Risperidone 1mg/Ml Oral Solution
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Stomach and intestine
Uncommon:
• constipation, digestive disorders in the form of a feeling of fullness in the upper abdomen, pain in the stomach, belching, nausea, vomiting and heartburn (dyspepsia), abdominal pain.
Very rare:
• vomiting.
Skin and subcutaneous tissue
Uncommon:
• skin rash and other hypersensitivity reactions.
Very rare:
• recurrent episodes of temporary, itchy accumulations of fluid (oedema) of the skin and/or the mucous membranes (angio-oedema).
Muscles
Uncommon:
• stiffness, movement disorders such as making involuntary movements.
Kidneys and urinary tract
Very rare:
• involuntary passage of urine (enuresis).
Sex organs and breasts
Uncommon:
• erectile disorders, problems with ejaculation or achieving orgasm, impotence (sexual incapacity in the male) in men who have not previously had sexual problems.
Rare:
• secretion of mi I k, development of b reasts in men, disorders of the menstrual cycle and absence of menstruation.
Very rare:
• persistent, often painful erection of the penis (priapism).
General
Uncommon:
• drowsiness, tiredness.
Rare:
• increase in weight.
Very rare:
• accumulation of fluid (oedema).
Examinations:
Very rare:
• Movement disorder with symptoms such as abnormal muscle movements of the tongue, face, mouth, jaws or arms and legs, sometimes accompanied by shaking (tardive dyskinesia) may occur if you use anti-psychotic drugs over long periods of time (particularly at high doses). These symptoms can also temporarily get worse or might even appear after treatment has stopped. Your doctor will regularly monitor you for such signs for up to six months after treatment has started. If you should experience symptoms like these during treatment with risperidone, your doctor may consider stopping your risperidone treatment. In the elderly and in persons with brain damage, there is a greater risk that such symptoms may become permanent.
Symptoms such as headache, nausea, confusion, muscle cramps, frts/convulsions and sometimes coma can occur. This can come about because too much water (or another liquid) has been drunk because of an increased sensation of thirst or a disorder in the secretion of a certain hormone (SIADH).
If you should develop symptoms such as high fever, heavy sweating, severe muscle stiffness, excessive saliva flow, rapid breathing, altered state of consciousness or paleness, muscle cramps and reddish-brown discolouration of the urine (symptoms of neuroleptic malignant syndrome). You must co ntact you r doctor i m med iately.
Antipsychotic drugs can sometimes cause the worsening of symptoms such as agitation, unrestand aggressiveness. If this should occu r, it may become necessary to I owe r you r d ose or to sto p yo u r treatment. Pleaseaskyourdoctor.
Fits/convulsions, exacerbation of depression (severe despondency) and a bleak mood, lack of control of body temperature can occur.
Blood dots in the veins especially in the legs (symptoms indude swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. Howto store Risperidone Oral Solution
Keep out of the reach and sight of children. Do not use Risperidone Oral Solution after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.Once opened, use within 2 months.
Medidnes should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect theenvironment.
6. Further Information
What Risperidone Oral Solution contains
The active ingredient is risperidone 1 mg/ml.
The other ingredients are tartaric acid (E334), benzoic acid (E210) and purified water
What Risperidone Oral Solution looks like and contents of the pack
Risperidone Oral Solution is a clear colourless solution. It is available in bottles containing 30 ml or 100 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd,
115NarboroughRoad,
Leicester, LE3 OPA
Manufacturer
• Morningside Healthcare Ltd, 5 Pavilion Way, Loughborough, LE11 5GW.
• Sofarimex IndustriaQuimicae Farmaceutica, Lda.Av.Das Industrias.Alto de
Colaride.Agualva, 2735 213 Cacem,Portugal.
• Monteresearch S.r.l., Via IV Novembre n.92,20021 Bollate (Ml), Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
Portugal : Risperidone Eurogenus
UK : Risperidone 1 mg/ml Oral Solution
This leaflet was last revised: May 2013
PACKAGE LEAFLET: INFORMATION FOR THE USER
Risperidone 1 mg/ml Oral Solution
Risperidone
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not I isted i n th is leaflet, please te 11 yo u r d octor or pharmacist.
In this leaflet:
1. What Risperidone Oral Solution is and what it is used for
2. Before you take Risperidone Oral Solution
3. How to take Risperidone Oral Solution
4. Possible side effects
5. How to sto re Risperidone Oral Solution
6. Further information
I.What Risperidone Oral Solution Is and what It are used for
Risperidone is one of a group of medicines called antipsychotics. It is used to treat schizophrenia, a condition which affects the way you think, feel and/or act. The condition may cause symptoms such as confusion, hallucinations (e.g. hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness (paranoia), emotional and social withdrawal. Risperidone may also be taken to keep schizophrenia under control after the previous symptoms have declined, to prevent the illness from returning in its full intensity.
In addition Risperidone may be used:
• to control the symptoms of mania for people with bipolar disorders.
Do not take Risperidone Oral Solution
• if you are allergic (hypersensitive) to Risperidone or any of the other ingredients of Risperidone. An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath.
Take special care with Risperidone Oral Solution
• if you suffer with dementia and have a history of the following: brain haemorrhage (stroke/ CVA) or a disorder that affects the blood supply to the brain (TIA), abnormally low blood pressure or diabetes. In such cases, the use of risperidone is not recommended. You or your caregiver/ family must consult your doctor immediately if any of the following symptoms should appear during treatment with risperidone: slackness or numbness of the cheeks, feelings of weakness in the arms or legs, difficulties in speaking or seeing. In such cases, risperidone treatment may have to be stopped.
• if you sufferfrom dementia as a result of Lewy body disease (acertaindisorder affecting thenervecellsinthebrain).
• if you have Parkinson’s disease, as the symptoms of Parkinson's disease may get worse.
• if you have a cardiovascular disorder (e.g. inability of the heart to pump blood property, heart attack, heart rhythm disorders, lack of fluid in the body tissues (dehydration),
abnormal low volume of circulating blood (hypovolaemia)or a disorder affecting the blood vessels in the brain). Risperidone must be used with caution, as - especially at the start of treatment - it may cause a sudden drop in blood pressure, accompanied by feelings of dizziness (e.g. on standing up from a sitting or lying position). Care must be taken when adjusting the starting dose.
■ if you have low blood pressure (hypotension). Your dosage may have to be reduced.
• if yo u h ave reduced I iver or kid n ey fo notion. 11 is advisable to halve both the starting dose and any dose increases. This also applies to dosage schedules forthe elderly.
• if you suffer from brain dysfunction (organic mental disorders).Theriskofside effects is g reate r.
■ if you have epilepsy (seizures). Risperidone must be used with caution, as it may bring on an attack.
• if you have diabetes. Abnormally high blood sugar levels (hyperglycaemia) or deterioration of existing diabetes may occur during treatment with risperidone.
• if you are using drugs that can prolong the QT interval (ask your doctor or pharmacist about this) or if you have a heart condition, a heart rhythm disorder or abnormal low levels of potassium in the blood. Risperidone must be used with caution.
• Risperidone must be used with particular caution if you have a special hormone-dependant tumour, a so called “Prolactin-dependent" tumour for example some breast cancer tumours.
• if you or anyone of your family suffer from heart disease (for e.g. unusual heart rhythm).
• if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood dots.
Elderly patients
There is little experience on the use of risperidone in elderly patients. Elderly patients receiving Risperidone may be more prone to dizziness, abnormal low blood pressure and a slow heartbeat. As a result, they are at greater risk of injury, caused by an increased tendency to fall.
Children and adolescents
Before treatment is started your, or your child's body weight may be measured and it may be regularly monitored during treatment.
As there is no experience on the use of risperidone in children below the age of 15, treatment with risperidone is not recommended.
There is no experience in the treatment of manic episodes in children and adolescents younger than 18 years.
Dementia
The risk of (mini) stroke (heart attack, sudden weakness or paralysis in the face, arms and legs, particularly down one side, or impaired speech) may be greater in patients with dementia who use risperidone. Talk to your doctor if you have dementia and have ever suffered from a (mini) stroke, high blood p ressu re or d iabetes.
Studies on elderly patients with dementia have shown that treatment with antipsychotics such as risperidone (so-called atypical antipsychotics) may harm the health of these patients. Please contact your doctor if you would like to discuss this. Risperidone can be particularly harmful to the health of elderly patients with dementia, if it is used at the same time as drugs
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that contain furosemide. Furosemide is a drug that is used for baby develops any of these symptoms you may need to contact the treatment of high blood pressure and swelling (oedema) as your doctor. aresultofabuild-upoffluidwithinthebody.Youshouldletyour doctor know if you are using drugs that contain furosemide. The active substance in Risperidone oral solution passes into breast milk in very small amounts. To date, there have been no Please tell your doctor if any one of the above warnings applies known harmful effects for breastfed infants. Risperidone can to you, or has applied to you in the past. increase the amount of breast milk produced. Risperidone should not be used in breast-feeding unless strictly necessary. Taking other medicines So you should talk with your doctor if you wish to breastfeed. Avoid taking neuroleptics (medicines used to treat psychoses Your doctor may then consider whether the benefits of and schizophrenia) at the same time. breastfeeding outweigh the potential risks for your child. Please tell your doctor or pharmacist if you are taking or have Driving and using machines recently taken any other medicines, including medicines Do not drive or use machines because Risperidone can obtainedwithoutaprescriptionorthefollowing: adversely affect you r ab i 1 ity to react. P1 ease contact you r d octo r • other drugs that act on the central nervous system, such as who will assess the effect of Risperidone on you and advise if alcohol, opioids (strong painkillers), antihistamines (drugs you are still able to drive or use machines. used to treat allergic reactions) and benzodiazepines properties). The effect of such drugs may be increased. • other antipsychotic drugs, lithium (a drug used to treat Always take Risperdone Oral Solution exactly as your doctor manic depression), drugs used in severe depression has to Id you. You should check with your doctor or pharmacist if (antidepressants) and anti-Parkinson drugs. There is a you are not sure. Risperidone Oral Solution may be taken as a greater risk of side effects, such as movement disorders. single dose, once a day or it may be taken in divided doses • levodopa and other drugs that raise dopamine levels (a twice a day (in the morning and in the evening). Remember -certain substance in the brain), such as those used in the each millilitre (ml) of liquid isequivalenttol mg. treatment of Parkinson's disease. Risperidone can reduce the effect of such drugs. Adults: • d ru gs that sti m u late 1 ive r fu ncti on, s u ch as carbamazepine (used in epilepsy), barbiturates (used in epilepsy and Schizophrenia: insomnia), phenytoin (used in epilepsy). These drugs Switching from another antipsychotic agent to risperidone: reduce the effect of risperidone. If you stop taking one of The treatment with the other antipsychotics should be these drugs, your risperidone dosage may have to be withdrawn gradually. In the case of treatment involving adjusted. injections, the risperidone treatment should be started at the • certain drugs used to treat high blood pressure, such as time the following injection would normally be given, phenoxybenzamine, labetalol, methyldopa and reserpine. Risperidone can increase the hypotensive (blood pressure Adults and adolescents over the age of 15 lowering) effect of these drugs. The dose on Day 1 is 2 mg (2 ml) of Risperidone (taken as a • guanethidine (used to treat high blood pressure). single dose or split into two doses). Your doctor may increase Risperidone can reduce the hypotensive (blood pressure this dose on Day 2, to 4 mg (4ml), taken as a single dose or split lowering) effect of guanethidine. into two doses (one taken in the morning and one in the • certain diuretics (water tablets), such as furosemide and evening). If needed, the dose will be slowly increased, usually chlorothiazide. Excretion of water, minerals (such as to between 4 mg and 6 mg of Risperidone a day, although sodium) and sometimes chloride can be increased. doses up to 8 mg are acceptable. • antacids (drugs used to neutralise stomach add). Antacids For elderly patients, the usual starting dose is 0.5 mg (0.5ml) reduce the effect of antipsychotic drugs, such as twice a day. Your doctor may increase this dose to 1 to 2 mg risperidone. twice a day. • drugs that also prolong the QT interval, such as certain anti- arrhythmic drugs (used to correct heart rhythm disorders), Children and adolescents up to 15 years of age macrolide antibiotics (used in infections), anti-malaria To date, there is no experience on the use of Risperidone in drugs, antihistamines (used to treat allergic reactions), children aged 15 or younger so that the use of risperidone in this antidepressants (used in cases of severe depression) and group is not recommended, drugs that cause abnormally low levels of potassium in the blood (e.g. certain diuretics). Risperidone use at the same In patients with reduced liver or kidney function time as such drugs must be avoided, as this may cause The recommended starting dose is 0.5 ml twice daily. This dose hypokalaemia (low potassium blood levels). can be adjusted, in steps of 0.5 ml twice daily, to a dose of 1 to2 ml twice daily. Caution should be exercised because little Taking Risperidone Oral Solution with food and drink experience has been acquired in the treatment of people with Risperidone may be taken before or after food. Risperidone impaired liver or kidney function. Oral Solution can be mixed with a non-alcoholic beverage, exce Wh i I e ti j s h carefu Ihow Patlentslnamanlcohase much alcohol you drink,as this medicine can increase the effect of the alcohol. Adults and adolescents over the age of 18 The starting dose is 2 mg (2ml) once daily. Your doctor may Pregnancy and breast-feeding slowly increase this by 1 mg (1ml) a day, if needed up to 6 mg Risperidone should not be used in pregnancy unless absolutely (6ml) once daily. Your doctor will regularly check your necessary. Ask your doctor for advice if you are pregnant or treatment, plan to become pregnant. The following symptoms may occur in newborn babies, of mothers that have used Risperidone in Children and adolescent the last trimester (last three months of their pregnancy): There is no experience in the treatment of manic episodes in shaking, muscle stiffness and/or weakness, sleepiness, children and adolescents younger than 18 years, agitation, breathing problems, and difficulty in feeding. If your |
Elderly patients Rare (in more than 1 in 10.000. but in less than 1 in The recommended starting dose is 0.5 ml twice daily. This dose 1,000 patients) canbeadjusted,instepsof0.5mltwicedaily,toadoseof1to2 Veryrare (inlessthan1in10,000 patients) ml twice daily. Caution should be exercised because little experience has been acquired in the treatment of elderly Infections patients. Uncommon: • inflammation of the mucous membrane of the nose, Important: Never take more than 16 ml Risperidone a day. characterised by blocked nose, sneezing and discharge (rhinitis). If you notice that the effect of Risperidone is too strong or too weak, talk to your doctor or pharmacist. Blood Veryrare: Directions for opening the bottle and using the pipette for • blood abnormality (deficiency of white blood cells) Risperidone Oral Solution associated with increased susceptibility to infections (neutropenia), blood abnormality (deficiency of blood Instructions for opening the bottle and using the dosing syringe platelets) associated with bruises and a tendency to • Remove cap from the bottle bleeding (thrombocytopenia). • Fit the adaptor into the neck of the bottle, it is not necessary to remove after use Endocrine system • While the bottle is sitting on a firm, flat surface, hold it Uncommon: steady with one hand. With the other hand insert the tip of • increase in the quantity of prolactin (a hormone) in the the syringe into the adaptor blood. ■ I n vert the bottle (tumupside-down) • Slowly pull back the plunger of the syringe until the mark Metabolism that matches the number of mg or ml to be taken is just Veryrare: visible ■ excessive blood sugar content (hyperglycaemia), • If la rg e bu bbl es ca n be seen in the syri nge, slowly push th e agg ravation of existi ng d iabetes. plunger back into the syringe. This will force the medicine back into the bottle. Repeat the above step again Mental disorders ■ Return the bottle to it original position, and remove the Common: dosing syringe • insomnia, agitation, anxiety. • The contents of the syri nge may be emptied directly into the Uncommon: mouthorintoadrinkofmineral water, orangejuiceorb lack ■ impairedconcentration. coffee, by slowly pushing down the plunger of the syringe. Donotmixwithtea. Ne rvous system • Close the bottle Common: ■ Rinse the dosing syri nge with water. ■ headache, drowsiness or somnolence (sedation). Uncommon: If you take more Risperidone Oral Solution than you • tremor, abnormal slowness of thinking and of physical should movements, restlessness (for example in being able to sit Contact your doctor or go to your nearest hospital casualty still), dizziness. department straight away. Take the container and any remaining Risperidone with you. Eye Signs of overdose are: drowsiness, sleepiness, accelerated Uncommon: heart rate, lowered blood pressure, severe trembling, severe • blurred vision. muscle stiffness. Organ of balance and ears If you forget to take Risperidone Oral Solution Uncommon: if you miss a dose, just cany on next one as usual. Do not take a • dizziness, double dose to make up for a forgotten dose. Heart If you stop taking Risperidone Oral Solution Uncommon: If you stop taking Risperidone Oral Solution tell your doctor as • accelerated heartbeat. This side effect occurs particularly soon as possible. Only stop taking your medication if your atthe higher starting doses, doctor tells you even if you are feeling well. Stopping the Veryrare: treatment suddenly may cause effects such as feeling sick, • excessive blood pressure, prolongation of the QT interval vomiting, sweating, sleeplessness, muscle stiffness or jerky which can result in a severe heart disease (torsade de movements, or your original medical problem may come back poirrtes). If you have any further questions on the use of this product, ask Bloodvessels your doctor or pharmacist. Uncommon: • fall in blood pressure, for example on standing up rapidly from a sitting or lying position, sometimes associated with dizziness (orthostatic hypotension). The following side effects can occur Rare ■ effects on the blood vessels in the brain, including Very common (in more than 1 in 10 patients) stroke/cerebral infarction, also known as cerebrovascular Common (in more than 1 in 100, but in less than 1 in 10 accident (CVA), temporary disorder of the blood supply to patients) thebrainleaving few ifanyresidualsigns(TIA). Uncommon (in more than 1 in 1,000, but in less than 1 in 100 patients) Respiration and chest Uncommon: • profuse salivation. | ||