Fludrocortisone Acetate Tablets USP 0.1 mg Taj pharma

1.Name of the medicinal product

Fludrocortisone Acetate Tablets USP 0.1 mg Taj pharma

2.Qualitative and quantitative composition

Each tablet contains:
Fludrocortisone acetate 0.1 mg
Excipients q.s.

Excipient(s) with known effect:

Each tablet also contains lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet

White to off-white round tablet.

4. Clinical particulars

4.1 Therapeutic indications

For partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome.

4.2 Posology and method of administration

Adults:

A daily dosage range of 0.05-0.3mg Fludrocortisone Acetate tablets orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid effect is desirable, cortisone or hydrocortisone by mouth should be given concomitantly with Fludrocortisone Acetate tablets.

Elderly:

No specific dosage recommendations (See 4.4 Precautions).

Children:

May be used adjusted to the age and weight of the child according to the severity of the condition. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases. (See 4.3 Contraindications).

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Systemic infections unless specific anti-infective therapy is employed.

Because of its marked effect on sodium retention, the use of Fludrocortisone Acetate in the treatment of conditions other than those indicated, is not advised.

Since Fludrocortisone Acetate is a potent mineralocorticoid both the dosage and salt intake should be carefully monitored to avoid the development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy.

Precautions:

Fludrocortisone Acetate is a potent mineralocorticoid and is used predominantly for replacement therapy. Although glucocorticoid side effects may occur, these can be reduced by reducing the dosage.

Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (See dosage section).

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. Patients on long-term systemic therapy with Fludrocortisone Acetate may require supportive corticosteroid therapy in times of stress (such as trauma, surgery or severe illness) both during the treatment period and up to a year afterwards. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage and the duration of treatment.

Anti-inflammatory/immunosuppressive effects:

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

Chickenpox, shingles and measles are of particular concern since these illnesses may be fatal in immunosuppressed patients. Patients should be advised to avoid exposure to these diseases, and to seek medical advice without delay if exposure occurs.

Chickenpox: Unless they have had chickenpox, patients receiving oral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should preferably be given within 3 days of exposure, and not later than 10 days after exposure to chickenpox. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Measles: Prophylaxis with normal immunoglobulin may be needed.

During corticosteroid therapy antibody response will be reduced and therefore affect the patient’s response to vaccines. Live vaccines should not be administered.

4.4 Special warnings and precautions for use

Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

Recent intestinal anastomoses, diverticulitis, thrombophlebitis, existing or previous history of severe affective disorders (especially previous steroid psychosis), exanthematous disease, chronic nephritis, or renal insufficiency, metastatic carcinoma, osteoporosis (post-menopausal females are particularly at risk); in patients with an active peptic ulcer (or a history of peptic ulcer). Myasthenia gravis. Latent or healed tuberculosis; in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics. In acute psychoses; in acute glomerulonephritis. Hypertension; congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver failure.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Corticosteroid effects may be enhanced in patients with hypothyroidism or decreased in hyperthyroid patients.

Corticosteroid effects may be enhanced in patients with cirrhosis.

Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Menstrual irregularities may occur, and this possibility should be mentioned to female patients.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies.

Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Children:

Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible.

Elderly:

The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Fludrocortisone Acetate tablets contain lactose monohydrate. Patients with rare heredity problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalemia.

Anticholinesterases: Effects of anticholinesterase agents may be antogonised.

Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.

Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.

Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.

CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, include oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic Enzyme Inducers (e.g. aminoglutethemide, barbiturates, carbamazepine, phenytoin, primidone, rifabutin, rifampicin): There may be increased metabolic clearance of Fludrocortisone Acetate. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.

Human growth hormone: The growth-promoting effect may be inhibited.

Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.

Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.

Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated. (See 4.4 Special Warnings and Special Precautions for Use.)

4.6 Fertility, pregnancy and lactation

Pregnancy

It may be decided to continue a pregnancy in a woman requiring replacement mineralocorticoid therapy, despite the risk to the foetus. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.

There is evidence of harmful effects in pregnancy in animals. There may be a small risk of cleft palate and intra-uterine growth retardation. Hypoadrenalism may occur in the neonate. Patients with pre-eclampsia or fluid retention require close monitoring.

Breast-feeding

Corticosteroids are found in breast milk.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy or during breast feeding should be carefully observed for signs of hypoadrenalism. Maternal treatment should be carefully documented in the infant’s medical records to assist in follow up.

Fertility

There are insufficient fertility data available to indicate whether fludrocortisone acetate has any effect on fertility.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Where adverse reactions occur they are usually reversible on cessation of therapy. The incidence of predictable side-effects, including hypothalamic-pituitary-adrenal suppression correlate with the relative potency of the drug, dosage, timing of administration and duration of treatment (See Warnings and Precautions). Patients should be watched closely for the following adverse reactions which may be associated with any corticosteroid therapy:

Anti-inflammatory and immunosuppressive effects: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (See Warnings and Precautions).

Fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, cardiac arrhythmias or ECG changes due to potassium deficiency, hypokalaemic alkalosis, increased calcium excretion and hypertension.

Musculoskeletal: muscle weakness, fatigue, steroid myopathy, loss of muscle mass, osteoporosis, avascular osteonecrosis, vertebral compression fractures, delayed healing of fractures, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones and spontaneous fractures, tendon rupture.

Gastrointestinal: dyspepsia, peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distension and ulcerative oesophagitis, candidiasis.

Hypersensitivity: Anaphylatic reactions, angiodema, rash, pruritus and urticaria, particularly where there is a history of drug allergies.

Dermatologic: impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lupus erythematosus-like lesions and suppressed reactions to skin tests.

Neurological: euphoria, psychological dependence, depression, insomnia, convulsions, increased intracranial pressure with papilloedema (pseudo-tumour cerebri) usually after treatment, vertigo, headache, neuritis or paraesthesias and aggravation of pre-existing psychiatric conditions and epilepsy.

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.

Endocrine/metabolic: menstrual irregularities and amenorrhoea; development of the Cushingoid state; suppression of growth in childhood and adolescence; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (eg. trauma, surgery or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycaemic agents in diabetes, weight gain. Negative protein and calcium balance. Increased appetite.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.

Others: necrotising angiitis, thrombophlebitis, thromboembolism, leucocytosis, insomnia and syncopal episodes.

Eye disorders: Vision, blurred (see also section 4.4)

Withdrawal Symptoms and Signs: On withdrawal, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss may occur. Too rapid a reduction in dose following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (See Warnings and Precautions).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

4.9 Overdose

A single large dose should be treated with plenty of water by mouth. Careful monitoring of serum electrolytes is essential, with particular consideration being given to the need for administration of potassium chloride and restriction of dietary sodium intake.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Mineralocorticoids

Qualitatively, the physiological action of fludrocortisone acetate is similar to hydrocortisone. In very small doses, fludrocortisone maintains life in adrenalectomised animals, enhances the deposition of liver glycogen and produces thymic involution, eosinopenia, retention of sodium and increased urinary excretion of potassium.

5.2 Pharmacokinetic properties

Fludrocortisone is rapidly and completely absorbed after oral administration. Man, dog, rat, monkey and guinea-pig were studied after i.v. and intraduodenal administration. Depending on species, 50% or more of the steroid remained unchanged 30 minutes after administration. Fludrocortisone is hydrolysed to produce the non-esterified alcohol; after administration of the acetate, only the non-esterified alcohol is detectable in blood. The blood level reaches a peak between 4 and 8 hours. The highest blood level after i.v. administration to human volunteers was 1.7 hours.

Elimination half life after i.v. administration was 30 minutes in dogs and in human volunteers. Following administration of the acetate to dogs, the blood concentration shows a triphasic decline and each phase may represent the elimination of a metabolite.

Fludrocortisone is widely distributed throughout the body. It is 70 to 80% bound to serum proteins, mainly to the globulin fractions. The concentrations ratio of the drug in CSF to that in plasma was 1:6 in human volunteers.

In rats, most of a dose is excreted in the bile, and in dogs and guinea-pigs most of the dose is excreted in the urine. In human volunteers, excretion through urine was about 80%, and it was concluded that about 20% were excreted by a different route. It is likely that, as for the metabolism of other steroids, excretion into the bile is balanced by re-absorption in the intestine and some part is excreted with the faeces.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.Pharmaceutical particulars

6.1 List of excipients

Sodium starch glycolate, Lactose monohydrate, Talc, Magnesium stearate

6.2 Incompatibilities

None applicable.

6.3 Shelf life

24 months

6.4 Special precautions for storage

Store below 30 °C. Store in the original package in order to protect from light.

6.5 Nature and contents of container

PVC/PVdC/Al blisters. Available in pack sizes of 30, 50 and 100 tablets.

6.6 Special precautions for disposal and other handling

No special requirement.

7. Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Fludrocortisone Acetate 0.1 mg Tablets Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Fludrocortisone Acetate 0.1 mg tablet is a steroid medicine prescribed for many different conditions, including serious illnesses.
You need to take it regularly to get the maximum benefit.
Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
Fludrocortisone Acetate 0.1 mg tablet can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.
Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).
If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

What is in this leaflet

1. What Fludrocortisone Acetate is and what it is used for
2. What you need to know before you take Fludrocortisone Acetate Tablets
3. How to take Fludrocortisone Acetate Tablets
4. Possible side effects
5. How to store Fludrocortisone Acetate Tablets
6. Contents of the pack and other information

What Fludrocortisone Acetate is and what it is used for

Fludrocortisone Acetate tablets belong to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Fludrocortisone Acetate tablets) is an effective way to treat various illnesses involving inflammation (swelling) in the body. Fludrocortisone Acetate tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Fludrocortisone Acetate is used to replace the hormones that are normally produced by glands attached to your kidneys. These hormones will not be produced by your body if you suffer from a condition called Addison’s disease.

Fludrocortisone Acetate is also used to treat a condition called ‘salt losing adrenogenital syndrome’ which is a different form of hormone imbalance.

2. What you need to know before you take Fludrocortisone Acetate Tablets

Do not take Fludrocortisone Acetate tablets:

If you are allergic to Fludrocortisone Acetate or any of the ingredients of this medicine (listed in section 6).
If you are suffering from an infection and are not taking any prescribed medication for it.
If you have a peptic ulcer, active tuberculosis or a mental illness in which you lose touch with reality and are unable to think and judge clearly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fludrocortisone Acetate if:

you have or have recently had any bacterial, viral or fungal infection that is not being treated
you have or ever have had tuberculosis
you have had any intestinal, bowel disorder or stomach ulcer
you have an infection or inflammation of the veins in your leg (thrombophlebitis)
you have had any mental disorders or epilepsy
you have had any kidney, liver or thyroid problems
you have recently suffered from any form of cancer
you have thin or brittle bones (osteoporosis)
you have myasthenia gravis (a disease which causes weak muscles) or any other muscle weakness
you have high blood pressure or heart failure
you or someone in your family has glaucoma (increased pressure in your eyes)
you are diabetic as your insulin dose may need to be changed or have a family history of diabetes
you have a skin rash typically caused by viral infection (e.g. measles)
you have muscle damage caused by steroid treatment
you are elderly (over 65 years old) as you may be more susceptible to side effects (see section 4 Possible side effects)
you are younger than 18 years old, as Fludrocortisone Acetate may lead to slowing of growth
you are suffering from stress (such as trauma, surgery or severe illness), as you may require supportive corticosteroid therapy both during the treatment period and for a year afterwards
you are to have or have had intestinal surgery
Contact your doctor if you experience blurred vision or other visual disturbances.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Fludrocortisone Acetate tablets.
If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Fludrocortisone Acetate tablets.

Steroid medicines suppress your body’s natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor as soon as possible.

Your doctor may want to send you for blood tests from time to time and check your salt intake regularly to make sure you do not develop high blood pressure, fluid retention or become overweight.

Other medicines and Fludrocortisone Acetate

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking or being treated for:

Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as corticosteroids can increase the chance of bleeding from the gut.
Any antifungals (e.g. ketoconazole, amphotericin)
Warfarin or other medicines to thin the blood
Oral contraceptive pill or hormone replacement therapy (HRT)
Human growth hormone
Muscle relaxants e.g. atracurium. These drugs are used during anaesthesia for surgery. Please inform your anaesthetist if you’re on Fludrocortisone Acetate.
A medicine called cyclosporin
Barbiturates. These drugs are used as sedatives (to produce a calming effect), as hypnotics (to produce sleep), or as an adjunct in anesthesia.
Some medicines may increase the effects of Fludrocortisone Acetate and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
High blood pressure (e.g. sodium phenylbutyrate, clonidine, methyldopa, ACE inhibitors, α and ß-blockers, angiotensin II receptor antagonists, calcium-channel blockers and diuretics)
Irregular heartbeat (e.g. digoxin)
Epilepsy or other sorts of fits (e.g. phenytoin, primidone, carbamazepine)
Tuberculosis (TB) (e.g. isoniazid, rifampicin, rifabutin)
Diabetes
Thyroid problems
Anti-progestogenic steroids (e.g. mifepristone)
Cushing’s syndrome (e.g. aminoglutethimide)
Glaucoma (e.g. acetazolamide)
Intestinal pain (e.g. hyoscine)
Asthma and Chronic Obstructive Pulmonary Disease (e.g. tiotropium)
Urinary retention (e.g. doxazosin)
Alzheimer’s dementia (e.g. donepezil, galantamine)
Myasthenia Gravis (e.g. neostigmine)

While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any vaccination without consulting your doctor.

If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.

Pregnancy and breast feeding

If you are pregnant, planning to become pregnant, or if you are breast-feeding you should make sure you discuss this with your doctor before taking Fludrocortisone Acetate.

Driving and using machines

Fludrocortisone Acetate has not been shown to impair your ability to drive or operate machinery.

Fludrocortisone Acetate contains lactose monohydrate

This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.

Steroid Treatment Card

Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse – before having any surgery or emergency treatment or if any new treatment is prescribed.

Dentist – before having any dental surgery

Pharmacist – before buying any medicine

Optician – it is advisable to have regular eye tests

3. How to take Fludrocortisone Acetate Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. You should check with them if you are not sure.

This medicine is for oral use.

Adults and the Elderly:

To treat Addison’s Disease the usual daily dose range is: 0.05 mg (one-half tablet) to 0.3 mg (3 tablets) to be taken once a day. Patients on long term treatment may require the addition of a different type of steroid tablet during times of illness or stress.

To treat Adrenal hyperplasia the usual daily dose range is: 0.1mg (one tablet) to 0.2mg (2 tablets).

Children:

The dose is adjusted according to size and weight but is always kept as low as possible.

Make sure you take the full course as prescribed by your doctor. Do not suddenly stop taking Fludrocortisone Acetate as this may make you ill.

If you take more Fludrocortisone Acetate than you should:

If you take too much of your medicine seek immediate medical advice from your doctor or your nearest hospital. Take the container and any remaining medicine with you.

If you forget to take Fludrocortisone Acetate:

If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not take a double dose.

Mental problems while taking Fludrocortisone Acetate:

Mental health problems can happen while taking steroids like Fludrocortisone Acetate tablets (see also section 4 Possible Side Effects).

These illnesses can be serious.
Usually they start within a few days or weeks of starting the medicine.
They are more likely to happen at high doses.
Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are presented in order of severity. The most severe side effects are listed first.

Stop taking Fludrocortisone Acetate tablets and contact your doctor straight away/immediately if the following happen as these may be signs of an allergic reaction (hypersensitivity reaction including anaphylaxis):

Difficulty breathing
Swelling of the face, lips or tongue
Severe pains in your stomach or abdomen
Skin rash

Serious effects – Tell your doctor straight away:

Steroids including fludrocortisone acetate can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Fludrocortisone Acetate.

Feeling depressed, including thinking about suicide.
Feeling high (mania) or have moods that go up and down.
Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Tell your doctor if the following occur:

An increased susceptibility to infections (lowered resistance to infections)
Infection of the veins in the legs
Blood clots (thromboembolism)
Thrush (white patches) or fungal infections (or sores in your mouth)
Muscle weakness, pain or wasting, tendon rupture (where muscles connect to bones)
Bone problems, including thinning or wasting or fractures and delays in bone healing
Pancreatitis (inflammation of the pancreas) which causes severe pain in the abdomen and back
Diverticulitis which is an inflammatory condition which may cause abdominal pain or diarrhoea
Ulcers of the stomach or intestine (which can lead to perforation or bleeding), pain or burning in your stomach or esophagus
Ulcers of the windpipe (pain in your windpipe)
Indigestion
Swelling of the stomach (feeling full or bloated)
Increased appetite
Skin problems including thinning of the skin and eye, bruising, facial redness, stretch marks, increased facial hair, acne
Poor wound healing
Increased sweating
Reactions to skin tests may be reduced
Heart failure (shortness of breath with activity, or after lying down for a while)
Irregular heartbeats
High blood pressure
Epilepsy or seizures
Fainting
Diarrhoea
Vertigo (spinning feeling)
Fits
Sleep problems
Headaches
Pins and needles
Severe blood loss
Increased number of white cells or other blood disorders
Irregular or absent periods
Failure to grow
Water and sodium (salt) retention
Glaucoma
Clouding of the lens (cataract)
Problems with vision
Infection of the cornea
Problems in the way your body manages your glucose levels including diabetes
Changes in your body’s mineral levels for example, calcium
High blood sugar levels
Tired
Weight gain
An imbalance in your body’s sodium, potassium or chloride levels
Low blood urea nitrogen levels
Problems with your endocrine system, which controls your hormones, including those which regulate your body’s growth and metabolism. Symptoms include increased appetite, weight gain, sweating and tiredness
Decreased pituitary function (a change in the levels of some hormones, mineral balance or protein in blood tests)
Hormone imbalance causing Cushing’s Syndrome (typical symptoms: a round face often called a ‘moon face’, upper body weight gain and rash on the face)
Increase in blood clotting
Blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see below). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fludrocortisone Acetate Tablets

Keep all medicines out of the sight and reach of children.

Store below 30 °C. Keep the tablets in the original container in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and blister as [EXP MM/YYYY]. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fludrocortisone Acetate Tablets contain:

The active substance (the ingredient that makes the tablets work) is fludrocortisone acetate. Each tablet contains 100 micrograms of the active ingredient.

The tablets also contain sodium starch glycolate, lactose monohydrate, talc and magnesium stearate.

What Fludrocortisone Acetate Tablets looks like and contents of the pack:

Fludrocortisone Acetate 0.1 mg Tablets are white to off-white round tablets.

Fludrocortisone Acetate tablets are available in boxes of 30, 50 and 100 tablets.

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Fludrocortisone Acetate Tablets USP 0.1 mg Taj pharma