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Co-flumactone (Spironolactone, hydroflumethiazide)

How does it work?

Co-flumactone tablets contain two active ingredients; spironolactone, which is a type of medicine called a potassium-sparing diuretic and hydroflumethiazide, which is a type of medicine called a thiazide diuretic.

Spironolactone works by blocking the actions of a hormone in the body called aldosterone. This hormone is produced by glands found above the kidneys called the adrenal glands. Aldosterone acts in the kidneys, where it is involved in controlling the balance of salt and water in the body. Blocking the action of aldosterone causes the kidneys to increase the amount of salts such as sodium that they filter out of the blood and into the urine.

Hydroflumethiazide works by directly causing the kidneys to increase the amount of salts such as potassium and sodium that are filtered out of the blood and into the urine.

When these salts are filtered out of the blood by the kidneys, water is also drawn alongside. Both these diuretics therefore increase the amount of water that is drawn out of the blood and into the urine. This helps excess fluid to be removed from the body.

Removing water from the blood decreases the volume of fluid circulating through the blood vessels. The drop in fluid volume results in a drop in the pressure of the fluid within the blood vessels, which helps to lower high blood pressure. It also decreases the effort required by the heart to pump blood around the body.

If used alone, hydroflumethiazide can cause the level of potassium in the blood to drop too low (hypokalaemia). Spironolactone on the other hand prevents potassium loss. It is included in this medicine not only to improve the effectiveness of hydroflumethiazide, but also to prevent excessive potassium loss that this diuretic might otherwise cause.

This medicine is used in heart failure, where the pumping mechanism of the heart is less effective. Heart failure can cause fluid to build up in the lungs, causing breathlessness and in the lower limbs, causing swollen ankles. Diuretic medicines are used to remove this excess fluid into the urine. This relieves the symptoms of heart failure and also makes it easier for the heart to pump the blood around the body.

What is it used for?

  • Congestive heart failure.

How do I take it?

  • The number of tablets to be taken daily will vary depending on your symptoms, but the number prescribed by your doctor should be taken once daily, in the morning.
  • Co-flumactone tablets should be swallowed with a drink of water. They should be taken with food.
  • As diuretics cause your kidneys to produce more urine, you may find that if you take a dose too late in the day that you need to get up in the night to visit the toilet. For this reason, it is recommended that you take this medicine in the morning. Seek further advice from your doctor or pharmacist.

Warning!

  • This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activities, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
  • While taking this medicine you may need to have regular blood tests to monitor your kidney function and the levels of salts such as potassium and sodium in your blood.
  • If you experience any of the following symptoms while taking this medicine you should inform your doctor promptly, so that the amount of fluids and salts in your body can be checked: thirst, lethargy, confusion, weakness, drowsiness, muscle cramps, scanty production of urine, abnormal heart rhythm, seizures, nausea and vomiting.
  • This medicine can cause the amount of potassium in your bloodstream to increase. For this reason you should avoid consuming large amounts of foods that have a high potassium content, for example dried fruit, bananas, tomatoes and 'low sodium' salt, while you are taking the medicine. You should also avoid potassium supplements.

Use with caution in

  • Elderly people.
  • Decreased liver function.
  • Decreased kidney function.
  • Diabetes.
  • People with a high level of uric acid in their blood (hyperuricaemia).
  • Gout.
  • An inflammatory disease of connective tissue (systemic lupus erythematosus).
  • People with high levels of fats (lipids) such as cholesterol and triglycerides in the blood (hyperlipidaemia).
  • Hereditary blood disorders called porphyrias.

Not to be used in

  • Kidney failure.
  • People whose kidneys are not producing urine.
  • People allergic to thiazide diuretics.
  • People allergic to medicines from the sulphonamide group, eg the antibiotic sulfamethoxazole.
  • People with a high level of calcium in their blood (hypercalcaemia).
  • People with a high level of potassium in their blood (hyperkalaemia).
  • People with inadequate production of natural steroid hormones by the adrenal glands (Addison's disease).

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • This medicine should not be used during pregnancy unless the expected benefit to the mother is greater than the possible risks to the developing baby. Seek further medical advice from your doctor.
  • This medicine passes into breast milk. It is not recommended for mothers who are breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

  • Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
  • Tiredness and feeling weak.
  • Headache.
  • Confusion.
  • Sleepiness.
  • Dizziness.
  • A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
  • Breast pain.
  • Abnormal enlargement of breasts in men (gynaecomastia).
  • Irregular menstrual cycle.
  • Changes in sex drive.
  • Leg cramps.
  • Raised level of uric acid in the blood (hyperuricaemia) which can cause kidney problems and gout.
  • Raised level of potassium in the blood (hyperkalaemia).
  • Raised level of calcium in the blood (hypercalcaemia).
  • Decreased amount of sodium in the blood (hyponatraemia).
  • Raised levels of fats such as cholesterol in the blood.
  • Decreased numbers of white blood cells, red blood cells or platelets in the blood.
  • Excessive hair growth (hypertrichosis).
  • Increased hair growth on the face (hirsutism).
  • Skin reactions such as rash, photosensitivity, hive-like rash.
  • Hair loss.
  • Kidney failure.
  • Liver problems.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

This medicine is likely to have an additive effect with other medicines that decrease blood pressure, particularly medicines that are used to treat high blood pressure (antihypertensives). This may cause dizziness, which can usually be relieved by lying down until the symptoms pass. If you feel dizzy while taking this medicine in combination with other medicines that can lower blood pressure you should let your doctor know, as your doses may need adjusting. Other medicines that decrease blood pressure include the following:

  • ACE inhibitors, eg enalapril
  • aldesleukin
  • alpha-blockers such as prazosin
  • alprostadil
  • angiotensin II receptor antagonists such as losartan
  • antipsychotics such as chlorpromazine
  • benzodiazepines, eg temazepam, diazepam
  • baclofen
  • beta-blockers such as propranolol
  • calcium-channel blockers such as verapamil, nifedipine.
  • clonidine
  • diazoxide
  • other diuretics, eg furosemide (if this medicine is used with other diuretics there may also be a greater chance of the level of sodium or potassium in your blood falling too low)
  • dopamine agonists, eg bromocriptine, apomorphine
  • hydralazine
  • levodopa
  • MAOI antidepressants, eg phenelzine
  • methyldopa
  • minoxidil
  • moxisylyte
  • moxonidine
  • nicorandil
  • nitrates, eg glyceryl trinitrate
  • tizanidine.

Since spironolactone can raise the level of potassium in the blood, Aldactide tablets should not be used in combination with other potassium-sparing diuretics or with potassium supplements, as this can cause the level of potssium in the blood to rise too high. The following medicines can also raise the level of potassium in the blood and if you take any of these with Aldactide the level of potassium in your blood should be regularly monitored:

  • ACE inhibitors, eg captopril
  • aliskiren
  • angiotensin-II receptor antagonists, eg losartan
  • ciclosporin
  • co-trimoxazole
  • drospirenone
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin
  • potassium-containing salt substitutes, eg Lo-salt
  • potassium salts, eg potassium citrate for cystitis
  • tacrolimus
  • trilostane
  • trimethoprim.

Hydroflumethiazide can decrease the amount of potassium in the blood. If Aldactide is used in combination with any of the following medicines, which can also lower potassium in the blood, the level of potassium in your blood could fall too low (hypokalaemia):

  • acetazolamide
  • amphotericin
  • corticosteroids, such as hydrocortisone and prednisolone
  • beta 2 agonists, eg salbutamol, terbutaline
  • other diuretics, eg furosemide
  • theophylline.

If the level of potassium in your blood falls during treatment, this can increase the risk of side effects on the heart from various other medicines, including digoxin, certain antipsychotics and medicines for abnormal heart rhythms (anti-arrhythmics), eg amiodarone.

Hydroflumethiazide can increase the amount of calcium in your blood. If you are taking calcium or vitamin D supplements, or regularly take large amounts of calcium-containing antacids, your doctor may want to monitor the level of calcium in your blood. Taking occasional antacids should not cause any problems.

Hydroflumethiazide and spironolactone both reduce the ability of the body to remove the medicine lithium, which can cause the level of lithium in the blood to rise too high. If you are taking lithium your lithium level should be checked after you start and stop treatment with this medicine, as well as after any dose changes. Your lithium dose may need adjusting.

Spironolactone may increase the level of another medicine used in heart failure called digoxin.

Colestipol and colestyramine reduce the absorption of diuretics from the gut and can make them less effective. If you take either of these medicines they should not be taken within four hours of taking Aldactide tablets.

The following medicines may reduce the diuretic effect of this medicine:

  • carbenoxolone
  • corticosteroids, such as dexamethasone or prednisolone
  • oestrogens, such as those in the contraceptive pill
  • regular use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or indomethacin (occasional painkilling doses are unlikely to have a significant effect).

Other medicines containing the same active ingredients

Aldactide