Spiretic Tablets 100mg
PATIENT INFORMATION LEAFLET
SPIRETIC TABLETS 25mg & 100mg
Spironolactone Tablets 25 & 100 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF SPIRETIC IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION
What is in your medicine?
The name of this medicine is Spiretic. It contains Spironolactone together with the following inactive ingredients: Calcium sulphate dihydrate, povidone, maize starch, crospovidone, pregelatinised maize starch, magnesium stearate, peppermint flavour and quinoline yellow E104.
Spiretic is available in tablets of two strengths containing either 25 mg or 100 mg of the drug.
Spiretic 25 mg tablets contain Spironolactone 25 mg and Spiretic 100 mg tablets contain Spironolactone 100 mg. Both strengths are packed in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Spiretic 25 mg tablets are pale yellow bi-convex, engraved SPIRETIC 25. Spiretic 100 mg tablets are pale yellow biconvex, engraved SPIRETIC 100.
The Product Licence holder of Spiretic is:
Chelonia Healthcare Ltd,
11 Boumpoulinas,1060 Nicosia, Cyprus.
The manufacturer of Spiretic is:
Meridian Healthcare (UK) Ltd.,
208-214 York Road, Battersea, London SW11 3SD.
How does Spiretic work?
Spiretic belongs to a group of medicines called potassiumsparing diuretics, commonly used to help reduce the amount of excess fluid accumulated in the body in the following conditions:
• Kidney disease (Nephrotic syndrome).
• Heart failure
• Cirrhosis of the liver
• Treatment of primary aldosteronism
• Collection of fluid due to certain tumours
If you are not sure why you have been prescribed Spiretic, then please ask you doctor.
Before taking your medicine
Before taking this medicine tell your doctor if you have ever had any unusual or allergic reactions to Spironolactone or other diuretics. Also tell your doctor or pharmacist if you are allergic to any substances such as foods, preservatives or dyes.
Do not take Spiretic if you:
• suffer from Addison’s disease
• cannot pass urine
The presence of other medical problems may affect the use of this medicine. Tell your doctor if you have any other medical problems, especially if you:
• have any liver or kidney problems
• have been told you have a high level of potassium in your blood or you are taking potassium supplements
• have been told you have a low level of sodium in your blood
• suffer from porphyria
• If you are taking any medicines for the treatment of blood pressure.
You doctor may decide to monitor your fluid, potassium and/or sodium levels.
An increase of potassium in the blood may occur if you have reduced kidney function or with an increase in potassium intake. This can cause you to experience muscle weakness, palpitations, irregular heartbeat or intervals in the normal heartbeat which can result in dizziness, tiredness or fainting. Tell your doctor if you experience these symptoms.
The long term use of Spiretic in young persons requires careful consideration of the benefits and the potential hazard involved, particularly as Spironolactone has been shown to produce tumours in rats when given high doses over a long period of time.
Use in Pregnancy
Because Spiretic or its by-products may enter the circulation of the foetus, your doctor will decide whether treatment with Spiretic is desirable during pregnancy.
Nursing mothers: the by-product of Spiretic (Canrenone) appears in breast milk. An alternative method of infant feeding will be suggested by your doctor if he considers that the use of Spiretic is essential.
Can you drive while taking Spiretic?
Spiretic may cause drowsiness or dizziness. Make sure that you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.
Can you take Spiretic with other medicines?
It is very important to tell your doctor or pharmacist about all the medicines which you are taking, whether prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.
You can take Spiretic with other medicines, but there are some medicines that can interfere with Spiretic.
Drugs which reduce blood pressure may have increased effects when used together with Spiretic, and your doctor may wish to reduce the dose of these other drugs.
Aspirin interferes with the effectiveness of Spiretic in reducing excess fluid in the body.
An increase in blood potassium levels may occur when Spiretic is taken together with other diuretics, non-steroidal anti-inflammatory drugs or certain other medicines.
It is important to tell your doctor if you are taking:
• Digoxin, digitoxin or any other medication for heart conditions
• Other diuretics or any other medication for high blood pressure
• Non steroidal anti-inflammatory drugs (eg, ibuprofen, indometacin, keterolac) or corticosteroids - for pain and inflammation relief
• Lithium - for depression
• Amisulpride, pimozide or sertindole - to treat mania
• Terfenadine - for allergy relief
• Ciclosporin or tacrolimus - used to suppress the immune system
• Oestrogens
• Chlorpropamide - to treat diabetes
• Carbamazepine - to treat epilepsy
• Carbenexolone - for stomach ulcers
• Aminogluthethimide
If you need to have an operation make sure the doctor or surgeon knows that you are taking Spiretic.
When and how to take Spiretic tablets
Take this medicine by mouth with food and only in the doses prescribed by your doctor.
Adults
Take this medicine as instructed by your doctor. The dose will depend on your condition and may need to be increased or decreased over time to control your symptoms.
Elderly:
Dosage in the elderly will be adjusted by your doctor on the basis of the response and tolerance to treatment, which may be less than the recommended adult dose.
Children:
Spiretic can be used in children under certain circumstances. Dosage for children will be determined by the doctor based upon bodyweight.
What to do if too many tablets are taken at the same time
If you think that you have taken an overdose of this medicine obtain emergency help at once. Some signs of overdose are:
Drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea.
The symptoms of increased potassium in your blood may cause tingling in your fingers and toes, irregular heartbeat, muscle weakness or muscle spasm.
Improvement of these conditions will occur after you stop taking this medicine.
What if you miss a dose
Do not take more of it or take it more often, or for a longer time than your doctor ordered.
If you feel that this medicine is not working as well after you have taken it for a short time (1 to 2 weeks), do not increase the dose; instead check with your doctor.
What side effects can Spiretic cause?
The majority of people who take spironolactone have no problems, however the medicine may cause some unwanted effects.
Check with your doctor immediately if any of these side effects occur:
• stomach upset
• headache
• feeling lack of energy, drowsy or confused
• Skin rashes and/or itching
• Swelling of the breasts in men (which will usually return to normal when the drug is stopped)
• Women may have irregular or heavy periods and their breasts may feel sore. Men may become impotent for a while.
Contact your doctor immediately if any of the following rare side effects occur:
• a change in heartbeat rhythm or regularity.
• liver or kidney problems
• an allergic reaction, generally visible as a severe skin condition / rash
• bone or blood conditions (which may manifest as excessive bleeding before clotting, easy bruising, blood in the urine or stools; high fever, sore throat, skin rash, infections or sores)
There have been reports of cancerous breast tumours in men.
Tell your doctor if you notice any other undesirable effects whilst taking this medicine.
Storing your medicine
You must keep this medicine in a safe place where children cannot get hold of it.
Store below 25°C in a dry place. Keep container well closed.
On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
PL numbers: 33414/0105 and 0106
This leaflet was revised in April 2011