Diprophos

Package Leaflet: Information for the User

Diprophos, (6.43 mg + 2.63 mg)/ml, suspension for injection
Betamethasone dipropionate+ Betamethasone sodium phosphate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• You should 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 symptoms 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.

Table of Contents of the Package Leaflet

• 1. What Diprophos is and what it is used for
• 2. Important information before using Diprophos
• 3. How to use Diprophos
• 4. Possible side effects
• 5. How to store Diprophos
• 6. Contents of the pack and other information

1. What Diprophos is and what it is used for

The medicine is indicated for use in the treatment of acute and chronic conditions that are responsive to corticosteroid therapy. Hormonal treatment with corticosteroids is a supplement to conventional therapy, but it cannot replace it.
Musculoskeletal and soft tissue disorders: rheumatoid arthritis, osteoarthritis, bursitis, tendinitis, tenosynovitis, psoriatic arthritis, ankylosing spondylitis, epicondylitis, nerve root irritation, coccydynia, lumbago, torticollis, ganglion cyst of tendon sheath, bone spurs, tendinitis.
Allergic diseases: chronic bronchial asthma (as an adjunct in asthmatic states), hay fever, angioedema, allergic bronchitis, seasonal or allergic rhinitis, drug reactions, serum sickness, insect bites.
Skin diseases: atopic dermatitis (eczema), lipodermatosclerosis, contact dermatitis, severe sunburn, urticaria, lichen planus, lichen simplex, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, herpes simplex, neurodermatitis, acne conglobata.
Collagen diseases: systemic lupus erythematosus, scleroderma, dermatomyositis, polyarteritis nodosa.
Other diseases: adrenogenital syndrome, ulcerative colitis, Crohn's disease, psoriasis, foot diseases (bursitis under the calcaneus, hallux rigidus, fifth toe tailor's bunion), diseases requiring subconjunctival injections, abnormal blood counts that can be treated with corticosteroids, nephrotic syndrome.

2. Important information before using Diprophos

When not to use Diprophos:

• if you are allergic to betamethasone or other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6),
• if you have a systemic fungal infection.

Do not use corticosteroids in the case of: tuberculosis, osteoporosis, emotional instability, peptic ulcer, glaucoma, premature closure of the epiphyseal plates, diabetes, Cushing's syndrome, renal insufficiency, bacterial, fungal or viral infections, pregnancy (especially the first three months), treatment of the respiratory distress syndrome after birth.

Warnings and precautions

Before starting treatment with Diprophos, discuss it with your doctor, pharmacist or nurse, especially if you have a pheochromocytoma (adrenal gland tumor).
Diprophos should not be administered intravenously or subcutaneously.
Severe neurological events, sometimes fatal, have been reported with epidural corticosteroid use.
Patients receiving corticosteroids should be warned not to discontinue therapy abruptly, as this may lead to exacerbation of their disease.
Corticosteroids should be used with caution in patients with the following conditions: non-specific ulcerative colitis, if there is a risk of perforation, abscess or other infections with pus formation, diverticulitis, recent intestinal anastomoses, peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
The use of corticosteroids can cause superinfection, and the development of new infections during their use is possible.
Long-term use of corticosteroids may lead to cataract formation (especially in children), glaucoma with possible optic nerve damage, and increased susceptibility to eye infections caused by fungi or viruses.
Medium and high doses of corticosteroids may cause an increase in blood pressure, sodium and water retention, and increased potassium excretion. These effects are less likely when the patient is receiving synthetic corticosteroid derivatives, except when high doses are used.
Corticosteroids may increase the excretion of calcium.
Vaccination with live vaccines should be avoided in patients taking immunosuppressive doses of corticosteroids.
Patients taking immunosuppressive doses of corticosteroids should avoid contact with people with chickenpox or measles, and if exposed, they should seek medical advice. This is especially important for children.
Corticosteroids may cause mental disturbances, and may exacerbate existing emotional instability or psychotic tendencies.
Corticosteroids should be used with caution in patients with the following conditions: non-specific ulcerative colitis, if there is a risk of perforation, abscess or other infections with pus formation, diverticulitis, recent intestinal anastomoses, peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.

Diprophos and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including those obtained without a prescription.
Concomitant use of phenobarbital, phenytoin, rifampicin or ephedrine may increase the metabolism of corticosteroids, reducing their therapeutic effect.
Patients receiving corticosteroids and estrogens should be monitored for increased corticosteroid effects.
Concomitant administration of corticosteroids with diuretics that lower potassium levels may increase the risk of hypokalemia. Corticosteroids given with cardiac glycosides may increase the risk of digitalis toxicity associated with hypokalemia.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no controlled data in human pregnancy. The use of corticosteroids in pregnant women or women of childbearing potential requires careful consideration of the benefits and risks to the mother and fetus.
Do not use corticosteroids for the treatment of the respiratory distress syndrome after birth.
In the prophylactic treatment of the respiratory distress syndrome in premature infants, do not administer corticosteroids to pregnant women with pre-eclampsia or eclampsia or with signs of placental damage.

Driving and using machines

Diprophos has no or negligible influence on the ability to drive and use machines.

Diprophos contains 9 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to neonates (less than 4 weeks old) may cause severe side effects, including gasping syndrome. Do not administer to neonates without medical advice.

Diprophos contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ml, and is therefore considered to be essentially 'sodium-free'.

Diprophos contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

This medicine may cause allergic reactions (including possible late reactions) and bronchospasm.

3. How to use Diprophos

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dosage of the medicine is different for different indications and is determined individually for each patient, depending on the type of disease, its severity and response to treatment.
At the beginning of treatment, the smallest effective dose should be established, which allows for a satisfactory response to treatment. If the patient does not improve during treatment (no response to treatment), the administration of the medicine should be discontinued and the administration of another medicine should be started.

Missed dose of Diprophos

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of the medicine, like other corticosteroids, depend on both the dose and the duration of treatment. These effects are usually reversible or can be minimized by reducing the dose of the medicine. This approach is more beneficial than discontinuing treatment.
Disorders of fluid and electrolyte balance: sodium retention, potassium loss, hypokalemic alkalosis, fluid retention, congestive heart failure in susceptible patients, hypertension.
Musculoskeletal and connective tissue disorders: muscle weakness, corticosteroid-induced myopathy, muscle mass loss, worsening of myasthenia gravis symptoms, osteoporosis, vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, pathological fractures of long bones, tendon rupture (due to injection into the tendon), joint instability (due to repeated intra-articular injections).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the regulatory authority or to the manufacturer.

5. How to store Diprophos

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Diprophos contains

• The active substances are betamethasone dipropionate and betamethasone sodium phosphate. One ampoule (1 ml) of suspension for injection contains 6.43 mg of betamethasone dipropionate (equivalent to 5 mg of betamethasone) and 2.63 mg of betamethasone sodium phosphate (equivalent to 2 mg of betamethasone).
• The other ingredients are: disodium phosphate dihydrate or disodium phosphate anhydrous, sodium chloride, disodium edetate, polysorbate 80, benzyl alcohol (E 1519), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium carboxymethylcellulose, macrogol, hydrochloric acid (for pH adjustment), water for injections.

What Diprophos looks like and contents of the pack

Diprophos is a suspension for injection.
A clear, colorless, slightly viscous liquid containing easily resuspendable white or almost white particles, without foreign particles.
The medicine is available in packs of 1 ampoule or 5 ampoules of 1 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Organon Polska Sp. z o.o.
Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: 11/2022