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Spironolactone Ceva - Patient leaflet, side effects, dosage

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Spironolactone Ceva

________

  • 16. MARKETING AUTHORISATION NUMBER(S)

EU/2/07/074/007

EU/2/07/074/008

EU/2/07/074/009

  • 17. MANUFACTU­RER’S BATCH NUMBER

Lot: {number}

  • 10. EXPIRY DATE

EXP: {month/year}

Partially used tablets to be used within 7 days.

  • 11. SPECIAL STORAGE CONDITIONS

Store partially used tablets in the original blister.


  • 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PROD WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

  • 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if ap plic able

For animal treatment only – to be supplied only on veterinary

on.


EU/2/07/074/002 (18 blisters of 10 tablets)


EU/2/07/074/0j3 (3 blisters of 10 tablets)

EU/2/07/074/J04 (18 blisters of 10 tablets)

EU/2/07/G74/J05 (3 blisters of 10 tablets)

EU/2'07/074/006 (18 blisters of 10 tablets)


MANUFACTURER’S BAT­CH NUMBER


ot: {number}


PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Bottle of 30 tablets

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs spironolactone


2. QUANTITY OF THE ACTIVE SUBSTANCE(S)




PACKAGE LEAFLET

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs


  • 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne

France

Tel: + 33 (0) 5 57 55 40 40

Fax : + 33 (0) 5 57 55 41 98


Manufacturers for batch release:

Ceva Santé Animale Z.I. Très le Bois 22600 Loudéac Fran­ce

Catalent Germany Schorndorf GmbH Steinbeistrasse 2 D-73614 Schorndorf Germany


  • 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs

Spironolactone


3. STATEME



E ACTIVE SUBSTANCE AND OTHER INGREDIENT


Spironolactone Ceva 10 mg contains 10 mg spironolactone

Spironolactone Ceva 40 mg contains 40 mg spironolactone

Spironolactone Ceva 80 mg contains 80 mg spironolactone

4.

CATION


ironolactone Ceva tablets are used in combination with standard therapy (including diuretic support, ere necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.

  • 5. CONTRAINDI­CATIONS

Do not use in dogs suffering from hypoadrenocor­ticism, hyperkalaemia or hyponatraemia.

Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dys­function).

Do not use during pregnancy or lactation.


Do not use in animals used for, or intended for use in breeding.

. (

  • 6. ADVERSE REACTIONS

A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


  • 7. TARGET SPECIES


Dogs.

  • 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral use.

Administer 2 mg/kg of body weight of spironolactone once daily.

Number of tablets

Bodyweight

Spironolacto ne Ceva 10 mg

Spironolactone Ceva 40 mg

Spironolactone Ceva 80 mg

1 to 2.5 kg

2.5 to 5 kg

5 to 10 kg

10 to 15 kg

2^ 3

15 to 20 kg

1

20 to 30 kg

1 + /

30 to 40 kg

1

40 to 50 kg

1 + %

50 to 60 kg

1 + /

  • 9. ADVICE ON CORRECT ADMINISTRATION

The veterinary medicinal product should be administered with food. The tablet can either be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding. The tablets contain beef flavouring to improve palatability, and a study conducted in healthy dogs showed that they were voluntarily and fully consumed 75% of the time.

  • 10. WITHDRAWAL PERIOD


  • 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Use within 2 months after first opening the bottle.

Partially used tablets should be stored in the original bottle.

Do not use after the expiry date which is stated on the carton after EXP.

  • 12. SPECIAL WARNING(S)

Special precautions for use in animals

Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and Angiotensin Converting Enzyme (ACE) inhibitors. Unlike in humans, an increased incidence of hyperkalaemia (raised blood potassium levels) was not observed in studies in dogs with this combination. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.

Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.

Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see section „Contraindica­tions“).

As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the veterinary medicinal product to growing dogs.

As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the veterinary medicinal product in dogs with liver dysfunction.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

May cause skin sensitisation: people with known hypersensitivity to spironolactone should avoid contact with the veterinary medicinal product. Wash hands after use.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation, laboratory studies in species (rat, mouse, rabbit and monkey) have shown evidence of developmental toxicity.


Interactions

Furosemide and pimobendan have been used together with Spironolactone Ceva in dogs with heart failure without any clinical evidence of adverse reactions.

Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.

The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone. Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc) may potentially lead to hyperkalaemia (see section „Special precautions for use in animals“).

Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.

Overdose

After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dosedependent adverse effects were noted (see section „Adverse Reactions“).

In case of an accidental massive ingestion by the dog, there is no specific antidote or treatment. It is therefore recommended to induce vomiting, gastric lavage (depending on risk assessment) and monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.

  • 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

  • 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (EMA)

  • 15. OTHER INFORMATION


Pack size:

Bottle containing 30 tablets packed in a cardboard box.


Not all pack sizes may be marketed.

Pharmacodynamic properties

Spironolactone and its active metabolites (including 7a-thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.

Spironolactone is a natriuretic drug (historically described as a soft diuretic). In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.

The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure. The result is an improvement in heart function.

In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone. Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.

In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.

In a clinical study investigating the survival time in dogs with congestive heart failure, there was a 65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in combination with standard therapy compared to dogs treated with standard therapy alone. (Mortality was classified as death or euthanasia due to heart failure).

When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “aldosterone escape”.

A slight increase in aldosterone blood levels may be observed in animals on treatment. This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.

There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.

PACKAGE LEAFLET FOR


Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs


  • 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER A THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR B RELEASE, IF DIFFERENT



Marketing authorisation holder :


Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne

France

Tel: + 33 (0) 5 57 55 40 40

Fax : + 33 (0) 5 57 55 41 98


Manufacturers for batch release:


Ceva Santé Animale Z.I. Très le Bois 22600 Loudéac Fran­ce


Catalent Germany Schorndorf GmbH

Steinbeistrasse 2 D-73614 Schorndorf

Germany


  • 2. NAME OF THE VETERINA


DICINAL PRODUCT



Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs


Spironolactone

3. STATEM


F THE ACTIVE SUBSTANCE AND OTHER INGREDIENT


Spironolactone Ceva 10 mg contains 10 mg spironolactone

Spironolactone Ceva 40 mg contains 40 mg spironolactone

Spironolactone Ceva 80 mg contains 80 mg spironolactone


ICATION


pironolactone Ceva tablets are used in combination with standard therapy (including diuretic support, here necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.

  • 5. CONTRAINDI­CATIONS

Do not use in dogs suffering from hypoadrenocor­ticism, hyperkalaemia or hyponatraemia.

Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dys­function).

Do not use during pregnancy or lactation.


Do not use in animals used for, or intended for use in breeding.

. (

  • 6. ADVERSE REACTIONS

A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


  • 7. TARGET SPECIES


Dogs.

  • 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral use.

Administer 2 mg/kg of body weight of spironolactone once daily.

Number of # tablets

Bodyweight

Spironolacto ne Ceva 10 mg

Spironolactone Ceva 40 mg

Spironolactone Ceva 80 mg

1 to 2.5 kg

2.5 to 5 kg

5 to 10 kg

10 to 15 kg

2^ 3

15 to 20 kg

1

20 to 30 kg

1 + /

30 to 40 kg

1

40 to 50 kg

1 + %

50 to 60 kg

1 + /

  • 9. ADVICE ON CORRECT ADMINISTRATION

The veterinary medicinal product should be administered with food. The tablet can either be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding.

  • 10. WITHDRAWAL PERIOD

    bined treatment


  • 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Partially used tablets should be stored in the original blister and used within 7 days.

Do not use after the expiry date which is stated on the carton and blister label after EXP.

  • 12. SPECIAL WARNING(S)

Special precautions for use in animals

Kidney function and serum potassium levels should be evaluated before initiati with spironolactone and Angiotensin Converting Enzyme (ACE) inhibitors. Unlike in humans, an increased incidence of hyperkalaemia (raised blood potassium levels) was not observed in studies in dogs with this combination. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.

Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.

Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see section „Contraindica­tions“).

As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the veterinary medicinal product to growing dogs.

As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the veterinary medicinal product in dogs with liver dysfunction.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

May cause skin sensitisation: people with known hypersensitivity to spironolactone should avoid contact with the veterinary medicinal product. Wash hands after use.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation, laboratory studies in species (rat, mouse, rabbit and monkey) have shown evidence of developmental toxicity.

Interactions

Furosemide and pimobendan have been used together with Spironolactone Ceva in dogs with heart failure without any clinical evidence of adverse reactions.

Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.

The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone. Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc) may potentially lead to hyperkalaemia (see section „Special precautions for use in animals“).

Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.

Overdose

After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dosedependent adverse effects were noted (see section „Adverse Reactions“).

In case of an accidental massive ingestion by the dog, there is no specific antidote or treatment. It is therefore recommended to induce vomiting, gastric lavage (depending on risk assessment) and monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.


  • 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WAST MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  • 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (EMA)

  • 15. OTHER INFORMATION

Sources: Original PDF (ema.europa.eu)

Frequently Asked Questions

What is Spironolactone Ceva used for?

Spironolactone Ceva is primarily used to treat conditions like high blood pressure, heart failure, and certain types of edema. It's also prescribed for hormonal issues, such as hirsutism in women.

How does Spironolactone Ceva work in the body?

Spironolactone Ceva works by blocking the action of aldosterone, a hormone that causes the body to retain sodium and water. This helps to reduce fluid overload and lower blood pressure.

Can I take Spironolactone Ceva if I'm pregnant?

Before taking Spironolactone Ceva during pregnancy, consult your doctor. It may not be safe for use during pregnancy as it can affect fetal development.

Are there any common side effects of Spironolactone Ceva?

Yes, some common side effects include dizziness, headache, gastrointestinal disturbances, and changes in menstrual cycles. Always report severe side effects to your healthcare provider.

How should I store Spironolactone Ceva?

Store Spironolactone Ceva at room temperature away from moisture and heat. Ensure it's kept out of reach of children.

Can I drink alcohol while taking Spironolactone Ceva?

It’s best to limit alcohol consumption while taking Spironolactone Ceva, as alcohol can affect blood pressure and increase the risk of side effects.

What should I do if I miss a dose of Spironolactone Ceva?

If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not double up.

Is there a specific diet I should follow while on Spironolactone Ceva?

While on Spironolactone Ceva, it's advisable to monitor your sodium intake and maintain a balanced diet. Always consult your doctor or nutritionist for personalized advice.

Can children take Spironolactone Ceva?

Spironolactone Ceva is sometimes prescribed for children with certain conditions but should only be taken under strict medical supervision. Consult your pediatrician.

Will Spironolactone Ceva affect my potassium levels?

Yes, Spironolactone can increase potassium levels in the blood. Regular monitoring may be necessary to prevent hyperkalemia (high potassium levels).

What happens if I overdose on Spironolactone Ceva?

An overdose may lead to severe symptoms such as confusion, irregular heartbeat, or muscle weakness. Seek emergency medical attention if you suspect an overdose.

Can I take other medications alongside Spironolactone Ceva?

Always inform your doctor about all medications you're taking, including over-the-counter drugs and supplements, as some can interact with Spironolactone.

How long does it take for Spironolactone Ceva to work?

Patients typically start noticing an effect within a few days; however, it may take several weeks for the full benefits to be experienced.

Does Spironolactone Ceva cause weight gain or loss?

Some patients may experience weight gain due to fluid retention reversal while others may lose weight as excess fluid is expelled from the body.

Is regular monitoring required while taking Spironolactone Ceva?

Yes, regular check-ups with your healthcare provider are essential to monitor kidney function and electrolyte levels during treatment.

Can I stop taking Spironolactone Ceva suddenly?

You should not stop taking Spironolactone abruptly without consulting your doctor, as this could worsen your condition or lead to withdrawal symptoms.

Are there alternatives to Spironolactone Ceva for my condition?

Yes, there are alternative medications available for conditions treated by Spironolactone. Consult your healthcare provider for options tailored to your needs.

What lifestyle changes can enhance the effectiveness of Spironolactone Ceva?

Incorporating regular exercise, a healthy diet low in salt and rich in fruits and vegetables, and managing stress can help enhance treatment effectiveness.

Is it safe to use over-the-counter pain relievers while on Spironolactone Ceva?

Some over-the-counter pain relievers can affect kidney function when taken with diuretics like Spironalcatones; always check with your healthcare provider first.