Betadexamine 0,25 mg/2 mg Tablets

BETADEXAMINE TABLETS belongs to a group of medicines known as corticosteroids in combination with anti-histamines. BETADEXAMINE TABLETS is used for the treatment of allergic rhinitis (hay fever) and certain allergic skin conditions.

Do not take BETADEXAMINE TABLETS

• if you are hypersensitive (allergic) to betamethasone, dexchlorpheniramine or any of the other ingredients of BETADEXAMINE TABLETS (listed in section 6).
• if you have an infection.
• if you take medicines referred to as Monoamine Oxidase Inhibitors (MAOIs), used to treat depression.

BETADEXAMINE TABLETS should not be administered to new-borns, premature infants or children (see section titled Children below).

Warnings and precautions

Take special care with BETADEXAMINE TABLETS

• BETADEXAMINE TABLETS may lead to disturbed concentration and excessive sleepiness (drowsiness).
• If you recently had a heart attack.
• If you need to go for a vaccination or have been exposed to measles.
• If you suffer from inflammatory illnesses, sores, infections or blockage of the digestive tract (ulcerative colitis, peptic ulcer, abscess, diverticulitis, pyloroduodenal obstruction).
• If you suffer from tuberculosis (TB).
• If you have kidney problems.
• If you suffer from a tumour of the adrenal gland (Pheochromocytoma).
• If you have high blood pressure.
• If you suffer from osteoporosis (thinning of the bones).
• If you suffer from an overactive or underactive thyroid gland (hyperthyroidism, hypothyroidism).
• If you have scarring on your liver (cirrhosis).
• If you have an eye infection or suffer from increased pressure in your eye (glaucoma).
• If you suffer from myasthenia gravis (weakness of the muscles).
• If you suffer from a heart disease.
• If you have diabetes mellitus or someone in your family has diabetes.
• If you are an elderly patient.
• If you suffer from mental disorders.
• If you suffer from muscle weakness (muscle disease).
• If you have liver failure.
• If you suffer from seizures.
• If you have an enlarged prostate gland which can cause difficulty in urinating (prostatic hypertrophy).

Children

There is no experience with BETADEXAMINE TABLETS in children younger than 12 years. BETADEXAMINE TABLETS should not be administered to new-borns, premature infants or children as it may affect their growth permanently (see section titled Do not take BETADEXAMINE TABLETS).

Other medicines and BETADEXAMINE TABLETS

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

Do not share medicines prescribed for you with any other person. Always take BETADEXAMINE TABLETS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will prescribe a dose specific to your condition and response to treatment. BETADEXAMINE TABLETS are only to be used for short-term treatment (less than 5 days). BETADEXAMINE TABLETS should not be mixed with other mixtures. BETADEXAMINE TABLETS should be taken after meals. The usual dose of BETADEXAMINE TABLETS in adults and children over 12 years of age is 1 (one) to 2 (two) tablets four times daily after meals and at bedtime. The dose should not exceed 8 (eight) tablets per day. Treatment should not exceed 5 days. Your doctor will tell you how long your treatment with BETADEXAMINE TABLETS will last. If you have the impression that the effect of BETADEXAMINE TABLETS is too strong or too weak, tell your doctor or pharmacist.

If you take more BETADEXAMINE TABLETS 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 TABLETS

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of BETADEXAMINE TABLETS, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

BETADEXAMINE TABLETS can have side effects. Not all side effects reported for BETADEXAMINE TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BETADEXAMINE TABLETS, please consult your healthcare provider for advice. If any of the following happens, stop taking/using BETADEXAMINE TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS).

These are all very serious side effects. If you have them, you may have had a serious reaction to BETADEXAMINE TABLETS. 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:

• Severe pain, rapid or immediate bruising, marked weakness and deformity of the area as these may be symptoms of a tendon rupture.
• Excessive bruising, prolonged bleeding from cuts, bleeding from your gums or nose as these may be symptoms associated with low platelet levels.
• Repeated fever and infections as these may be symptoms associated with a low white blood cells levels.
• Fever as this may be a sign of an underlying infection.
• Seizures (fits).
• Pain or infection in the eye/s.
• Cataracts (cloudy window over your eye).
• Hearing loss (acute labyrinthitis).
• Involuntary repetitive movements of the mouth and face (facial dyskinesias).
• Growth retardation, when a baby or child stops growing.
• Thinning of the bones (osteoporosis) or breaking of the bones (fractures).
• Chest pain and/or changes in the way your heart beats, for example, if you notice it beating faster.
• Increased, difficulty or hesitation to urinate.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• Drowsiness.

Side effects with an unknown frequency:

• Confusion, restlessness, excitation, nervousness, irritability, inability to sleep (insomnia), intense excitement (euphoria);
• dizziness, sleepiness, disturbed coordination;
• hysteria, depression, seeing and hearing things that are not real (hallucinations), inability to concentrate, anxiety;
• shaking movements (tremors), pins and needles in the fingers and toes (paraesthesia), inflammation of the nervous system (neuritis);
• increased or lowered response of the muscles to stimuli (hyperreflexia/hyporeflexia);
• headache, blurred vision, ringing in the ear/s, double vision, dilated pupils;
• low blood pressure;
• dryness of the nose, mouth and throat;
• thickening of bronchial secretions, tightness of the chest, wheezing, nasal stuffiness;
• fungal infection of the skin, mouth, throat, gut or vagina (candidiasis);
• loss of appetite, nausea, vomiting, diarrhoea, constipation, absence of saliva (xerostomia), appetite stimulation;
• impaired healing of wounds, thinning of the skin, acne, red lines on the skin (telangiectasia), lines on the skin (stria), photosensitivity;
• muscle weakness, general feeling of unwellness (malaise), hiccups, excessive perspiration, chills, physical or mental weariness (lassitude);
• early menstruation, menstrual irregularity;
• excessive growth of dark or coarse hair in a male like pattern in women e.g. on the face, chest and back (hirsutism).

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

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of BETADEXAMINE TABLETS.

Store all medicines out of reach of children. Store at or below 30 °C. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).