If you are taking MAKTUDA, or caring for someone who is, it helps to understand what this medicine is for, how to take it safely, and what warning signs to look out for. MAKTUDA contains lurasidone hydrochloride, a medicine used for certain mental health conditions.
In South Africa, MAKTUDA is a Schedule 5 (S5) medicine. This means it must be prescribed and monitored by a healthcare professional. You should not start, stop, share, or change the dose of this medicine without speaking to your doctor.
Quick facts: MAKTUDA is taken once daily by mouth and must be taken with food. It is used for schizophrenia in adults and adolescents aged 13 years and older, and for depressive episodes linked to bipolar disorder in adults. You should avoid grapefruit juice while taking it, and you must tell your doctor about all other medicines, herbal products, and supplements you use.
What it is and what it is used for
MAKTUDA contains the active ingredient lurasidone hydrochloride. It belongs to a group of medicines called antipsychotics. These medicines act in the brain and are used to help manage symptoms linked to certain mental health conditions.
MAKTUDA is available as film-coated tablets in these strengths:
- MAKTUDA 20 mg
- MAKTUDA 40 mg
- MAKTUDA 60 mg
- MAKTUDA 80 mg
- MAKTUDA 120 mg
Each tablet contains the matching amount of lurasidone hydrochloride.
MAKTUDA is used for:
- Schizophrenia in adults and adolescents aged 13 years and older
- Major depressive episodes associated with bipolar disorder, also called bipolar depression, in adults
For bipolar depression, the source states that MAKTUDA may be used as monotherapy. The dosing information also mentions use together with lithium or valproate. MAKTUDA has not been established as effective for treating mania associated with bipolar disorder.
How it works
MAKTUDA works by affecting certain chemical messengers in your brain, especially dopamine and serotonin. These chemicals play a role in mood, thoughts, behaviour, motivation, and how you experience reality.
When these chemical systems are out of balance, you may experience symptoms such as unusual thoughts, changes in mood, distressing beliefs, low mood, or difficulty functioning. MAKTUDA helps by changing how these messenger systems act in the brain.
You may not feel better immediately after starting MAKTUDA. Medicines for mental health conditions often need regular use and follow-up appointments. Keep taking it as prescribed unless your doctor tells you otherwise.
Who should NOT use this medicine
Do not use MAKTUDA if you:
- Are allergic to lurasidone hydrochloride
- Are allergic to any of the other ingredients in the tablet
- Are taking a strong CYP3A4 inhibitor, such as:
- Ketoconazole
- Clarithromycin
- Ritonavir
- Voriconazole
- Mibefradil
- Boceprevir
- Cobicistat
- Indinavir
- Itraconazole
- Nefazodone
- Nelfinavir
- Posaconazole
- Saquinavir
- Telaprevir
- Telithromycin
- Are taking a strong CYP3A4 inducer, such as:
- Rifampicin or rifampin
- Avasimibe
- St John’s wort
- Phenytoin
- Carbamazepine
- Phenobarbital
Warning: St John’s wort may be sold as a natural or herbal product, but it can still interact seriously with MAKTUDA. Do not take it with MAKTUDA.
Warnings and precautions
Suicidal thoughts or behaviour
If you have a psychotic illness or bipolar depression, there may be a risk of suicidal thoughts or behaviour. The source also states that suicidal behaviour has sometimes been reported early after starting or changing antipsychotic treatment.
If you are a caregiver, family member, or friend, watch for sudden changes in mood, behaviour, or safety. If you are the person taking MAKTUDA and you feel at risk of harming yourself, seek urgent help.
Parkinson’s disease
If you have Parkinson’s disease, MAKTUDA may worsen Parkinson-like symptoms. These may include stiffness, shaking, slower movement, posture changes, or walking difficulties.
Your doctor should carefully weigh the benefits and risks before prescribing MAKTUDA if you have Parkinson’s disease.
Movement problems
MAKTUDA may cause movement-related side effects. These are sometimes called extrapyramidal symptoms.
You may notice:
- Stiff muscles
- Shaking or tremor
- A mask-like facial expression
- Drooling
- Unusual posture
- Changes in walking
- Muscle spasms or abnormal movements
Another movement problem called tardive dyskinesia may also occur. This can cause repeated involuntary movements, especially of the tongue or face. If this happens, your doctor may consider stopping antipsychotic treatment.
Heart rhythm and blood pressure
Tell your doctor if you have heart disease, a family history of QT prolongation, low potassium levels, or if you take medicines that may affect heart rhythm.
MAKTUDA may also cause a drop in blood pressure when you stand up. You may feel dizzy, light-headed, faint, or unsteady.
Take care when getting up from sitting or lying down, especially when you first start treatment or after a dose change.
Seizures
If you have ever had seizures, fits, blackouts, or a condition that may make seizures more likely, tell your doctor before taking MAKTUDA.
Neuroleptic malignant syndrome
A rare but serious condition called neuroleptic malignant syndrome, or NMS, has been reported with lurasidone.
Get urgent medical help if you develop:
- Very high temperature
- Severe muscle stiffness
- Confusion or reduced awareness
- Sweating or unstable blood pressure
- Fast or irregular heartbeat
- Signs of severe illness
Warning: NMS can be life-threatening and needs urgent medical care.
Elderly people with dementia
MAKTUDA has not been studied in elderly people with dementia. Other similar antipsychotic medicines have been linked with an increased risk of death in elderly patients with dementia.
Some antipsychotics have also been linked with an increased risk of stroke-like events in people with dementia. MAKTUDA should be used cautiously in elderly patients with dementia who have risk factors for stroke.
Blood clots
Blood clots have been reported with antipsychotic medicines. Your doctor should consider your risk factors before and during treatment.
Seek urgent help if you have symptoms such as sudden shortness of breath, chest pain, or painful swelling in a leg.
Raised prolactin levels
MAKTUDA can increase a hormone called prolactin. Raised prolactin may cause:
- Breast enlargement
- Milk production from the breast when not breastfeeding
- Missed menstrual periods
- Erectile dysfunction
Tell your doctor if you notice any of these changes.
Weight and blood sugar
Weight gain has been seen with atypical antipsychotic medicines. Your doctor may monitor your weight during treatment.
Rare blood sugar-related side effects, such as increased blood glucose, have been reported with MAKTUDA. If you have diabetes or risk factors for diabetes, your doctor should monitor you appropriately.
Driving, cycling, and using machines
MAKTUDA may affect your ability to drive, cycle, or use machines. Do not do these activities until you know how the medicine affects you.
This is also important for adolescents who may cycle, even if they are not old enough to drive.
Alcohol
MAKTUDA acts on the central nervous system. The source says it should be used with caution together with alcohol.
Speak to your doctor or pharmacist about alcohol use while taking MAKTUDA.
Pregnancy, planning pregnancy, and breastfeeding
Pregnancy
MAKTUDA should not be used during pregnancy unless it is clearly necessary. This means your doctor should only consider it if the benefit to you clearly outweighs the possible risk to the unborn baby.
If you decide to become pregnant while taking MAKTUDA, your treatment should be carefully reviewed by your doctor.
Breastfeeding
It is not known whether lurasidone or its metabolites pass into human breast milk. The source states that lurasidone was found in the milk of rats during animal studies.
If you are breastfeeding, MAKTUDA should only be considered if the possible benefit of treatment justifies the possible risk to the child. Speak to your doctor before breastfeeding while taking this medicine.
Fertility
Animal studies showed some effects on fertility, mainly linked to raised prolactin. The source states that these effects are not considered relevant to human reproduction.
Interactions
MAKTUDA can interact with other medicines, herbal products, and grapefruit juice. Always tell your doctor or pharmacist what you are taking, even if you bought it without a prescription.
Grapefruit juice
Avoid grapefruit juice while taking MAKTUDA. Grapefruit juice may increase the amount of lurasidone in your body.
Medicines you must not take with MAKTUDA
Do not take MAKTUDA with strong CYP3A4 inhibitors or strong CYP3A4 inducers.
Strong CYP3A4 inhibitors can greatly increase MAKTUDA levels. These include medicines such as ketoconazole, clarithromycin, ritonavir, itraconazole, voriconazole, and posaconazole.
Strong CYP3A4 inducers can greatly reduce MAKTUDA levels. These include rifampicin, carbamazepine, phenytoin, phenobarbital, and St John’s wort.
Other medicines that may need caution
Your doctor may need to monitor you or adjust treatment if you take medicines such as:
- Diltiazem
- Erythromycin
- Fluconazole
- Verapamil
- Armodafinil
- Modafinil
- Efavirenz
- Etravirine
- Bosentan
- Prednisone
- Rufinamide
- Nafcillin
Medicines that affect heart rhythm
Caution is needed if you take medicines that may prolong the QT interval, including:
- Quinidine
- Disopyramide
- Amiodarone
- Sotalol
- Some antihistamines
- Some antipsychotics
- Some antimalarials such as mefloquine
Serotonergic medicines
Taking MAKTUDA with serotonergic medicines may increase the risk of serotonin syndrome, which can be life-threatening.
These medicines include:
- Buprenorphine or opioids
- MAO inhibitors
- SSRIs
- SNRIs
- Tricyclic antidepressants
Symptoms may include changes in mental state, body instability, muscle or nerve symptoms, and stomach or bowel symptoms.
Lithium and oral contraceptives
The source states that lithium had clinically negligible effects on lurasidone levels, and MAKTUDA does not affect lithium concentrations.
The source also states that MAKTUDA can be taken with oral contraceptives containing norgestimate and ethinyl estradiol.
How to take MAKTUDA
Take MAKTUDA exactly as your doctor tells you.
- Take it once daily
- Take it by mouth
- Take it with food
- Try to take it at the same time each day
- Do not change your dose unless your doctor tells you to
- Do not stop taking it suddenly without medical advice
Note: MAKTUDA must be taken with food because food increases how much lurasidone your body absorbs.
Adults with schizophrenia
The recommended starting dose is 40 mg once daily. Initial dose titration is not required.
The effective dose range is 40 mg to 160 mg per day. The maximum recommended dose is 160 mg per day.
Adolescents aged 13 years and older with schizophrenia
The recommended starting dose is 40 mg once daily. Initial dose titration is not required.
The effective dose range is 40 mg to 80 mg per day. The maximum recommended dose is 80 mg per day.
Adults with bipolar depression
The recommended starting dose is 20 mg once daily. Initial dose titration is not required.
The effective dose range is 20 mg to 120 mg per day. The maximum recommended dose is 120 mg per day.
The source states that, in the monotherapy study, higher doses of 80 mg to 120 mg per day did not provide additional average benefit compared with 20 mg to 60 mg per day.
If you have kidney problems
If you have moderate or severe kidney impairment, your doctor may prescribe a lower dose.
The recommended starting dose is 20 mg per day. The dose should not exceed 80 mg per day.
If you have liver problems
If you have moderate or severe liver impairment, your doctor may prescribe a lower dose.
The recommended starting dose is 20 mg per day.
The maximum dose is:
- 80 mg per day for moderate liver impairment
- 40 mg per day for severe liver impairment
Missed dose
Not specified in the source. Ask your doctor or pharmacist what to do if you miss a dose.
Overdose
If you take too much MAKTUDA, get medical help urgently. There is no specific antidote.
Treatment may include close medical supervision, heart monitoring, supportive care, and other measures decided by healthcare professionals.
Dosing table
| Patient group or use | Starting dose | Frequency | Dose range stated in source | Maximum daily dose |
|---|---|---|---|---|
| Adults with schizophrenia | 40 mg | Once daily | 40 mg to 160 mg | 160 mg |
| Adolescents 13 years and older with schizophrenia | 40 mg | Once daily | 40 mg to 80 mg | 80 mg |
| Adults with bipolar depression | 20 mg | Once daily | 20 mg to 120 mg | 120 mg |
| Moderate or severe kidney impairment | 20 mg | Once daily | Not specified in the source | 80 mg |
| Moderate liver impairment | 20 mg | Once daily | Not specified in the source | 80 mg |
| Severe liver impairment | 20 mg | Once daily | Not specified in the source | 40 mg |
Possible side effects
Like all medicines, MAKTUDA can cause side effects, although not everyone gets them. Some side effects may be mild, while others need urgent medical attention.
The most commonly reported side effects were:
- Akathisia, which means feeling restless or unable to sit still
- Nausea
- Movement-related symptoms
- Insomnia
Common side effects
You may experience:
- Restlessness
- Nausea
- Vomiting
- Diarrhoea
- Indigestion
- Dry mouth
- Increased saliva
- Stomach discomfort
- Difficulty sleeping
- Anxiety
- Agitation
- Sleepiness
- Dizziness
- Muscle stiffness
- Abnormal movements
- Tremor
- Weight increase
- Reduced appetite
- Raised prolactin levels
- Erectile dysfunction
- Missed periods
- Painful periods
- Breast pain
- Milk production from the breast
- Tiredness
- Back pain
- Rash or itching
- Fast heartbeat
- Increased blood pressure
- Cold-like symptoms such as nasopharyngitis
In adolescents, common side effects may also include headache, abnormal dreams, irritability, upper respiratory tract infection, rhinitis, changes in appetite, and muscle rigidity.
Less common side effects
Less common side effects may include:
- Anaemia
- Low white blood cell counts
- Increased blood glucose
- Low sodium levels
- Nightmares
- Panic attacks
- Suicidal behaviour
- Fainting
- Convulsions
- Blurred vision
- Chest pain from angina
- Low blood pressure
- Low blood pressure on standing
- Hot flushes
- Difficulty swallowing
- Gastritis
- Increased liver enzymes
- Excessive sweating
- Swelling from angioedema
- Joint stiffness
- Muscle pain
- Neck pain
- Muscle breakdown
- Kidney-related problems
- Painful urination
- Breast enlargement
- Walking disturbance
Serious side effects — seek urgent help
Get urgent medical help if you notice:
- Suicidal thoughts or behaviour
- Seizures
- Fainting or collapse
- Severe muscle stiffness with fever or confusion
- Severe uncontrolled movements of the face or tongue
- Signs of stroke, such as sudden weakness, facial drooping, or speech problems
- Severe allergic reaction or swelling
- Severe skin reaction
- Sudden chest pain or shortness of breath
- Painful swelling in a leg
- Symptoms that may suggest serotonin syndrome
Warning: If a symptom feels sudden, severe, or frightening, do not wait. Contact a doctor, clinic, emergency unit, or pharmacist urgently.
Storage and disposal
Store MAKTUDA at or below 30 °C.
Keep the tablets in the blister and in the carton until you need to take them.
Do not store MAKTUDA in a refrigerator.
Keep this medicine out of reach of children.
The shelf life for the blister pack is 24 months. Do not use the tablets after the expiry date.
No special disposal requirements are specified in the source. Ask your pharmacist how to safely dispose of unused or expired tablets.
What the medicine contains
The active ingredient is lurasidone hydrochloride.
Each tablet contains one of the following strengths:
- 20 mg lurasidone hydrochloride
- 40 mg lurasidone hydrochloride
- 60 mg lurasidone hydrochloride
- 80 mg lurasidone hydrochloride
- 120 mg lurasidone hydrochloride
MAKTUDA is sugar free.
Other ingredients include:
- Mannitol
- Croscarmellose sodium
- Hydroxypropyl methylcellulose
- Colloidal silicon dioxide
- Magnesium stearate
- Hypromellose
- Polyethylene glycol
- Titanium dioxide
- Yellow iron oxide
- FD and C Blue No. 2 Al lake
Pack information and appearance
MAKTUDA tablets are film-coated.
| Strength | What the tablet looks like |
|---|---|
| 20 mg | White to off-white, round, biconvex, marked “F3” on one side |
| 40 mg | White to off-white, round, biconvex, marked “F4” on one side |
| 60 mg | White to off-white, capsule-shaped, biconvex, marked “F5” on one side |
| 80 mg | Pale green, oval, biconvex, marked “F6” on one side |
| 120 mg | White to off-white, oval, biconvex, marked “F7” on one side |
MAKTUDA may be supplied in blister packs or HDPE containers.
Blister pack sizes may include:
- 14 tablets
- 28 tablets
- 56 tablets
- 84 tablets
- 90 tablets
- 100 tablets
HDPE container pack sizes may include:
- 30 tablets
- 90 tablets
Not all pack sizes may be marketed.
Practical FAQs
Can I take MAKTUDA without food?
No. You must take MAKTUDA with food. Food helps your body absorb the medicine properly.
Can I drink grapefruit juice while taking MAKTUDA?
No. Avoid grapefruit juice because it may increase MAKTUDA levels in your body.
Can I drink alcohol while taking MAKTUDA?
Use caution with alcohol. MAKTUDA affects the central nervous system, so speak to your doctor or pharmacist about whether alcohol is safe for you.
Can I drive while taking MAKTUDA?
Be careful. Do not drive, cycle, or use machines until you know how MAKTUDA affects you.
Is MAKTUDA used for bipolar mania?
The source states that MAKTUDA has not been established as effective for mania associated with bipolar disorder.
Can teenagers take MAKTUDA?
MAKTUDA is indicated for schizophrenia in adolescents aged 13 years and older. The maximum recommended dose for adolescents is 80 mg per day.
What should I do if I become pregnant?
Speak to your doctor as soon as possible. Your doctor should carefully review whether you should continue MAKTUDA.
Can I breastfeed while taking MAKTUDA?
It is not known whether lurasidone passes into human breast milk. Breastfeeding should only be considered if the benefit of treatment justifies the possible risk to the child.
What if I take too much?
Get urgent medical help. Overdose needs medical monitoring and supportive care.
Does MAKTUDA contain sugar?
The source states that MAKTUDA is sugar free.
Sources :
Written by: RxZest Editorial Team
Editorial review: Checked for readability, structure, and source alignment
Based on SAHPRA-approved information
Last updated: [01/05/2026]
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2026/04/Final_pi_Maktuda-1.pdf
