Betadexamine Liquid

BETADEXAMINE is used as a second-line therapy when antihistamines only are not effective for the treatment of:

• Short-term treatment of allergic rhinitis (hay fever).
• Allergic skin disorders that respond to cortisone-like medicines, as contained in BETADEXAMINE.

Do not take BETADEXAMINE:

• If you are hypersensitive (allergic) to cortisone medicines including betamethasone or to antihistamines, including dexchlorpheniramine or any of the other ingredients of BETADEXAMINE (see WHAT BETADEXAMINE CONTAINS).
• If you have a fungal infection, BETADEXAMINE can cause slower healing or worsen existing infections.
• If you are taking monoamine oxidase inhibitor (MAOI) type antidepressant medicines or within 2 weeks after use of a MAOI, as the combined use of these two medicines may prolong and intensify side effects.
• In newborn or premature babies, as young infants are more prone to serious side effects such as excitation or seizures.
• Safety in children below the age of 12 years has not been established.
• If you suffer from glaucoma (increased pressure in the eye).

Take special care with BETADEXAMINE:

• BETADEXAMINE is not indicated for treatment of longer than five days.
• BETADEXAMINE must be used only for the period that your doctor has specified.
• BETADEXAMINE can cause drowsiness. This may be worsened by the simultaneous intake of alcohol or other medicine that act on the central nervous system.

Always take BETADEXAMINE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Adults and children over 12 years

The dosage of BETADEXAMINE depends on the condition being treated and your response to therapy. BETADEXAMINE is for short-term use only (not more than 5 days). BETADEXAMINE should not be mixed with other mixtures. The usual dose for adults and children over 12 years of age is: Take 5 ml to 10 ml four times daily after meals and at bedtime. The dose should not exceed 40 ml daily. Shake bottle well before use. Treatment should not exceed 5 days. Do not take another course of treatment with BETADEXAMINE within 28 days unless your doctor specifically tells you to do so. If you have the impression that the effect of BETADEXAMINE is too strong or too weak, speak to your doctor or pharmacist. Do not share medicines prescribed for you with any other person. Not for use in children under 12 years of age.

If you take more of BETADEXAMINE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take BETADEXAMINE

If you miss a dose of BETADEXAMINE, take it as soon as you remember that day. If you only remember the next day, skip the missed dose and go back to your normal dosing schedule. Do not take a double dose to make up for forgotten individual doses.

Effects when treatment with BETADEXAMINE is stopped

If BETADEXAMINE has been taken for a long time (contrary to the recommended dosing schedule), a withdrawal syndrome can occur if you suddenly stop taking the medicine. In this case, your doctor will advise you to reduce the dose slowly before stopping the medicine completely.

BETADEXAMINE can have side effects. Not all side effects reported for BETADEXAMINE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BETADEXAMINE, please consult your healthcare provider for advice.

If any of the following happens, stop taking BETADEXAMINE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, shortness of breath, skin rash, tightness in the chest, unusual tiredness or weakness and wheezing;
• hypersensitivity reactions. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BETADEXAMINE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Cushing’s Syndrome (e.g. ‘buffalo hump’, round/puffy face);
• liver problems; symptoms include, but are not limited to, abdominal or stomach pain, chills, clay-coloured stools or dark urine, diarrhoea, dizziness, fever, headache, itching;
• convulsions (seizures/fits);
• burning, prickly sensation, or tingling feeling on the body;
• sore throat, fever, unusual bleeding or bruising, as this can be indicative of blood problems;
• adrenal crisis (a life-threatening condition) has also been reported in patients of all ages. Symptoms include, but are not limited to, confusion, coma, darkening of the skin, abdominal pain, fatigue, high fever, joint pain, low blood pressure, vomiting;
• blood disorders, for example an abnormal breakdown in red blood cells, a decrease in the number of white blood cells, a decrease in the number of platelets;
• abnormal heart rhythm, palpitations;
• constant pain in the upper abdomen that radiates to the back as these may be symptoms of pancreatitis;
• increased pressure in the eye with symptoms like blurry vision or severe eye pain;
• breathing difficulty, chest pain, cough with mucous, coughing up blood, excessive sweating, weight loss as these may be symptoms of pulmonary tuberculosis;
• decrease in bone strength resulting in bone fractures.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

The following side effects have been reported frequently:

• Increased occurrence of infection;
• decreased body growth;
• depression;
• profound sense of wellbeing;
• increase in blood pressure;
• gastric irritation (a symptom of stomach disorders with symptoms like abdominal pain and gas), nausea, vomiting, indigestion, increased appetite;
• impaired skin healing, decrease in skin thickness;
• state or feeling of weariness, diminished energy, or listlessness, incoordination, dizziness, headache, slowdown in thoughts;
• blurred vision;
• thickening of the mucus, dryness of nasal mucosa, dry mouth, constipation, increased gastric reflux;
• urinary difficulty or retention.

The following side effects have been reported less frequently:

• Low or high blood sugar;
• low potassium blood levels;
• salt and fluid retention resulting in swelling of the feet, hands, tummy (abdomen), breasts and face;
• nervousness, restlessness;
• cataract (a clouding of the lens in the eye leading to a decrease in vision. Symptoms may include faded colors, blurry vision, halos around light, trouble with bright lights, and trouble seeing at night);
• stomach ulcers, the major symptom of an ulcer is a burning or gnawing feeling in the stomach area that lasts between 30 minutes and 3 hours;
• sleep disturbances, confusion;
• ringing in the ears;
• low blood pressure;
• hair loss;
• muscle weakness;
• rhythmic muscle contractions or involuntary muscle contractions;
• fluid and electrolyte disturbances;
• sweating.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C, in a well-closed container

Protect from light

Do not store in bathroom

Do not use after the expiry date stated in label

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Keep in original packaging until required for use

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.