What are Calvepen 666 mg tablets used for

spiro-ct 100 mg tablets

Pharmacological groupPotassium saving agents

All information

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CT Arzneimittel GmbH

What is it and what is it used for?

What Spiro-CT 100 mg tablets is and what it is used for
Spiro-CT 100 mg tablets is a potassium-sparing diuretic / aldosterone antagonist
of:
CT-Arzneimittel GmbH
Lengeder Str.42a, 13407 Berlin
Telephone: 0 30 90 08-0, Fax: 0 30 90 08-21
www.ct-arzneimittel.de
Spiro-CT 100 mg tablets is used for
- primary aldosteronism, unless surgery is indicated
- Edema and / or ascites in diseases associated with secondary aldosteronism
How and when should you take Spiro-CT 100 mg tablets?
The tablets should be swallowed whole with sufficient liquid (preferably 1 glass of water).

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What do you need to consider before use?

Spiro-CT 100 mg tablets must not be taken
- if you are allergic (hypersensitive) to spironolactone or any of the other ingredients of Spiro-CT 100 mg tablets
- if there is no urine excretion (anuria)
- in acute kidney failure
- with severe renal impairment (renal insufficiency with a creatinine clearance below 30 ml / min per 1.73 m2 body surface or with a serum creatinine above 1.8 mg / dl)
- if there is an increased potassium content in the blood (hyperkalaemia)
- if you have a sodium deficiency (hyponatremia)
Take special care with Spiro-CT 100 mg tablets
- if you suffer from a minor degree of kidney function impairment (serum creatinine between 1.2 and 1.8 mg / dl or creatinine clearance between 60 and 30 ml / min)
- in patients who are prone to acidosis and / or hyperkalaemia as a result of their underlying disease (e.g. diabetes mellitus).
- if you have very low blood pressure (hypotension)
- if the amount of blood in circulation is reduced (hypovolaemia)
Particularly careful medical supervision is required for the diseases listed above.
Simultaneous use of spironolactone and potassium-sparing diuretics, potassium substituents or ACE inhibitors can lead to life-threatening hyperkalemia. The combination of the above drugs with spironolactone is therefore generally not recommended.
Treatment with Spiro-CT 100 mg tablets requires regular monitoring of serum sodium, serum potassium, serum creatinine and the acid-base status. Close monitoring of the serum potassium level is necessary in the case of impaired kidney function with serum creatinine values ​​between 1.2 and 1.8 mg / dl or a creatinine clearance below 60 ml / min per 1.73 m2 of body surface and when using spiro CT 100 mg tablets in combination with other drugs that can lead to an increase in the potassium level (see also under 2.3? Interactions with other drugs?).
Spironolactone can interfere with certain diagnostic tests (e.g. RIA determination of digoxin serum concentration).
a) children
Because of the high content of active ingredients, Spiro-CT 100 mg tablets are not suitable for use in children.
b) Elderly people
In the elderly, attention should be paid to a possible impairment of kidney function (see above).
c) pregnancy
Spironolactone should not be taken during pregnancy as there are indications of hormonal disorders in male and female offspring due to the active ingredient spironolactone.
d) Breastfeeding
Spironolactone should not be taken during breastfeeding or breastfeeding should be discontinued if it is necessary to use spironolactone, as the active ingredient or its breakdown product passes into breast milk.
e) ability to drive and use machines
Even when used as intended, this medicinal product can change the ability to react to such an extent that the ability to actively participate in road traffic, to operate machines or to work without a secure footing is impaired. This applies to a greater extent at the start of treatment, when the dose is increased and when the drug is changed, as well as in conjunction with alcohol.
f) Important warnings about certain components of Spiro-CT 100 mg tablets
This medicine contains lactose. Therefore, please only take Spiro-CT 100 mg tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

How is it used?

How to take Spiro-CT 100 mg tablets
Always take Spiro-CT 100 mg tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.
type of application
Oral tablets.
How long should you take Spiro-CT 100 mg tablets?
The practicing doctor will decide about the length of the treatments. It should be limited to the shortest possible period. The need for long-term therapy should be checked regularly.
Children should not be given Spiro-CT 100 mg tablets for more than 30 days.
If you take more Spiro-CT 100 mg tablets than you should
If you suspect an overdose with Spiro-CT 100 mg tablets, inform your doctor immediately. He will decide on any necessary measures based on the symptoms. Immediate medical treatment is required in the event of severe symptoms.
Possible signs of an overdose may be drowsiness and confusion, or cardiac arrhythmias due to disturbances in the electrolyte and fluid balance.
If it was taken only a short time ago, attempts can be made to reduce further systemic uptake of the active ingredient by measures such as inducing vomiting, gastric lavage or administration of activated charcoal.
If you forget to take Spiro-CT 100 mg tablets
Do not take a double or multiple amount after a forgotten single dose, but continue the treatment with the prescribed dose.
Effects of stopping treatment with Spiro-CT 100 mg tablets
Do not interrupt or end the treatment with Spiro-CT 100 mg tablets without consulting your doctor!

What are the possible side effects?

Interactions with other means
Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
The combination of non-steroidal anti-inflammatory substances with spironolactone can lead to hyperkalemia.
The use of spironolactone in combination with potassium salts (e.g. potassium chloride) with substances that reduce the excretion of potassium (potassium-sparing diuretics such as triamterene or amiloride) or with ACE inhibitors can lead to an increase in the serum potassium level that can be severe life-threatening hyperkalemia (too high potassium levels in the blood). (See also 2.2? Take special care when taking Spiro-CT 100 mg tablets ?.)
If ACE inhibitors, furosemide and spironolactone are used at the same time, acute kidney failure can occur.
Spironolactone and carbenoxolone can mutually impair the effect of one another. Larger amounts of licorice act like carbenoxolone in this regard.
Simultaneous administration of non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, indomethacin) can weaken the diuretic effect of spironolactone.
Simultaneous use of digoxin and spironolactone can lead to increased digoxin blood levels.
Neomycin can delay the absorption of spironolactone.
Please note that this information can also apply to recently used drugs.
What side effects are possible?
Like all medicines, Spiro-CT 100 mg tablets can have side effects.
When evaluating side effects, the following frequencies are used as a basis:

very oftenmore than 1 in 10 people treated
oftenless than 1 in 10 but more than 1 in 100 patients
occasionallyless than 1 in 100 but more than 1 in 1000 patients
Rareless than 1 in 1000 but more than 1 in 10,000 patients
very rareless than 1 in 10,000 people, including isolated cases

Side effects
Blood and lymphatic system disorders
Occasionally, decreases in the platelet count (thrombocytopenia) due to antibodies induced by spironolactone, eosinophilia in patients with liver cirrhosis and a severe decrease in certain white blood cells with a tendency to infections and severe general symptoms (agranulocytosis) have occurred.
Hormonal diseases
In women, spironolactone can lead to increased hairiness of the male type (hirsutism) and a deepening of the pitch of the voice, in men to an increase in the pitch of the voice and impotence.
Metabolism and nutrition disorders
Very often - especially in patients with impaired kidney function - threatening increases in potassium levels (hyperkalaemia) occur, which can lead to cardiac arrhythmias and paralysis (hyperkalaemic paralysis).
A sodium deficiency (hyponatremia) can occur especially after an extensive intake of water while taking spironolactone. Electrolyte changes may manifest as cardiac arrhythmias, fatigue, general muscle weakness, muscle cramps (e.g., calf cramps), or dizziness.
Spironolactone can induce or worsen metabolic acidification of the blood (hyperchloraemic metabolic acidosis). There may be a reversible increase in nitrogen-containing substances in the urine. An increase in the uric acid level is often observed.
Nervous system disorders
Often headaches, drowsiness, disorders of the movement sequences (ataxia) and states of confusion can occur.
Heart disease
An undesirable drop in blood pressure can occur. The occurrence of circulatory disorders with reduced blood pressure when changing from lying down to standing (orthostatic regulation disorders) has been described.
Gastrointestinal disorders
Gastrointestinal disorders (nausea, vomiting, diarrhea, gastrointestinal cramps), bleeding of the gastric mucosa and gastrointestinal ulcers can occur with spironolactone.
Liver and biliary diseases
Liver-damaging effects (hepatotoxicity) with an increase in liver enzymes and histologically proven liver inflammation (hepatitis) have been described very rarely.
Skin and subcutaneous tissue disorders
Skin reddening, hives (urticaria), erythema annulare, as well as lupus erythematosus, lichen planus-like skin changes and hair loss (alopecia) have been described very rarely.
Musculoskeletal, connective tissue and bone diseases
Softening of the bones (osteomalacia) has been described very rarely.
Reproductive system and breast disorders
A reversible increase in the size of the male breast (gynecomastia) is very common in men. In women, painful swellings of the breast (mastodynia), intermenstrual bleeding and the absence of menstrual bleeding (amenorrhea) have been described. The occurrence of these side effects is dose-dependent.
Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.

How should it be stored?

Store drug out of reach of children.
Do not use the medicine after the expiry date which is stated on the blister pack and the folding box.
Status of information:
April 2005
CT-Arzneimittel wishes you a speedy recovery!
Version code: Z04

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