Norflex Side Effects

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Answer the side-effect intent for norflex without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Norflex?

Norflex contains the active ingredient Paracetamo. Orphenadrine citrate.

• Active ingredient — Paracetamo. Orphenadrine citrate
• Registration number — 32/2.8/0605
• Registration holder — Adcock Ingram Limited

It is approved for:

• UNIFLEX contains paracetamol 450 mg and orphenadrine citrate 35 mg, which belongs to a group of medicine referred to as analgesic combinations
• UNIFLEX is used for generalised pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions

Common side effects of Norflex

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day)
• swelling of the eyelids, face, tongue or lips
• severe dizziness
• difficulty in breathing
• Serious skin reactions such as swelling, itching, red severe rash especially those covering your whole body (appearing as allergic wheals), stop giving UNIFLEX immediately and contact your doctor. 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), anaemia (low number of red blood cells). Stomach and bowel disorders: Pancreatitis (inflammation of the pancreas). Dryness of the mouth with difficulty in swallowing and talking, thirst, constipation and occasionally vomiting. Skin disorders: Skin rashes, dryness of the skin and other allergic reactions. 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)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• 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 eye’s 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

Use with care, and tell your doctor, if

• 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
• Dosages in excess of those recommended may cause severe liver damage
• Do not use continuously for more than 10 days without consulting your doctor
• Serious skin reactions such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), have been reported in patients receiving paracetamol. If your child experiences any signs of serious skin reactions such as swelling, itching, red severe rash, stop using UNIFLEX immediately and contact your doctor. Children and adolescents The use of UNIFLEX in children and adolescents has not been established

Pregnancy and breastfeeding

• The safety of using UNIFLEX 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 healthcare professional for advice before taking this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• 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
• Sleeping medication taken together with paracetamol decreases the therapeutic effect of paracetamol
• Risk of hepatotoxicity with single toxic doses or prolonged use of high doses of paracetamol may be increased in alcoholics or in patients taking other hepatotoxic medications or hepatic enzyme inducers
• UNIFLEX with food and drinks No known interactions with food and drink

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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