Do not use Heloper LA if:
- You are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6)
- You are allergic to sesame oil. Heloper LA contains sesame oil. See ‘Heloper LA contains’ below
- You are less aware of things around you or your reactions become unusually slow
- You have Parkinson’s disease
- You have a type of dementia called ‘Lewy body dementia’
- You have progressive supranuclear palsy (PSP)
- You have a heart condition called ‘prolonged QT interval’, or any other problem with your heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram)
- You have heart failure or recently had a heart attack
- You have a low level of potassium in your blood, which has not been treated
- You take any of the medicines listed under ‘Other medicines and Heloper LA – Do not use Heloper LA if you are taking certain medicines for’.
This medicine must not be used if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before being given Heloper LA.
Warnings and precautions Serious side effects
Heloper LA can cause problems with the heart, problems controlling body or limb movements
and a serious side effect called ‘neuroleptic malignant syndrome’. It can also cause severe allergic reactions and blood clots. You must be aware of serious side effects while you are using Heloper LA because you may need urgent medical treatment. See ‘Look out for serious side effects’ in section 4.
Elderly people and people with dementia
A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines. Talk to your doctor before being given Heloper LA if you are elderly, particularly if you have dementia.
Talk to your doctor if you have:
- A slow heartbeat, heart disease or anyone in your close family has died suddenly of heart problems
- Low blood pressure, or feel dizzy upon sitting up or standing up
- A low level of potassium or magnesium (or other ‘electrolyte’) in your blood. Your doctor will decide how to treat this
- Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
- Epilepsy or have ever had fits (convulsions)
- Problems with your kidneys, liver or thyroid gland
- A high level of the hormone 'prolactin' in your blood, or cancer that may be caused by high prolactin levels (such as breast cancer)
- A history of blood clots, or someone else in your family has a history of blood clots
- Depression.
You may need to be more closely monitored, and the amount of Heloper LA you are given may have to be altered.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Heloper LA.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Heloper LA. The ECG measures the electrical activity of your heart.
Blood tests
Your doctor may want to check the levels of potassium or magnesium (or other ‘electrolyte’) in your blood before or during your treatment with Heloper LA.
Children and adolescents
Heloper LA should not be used in children and adolescents below 18 years. This is because it has not been studied in these age groups.
Other medicines and Heloper LA
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Do not use Heloper LA if you are taking certain medicines for:
- Problems with your heartbeat (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol)
- Depression (such as citalopram and escitalopram)
- Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
- Bacterial infections (such as azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin)
- Fungal infections (such as pentamidine)
- Malaria (such as halofantrine)
- Nausea and vomiting (such as dolasetron)
- Cancer (such as toremifene and vandetanib).
Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a pain killer or to treat drug addiction).
These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Heloper LA (see ‘Do not use Heloper LA if’).
Special monitoring may be needed if you are using lithium and Heloper LA at the same time. Tell your doctor straight away and stop taking both medicines if you get:
- Fever you can’t explain or movements you can’t control
- Confused, disoriented, a headache, balance problems and feel sleepy. These are signs of a serious condition.
Certain medicines may affect the way that Heloper LA works or may make heart problems more likely
Tell your doctor if you are taking:
- Alprazolam or buspirone (for anxiety)
- Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John’s Wort (Hypericum, perforatum) or venlafaxine (for depression)
- Bupropion (for depression or to help you stop smoking)
- Carbamazepine, phenobarbital or phenytoin (for epilepsy)
- Rifampicin (for bacterial infections)
- Itraconazole, posaconazole or voriconazole (for fungal infections)
- Ketoconazole tablets (to treat Cushing’s syndrome)
- Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
- Chlorpromazine or promethazine (for nausea and vomiting)
- Verapamil (for blood pressure or heart problems).
Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Your doctor may have to change your dose of Heloper LA if you are taking any of these medicines.
Heloper LA can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
- Calming you down or helping you to sleep (tranquillisers)
- Pain (strong pain killers)
- Depression (‘tricyclic antidepressants’)
- Lowering blood pressure (such as guanethidine and methyldopa)
- Severe allergic reactions (adrenaline)
- Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as ‘stimulants’)
- Parkinson’s disease (such as levodopa)
- Thinning the blood (phenindione).
Talk to your doctor or nurse before being given Heloper LA if you are taking any of these medicines.
Heloper LA and alcohol
Drinking alcohol while you are using Heloper LA might make you feel sleepy and less alert. This means you should be careful how much alcohol you drink. Talk to your doctor about drinking alcohol while using Heloper LA, and let your doctor know how much you drink.
Pregnancy, breast-feeding and fertility
Pregnancy – if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor may advise you not to use Heloper LA while you are pregnant.
The following problems may occur in newborn babies of mothers that use Heloper LA in the last 3 months of their pregnancy (the last trimester):
- Muscle tremors, stiff or weak muscles
- Being sleepy or agitated
- Problems breathing or feeding.
The exact frequency of these problems is unknown. If you used Heloper LA while pregnant and your baby develops any of these side effects, contact your doctor.
Breast-feeding – talk to your doctor if you are breast-feeding or planning to breast-feed. This is because small amounts of the medicine may pass into the mother’s milk and on to the baby. Your doctor will discuss the risks and benefits of breast-feeding while you are using Heloper LA.
Fertility – Heloper LA may increase your levels of a hormone called ‘prolactin’, which may affect fertility in men and women. Talk to your doctor if you have any questions about this.
Driving and using machines
Heloper LA can affect your ability to drive and use tools or machines. Side effects, such as feeling sleepy, may affect your alertness, particularly when you first start using it or after a high dose. Do not drive or use any tools or machines without discussing this with your doctor first.
Heloper LA contains benzyl alcohol and sesame oil
This medicine contains 15 mg of benzyl alcohol in each ml of the solution. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called ‘metabolic acidosis’).
This medicine also contains sesame oil, which may rarely cause severe allergic reactions.
Informacinė sistema gydytojams
