels of calcium in your blood (hypercalcemia) or an electrolyte disturbance (hyponatraemia). Your doctor will advise you.
• have a disease of the adrenal glands causing weakness, weight loss and a deficiency of hormones in the blood (Addison’s disease)
• you have heart problems such as heart failure which is not under control, heart block, slow or uneven heart beats, low blood pressure or very poor circulation
• you have not been eating (fasting) for a long period of time or if your blood has become too acidic (metabolic acidosis)
• you have chest pain that happens when you are resting rather than during exercise (called ‘prinzmetal angina’)
• suffer now or have suffered in the past from asthma or attacks of wheezing
• have an untreated tumour in the adrenal glands (phaeochromocytoma)
Take special care with Trasidrex®Tablets if you:
• suffer from low blood sugar
• problems with your liver or kidneys or heart
• are being sick (vomiting) or have diarrhoea
• have a history of allergic reactions
• suffer with muscle weakness (myasthenia gravis)
• suffer from high blood pressure due to liver problems
• have a heart weakness
• are suffering from a skin disease called psoriasis or had it in the past
• are suffering from diabetes
• are unwell or have a fever
• are elderly
• have blood abnormalities of potassium or calcium, or have too much fat (lipids) circulating in the blood (your doctor will advise you)
• suffer from any serious blood vessel disorders
• have a chronic skin disease (such as lupus erythematosus)
• suffer from Raynaud’s disease (very poor circulation in the hands and feet)
• suffer from bronchitis or emphysema
• have an overactive thyroid gland
• are being treated for high cholesterol levels
If any of the above applies to you, make sure your doctor is aware of this.
Your doctor may monitor your blood or urine, especially if you are elderly or have problems with your kidneys.
If you are going to have a general anaesthetic (for example, during an operation), please let the doctor or dentist taking Trasidrex®Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking:
• Vitamin D or calcium salts
• Medicines for infections (amphotericin)
• Medicines used as anaesthetics
• Medicines to treat ulcers (carbenoxolone, cimetidine)
• Corticosteroids to treat inflammatory conditions such as arthritis or asthma
• Medicines to treat heart problems, blood vessel disorders and Raynaud’s disease
• Antidepressants such as Monoamine Oxidase Inhibitors (MAOIs), e.g. phenelzine
• Medicines to treat cancer (cyclophosphamide or methotrexate)
• Medicines for stomach and gut problems (anticholinergics)
• Medicines for Parkinsons’s or viral infections (e.g. amantadine)
• Medicines to treat rheumatic disease or skin problems or for transplants (cyclosporine)
• Medicines for severe mental illness (e.g. lithium)
• Medicines for high cholesterol levels (e.g. cholestyramine)
• Other medicines that treat high blood pressure
• Medicines to treat diabetes
• Analgesics (medicines for pain relief) including non-steroidal anti-inflammatory drugs (NSAIDs) or muscle relaxants
• Medicines to treat gout (painful inflammation of the joints)
• Barbiturates (or “downers”)
Pregnancy and breast feeding
Trasidrex®Tablets should not be used during pregnancy or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel you feel dizzy or have problems with your vision when you start taking these tablets, do not drive or work machines until these effects wear off.
Taking with food and drink
You should avoid drinking alcohol whilst you are taking this medicine as it may change the effects of Trasidrex®Tablets. Since these tablets may reduce the amount of salt in the body, you should avoid strict low salt diets.
Important information about some of the ingredients of Trasidrex®Tablets
This medicine also contains:
• sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Trasidrex®Tablets
Always take Trasidrex®Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will decide the best dose for you and may change it depending on how you respond to treatment. You may also be given other medicines.
It is best to take your tablets in the morning. You should swallow the tablets whole with a glass of water.
USUAL DOSE:
In mild to moderate high blood pressure, the usual adult dose is one tablet a day, alone or with other medicines. This can be increased by your doctor, if necessary.
If you are elderly or have kidney problems, your doctor may give you a lower dose.
Keep taking Trasidrex®Tablets even if you feel well. Do not stop taking Trasidrex®Tablets unless your doctor tells you to.
Your doctor may give you regular blood or urine tests during treatment.
Do not give Trasidrex®Tablets to children under 12 years.
If you take more Trasidrex®Tablets than you should:
If you think that you, or any other person, have taken too many Tablets, contact your doctor or hospital casualty department immediately. Take any remaining Tablets and this leaflet with you so that the medical staff know exactly what you have taken.
If you forget to take your Trasidrex®Tablets:
If you miss taking Trasidrex®Tablets in the morning, then take it as soon as you remember and carry on taking the Tablets as normal on the following morning. Never take two doses at the same time.
4. Possible side effects
Like all medicines Trasidrex®Tablets can sometimes cause side-effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
As Trasidrex®Tablets remove excess water from your body, the number of times that you need to pass urine will increase. This will be most noticeable when you first start taking Trasidrex®Tablets.
If you get any of the following, tell your doctor:
• Attacks of wheezing or feeling short of breath
• Unusual bleeding or bruising
• Yellowing of the skin or whites of the eyes (jaundice)
• Attacks of gout
• A very slow pulse (under 55 beats per minute)
• Dry or sore eyes
• Very rarely, some patients may develop a skin rash especially when the skin is exposed to daylight.
• Muscle pains or cramps
• Persistent sore throat or high temperature
• Increased or irregular heart beat
• Increased sugar in the blood or urine Other side effects may include:
These effects are often mild and may wear off after a few days’ treatment. If they are severe or last for more than a few days, tell your doctor:
• Feeling sick or being sick and diarrhoea.
• Loss of appetite, stomach pain, constipation, wind
• Feeling thirsty or having a dry mouth
• Feeling weak or dizzy and/or have muscle cramps, headaches, mood changes, sleepiness, unusual tiredness, nightmares
• Headaches or problems with your vision, usually when first starting treatment with these tablets
• Males may suffer from impotence. This problem resolves after you stop taking the medicine.
• Fainting or dizziness when getting up from a sitting or lying position.
Certain other unwanted effects such as changes in the blood levels of chemicals and salts can only be detected by your doctor. To check for this your doctor may occasionally want to do some blood tests.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Trasidrex®Tablets
Keep out of the reach and sight of children.
Do not use Trasidrex®Tablets after the expiry date which is stated on the packaging. If your Tablets are out of date, take them to your pharmacist who will get rid of them safely.
Do not store above 25°C. Store in the original package.
Protect from light and moisture
Further information
Each Trasidrex®Tablets contains the active ingredients oxprenolol hydrochloride and cyclopenthiazide.
Trasidrex®Tablets also contains steric acid, aerosol R972, povidone K25. The coating contains avicel PH101, polyethylene glycol 6000, povidone 30, purified talc special, sucrose, erythrosine (E127)
What Trasidrex®Tablets look like and contents of the pack
Each film coated tablet contains 160mg oxprenolol hydrochloride in slow release form and 0.25mg cyclopenthiazide. They are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer
Novartis Pharmaceuticals UK Ltd., Wimblehurst Road, Horsham, West Sussex, RH12 5AB, UK This leaflet was last revised in April 2014
Copyright ©2006 Mercury Pharmaceuticals Ltd. - All rights reserved ‘Trasidrex’ is registered trademark