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Active substance(s): AMILORIDE HYDROCHLORIDE DIHYDRATE / HYDROCHLOROTHIAZIDE / AMILORIDE HYDROCHLORIDE DIHYDRATE / HYDROCHLOROTHIAZIDE / AMILORIDE HYDROCHLORIDE DIHYDRATE / HYDROCHLOROTHIAZIDE
SYNURETIC 25 Tablets
SYNURETIC 50 Tablets
Co-Amilozide (Amiloride Hydrochloride and Hydrochlorothiazide)
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF SYNURETIC
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE
What is in your medicine?
The name of this medicine is SYNURETIC. Synuretic comes in two strengths:
'Synuretic 25' contains 2.85 mg Amiloride Hydrochloride BP (as dihydrate) and 25.00 mg Hydrochlorothiazide BP.
'Synuretic 50' contains 5.69 mg Amiloride Hydrochloride BP (as dihydrate) and 50.00 mg Hydrochlorothiazide BP.
Both strengths contain the following inactive ingredients: lactose, calcium hydrogen phosphate, maize starch, pregelatinised maize
starch, sodium starch glycollate and magnesium stearate.
Both strengths are cream coloured tablets engraved SYNURETIC on one side.
Both strengths are available 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.
The manufacturer of Synuretic is either:
DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE or Meridian Healthcare (UK) Ltd, Rich Industrial
Estate, Chatfield Road, off York Road, Battersea, London SW11 3SE.
The Product Licence holder is:
Chelonia Healthcare Limited, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus
How does Synuretic work?
Synuretic belongs to a group of medicines known as potassium-sparing diuretics which increase the amount of urine you pass but
without loss of potassium.
Why have you been prescribed Synuretic?
Your doctor has prescribed this medicine for you because he considers that you have one of the following conditions:
• Hypertension (high blood pressure).
• Heart failure.
• Hepatic cirrhosis with ascites (liver disease causing accumulation of fluid in the abdomen).
If you are not sure why you have been prescribed Synuretic, then please ask your doctor.
Before taking your medicine
Before taking this medicine, tell your doctor if:
• You have ever had any unusual or allergic reactions to Synuretic or any of the other ingredients in the tablet.
• You have experienced sensitive reactions to either Amiloride or Hydrochlorothiazide, or any other drugs used to lower your
blood pressure or increase the amount of urine you pass.
• You are allergic to any foods, preservatives or dyes.
• You are pregnant, planning a baby, or are breastfeeding.
• You are taking potassium supplements, or eat a lot of potassium-rich foods such as bananas, prunes and raisins.
• You have an intolerance to some sugars, including lactose.
The presence of other medical conditions may affect the use of Synuretic. Inform your doctor and do not use Synuretic you have
any of the following conditions:
• Too much potassium (hyperkalaemia) or calcium (hypercalcaemia) in the blood
• Difficulty passing urine
• Kidney failure or severe kidney disease
• Diabetic kidney disease
• Severe liver disease
• Addision's disease (a disorder characterised by a reduction in secretion of hormones from a gland called the adrenal cortex,
causing a reduction in blood volume, blood pressure, muscular weakness and a reduction in the level of red blood cells).
It is also important to let your doctor know if you suffer from any of the following conditions:
• Liver or kidney disease
• Lung problems (including asthma)
• Skin rashes or a condition known as Lupus erythematosus
If you undergo any medical tests, particularly tests to determine whether you are diabetic, make sure the person conducting the
tests is aware that you are taking Synuretic.
This medicine should not be taken by anyone under 18 years of age.
Use in pregnancy and while breast-feeding
If you are pregnant, planning a baby or breast-feeding do not take this medicine.
Can you take Synuretic with other medicines?
There are some medicines that can interfere with Synuretic. It is very important to tell your doctor or pharmacist about all the
medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a
prescription from the pharmacy or elsewhere. Your doctor will be able to identify medicines you should not take with Synuretic.
This medicine will add to the effect of other medicines that lower blood pressure, such as timolol and methyldopa.
Synuretic tablets should not be taken with:
• Other potassium-sparing diuretics, e.g. triamterene or Spironololactone )
• Lithium (used for psychiatric problems)
Synuretic tablets may interact with the following medicines:
• Other sulphonamide drugs
• Other diuretics - (water tablets)
• Certain other medicines for heart conditions (including ACE inhibitors e.g. Captopril; Angiotensin- II receptor antagonists e.g.
Losartan; and medicines for irregular or rapid heartbeat e.g. sotalol).
• Ciclosporin or tacrolimus - used in organ transplants
• Amisulpride, pimozide or sertindole - for mental disorders.
• The group of drugs known as barbiturates, which includes phenobarbitone, amylobarbitone, butobarbitone, pentobarbitone.
• The group of drugs known as narcotics which include morphine and others
• NSAIDs - used to relieve pain, e.g. indometacin or ibuprofen
• Theophylline - for asthma
• The anti-fungal agents amphotericin or fluconazole
• Adrenaline - to raise blood pressure
• Reboxetine and other medicines used to treat depression
• Corticosteriods e.g.prednisolone
• Chlorpropramide - for diabetes
• Carbemazipine - for epilepsy
• Sources of potassium, calcium and vitamin D
• Toremifene or cisplatin - used to treat particular types of cancer
• Carbenoxolone for stomach problems including ulcers
• Medicines known as anion-exchange resins which are used for reducing cholesterol levels
• The contraceptive pill
When and how to take Synuretic tablets
Synuretic tablets should be taken by mouth and only in the doses prescribed by your doctor. Your dosage will depend upon your
response to treatment and whether you are taking other medicines. Do not take more of it, and do not take it more often or for a
longer time than your doctor ordered.
Usual doses are stated below:
Hypertension (high blood pressure): Usually ½ Synuretic 50 tablet or 1 Synuretic 25 tablet once a day.
The dose may be increased by your doctor to 1 Synuretic 50 tablet or 2 Synuretic 25 tablets if necessary.
Synuretic may be prescribed alone or together with other blood pressure lowering drugs such as methyldopa or timolol maleate.
Congestive heart failure: Initially ½ Synuretic 50 tablet or 1 Synuretic 25 tablet a day, which will be adjusted as required but not
exceeding 2 Synuretic 50 tablets or 4 Synuretic 25 tablets a day.
Hepatic cirrhosis with ascites (liver disease causing accumulation of fluid in the abdomen): Initially 1 Synuretic 50 tablet or 2
Synuretic 25 tablets a day, which will be adjusted as required but not exceeding 2 Synuretic 50 tablets or 4 Synuretic 25 tablets a
Your doctor may want to reduce your dose later on when your symptoms are under control.
Elderly: The doses are the same as for adults but particular care should be taken to ensure that an increase in potassium in the
blood does not occur. Your doctor will do blood tests at regular intervals to check potassium levels.
What to do if too many tablets are taken at the same time
If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take
any remaining tablets with you and keep in the original container or packaging so that they can be identified
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take two doses at once. If you feel
that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check
with your doctor. Your doctor will prescribe the lowest dose necessary to control your symptoms.
What side effects can Synuretic cause?
Along with its needed effects, the medicine may cause some unwanted effects. Common side effects among these include:
Headache, weakness, fatigue, malaise (feeling generally unwell), chest pain, back pain, fainting attacks; irregular heartbeat, rapid
heartbeat, feeling of dizziness and weakness when standing after a sitting position; angina pectoris, flatulence and thirst.
An imbalance of chemicals (such as sodium potassium, chlorine and magnesium) in your body.
Do not drive or operate machinery if affected by weakness, tiredness or dizziness.
Other side effects include:
• Loss of appetite, nausea, vomiting, diarrhoea, constipation, abdominal pain, changes in appetite, abdominal fullness, bleeding
from the digestive system, hiccups.
• Gout, dehydration.
• Rash, itching, sudden feeling of warmth and redness of the skin known as flushing.
• Muscle cramps, joint pain, neck ache, pains in hands and feet.
• Dizziness, falling to one side (vertigo), tingling sensation in the arms, fingers, legs and toes, partial loss of consciousness.
• Insomnia (difficulty in sleeping), nervousness, mental confusion, depression, sleepiness.
• Cough, difficulty in breathing.
• Bad taste, visual disturbances, nasal congestion.
• Reduced loss of sexual desire, difficulty in passing urine, or uncontrolled passing of urine, increased passing of urine at night.
• Previously existing stomach or duodenal ulcer may be aggravated, yellowing of whites of eyeballs or skin (jaundice).
• Dry mouth, loss of hair, increased sweating.
• Synuretic can reduce the number of certain types of blood cells. If you get a bad sore throat or high fever, or become gradually
more tired and pale, or notice bruises or nose bleeds, stop taking Synuretic and contact your doctor.
• Ringing in the ears, increased eyeball pressure.
• Kidney inflammation
If you notice any of the above reactions or side effects, or if you notice other unusual or worrying changes contact your
Storing your medicine
You must keep this medicine in a safe place where children cannot get hold of it. Your medicine could harm them.
Store below 25°C in a dry place. Keep containers securely closed. Keep the tablets in the containers in which they were given to
On the label you will find the words "Expiry Date" followed by numbers indicating the month and year.
This is the date when the medicine is no longer fit for use. Do not use Synuretic after this date, but return it to your doctor or
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 No's: 33414/30 and 0031
This leaflet was revised in January 2009.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.