25 mg, 50 mg and 100 mg film-coated tablets
spironolactone
Read this leaflet carefully before you start using this medicine. It contains information that is important to you.
– Save this information, you may need to read it again.
– If you have further questions, ask your doctor or pharmacist.
– This medicine has been prescribed only for you. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
– If you get any side effects , talk to a doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this information. See section 4.
In this leaflet you will find information on:
1. What Spironolactone Accord is and what it is used for
2. What you need to know before taking Spironolactone Accord
3. How to take Spironolactone Accord
4. Possible side effects
5. How to store Spironolactone Accord
6. Contents of the packaging and other information
1. What Spironolactone Accord is and what it is used for
The active ingredient in these tablets is spironolactone . Spironolactone belongs to a group of drugs called aldosterone antagonists, which counteract the effect of the hormone et aldosterone . One of the functions of aldosterone is to ensure that the body retains sodium (salt). It forms part of a system that regulates the body’s balance of fluids and salts (RAAS, the renin – angiotensin -aldosterone system). Spironolactone promotes the excretion of urine in patients who have an accumulation of fluid in the tissues ( edema ) or in the abdominal cavity ( ascites) by increasing the amount of sodium excreted in the urine. The loss of potassium that can occur due to the use of certain diuretics ( diuretics ) is reduced. The blood pressure-lowering effect is dependent on the excretion of water and salt.
Spironolactone Accord can be prescribed by a doctor for the treatment of:
- fluid accumulation in the tissues as a result of heart disease
- Moderate to severe heart failure (NYHA class III-IV)
- elevated blood pressure , in addition to a salt-free diet and diuretic drugs
- certain kidney diseases
- fluid accumulation in the tissues in the abdominal cavity
Spironolactone Accord can also be used during medical examinations to confirm the presence of diseases in which too much aldosterone is produced in the adrenal cortex (a condition called Conn’s disease), and to treat these diseases.
Children should only be treated by a paediatrician.
The spironolactone contained in Spironolactone Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you take Spironolactone Accord
Do not take Spironolactone Accord
- if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6).
- if you have severely impaired kidney function or if your kidney disease worsens rapidly or suddenly, which may mean that no urine or very little urine is produced.
- if you have low levels of sodium in your blood ( hyponatremia )
- if you have hyperkalemia (increased potassium levels in the blood) or other conditions that may occur in association with hyperkalemia .
- if you are taking potassium-sparing diuretics (including eplerenone) or potassium supplements or if you have a double blockade of the RAAS due to a combination of two antihypertensive drugs: an ACE inhibitor (angiotensin-converting enzyme inhibitor) and an ARB (angiotensin receptor blocker).
Children
Children with moderate to severe kidney disease must not take Spironolactone Accord.
Take special care with Spironolactone Accord
- if you have a kidney disease, this applies especially to children with high blood pressure . The doctor will check you regularly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Spironolactone Accord
- if you need to use Spironolactone Accord for a longer period, your doctor will do regular checks (eg checking the levels of potassium and sodium in your blood), especially if you are elderly.
- if you have liver disease, your doctor will use caution when treating you
- if you have kidney disease, your doctor will use caution when treating you
- if you have an elevated level of potassium in your blood or impaired kidney function, treatment with Spironolactone Accord is not recommended (see also “Do not take Spironolactone Accord”)
- if you have severely impaired kidney function and are being treated with potassium supplements, as severe hyperkalaemia can occur which can lead to cardiac arrest (sometimes fatal)
- if you are using certain diuretic medicines called potassium-sparing diuretics (eg amiloride and triamterene) simultaneous use with Spironolactone Accord is not allowed because the risk of very high levels of potassium in the blood ( hyperkalemia ) increases
- for long-term use of Spironolactone Accord in young patients, the doctor should carefully weigh the benefits against the long-term disadvantages.
- Concomitant administration of Spironolactone Accord with certain medicines, potassium supplements and foods high in potassium can cause severe hyperkalaemia (increased level of potassium in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
Tell your doctor if any of the above warnings apply to you, or if they have ever applied to you.
Other medicines and Spironolactone Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor may change your dose of Spironolactone Accord if you are taking any of the following:
- medicines for high blood pressure including ACE inhibitors and medicines called ganglion blocking medicines
- other diuretic medicines
- non-steroidal anti-inflammatory drugs ( NSAIDs ), e.g. aspirin and ibuprofen
- potassium supplements
- heparin or low molecular weight heparin (medicines used to prevent blood clots)
- drugs that inhibit the blood’s ability to clot ( anticoagulants , blood thinners), norepinephrine (an agent with a stimulating effect on certain parts of the nervous system)
- lithium (used to treat depression)
- digoxin (used to treat various heart conditions)
- alcohol, barbiturates (e.g. used in epilepsy ), or narcotics
- medicines known to cause hyperkalaemia (increased levels of potassium in the blood)
- cholestyramine (used to reduce cholesterol levels in the blood)
- corticosteroids , ACTH (adrenocorticotropic hormone , used in various epileptic conditions)
- ammonium chloride (e.g. found in licorice)
- ciclosporin (used after transplant)
- trimethoprim and trimethoprim-sulfamethoxazole
- if you are using abiraterone to treat prostate cancer
Spironolactone Accord with food
The effect of Spironolactone Accord is not affected by food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Spironolactone should not be used during pregnancy.
Spironolactone should only be used during pregnancy if absolutely necessary.
If you are breast-feeding, you should discuss the use of spironolactone with the doctor, who will advise you to consider another method of feeding the baby while taking this medicine.
If you are planning to have children, you should be aware that spironolactone can induce impotence and irregular menstruation.
Driving ability and use of machinery
Side effects such as dizziness, headache and confusion can sometimes occur when using Spironolactone Accord. If this happens, do not drive or use machinery.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure
Spironolactone Accord contains lactose
The medicine contains lactose . If you have an intolerance to certain sugars, you should consult your doctor before taking this medication
3. How to take Spironolactone Accord
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
The recommended dose is 100 mg daily, as a single dose or multiple doses . Dosage for adults varies from 25 mg to 400 mg of spironolactone per day. If you do not know how much to take, ask your doctor or pharmacist for advice.
The tablets should be taken with a meal. If the total dose is more than 100 mg per day, the dose must be given as divided doses spread throughout the day.
Use for children
The recommended dose is 3 mg per kg of body weight daily, in several divided doses . To make it easier for children to take the tablets, they can first be crumbled or crushed and then dissolved in a glass of water by stirring.
Older
Elderly patients should start with the lowest possible dose which is gradually increased until the desired effect is achieved. Caution and regular medical check-ups are recommended, especially in case of impaired renal function.
Remember to take the medicine. You get the best effect if you take the tablets at the same time every day. It also helps you remember to take the tablets.
If you have taken too much Spironolactone Accord
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, immediately contact a doctor, pharmacist, hospital or the Poison Information Center (tel. 112) for an assessment of the risk and advice.
Keep the packaging so that healthcare professionals know which medicine you have taken. Symptoms of overdose may include nausea and vomiting and, in rare cases, drowsiness, confusion, rash or diarrhoea. Disturbances of the fluid and salt balance and dehydration may occur.
If you forget to take Spironolactone Accord
If you have forgotten to take a dose , take it as soon as you remember, provided it is not soon time to take the next dose . If it is almost time to take the next dose , do not take the missed dose , but instead continue according to the treatment schedule. Do not take a double dose to make up for a missed dose . Ask your doctor or pharmacist if you are unsure.
If you stop using Spironolactone Accord
If you stop taking Spironolactone Accord, the original symptoms may return. Always contact a doctor if you want to stop using this medicine.
If you have any further questions about this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Side effects depend on dose and duration of treatment.
The most common side effects are hyperkalemia and problems in the reproductive organs and mammary gland, including gynecomastia (enlarged mammary glands in men). Gynecomastia appears to be related to both dose level and duration of treatment, and usually returns to normal when treatment is discontinued. Other very common side effects are headache, indigestion, diarrhea, fatigue and sleepiness.
Very common (may affect more than 1 in 10 users)
- Hyperkalemia in patients with severely impaired renal function who are simultaneously receiving treatment with potassium supplements
- Headache
- Indigestion, diarrhea
- Men: decreased libido (sex drive), erection problems ( impotence ), enlargement of mammary glands ( gynecomastia )
- Women: mammary gland problems, breast tenderness, menstrual disorders, darker voice (irreversible in many cases)
- Fatigue, sleepiness
Common (may affect up to 1 in 10 users)
- Low levels of sodium in the blood ( hyponatremia occurs mainly during combined intensive treatment with diuretics called thiazide diuretics), hyperkalemia in:
– patients with severe renal impairment,
– patients receiving treatment with ACE inhibitors or potassium chloride,
– the elderly,
– diabetic patients . - Nausea and vomiting
- Women: changes in vaginal secretions (e.g. discharge), decreased libido (sex drive), absence of periods ( amenorrhea ), postmenopausal bleeding (abdominal bleeding after menopause)
- Weakness, sleepiness (lethargy) in patients with cirrhosis ( cirrhosis ), tingling, itching or tickling for which there is no cause ( paresthesia )
- General weakness
Uncommon (may affect up to 1 in 100 users)
- Acid poisoning in the blood ( acidosis ) in patients with liver problems
- Confusion
- Skin rash, hives ( urticaria ), redness of the skin ( erythema ), chloasma (pigmented spots on the skin, especially on the face), generalized itching
- Muscle cramps
- Leg cramps
- Elevated levels of serum creatinine
Rare (may affect up to 1 in 1,000 users)
- Very serious abnormalities in the content of the blood (lack of white blood cells ) accompanied by sudden high fever, severe throat pain and mouth ulcers ( agranulocytosis ), other abnormalities in the content of the blood (lack of platelets ) accompanied by bruising and a tendency to bleed ( thrombocytopenia )
- Allergic reactions
- Insufficient fluid in the tissues (dehydration), metabolic disease ( porphyria ), temporary increase in nitrogen levels in the blood and urine, increased levels of uric acid in the blood (hyperuricemia). This can lead to gout attacks (joint inflammation) in sensitive patients.
- Paralysis, bilateral paralysis (paraplegia) in e.g. arms and legs due to hyperkalemia
Very rare (may affect up to 1 in 10,000 users)
- Breast cancer
- Inflammation of blood vessel walls ( vasculitis )
- Stomach inflammation, peptic ulcer , intestinal bleeding, cramps
- Liver inflammation ( hepatitis )
- Hair loss ( alopecia ), eczema , EAC (annular erythema)
- Systemic lupus erythematosus ( SLE , a disease in which the immune system attacks various organs in the body)
- Acute renal failure
- Increased hair growth (hypertrichosis)
- Softening of bone tissue ( osteomalacia )
Has been reported (occurring in an unknown number of users)
- Mild androgenic effects (development of male characteristics), including hirsutism (strongly increased hair growth that is hormonally determined)
- In some patients with decompensated liver cirrhosis (severe symptoms/complications of cirrhosis), reversible hyperchloraemic metabolic acidosis (disturbed acid-base balance with low blood pH ) and usually also abnormally high levels of potassium in the blood have been reported. This has also occurred in cases where kidney function was normal.
- Dizziness, coordination difficulties ( ataxia )
- Slight lowering of blood pressure et
- Itching and blistering of the skin around the lips and the rest of the body (Stevens-Johnson syndrome)
- Detachment of the upper skin layer from the lower skin layers over the entire body ( toxic epidermal necrolysis )
- Skin rash, fever and swelling (which can be symptoms of something more serious, drug-induced rash and changes in blood count and systemic symptoms)
- Pemphigoid (a condition that causes fluid-filled blisters on the skin)
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Swedish Medicines Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase information about drug safety.Postal address
5. How to store Spironolactone Accord
Keep this medicine out of the sight and reach of children.
No particular storage temperature. Store in the original packaging. Light sensitive.
Use before the expiry date stated on the carton and blister after EXP or EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
6. Contents of the packaging and other information
Contents declaration
- The active substance is spironolactone . Spironolactone Accord contains 25 mg, 50 mg or 100 mg of spironolactone .
- Other ingredients are:
Tablet core:Lactose monohydrate , pregelatinized corn starch, anhydrous calcium hydrogen phosphate, povidone K25, peppermint oil, purified talc, colloidal anhydrous silica, magnesium stearate (E470b).
Coating:Hypromellose, macrogol, titanium dioxide (E171).
Appearance and package sizes of the medicine
Spironolactone Accord 25 mg film-coated tablets are white to off-white, round, biconvex tablets debossed with “AD” on one side and plain on the other side. The 25 mg tablet has a diameter of approximately 8.1 mm.
Spironolactone Accord 50 mg film-coated tablets are white to off-white, round, biconvex tablets debossed with “AE” on one side and plain on the other side. The 50 mg tablet has a diameter of approximately 10.1 mm.
Spironolactone Accord 100 mg film-coated tablets are white to off-white, round, biconvex tablets debossed with “AF” on one side and plain on the other side. The 100 mg tablet has a diameter of approximately 11.2 mm.
The tablets are packed in PVC/aluminium blisters and HDPE cans.
Pack sizes:
Blisters: 20, 28, 30, 50, 60, 90 and 100 tablets.
HDPE cans: 250, 500 and 1000 tablets (intended for hospital use and dose dispensing only).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands