Betapam Side Effects

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

What is Betapam?

Betapam contains the active ingredient Diazepam. TARTRAZINE.

• Active ingredient — Diazepam. TARTRAZINE
• Registration number — L/2.6/185
• Registration holder — Ranbaxy Pharmaceuticals (Pty) Ltd

It is approved for:

• Anxiety
• Muscle spasm (cramps) such as those caused by cerebral spasticity

Common side effects of Betapam

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.

Frequent side effects

• Feeling tired
• Weak muscles

Less frequent side effects

• Poor co-ordination, including feeling unsteady when you walk
• Slow or slurring of speech
• Headache
• Feeling dizzy
• Uncontrollable movements, for example of your hands (tremor)
• Anterograde amnesia (difficulty remembering new things)
• Confusion
• Depression
• Being less alert
• blood disorders (you may develop sore throats, nose bleeds or infections)
• sleepiness, feeling disorientated Heart and circulation
• Low blood pressure. The signs include feeling dizzy or light-headed
• Uneven heartbeat, heart failure and cessation of heartbeat (cardiac arrest)
• respiratory arrest (cessation of breathing) Stomach and gut
• Feeling sick (nausea)
• Constipation
• Diarrhoea
• Dry mouth
• Indigestion
• Diarrhoea
• increased salivation
• blood disorders (you may develop sore throats, nose bleeds or infections)
• Sexual
• changes in sexual drive (libido)
• irregular menstruation Eyes and ears
• Problems with your eye-sight, including double or blurred vision
• Vertigo. The signs include feeling dizzy or a spinning sensation. Skin
• Skin rashes
• jaundice (yellowing of your skin or the white of your eyes). Liver and kidneys
• Changes in how well your liver is working (shown by blood tests)
• Loss of bladder control (wetting yourself). Injury When you take BETAPAM you are at risk of falling and breaking your bones. This risk is increased if you are elderly or are taking other sedatives (including alcohol). Withdrawal symptoms: You can become dependent on benzodiazepine medicines like BETAPAM. This means that if you stop treatment suddenly, or lower the dose too quickly, you may get withdrawal symptoms. The symptoms can include: Frequent withdrawal symptoms include:
• Headache
• Muscle pain and feeling restless
• Feeling very worried, tense, confused or bad tempered
• Emotional withdrawal
• Memory loss Less frequent withdrawal symptoms include:
• Feeling sensitive to light, noise and touch
• Seeing or hearing things that are not really there (hallucinations)
• Tingling and numb in your arms and legs
• Feeling lost or losing contact with reality
• Fits (seizures)

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

• if you are hypersensitive (allergic) to diazepam or any of the other ingredients of BETAPAM (listed in section 6)
• if you have breathing or lung problems
• if you have severe liver problems
• if you have a condition called “sleep apnoea syndrome” (where your breathing stops when you are asleep)
• if you have a condition called “myasthenia gravis” (where your muscles are weak and get tired easily)
• if you are addicted to CNS depressants (e.g., tranquilisers, sleep medicine) including alcohol
• if you have problems with phobias (strong fears) or obsessions (troublesome, unwanted and repeated thoughts, ideas or feelings)
• Do not use BETAPAM alone to treat depression or anxiety associated with depression
• if you have an allergy to BETAPAM or any other benzodiazepine medicine (e.g. clonazepam, flurazepam and temazepam)

Use with care, and tell your doctor, if

• if you regularly drink alcohol and/or CNS depressants, or take recreational drugs
• if you have had problems with alcohol or drug abuse in the past
• if you experience total or partial memory loss, memory loss is more likely to occur when taking high doses of BETAPAM
• if you have acute narrow-angle glaucoma (eye disorder where the nerve connecting the eye to the brain is damaged, usually due to high eye pressure)
• if you have liver, kidney, lung or heart problems
• if you have difficulty in swallowing or breathing or suffer from a lung disease called chronic obstructive pulmonary disease
• if you are being treated for depression
• if you have suicidal thoughts
• if you have a personality disorder
• if you are elderly or weak, your doctor will decide whether to prescribe a lower dose of BETAPAM for you
• if you suffer from arteriosclerosis (build-up of fats, cholesterol and other substances in and on the artery walls)
• if you have low blood pressure
• if you are suffering from porphyria
• if you are driving a car and/or operating machinery
• if you have been told that you cannot tolerate or digest some sugars
• if you are to give BETAPAM to a child younger than 6 months of age. BETAPAM is not recommended for use in this age group unless there are no other treatment options Symptoms such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other side effects are known to occur when using BETAPAM. Should this occur, the use of BETAPAM should be discontinued. They are more likely to occur in the elderly. Patients taking BETAPAM have developed blood disorders and periodic blood counts are recommended. Tolerance If after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should speak to your doctor. Dependence When taking this medicine there is a risk of dependence, which increases with the dose and duration of treatment and also in patients with a history of alcoholism and drug abuse. Therefore, you should take BETAPAM tablets for as short a period of time as possible. Withdrawal Treatment should be gradually withdrawn. Withdrawal symptoms occur with BETAPAM tablets even when normal doses are given for short periods of time.’

Pregnancy and breastfeeding

• 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 professional for advice before taking BETAPAM
• The safety of BETAPAM during pregnancy has not been established
• There is an increased risk of birth defects to your baby if you take BETAPAM during pregnancy
• It can also result in so-called floppy-infant syndrome that is characterised by poor muscle tone, problems with sucking and swallowing, difficulty breathing, and low body temperature
• Special care must be taken when BETAPAM is used during labour and delivery, as high single doses may produce irregularities in your baby’s heart rate and muscle tone, poor sucking, reduced BETAPAM is excreted in breastmilk and should not be used by mothers who are breastfeeding
• Data on fertility is not currently available

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines to treat mental health problems (e.g., clozapine, phenothiazines, levomepromazine, olanzapine)
• antidepressants (e.g., fluvoxamine, fluoxetine)
• Other medicines to relieve anxiety such as other benzodiazepine medicines (clonazepam, flurazepam and temazepam)
• Medicines to help you sleep
• strong pain killers, such as methadone, morphine or pethidine
• Medicines for allergies, which make you sleepy
• medicine to treat Parkinson’s disease such as levodopa
• medicines to treat asthma and other breathing disorders (theophylline)
• anaesthetic medicine such as ketamine
• Medicines to treat convulsions or epilepsy such as phenytoin or carbamazepine
• medicines to treat stomach problems and heartburn, such as cimetidine, cisapride
• medicines to treat fungal skin infections, such as ketoconazole
• oral contraceptives
• medicines to treat alcohol addiction such as disulfiram
• medicines to treat tuberculosis such as isoniazid
• medicines to treat high blood pressure such as diltiazem
• medicines to treat excessive sleepiness caused by sleep apnoea, narcolepsy, or shift work sleep disorder such as modafinil or armodafinil
• antiviral medicine such as ritonavir
• antibiotics such as erythromycin, clarithromycin
• medicines to treat infections (an antibiotic), such as rifampicin
• anticonvulsant medication, such as carbamazepine
• medicines that block the action of acetylcholine, such as atropine Anaesthetics: If you are going to have an anaesthetic for an operation or dental treatment, it is important to tell your doctor or dentist that you are taking BETAPAM. BETAPAM with food, drink and alcohol Drinking alcohol: Do not drink alcohol while you are taking BETAPAM, because BETAPAM can make you sleepy. You are more likely to have problems with your concentration and to fall more deeply asleep which may cause serious problems with your breathing or heartbeat. Grapefruit juice may increase the amount of diazepam in your blood. If you are elderly, suffer from cirrhosis or any of the conditions listed in section 2, this could possibly increase the sedative effects of BETAPAM tablets and you should speak to your doctor or pharmacist Drinks containing caffeine may reduce the effects of BETAPAM

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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