Betamethasone Sonphar 0.5 mg/ml oral solution EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Betametasona Sonphar 0.5 mg/ml oral drops solution EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Betametasona Sonphar is and what it is used for

This medicine contains the active substance betamethasone and belongs to a group of medicines called corticosteroids.

Betametasona Sonphar is used in certain conditions due to its anti-inflammatory action, such as collagen and connective tissue diseases, dermatological, respiratory, ear-nose-throat (ENT), or rheumatological disorders, severe allergic reactions, and generally in those conditions requiring treatment with glucocorticoids.

2. What you need to know before taking Betametasona Sonphar

Do not take Betametasona Sonphar:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have an infection and are not receiving appropriate anti-infective treatment (antibiotic/antiviral) to control it.

This medicine should not be taken, unless otherwise directed by your doctor, together with medicines that may cause heart rhythm problems (see section: Taking Betametasona Sonphar with other medicines).

If in doubt, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Betametasona Sonphar.

Treatment with this medicine must always be administered under strict medical supervision (see section 3: How to take Betametasona Sonphar).

Before treatment

Inform your doctor:

• If you have recently been vaccinated or if you have a vaccination scheduled (especially if it involves live attenuated virus vaccines)
• If you have peptic ulcer, intestinal diseases, or recent intestinal surgery
• If you have diabetes or a family history of diabetes, or if you suffer from high blood pressure or any heart disease, as your doctor may need to monitor you regularly
• If you have any type of infection (particularly a history of tuberculosis or viral infections such as hepatitis, herpes, or chickenpox) or if you have recently been in contact with people affected by these infections
• If you have a thyroid disorder, liver failure, or kidney failure, as you may require a lower dose of the medicine
• If you have myasthenia gravis (a muscle disorder causing muscle fatigue) or osteoporosis
• If you have epilepsy
• If you have had or currently have mental health problems, particularly related to corticosteroid use
• If you experience blurred vision or other visual disturbances
• If you have phaeochromocytoma (a tumor of the adrenal gland)

Inform your doctor if you have stayed in tropical or subtropical regions due to the risk of parasitic diseases.

During treatment

Avoid contact with patients who have chickenpox or measles.

If undergoing prolonged treatment, do not stop the treatment abruptly. Follow your doctor's instructions regarding dose reduction.

During treatment and for up to one year after stopping it, inform your doctor that you have taken corticosteroids if you undergo surgery or experience a stressful situation (fever, illness).

Precautions for use

During treatment, your doctor may advise you to follow a special diet, particularly one low in salt.

If in doubt, consult your doctor or pharmacist.

Taking Betametasona Sonphar with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Betametasona Sonphar may interact with the following medicines:

Contraindicated combination:

• Medicines that induce a condition known as "torsades de pointes," including: astemizole, bepridil, erythromycin IV, pentamidine, halofantrine, sparfloxacin, sultopride, terfenadine, and vincamine.

Combinations requiring caution:

• Acetylsalicylic acid and other salicylates (analgesic and anti-inflammatory medicines)
• Antiarrhythmics that may cause "torsades de pointes," such as amiodarone, bretylium, disopyramide, quinidine, sotalol (medicines used to treat heart arrhythmias)
• Oral anticoagulants (medicines used to prevent blood clotting)
• Diuretics that reduce potassium levels (used to increase urine production)
• Stimulant laxatives (promote bowel movements)
• Amphotericin B (an antibiotic)
• Cardiac glycosides such as digoxin (medicines used to treat heart failure)
• Intravenous heparin (a medicine to prevent blood clotting)
• Alcohol and NSAIDs (non-steroidal anti-inflammatory drugs)
• Enzyme inducers (of enzyme CYP3A4) such as rifampicin, rifabutin (antibiotics); phenytoin, carbamazepine, barbiturates, primidone, phenobarbital (medicines used to treat epilepsy); ephedrine (adrenergic agonist); and aminoglutethimide (anti-steroidal agent)
• Enzyme inhibitors (of enzyme CYP3A4) such as ketoconazole and itraconazole (used for fungal infections) may increase the effect of corticosteroids. Your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat)
• Somatotropin (used to treat growth disorders)
• Antidiabetic medicines such as insulin, metformin, or sulfonylureas
• Anticholinesterases (medicines used for muscle spasms, to treat myasthenia gravis, or paralytic ileus)
• Cholestyramine (used to lower cholesterol levels)
• Cyclosporine (an immunosuppressant used in transplant patients)
• Isoniazid (an anti-tuberculosis medicine)
• Gastrointestinal topical agents: salts, oxides, and hydroxides of magnesium, aluminum, and calcium

Combinations to be aware of:

• Antihypertensives (used to control blood pressure)
• Interferon alfa (modulates the body's immune response)
• Live attenuated vaccines
• Estrogens, including oral contraceptives (used to prevent pregnancy)
• Macrolides (antibiotics)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used during pregnancy if clearly needed. If you discover you are pregnant while taking this medicine, consult your doctor, as only your doctor can decide whether to continue treatment.

Breastfeeding should be avoided during treatment, as the medicine passes into breast milk.

For athletes

This medicine contains an active substance that may cause a positive result in anti-doping tests.

Driving and using machines

The effect of betamethasone on the ability to drive and use machines is negligible or none. However, due to its propylene glycol content, this medicine may produce symptoms similar to those of alcohol, which should be considered if you are driving or operating machinery.

Betametasona Sonphar contains sucrose, sorbitol (E-420), propylene glycol (E-1520), and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

May be harmful to teeth.

This medicine contains 300 mg of sorbitol per ml (equivalent to 40 drops).

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 343 mg of propylene glycol per ml (equivalent to 40 drops).

If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if other medicines containing propylene glycol or alcohol have been administered.

If the child is under 5 years of age, consult your doctor or pharmacist, particularly if other medicines containing propylene glycol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

If you have liver or kidney failure, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

This medicine contains 0.70 mg of sodium (a main component of table/cooking salt) per ml; this is essentially "sodium-free".

3. How to take Betametasona Sonphar

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is very important to follow the treatment regularly and not to modify or stop it abruptly without medical advice.

Dosage

For use in infants and children.

The dose is strictly individual.

Children: The dose will be determined by your doctor according to body weight, the condition being treated, and the severity of symptoms, and should be adjusted according to the individual patient's response.

The lowest effective dose should be used. When possible, the dose should be reduced gradually in stages.

In general, the recommended dose is:

• Initial treatment: 0.075 mg/kg/day, i.e. 6 drops/kg/day, up to 0.3 mg/kg/day of betamethasone, i.e. 24 drops/kg/day (equivalent to 0.5–2 mg/kg/day of prednisone).

As a guide: 150 to 600 drops/day for a 25 kg child.

• Maintenance treatment: 0.03 mg/kg/day (or 3 drops/kg/day).

As a guide: 75 drops for a 25 kg child.

40 drops correspond to 1 ml of solution and to 0.5 mg of betamethasone.

Method of administration

Oral use.

Add the drops to a small amount of water.

The daily dose may be taken as a single dose, preferably in the morning with food, at the end of the meal. During prolonged treatment with high doses, the daily dose may be divided into two administrations.

Duration of treatment

The duration of treatment will be determined by your doctor.

In case of prolonged treatment, do not stop the treatment abruptly and follow your doctor's instructions for tapering the dose.

Discontinuation of treatment

The rate of dose reduction depends mainly on the duration of treatment, the initial dose, and the underlying disease.

If you take more Betametasona Sonphar than you should

Contact your doctor or pharmacist if you have taken this medicine in greater amounts or for a longer duration than prescribed.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Betametasona Sonphar

For this medicine to be effective, it must be used regularly. However, if you forget to take a dose, continue treatment as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Betametasona Sonphar

Do not stop treatment without first informing your doctor, even if your condition has improved completely or if you experience any adverse effects, unless your doctor has instructed you otherwise.

Abruptly stopping a prolonged treatment may cause adverse effects such as muscle and joint pain, worsening of disease symptoms, or acute adrenocortical insufficiency with cortisone withdrawal syndrome, characterized by general malaise, weakness, and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, low blood pressure, and low blood glucose levels, among others.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

This medicine is generally well tolerated when used according to the recommended guidelines (see section: Warnings and precautions).

However, depending on the dose and duration of treatment, it may cause more or less bothersome side effects. The most common ones are:

• fluid retention (edema), swelling and redness of the face,
• increased appetite, weight gain,
• increased blood pressure,
• excitability and sleep disturbances,
• bone fragility,
• changes in certain biological parameters (salt, sugar, potassium), which may require dietary adjustments or additional treatment: loss of potassium (which may lead to cardiac rhythm disturbances), increased blood sugar, diabetes mellitus, increased levels of cholesterol and triglycerides in the blood,
• alterations in blood cells (white blood cells and lymphocytes, among others). Delayed wound healing.

Other, much rarer, side effects have been observed:

• risk of adrenal insufficiency (reduced secretion by the adrenal gland),
• growth retardation in children,
• menstrual disorders, sexual impotence, excessive hair growth,
• muscle diseases and muscle weakness, tendon alterations, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis. Rapid dose reduction after long-term treatment may cause muscle and joint pain,
• hiccups, gastrointestinal ulcers, nausea, heartburn, pancreatitis (inflammation of the pancreas), abdominal discomfort and other digestive disorders,
• acne or other skin problems (allergy, bruising, stretch marks), edema, changes in skin color, perioral dermatitis,
• certain forms of glaucoma (increased intraocular pressure) and cataracts (lens opacity), corneal thinning,
• hypersensitivity reactions, severe allergic reactions such as: cardiac rhythm disturbances, bronchospasm, changes in blood pressure, circulatory failure, cardiac arrest,
• existing infections may worsen, and new infections that are difficult to diagnose may appear,
• increased intracranial pressure (especially in children), manifesting as pulsating headaches and visual disturbances, which worsens with sudden movements; increased seizures in epileptic patients or onset of epilepsy,
• depression, hallucinations, emotional instability, irritability, increased activity, psychosis, mania, euphoria, anxiety, suicidal thoughts,
• increased risk of atherosclerosis (narrowing and hardening of arteries) and thrombosis (blood clot formation), vasculitis, capillary fragility.

Adverse effects of unknown frequency: Blurred vision (see also section 4.4).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betametasona Sonphar

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25 °C.

Once opened, this medicine can be kept for a maximum of 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betametasona Sonphar

• The active substance is betamethasone. Each ml of solution (40 drops) contains 0.5 mg of betamethasone.
• The other components are sodium edetate, sodium benzoate (E-211), anhydrous sodium hydrogen phosphate, citric acid, sucrose, propylene glycol (E-1520), 70% sorbitol solution (E-420), orange flavour, purified water.

Appearance of Betametasona Sonphar and contents of the pack

Clear, colourless solution.

The pack contains 1 bottle of 30 ml (=1,200 drops) and a dropper cap with a 1 ml capacity and dosage markings for 20, 30 and 40 drops.

Marketing Authorization Holder

Laboratorios Sonphar, S.L.

París, 64 Escalera C 1º 3ª

08029 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Date of the most recent revision of this leaflet: September 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/