Spironolactone

• Used to treat high blood pressure, oedema and heart failure
• Diuretic (water tablet)
• Take at set times
• Not to be used while pregnant

Spironolactone belongs to a particular group of medicines known as aldosterone antagonists, which inhibit the action of the hormone aldosterone. One of the functions of aldosterone is to ensure that the body retains sodium. It forms part of a system that regulates the balance of fluids and salts in the body.

Spironolactone promotes the excretion of urine in patients in whom there is an accumulation of fluid in the tissues (oedema) or in the abdominal cavity (ascites) by increasing the amount of sodium (salt)

excreted in the urine. Potassium loss as a possible consequence of using certain diuretics is reduced. The antihypertensive (blood pressure-lowering) effect relies on the excretion of water and salt.

Spironolactone tablets may be prescribed by your doctor for the treatment of:

Accumulation of fluid in the tissues as a result of heart disorders.
Severe heart failure (NYHA III-IV).
Raised blood pressure as an adjunct to a salt-free diet and diuretics.
Certain kidney disorders.
Accumulation of fluid in the tissues in the abdominal cavity caused by a liver condition.
How to take Spironolactone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is:

• Adults: The recommended dose is 100 mg daily, administered as one or several doses. The adult dose varies from 25 mg to 200 mg Spironolactone Teva a day. Dosage should be determined by a doctor.
  You should take the tablets with meals. If the total dose is more than 100 mg per day, the dose must be administered in divided doses spread throughout the day.
• Children: The recommended dose is 3 mg per kg body weight daily, in several divided doses.
  In order to make it easier for children to take, the tablets may first be ground or crushed and then suspended in a glass of water by stirring.
• Elderly: It is recommended that elderly patients should be started on the lowest possible dose, increasing this gradually until the desired effect is achieved.
  Caution and regular medical checks are advised, especially in the event of renal impairment.

The tablets should be taken at the same time each day with plenty of water. Spironolactone can be taken with or without food.

If you take more or less Spironolactone than you should/stop taking Spironolactone

If you have taken more Spironolactone tablets than you should, contact your doctor or pharmacist immediately.

If you have forgotten to take a dose, take it as soon as possible unless it is almost time to take the next dose, in which case you should not take the forgotten dose, but continue according to the schedule prescribed. Do not take a double dose to make up for a forgotten dose.

Always contact your doctor if you want to stop using the medicine.

Spironolactone is not suitable for everyone. Do not take this medicine if:

• You are allergic to spironolactone or any of the other ingredients of this medicine (see section ‘What Spironolactone contains').
• You suffer from severely impaired kidney function or from a sudden or rapidly deteriorating
• kidney disease, including cases in which no urine, or very little urine, is being produced.
• You have low blood sodium levels (hyponatraemia).
• You have hyperkalaemia (raised blood potassium levels), or any other conditions associated with hyperkalaemia.
• You are taking potassium-sparing diuretics (including eplerenone) or potassium supplements, or dual-RAAS blockade with the combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB). (Both medicines are used to treat high blood pressure.)

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking this medicine if:

• You are taking Spironolactone Teva in combination with certain medicines, potassium supplements or food rich in potassium. This may lead to severe hyperkalaemia (increased potassium blood level).
• You need to use Spironolactone Teva tablets for a long time; your doctor should perform
• regular follow-up checks.
• You have a liver disorder.
• You have a raised level of potassium in the blood or impaired kidney function; administration of Spironolactone Teva is not advised.
• You have severe renal dysfunction which is being simultaneously treated with potassium
• supplements, since severe hyperkalaemia can occur which can result in cardiac arrest.
• You use certain diuretics, called potassium-sparing diuretics. Concomitant use with Spironolactone tablets is contra-indicated, because the risk of excessively high levels of potassium in the blood (hyperkalaemia) is increased.
• In the case of long-term treatment of young patients with Spironolactone Teva tablets, your
• doctor should weigh the advantages carefully against the long-term disadvantages.

Pregnancy, breastfeeding and fertility

Spironolactone should not be used during pregnancy.

Spironolactone should only be used during breastfeeding if clearly needed.

Spironolactone may induce impotence and menstrual irregularities.

Other medicines and Spironolactone

Medicines and dietary supplements may interact with Spironolactone. Your doctor may wish to alter your dose of Spironolactone Teva tablets if you are taking any of the following:

• Medicines for high blood pressure including ACE inhibitors, ganglion-blocking drugs.
• Other diuretics.
• Non-steroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen.
• Potassium supplements.
• Heparin or low molecular weight heparin (medicines used to prevent blood clots).
• Medicines that inhibit blood coagulation (anticoagulants, ‘blood thinners’).
• Noradrenaline (an agent with a stimulant effect on a particular part of the nervous system).
• Lithium (used to treat depression).
• Digoxin (used in the treatment of various heart conditions).
• Alcohol, sedatives (barbiturates) or anaesthetics (narcotics).
• Medicines known to cause hyperkalaemia (raised blood potassium levels).
• Cholestyramine (used for reducing cholesterol levels in the blood).
• Corticosteroids, ACTH (prescribed for different epileptic conditions).
• Ammonium chloride (e.g., in liquorice).
• Trimethoprim and trimethoprim-sulfamethoxazole.

Tell your doctor or pharmacist if you are taking, have recently taken or might take these medicines. For more information about the above warnings, see the package leaflet.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are some of the side effects that are known to be associated with this medicine.

Very common:

• Excessively high levels of potassium in the blood (hyperkalaemia) in patients with severe renal dysfunction who are receiving concomitant treatment with potassium supplements.
• Headache.
• Indigestion, diarrhoea.
• Men: reduced libido, erectile dysfunction, impotence, enlargement of the mammary glands
• (gynaecomastia).
• Women: breast disorders, tenderness of the breasts, menstrual disorders, deepening of the voice (in many cases irreversible).
• Fatigue, sleepiness.

Common:

• A reduced level of sodium in the blood (hyponatraemia) or an increased level of potassium in the blood (hyperkalaemia), in particular in patients with severe renal dysfunction, patients receiving treatment with ACE inhibitors or potassium chloride, the elderly, and diabetic patients.
• Nausea and vomiting.
• Women: changes in vaginal secretions, reduced libido, absence of periods (amenorrhoea), postmenopausal bleeding.
• Weakness, somnolence (lethargy) in patients with cirrhosis, sensations of tickling, itching or tingling for which there is no cause (paraesthesia).
• General weakness.

For a list of uncommon and rare side effects, please see the package leaflet. Consult your doctor or pharmacist if you experience these or other side effects.

What ingredients are in this medicine?

• The active substance is spironolactone. Spironolactone tablets contain 25 mg, 50 mg or 100 mg spironolactone.
• The other ingredients are maize starch, cellulose microcrystalline (E460), povidone (E1201), calcium sulphate dihydrate (E516), magnesium stearate (E572), peppermint oil.

The manufacturer of Spironolactone Teva is:

Pharmachemie BV
Swensweg 5
2031 GA Haarlem
The Netherlands

Read the package leaflet before use. You can download the official package leaflet of Spironolactone Teva here.