BETAFLEX NC contains paracetamol 450 mg and orphenadrine citrate 35 mg, which belongs to a group of medicine referred to Analgesic combinations. BETAFLEX NC is used for Generalised pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions.
1. What BETAFLEX NC is and what it is used for
2. What you need to know before you take BETAFLEX NC
Do not take BETAFLEX NC:
- If you are hypersensitive (allergic) to paracetamol and orphenadrine or any of the other ingredients of BETAFLEX NC (listed in section 6)
- If you suffer from the following:
- severe liver function
- enlarged prostate
- achalasia (a failure of smooth muscle fibres to relax, which can cause the lower oesophageal sphincter to remain closed)
- bladder neck obstruction
- glaucoma (a condition in which the pressure of fluid in the eye is high. This can damage your eyes’ optic nerve)
- myasthenia gravis (a disorder causing extreme muscle weakness and can impact a person’s ability to see, smile, walk, talk and breathe)
- peptic ulcer (a lesion in the lining (mucosa) of the digestive tract, typically in the stomach or duodenum)
- stenosing and pyloric or duodenal obstruction
- porphyria (a group of diseases in which substances called porphyrins build up, negatively affecting the skin or nervous system)
- If you are pregnant or breast-feeding
Warnings and precautions
This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. Dosages in excess of those recommended may cause severe liver damage.
Special care should be taken with BETAFLEX NC:
- If you suffer from liver or kidney disease
- If you are taking other central nervous system depression-producing medication as well as patients on anticholinergics or medication with anticholinergic properties.
- If you suffer from porphyria
- Use with caution in patients with cardiac disease
- Do not use continuously for more than 10 days without consulting your doctor.
Use in children and adolescents
Only for use in adults 18 years and older.
Other medicines and BETAFLEX NC
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicine.) Orphenadrine may increase central nervous system depression if taken concurrently with alcohol or central nervous system depressants. Anticholinergic effects may be intensified if orphenadrine is taken concurrently with anticholinergics or medication with anticholinergic effects. Prolonged use of paracetamol and a salicylate significantly increases the risk of kidney damage. Use of paracetamol with anticoagulants (medicines used to prevent blood clots) coumarin- or indandione-derivative may increase their effects.
BETAFLEX NC with food and drink
No known interactions with food and drink.
Pregnancy and breast-feeding
The safety of using BETAFLEX NC during pregnancy and breastfeeding has not been established. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.
Driving and using machines
This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.
3. How to take BETAFLEX NC
Do not share medicines prescribed for you with any other person. Always take BETAFLEX NC exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Adults: 2 tablets 3 times a day. Do not exceed the recommended dosage.
If you take more BETAFLEX NC than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison Centre. The most likely symptoms of overdosage are stomach pain and nausea, vomiting and insomnia.
If you forget to take BETAFLEX NC
Do not take a double dose to make up for forgotten individual doses.
4. Possible side effects
BETAFLEX NC can have side effects: Not all side effects reported for BETAFLEX NC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BETAFLEX NC, please consult your health care provider for advice.
If any of the following happens, stop taking BETAFLEX NC and tell your doctor immediately or go to the casualty department at your nearest hospital. Side effects include:
Blood disorders:
Thrombocytopenia (decreased number of blood platelets), leucopenia (decreased number of white blood cells), pancytopenia (decreased number of cell elements in the blood), neutropenia (decreased number of neutrophilic leukocytes cells in the blood), agranulocytosis (low number of granulocytes, a type of white blood cell) and anaemia (low number of red blood cells).
Skin disorders:
Skin rashes, dryness of the skin and other allergic reactions.
Stomach and bowel disorders:
Pancreatitis (inflammation of the pancreas). Dryness of the mouth with difficulty in swallowing and talking, thirst, constipation and occasionally vomiting.
Liver disorders:
Hepatitis (inflammation of the liver).
Kidney disorders:
Renal colic (pain caused by a urinary tract stone), renal failure and sterile pyuria (urine which contains white blood cells) and difficulty in urination.
Eye disorders:
Dilation of the pupils with loss of accommodation and photophobia (extreme sensitivity to light).
Heart disorders:
Transient bradycardia (slowing of the heart beat) followed by tachycardia (fast heart beat) with palpitations and arrhythmias (abnormal rhythm of the heart).
Lung disorders:
Bronchial secretion.
Nervous system disorders:
Confusion, dizziness and walking unsteadily.
Blood vessels disorders:
Flushing (sudden increase in flow).
Psychiatric disorders:
Insomnia (inability to sleep).
If you notice any side effects not mentioned in this leaflet, please inform your doctor of pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BETAFLEX NC. May also report to Adcock Ingram Limited using the following email: [email protected].
5. How to store BETAFLEX NC
STORE ALL MEDICINES OUT OF REACH OF CHILDREN
Store at or below 25 °C. Protect from light. Store in the original container. Keep the container tightly closed. Do not store in a bathroom. Do not use after the expiry date stated on the label/carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).