Bentelan

Patient information leaflet

Bentelan 0.5 mg effervescent tablets

Betamethasone (as disodium phosphate)
Please read all of this leaflet carefully before you or your child take this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bentelan is and what it is used for
2. What you need to know before taking or giving Bentelan to your child
3. How to take or give Bentelan to your child
4. Possible side effects
5. How to store Bentelan
6. Contents of the pack and other information

1. What Bentelan is and what it is used for

Bentelan contains the active substance betamethasone, which belongs to a group of medicines called corticosteroids. Bentelan is a hormonal medicine belonging to the class of glucocorticoids.
Bentelan is indicated for the treatment of a wide range of diseases, including the main ones listed below:

• bronchial asthma
• severe allergic diseases
• chronic and autoimmune joint inflammation (rheumatoid arthritis)
• inflammatory connective tissue diseases of the skin and mucous membranes (collagenoses)
• inflammatory skin disorders
• lymphatic system tumours such as:
  • acute and chronic malignant lymphoproliferative disorders
  • Hodgkin's disease

Bentelan is also indicated for the treatment of other diseases:

• severe kidney disease (nephrotic syndrome)
• chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
• autoimmune diseases of the skin and mucous membranes characterized by blister formation (pemphigus)
• a disease characterized by granuloma formation in various organs and tissues (sarcoidosis)
• heart inflammation associated with rheumatic fever (rheumatic carditis)
• chronic autoimmune inflammatory disease of the spine (ankylosing spondylitis)
• blood disorders such as:
  • reduced number of red blood cells due to their destruction (haemolytic anaemia)
  • reduced number of a specific type of white blood cells (agranulocytosis)
  • blood coagulation disorder due to reduced platelets (thrombocytopenic purpura)

2. What you should know before taking or administering Bentelan to a child

Do not take or administer Bentelan to the child if you or the child:

• are allergic to betamethasone, other corticosteroid medicines, or any of the other ingredients of this medicine (listed in section 6);
• have infections affecting the entire body and are not receiving specific treatment for them;
• are receiving vaccinations with attenuated viruses or other types of vaccines.

Warnings and precautions
Talk to your doctor or pharmacist before taking or administering Bentelan to the child.
Inform your doctor before taking or administering Bentelan to the child, if you or the child:

• have phaeochromocytoma (a tumour of the adrenal gland)
• have a serious heart condition (congestive heart failure)
• suffer from psychological or emotional disorders, as these conditions may worsen during treatment with Bentelan
• have epilepsy
• have diabetes
• have increased eye pressure (glaucoma)
• have chronic inflammation of the final part of the intestine (ulcerative colitis)
• have an abscess or an infection
• have inflammation of the diverticula, small naturally occurring or formed pouches in the terminal part of the intestine (diverticulitis)
• have recently undergone surgery to connect parts of the intestine (intestinal anastomosis)
• have an active or latent stomach or duodenal ulcer
• have impaired kidney function
• have impaired liver function
• have chronic liver damage (hepatic cirrhosis)
• have high blood pressure
• have a disease characterized by loss of bone tissue (osteoporosis)
• have a disease causing severe muscle weakness (myasthenia gravis)
• have had muscle problems after previous treatment with medicines similar to Bentelan (steroids)
• have poorly functioning thyroid gland
• have herpes simplex eye infection
• have reduced blood clotting (hypoprothrombinemia) and need to use acetylsalicylic acid (e.g. aspirin)

Inform your doctor if, during treatment with Bentelan, you or the child:

• need to undergo a radiological examination of the gallbladder using a contrast agent (cholecystography), as Bentelan may reduce the effects of the contrast agents used during this examination;
• are under particular stress, for example during surgery, as in these situations the dose of Bentelan may need to be adjusted;
• develop psychological or emotional disturbances, such as elation, excessive exuberance and happiness (euphoria), insomnia, severe depression, mood and personality changes, disturbances in mental balance, delusions, or hallucinations (psychosis).

Contact your doctor if blurred vision or other visual disturbances occur.
Pay special attention during treatment with Bentelan:

• you or the child should avoid contact with people affected by measles or chickenpox if taking high doses of this medicine. If such contact occurs, contact your doctor;
• glucocorticoids, such as Bentelan, may:
  o mask signs of infection and, during their use, infections may occur due to reduced immune defences. In such cases, your doctor will assess whether appropriate antibiotic therapy is needed.
  o cause adrenal insufficiency; in such cases, your doctor will advise whether to gradually reduce the dose or temporarily stop treatment. This type of insufficiency may last up to one year after stopping treatment. If a stressful condition occurs during the period after stopping Bentelan, your doctor may advise resuming treatment with this medicine.
  o cause systemic effects when used by inhalation (via aerosol) at high doses and for prolonged periods; for this reason, your doctor will prescribe the lowest possible inhaled dose to maintain effective asthma control. These effects are less likely than with oral corticosteroid treatment.

The use in active tuberculosis should be limited to cases of fulminant or disseminated disease, in which the glucocorticoid should be used together with appropriate antituberculosis therapy.
If glucocorticoids are administered to patients with latent tuberculosis or with a positive tuberculin reaction, close monitoring is required, as reactivation of the disease may occur (see section 4).
During treatment with Bentelan, your doctor may prescribe for you or the child:

• appropriate therapy to prevent infections, if you or the child need to use Bentelan for long periods;
• sodium and potassium supplements if you or the child develop disturbances in body fluids and electrolytes.

Children and adolescents
Your doctor will prescribe Bentelan to children and adolescents at the lowest possible doses and for the shortest possible duration. Depending on the case, your doctor will evaluate the possibility of administering the medicine once every other day. See section 3.
Your doctor will carefully monitor growth and development in children and adolescents undergoing prolonged treatment with Bentelan.
Children are particularly at risk of increased intracranial pressure.
Elderly patients
In elderly patients, treatment with Bentelan, especially if prolonged, may more frequently cause undesirable effects such as loss of bone tissue (osteoporosis), worsening of diabetes or high blood pressure, increased susceptibility to infections, and skin thinning. Taking this into account, your doctor will evaluate the most appropriate dose of Bentelan for you. See section 3.
Other medicines and Bentelan
Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Inform your doctor if you or the child are taking or need to take one or more of the following medicines:

• anticholinesterases
• anti-inflammatory medicines:
  o acetylsalicylic acid
  o other salicylates
  o non-steroidal anti-inflammatory drugs
• medicines that increase urine production (diuretics), particularly furosemide and thiazide diuretics
• amphotericin (antifungal)
• xanthines, e.g. theophylline
• medicines for diabetes, e.g. insulin
• cyclosporine (immunosuppressant)
• ketoconazole (medicine for treating fungal infections)
• phenytoin and phenobarbital (used to treat epileptic seizures)
• ephedrine
• rifampicin (antibiotic)
• anticoagulants (medicines that reduce blood clotting)

Some medicines may increase the effects of Bentelan, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Laboratory tests
Bentelan may reduce the effects of contrast agents in cholecystography. Inform your doctor that you or the child are being treated with Bentelan if you are scheduled for cholecystography.
Alterations in electrolyte levels (such as sodium or potassium) may occur, especially during prolonged treatment and with high doses of Bentelan; in such cases, your doctor will arrange for laboratory tests and give you appropriate advice.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/child before prescribing Bentelan.
Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery. However, rare neurological side effects have been reported.
Bentelan contains sodium
This medicine contains 0.89 mmol (or 20.4 mg) of sodium per tablet. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically 'sodium-free'.
This medicine contains 4 mg of sodium benzoate per tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
For those engaged in sports
Using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Bentelan

Take or administer this medicine to the child exactly as directed by your doctor or
pharmacist. If in doubt, consult your doctor or pharmacist.
The tablet may be divided into equal parts.

Use in adults
Short-term therapy
The recommended dose is 4–6 tablets per day. Your doctor will then advise you on how to gradually reduce the dose according to the progression of your condition.

Long-term therapy
The recommended initial dose at the beginning of treatment is 6–8 tablets per day.
Your doctor will then advise you on how to gradually reduce the dose until reaching the maintenance dose needed to control your condition.

Maintenance therapy
The recommended dose is 1–2 tablets per day.

Use in children
The recommended dose is 0.1–0.2 mg per kg of body weight per day.
You may also administer Bentelan to the child via aerosol. Dissolve 0.5–1 mg (1–2 tablets) just before use in 1–2 ml of water.

Elderly patients
Your doctor will determine the most appropriate dose of Bentelan for you.
Your doctor will prescribe the lowest maintenance dose capable of controlling the disease.
If necessary, your doctor will instruct you to gradually reduce the dose over several weeks or months, depending on the initial dose and duration of therapy.

If you take or administer more Bentelan than you should
In case of accidental ingestion of an excessive dose of Bentelan, contact your doctor immediately or go to the nearest hospital.
Generally, ingestion of an excessive dose of glucocorticoids, including Bentelan, is not life-threatening, except when very high doses are taken or if you or the child have specific clinical conditions such as:

• diabetes mellitus
• increased eye pressure (glaucoma)
• stomach or duodenal ulcer
• concomitant treatment with medicines such as digitalis (a heart medicine), anticoagulant medicines (coumarins), or potassium-depleting diuretics.

If you forget to take or administer Bentelan to the child
Do not take or administer a double dose to make up for the forgotten dose.

If you or the child stop treatment with Bentelan
Treatment with Bentelan must not be stopped without first consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During treatment with corticosteroids, especially with intensive and prolonged therapy, the following side
effects may occur:
Side effects with unknown frequency (frequency cannot be estimated from the available data):

• severe heart failure (congestive heart failure)
• adrenal insufficiency
• reduction in the size of the adrenal gland (adrenal atrophy)
• disorders of the adrenal glands such as Cushing's syndrome, hyperadrenocorticism
• diabetes mellitus
• increased blood sugar levels
• excessive growth of body hair or beard
• increased eye pressure (glaucoma)
• opacity in the posterior capsule of the lens (posterior subcapsular cataract)
• increased ocular tension
• perforation of a pre-existing gastric or intestinal ulcer prior to starting treatment with Bentelan
• gastric and duodenal ulcers
• acute inflammation of the pancreas
• inflammation of the esophagus
• nausea
• incomplete healing
• severe allergic reaction
• urticaria
• skin inflammation due to allergy
• reactivation of tuberculosis
• infections caused by fungi or viruses
• reduction in potassium levels
• reduction in blood nitrogen levels
• reduction in proteins
• reduction in lymphocytes (white blood cells) in the blood
• reduced glucose tolerance
• weight gain or weight loss
• loss of bone tissue (osteoporosis)
• death of bone tissue (osteonecrosis)
• swelling due to fluid retention (edema)
• increased appetite
• growth retardation
• muscle disorders
• collagen diseases
• fracture
• tendon rupture
• increased intracranial pressure
• swelling of the optic nerve head due to increased intracranial pressure (papilledema)
• blurred vision
• dizziness
• headache
• psychiatric disorders
• anxiety
• irritability
• menstrual cycle disturbances
• thinning of the skin
• acne
• bruising
• skin erythema
• skin changes such as delayed wound healing
• excessive sweating
• high blood pressure
• hiccups

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or
pharmacist. You may also report side effects directly via the national reporting system at the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bentelan

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bentelan contains

• The active substance is betamethasone. Each effervescent tablet contains 0.6578 mg of betamethasone disodium phosphate, equivalent to 0.5 mg of betamethasone.
• The other components are sodium citrate, sodium bicarbonate, sodium saccharin, polyvinylpyrrolidone, sodium benzoate.

Description of the appearance of Bentelan and pack contents
Each pack contains 10 effervescent tablets of 0.5 mg.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30.400 - 00071 Pomezia (Rome)

Patient information leaflet

Bentelan 1 mg effervescent tablets

Betamethasone (as disodium phosphate)
Please read this leaflet carefully before taking or administering this medicine to your child
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bentelan is and what it is used for
2. What you need to know before taking or administering Bentelan to your child
3. How to take or administer Bentelan to your child
4. Possible side effects
5. How to store Bentelan
6. Contents of the pack and other information

1. What Bentelan is and what it is used for

Bentelan contains the active substance betamethasone, which belongs to a group of medicines called corticosteroids. Bentelan is a hormonal medicine belonging to the class of glucocorticoids.
Bentelan is indicated for the treatment of a wide range of diseases, including the following main ones:

• bronchial asthma
• severe allergic diseases
• chronic and autoimmune joint inflammation (rheumatoid arthritis)
• connective tissue diseases of the skin and mucous membranes (collagenoses)
• inflammatory skin diseases
• lymphatic system tumours such as:
  • acute and chronic malignant lymphoproliferative disorders
  • Hodgkin's disease

Bentelan is also indicated for the treatment of other diseases:

• severe kidney disease (nephrotic syndrome)
• chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
• autoimmune skin and mucous membrane diseases characterized by blister formation (pemphigus)
• disease characterized by granuloma formation in various organs and tissues (sarcoidosis)
• heart inflammation associated with rheumatic fever (rheumatic carditis)
• chronic autoimmune inflammatory disease of the spine (ankylosing spondylitis)
• blood disorders such as:
  • reduced number of red blood cells due to their destruction (haemolytic anaemia)
  • reduced number of a specific type of white blood cells (agranulocytosis)
  • impaired blood clotting due to low platelet count (thrombocytopenic purpura)

2. What you should know before taking or administering Bentelan to a child

Do not take or administer Bentelan to the child if you or the child:

• are allergic to betamethasone, to other corticosteroid medicines, or to any of the other ingredients of this medicine (listed in section 6);
• have infections affecting the whole body and are not receiving specific treatment for them;
• are receiving vaccinations with attenuated viruses or other types of vaccines.

Warnings and precautions
Talk to your doctor or pharmacist before taking or administering Bentelan to the child.
Inform your doctor before taking or administering Bentelan to the child, if you or the child:

• have phaeochromocytoma (a tumour of the adrenal gland);
• have a serious heart condition (congestive heart failure);
• suffer from psychological or emotional disturbances, as these conditions may worsen during treatment with Bentelan;
• have epilepsy;
• have diabetes;
• have increased pressure in the eye (glaucoma);
• have chronic inflammation of the lower part of the intestine (ulcerative colitis);
• have an abscess or an infection;
• have inflammation of the diverticula, small naturally occurring or formed pouches in the lower part of the intestine (diverticulitis);
• have recently undergone surgery to connect parts of the intestine (intestinal anastomosis);
• have an active or latent stomach or duodenal ulcer;
• have impaired kidney function;
• have impaired liver function;
• have chronic liver damage (hepatic cirrhosis);
• have high blood pressure;
• have a disease characterised by loss of bone tissue (osteoporosis);
• have a disease causing severe muscle weakness (myasthenia gravis);
• have had muscle problems after previous treatment with medicines similar to Bentelan (steroids);
• have an underactive or overactive thyroid gland;
• have herpes simplex infection of the eye;
• have reduced blood clotting (hypoprothrombinaemia) and need to use acetylsalicylic acid (e.g. aspirin).

Inform your doctor if, during treatment with Bentelan, you or the child:

• need to undergo a radiological examination of the gallbladder using a contrast medium (cholecystography), as Bentelan may reduce the effects of the contrast agents used during this examination;
• are under particular stress, for example due to surgery, as in these situations it may be necessary to adjust the dose of Bentelan;
• develop psychological or emotional disturbances such as elation, excessive excitement and happiness (euphoria), insomnia, severe depression, changes in mood and personality, disturbances in mental balance, delusions, or hallucinations (psychosis).

Contact your doctor if blurred vision or other visual disturbances occur.
Pay special attention during treatment with Bentelan:

• you or the child should avoid contact with people who have measles or chickenpox if you are taking high doses of this medicine. If contact occurs, contact your doctor;
• glucocorticoids, such as Bentelan, may:
  • mask signs of infection, and infections may occur due to reduced immune defences. In such cases, your doctor will assess whether appropriate antibiotic therapy is needed;
  • cause adrenal insufficiency; in such cases, your doctor will advise whether to gradually reduce the dose or temporarily stop treatment.
    This type of insufficiency may last up to one year after stopping treatment. If a stressful condition occurs during the period after stopping Bentelan, your doctor may advise resuming treatment with this medicine;
  • cause systemic effects when used by inhalation (via aerosol) at high doses and for prolonged periods; for this reason, your doctor will prescribe the lowest possible inhaled dose to maintain effective asthma control. These effects are less likely than with oral corticosteroid treatment.
• The use of glucocorticoids in active tuberculosis should be limited to cases of fulminating or disseminated disease, in which the glucocorticoid should be used together with appropriate antituberculosis therapy. If glucocorticoids are administered to patients with latent tuberculosis or a positive tuberculin reaction, close monitoring is required, as reactivation of the disease may occur (see section 4).

During treatment with Bentelan, your doctor may prescribe for you or the child:

• appropriate therapy to prevent infections, if you or the child need to use Bentelan for long periods;
• sodium and potassium supplements if you or the child develop disturbances in body fluids and electrolytes.

Children and adolescents
Your doctor will prescribe Bentelan to children and adolescents at the lowest possible doses and for the shortest possible duration. Depending on the individual case, your doctor may consider administering the medicine as a single dose on alternate days. See section 3.
Your doctor will closely monitor growth and development in children and adolescents undergoing prolonged treatment with Bentelan.
Children are particularly at risk of increased intracranial pressure.

Elderly patients
In elderly patients, treatment with Bentelan, especially if prolonged, may more frequently cause undesirable effects such as loss of bone tissue (osteoporosis), worsening of diabetes, high blood pressure, increased susceptibility to infections, and thinning of the skin. Taking this into account, your doctor will evaluate the most appropriate dose of Bentelan for you. See section 3.

Other medicines and Bentelan
Inform your doctor or pharmacist if you or the child are using, have recently used, or might use any other medicines, including those obtained without a prescription.
Inform your doctor if you or the child are using or are due to use one or more of the following medicines:

• anticholinesterases;
• anti-inflammatory medicines:
  • acetylsalicylic acid or other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines that increase urine production (diuretics), particularly furosemide and thiazide diuretics;
• amphotericin (antifungal);
• xanthines, e.g. theophylline;
• medicines for diabetes, e.g. insulin;
• cyclosporine (immunosuppressant);
• ketoconazole (medicine used to treat fungal infections);
• phenytoin and phenobarbitone (used to treat epileptic seizures);
• ephedrine;
• rifampicin (antibiotic);
• anticoagulants (medicines that reduce blood clotting).

Some medicines may increase the effects of Bentelan, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Laboratory tests
Bentelan may reduce the effects of contrast media in cholecystography. Inform your doctor that you or the child are being treated with Bentelan if you need to undergo cholecystography.
Alterations in electrolyte levels (such as sodium or potassium) may occur, especially during prolonged treatment and with high doses of Bentelan; in such cases, your doctor will arrange laboratory tests and provide appropriate advice.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, your doctor will assess whether the benefits to you clearly outweigh the risks to the foetus/child before prescribing Bentelan.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery. However, rare neurological side effects have been reported.

Bentelan contains sodium and sodium benzoate
This medicine contains 0.85 mmol (or 19.6 mg) of sodium per tablet. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is practically 'sodium-free'.
This medicine contains 4 mg of sodium benzoate per tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Bentelan

Take or administer this medicine to the child exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablet may be divided into equal parts.

Use in adults
Short-term therapy
The recommended dose is 2-3 tablets daily. Subsequently, your doctor will advise you on how to gradually reduce the dose according to the progression of your condition.

Long-term therapy
The recommended starting dose is 3-4 tablets daily.
Subsequently, your doctor will advise you on how to gradually reduce the dose until reaching the maintenance dose needed to control your condition.

Maintenance therapy
The recommended dose for an adult of average weight is 1-2 tablets daily.

Use in children
The recommended dose is 0.1-0.2 mg per kg of body weight daily.
You may also administer Bentelan to the child via aerosol. Dissolve 0.5-1 mg (half or 1 tablet) in 1-2 ml of water immediately before use.

Elderly patients
Your doctor will determine the most appropriate dose of Bentelan for you.
Your doctor will prescribe the lowest effective maintenance dose capable of controlling the disease.
If necessary, your doctor may instruct you to gradually reduce the dose over several weeks or months, depending on the initial dose and duration of treatment.

If you take or administer to the child more Bentelan than you should
In case of accidental ingestion of an excessive dose of Bentelan, contact your doctor immediately or go to the nearest hospital.
Generally, ingestion of an excessive dose of glucocorticoids, including Bentelan, is not life-threatening, except when very high doses are taken or if you or the child have specific clinical conditions such as:

• diabetes mellitus
• increased intraocular pressure (glaucoma)
• stomach or duodenal ulcer
• concomitant treatment with medicines such as digitalis (a heart medicine), anticoagulant medicines (coumarins), or potassium-depleting diuretics.

If you forget to take or administer Bentelan to the child
Do not take or administer a double dose to make up for the forgotten dose.

If you or the child stop treatment with Bentelan
Treatment with Bentelan must not be stopped without first consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with unknown frequency (frequency cannot be estimated from the available data)

• severe heart failure (congestive heart failure)
• adrenal insufficiency
• reduction in adrenal gland size (adrenal atrophy)
• disorders of the adrenal glands such as Cushing's syndrome, hyperadrenocorticism
• diabetes mellitus
• increased blood sugar levels
• excessive hair growth or beard growth
• increased eye pressure (glaucoma)
• opacity of the posterior lens capsule (posterior subcapsular cataract)
• increased ocular tension
• perforation of a pre-existing stomach or intestinal ulcer prior to starting Bentelan treatment
• stomach and duodenal ulcers
• acute inflammation of the pancreas
• inflammation of the oesophagus
• nausea
• incomplete healing
• severe allergic reaction
• urticaria
• skin inflammation due to allergy
• reactivation of tuberculosis
• fungal or viral infections
• reduced potassium levels
• reduced blood nitrogen levels
• reduced protein levels
• reduced lymphocyte count (white blood cells) in the blood
• reduced glucose tolerance
• weight gain or weight loss
• loss of bone tissue (osteoporosis)
• death of bone tissue (osteonecrosis)
• swelling due to fluid retention (oedema)
• increased appetite
• growth retardation
• muscle disorders
• collagen diseases
• fracture
• tendon rupture
• increased intracranial pressure
• swelling of the optic nerve head due to increased intracranial pressure (papilledema)
• blurred vision
• dizziness
• headache
• psychiatric disorders
• anxiety
• irritability
• menstrual cycle disturbances
• thinning of the skin
• acne
• bruising
• skin erythema
• skin changes such as delayed wound healing
• excessive sweating
• high blood pressure
• hiccups

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bentelan

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bentelan contains

• The active substance is betamethasone. Each effervescent tablet contains 1.316 mg of betamethasone disodium phosphate, equivalent to 1 mg of betamethasone.
• The other components are sodium citrate, sodium bicarbonate, polyvinylpyrrolidone, sodium benzoate.

Description of the appearance of Bentelan and the contents of the pack
Each pack contains 10 effervescent tablets of 1 mg.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30.400 - 00071 Pomezia (Rome)