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HELOPER L. A. (Haloperidol Decanoate 70.52mg) 50mg/ml injekcinis tirpalas 1ml N1 |
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Vardinis vaistinis preparatas - informacinis lapelis pateikiamas tik anglų kalba
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HELOPER L. A. (Haloperidol Decanoate 70.52mg) 50mg/ml injekcinis tirpalas 1ml N1 |
Informacinis lapelis |
Vardinis vaistinis preparatas - informacinis lapelis pateikiamas tik anglų kalba
Package leaflet: Information for the patient Heloper LA 50 mg/ml solution for injection Haloperidol Decanoate
Presentation: Each ml contains: Haloperidol Decanoate B.P. 70.52 mg equivalent to Haloperidol 50.00 mg
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
The name of your medicine is Heloper LA. Heloper LA contains the active substance haloperidol (as haloperidol decanoate). This belongs to a group of medicines called ‘antipsychotics’.
Heloper LA is used in adults whose condition has previously been treated with haloperidol taken by mouth. It is used for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia). These illnesses may make you:
Do not use Heloper LA if:
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:
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:
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:
Certain medicines may affect the way that Heloper LA works or may make heart problems more likely Tell your doctor if you are taking:
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:
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):
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.
How much medicine will you be given Your doctor will decide how much Heloper LA you need and for how long. Your doctor will adjust the dose to suit you, and may also give you a type of haloperidol that you take by mouth. Your dose of haloperidol decanoate will depend on:
Adults
Elderly people
How Heloper LA is given Heloper LA will be given by a doctor or nurse. It is for intramuscular use, and is given as an injection deep into a muscle. A single dose of Heloper LA will normally last for 4 weeks. Heloper LA must not be injected into a vein.
If you have too much Heloper LA A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much. If you are worried, tell the doctor or nurse.
If you miss a dose or stop using Heloper LA You should not stop this medicine unless told to do so by your doctor as your symptoms may return. If you miss an appointment, contact your doctor right away to make a new appointment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects Tell your doctor or nurse straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Problems with the heart:
Heart problems are uncommon in people using Heloper LA (may affect up to 1 in 100 people). Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.
A serious problem called ‘neuroleptic malignant syndrome’. This causes a high fever, severe muscle stiffness, confusion and loss of consciousness. The exact frequency of this side effect in people using Heloper LA is unknown.
Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
These are very common in people using Heloper LA (may affect more than 1 in 10 people). If you get any of these effects, you may be given an additional medicine.
Severe allergic reaction that may include:
The exact frequency of an allergic reaction in people using Heloper LA is unknown.
Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. The signs of a DVT in the leg include swelling, pain and redness in the leg, but the clot may move to the lungs causing chest pain and difficulty in breathing. Blood clots can be very serious, so tell your doctor straight away if you notice any of these problems.
Tell your doctor straight away if you notice any of the serious side effects above.
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
The following side effects have also been reported, but their exact frequency is unknown:
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse.
Keep this medicine out of the sight and reach of children.
Heloper LA should not be used after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. Store in the original package to protect from light.
What Heloper LA contains 50 mg/ml solution: The active substance is haloperidol. Each ml of the solution for injection contains 70.52 mg of haloperidol decanoate, equivalent to 50 mg of haloperidol base. The other ingredients are benzyl alcohol and sesame oil.
What Heloper LA looks like and contents of the pack 50 mg/ml solution: Heloper LA is a slightly amber, slightly viscous solution, with no visible particles. It is supplied in amber glass ampoules containing 1 ml of solution in packs of 1 ampoule.
Manufactured By: Finesse Pharmaceuticals Pvt Ltd Plot No.:827/6, Village Santej, Taluka Kalol, Gandhinagar(Gujarat), India.
Marketed By: Dellwich Healthcare LLP 1, Suramya Greens, Near Bhagwat vidhyapith, Sola, Ahmedabad- 380060, Gujarat, India. |
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