Baclofen Side Effects

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

What is baclofen?

Baclofen contains the active ingredient baclofen.

• Active ingredient — baclofen
• Registration number — 58/2.10/0090
• Registration holder — Activo Health (Pty) Ltd

It is approved for:

• BACLOFEN ACTIVO contains baclofen, which belong to a group of medicines called muscle relaxants
• BACLOFEN ACTIVO is used in adults and children to reduce and relieve the excessive tension (spasms) in your muscles occurring in various conditions such as multiple sclerosis, diseases or injuries of the spinal cord, and certain brain diseases
• Activo Health (Pty) Ltd fcfchicedgeeje Baclofen Activo

Common side effects of baclofen

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting
• These are all very serious side effects. If you have them, you may have had a serious reaction to BACLOFEN ACTIVO. 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:
• Difficulty breathing
• Shortness of breath at rest or with activity, swelling in the legs and tiredness (signs of decreased cardiac output)
• Trouble breathing during sleep (sleep apnoea syndrome)
• Difficulty passing urine, pain when passing urine or a sudden decrease in urine
• Yellowing of the skin and eyes, dark urine, abdominal pain, tiredness which may be symptoms of liver problems
• Symptoms after suddenly stopping taking the medicine (medicine withdrawal syndrome) as explained in the section ‘If you stop taking BACLOFEN ACTIVO’ above
• These are all serious side effects. You may need urgent medical attention. Activo Health (Pty) Ltd fcfchicedgeeje Baclofen Activo Tell your doctor if you notice any of the following: Side effects that may occur frequently:
• Excessively weak limbs or feeling tired and exhausted, aching muscles
• Unsteadiness, trembling or other problems with muscle control
• Headache, dizziness or light-headedness
• Mood changes, confusion, hallucinations or nightmares
• Dry mouth
• Eye-focusing problems, resulting in blurred vision
• Low blood pressure (fainting)
• Nausea, vomiting, retching, constipation and diarrhoea
• Excessive sweating, rash. Side effects that may occur less frequently:
• Numbness or tingling in hands or feet
• Increased muscle spasm
• Disturbed sense of tasted
• Stomach-ache
• Sexual problems in men e.g. difficulty keeping an erection (impotence)
• Hypothermia (low body temperature)
• Ringing noise in the ear (tinnitus). Side effect that may occur with unknown frequency:
• Raised, itchy rash (urticaria)
• Increase in blood sugar
• Slow heart rate (bradycardia)

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 baclofen or any of the other ingredients of BACLOFEN ACTIVO (listed in section 6 of this leaflet)
• If you suffer from porphyria (rare inherited blood disorder)

Use with care, and tell your doctor, if

• You have certain mental illnesses accompanied by confusion or depression
• You are suffering from Parkinson’s disease
• You are suffering from epilepsy (seizures)
• You have a history of pain in your stomach (ulcers) or intestines
• You have breathing problems, a kidney or liver disease, or a disease of circulation in your brain
• You have difficulty urinating
• You are a diabetic
• You have depression, if you have been using alcohol excessively, or if you had thoughts of killing yourself
• You have a history of drug abuse or dependance. Take special care if:
• You have thoughts of harming or killing yourself at any time while taking BACLOFEN ACTIVO, speak to your doctor straight away or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behaviour and ask them to read this leaflet
• You are elderly or have muscle spasms caused by a brain disease. You may experience more side effects therefore, your doctor will keep you under appropriate surveillance and may adapt the dose of BACLOFEN ACTIVO you take. Activo Health (Pty) Ltd fcfchicedgeeje Baclofen Activo

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 provider for advice before taking BACLOFEN ACTIVO
• You should not take BACLOFEN ACTIVO during breastfeeding
• Activo Health (Pty) Ltd fcfchicedgeeje Baclofen Activo

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to treat Parkinson’s disease may intensify the adverse events associated with central nervous system as well as the symptoms of Parkinson’s disease, e.g. levodopa or carbidopa
• Medicines which slow down the nervous system, e.g. antihistamines such as promethazine, sedatives such as temazepam, opiates for pain relief such as morphine and anti-epileptic medicines, such as carbamazepine
• Medicines to treat mood disorders such as lithium or tricyclic antidepressants such as amitriptyline
• Medicines used to treat high blood pressure may result in a further decrease in blood pressure
• Medicines for arthritis or pain may intensify the side effects of BACLOFEN ACTIVO by weakening kidney function. BACLOFEN ACTIVO with food and drink: Be careful when drinking alcohol, as it may intensify the sedative effect of BACLOFEN ACTIVO

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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