0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg film-coated tablets
risperidone<\/p>\n\n\n\n
– Save this information, you may need to read it again.<\/p>\n\n\n\n
– If you have any further questions, ask your doctor or pharmacist.<\/p>\n\n\n\n
– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.<\/p>\n\n\n\n
– If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.<\/p>\n\n\n\n
In this leaflet:
1. What Risperidone Actavis is and what it is used for
2. What you need to know before you use Risperidone Actavis
3. How to take Risperidone Actavis
4. Possible side effects
5. How to store Risperidone Actavis
6. Contents of the pack and other information<\/p>\n\n\n\n
Risperidone Actavis belongs to a group of medicines called antipsychotics.<\/p>\n\n\n\n
Risperidone Actavis is used to treat:<\/p>\n\n\n\n
Risperidone Actavis can help relieve the symptoms of your illness and prevent the symptoms from returning.<\/p>\n\n\n\n
Risperidone contained in Risperidone Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.<\/p>\n\n\n\n
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using risperidone.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Risperidone Actavis if:<\/p>\n\n\n\n
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidon Actavis.<\/p>\n\n\n\n
In rare cases, a dangerously low level of a certain type of white blood cell needed to fight infection in the blood has been seen in patients taking Risperidone Actavis. Your doctor may check your white blood cell levels.<\/p>\n\n\n\n
Risperidone Actavis may cause weight gain. Significant weight gain can have a negative impact on your health. Your doctor should check your body weight regularly.<\/p>\n\n\n\n
Because diabetes mellitus or worsening of existing diabetes mellitus has been seen in patients taking Risperidone Actavis, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus , blood glucose should be monitored regularly.<\/p>\n\n\n\n
It is common for risperidone to increase the levels of a hormone called “prolactin”. This can lead to side effects such as menstrual disorders or fertility problems in women, swelling of the breasts in men (see Possible side effects ). If such side effects occur, assessment of prolactin levels in the blood is recommended.<\/p>\n\n\n\n
In cataract surgery ( cataract ) it may happen that the pupil one (the black circle in the middle of the eye) does not increase in size as much as needed. In addition, you can get reduced muscle tension in the iris (colored part of the eye) during the operation and it can lead to eye injuries. If you have an eye operation planned, you must inform your ophthalmologist that you are using this medicine.<\/p>\n\n\n\n
Elderly people with dementia<\/strong><\/p>\n\n\n\n Elderly patients with dementia are at greater risk of developing stroke . You should not use risperidone if you have dementia caused by a stroke .<\/p>\n\n\n\n You should have regular contact with your doctor while you are being treated with risperidone .<\/p>\n\n\n\n Seek medical attention immediately if you or the person caring for you notice a sudden change in your mental state or if you suffer from sudden weakness or numbness in the face, arms or legs, especially on one side, or slurred speech, even if it is only short-lived. The listed symptoms may be signs of a stroke.<\/p>\n\n\n\n Children and young people<\/strong><\/p>\n\n\n\n Before initiating treatment for a behavioral disorder, other causes of the aggressive behavior must have been ruled out.<\/p>\n\n\n\n If fatigue occurs during treatment with risperidone , a change in timing of drug intake may result in improved attention span.<\/p>\n\n\n\n Before starting treatment, you or your child may be weighed and the weight may be monitored regularly during treatment.<\/p>\n\n\n\n A small and incomplete study has reported an increase in length in children taking risperidone , but whether this is an effect of the drug or due to something else is unknown.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<\/p>\n\n\n\n It is especially important that you talk to your doctor or pharmacist if you are taking any of the following:<\/strong><\/p>\n\n\n\n The following medicines may reduce the effect of risperidone<\/strong><\/p>\n\n\n\n If you start or stop taking these medicines, you may need another dose of risperidone .<\/p>\n\n\n\n The following medicines may increase the effect of risperidone<\/strong><\/p>\n\n\n\n If you start or stop taking these medicines, you may need another dose of risperidone .<\/p>\n\n\n\n If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidon Actavis.<\/p>\n\n\n\n You can take this medicine with or without food. You should avoid drinking alcohol while using Risperidone Actavis.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can use this medicine.<\/p>\n\n\n\n The following symptoms may occur in newborns of mothers who have used Risperidone Actavis during the last trimester (last three months of pregnancy): tremors, muscle stiffness and \/ or weakness, drowsiness, anxiety, difficulty breathing and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.<\/p>\n\n\n\n Risperidone Actavis may increase your levels of a hormone called “prolactin” which may affect fertility (see section 4 “Possible side effects”).<\/p>\n\n\n\n Dizziness, fatigue and vision problems may occur during treatment with Risperidone Actavis. Do not drive or use any tools or machines without first talking to your doctor.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and \/ or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n The recommended dose is as follows:<\/strong><\/p>\n\n\n\n Treatment of schizophrenia<\/strong><\/em><\/p>\n\n\n\n Adults<\/em><\/p>\n\n\n\n Elderly<\/em><\/p>\n\n\n\n Treatment of mania<\/strong><\/em><\/p>\n\n\n\n Adults<\/em><\/p>\n\n\n\n Elderly<\/em><\/p>\n\n\n\n Treatment of long-term aggression in people with Alzheimer’s disease<\/strong><\/em><\/p>\n\n\n\n Adults (including the elderly)<\/em><\/p>\n\n\n\n Use for children and adolescents<\/strong><\/p>\n\n\n\n Treatment of conduct disorder<\/strong><\/em><\/p>\n\n\n\n Dosage one depends on how much your child weighs:<\/p>\n\n\n\n Children weighing less than 50 kg<\/em><\/p>\n\n\n\n Children weighing 50 kg or more<\/em><\/p>\n\n\n\n The treatment time in patients with behavioral disorders should not exceed 6 weeks.<\/p>\n\n\n\n Children under 5 years of age should not be treated with Risperidone Actavis for behavioral disorders.<\/p>\n\n\n\n People with kidney or liver problems<\/strong><\/p>\n\n\n\n Regardless of the disease being treated, all starting doses and subsequent doses of risperidone should be halved.<\/p>\n\n\n\n Dose increases should be slower in these patients.<\/p>\n\n\n\n Risperidone should be used with caution in this patient population. <\/p>\n\n\n\n Method of administration<\/strong><\/p>\n\n\n\n You should swallow the tablet with a little water. Your doctor will tell you how much medicine to take and for how long. This depends on your condition and varies from person to person.<\/p>\n\n\n\n Seek medical attention immediately. Take the medicine pack with you.<\/p>\n\n\n\n If you have taken an overdose, you may feel sleepy or tired, you may have abnormal body movements or problems with standing and walking, you may feel dizzy due to low blood pressure and you may also have abnormal heartbeats or seizures.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital or the Poison Information Center (tel.112) for risk assessment and advice.<\/p>\n\n\n\n If you forget to take a dose , take it as soon as you remember. But if it is almost time for you to take the next dose , skip the missed dose and continue as usual. If you miss two or more doses , contact your doctor.<\/p>\n\n\n\n Do not take a double dose (two doses at the same time) to compensate for a missed dose .<\/p>\n\n\n\n You should not stop taking this medicine unless you have been asked to do so by your doctor. If you stop treatment, your symptoms may return. If your doctor decides to stop the treatment, it can be done by gradually reducing the dose over a few days.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them.<\/p>\n\n\n\n Tell your doctor immediately if you get any of the following less common side effects (may affect up to 1 in 100 people):<\/strong><\/p>\n\n\n\n Tell your doctor immediately if you get any of the following rare side effects (affects up to 1 in 1000 people):<\/strong><\/p>\n\n\n\n The following other side effects may also occur:<\/p>\n\n\n\n Very common (may affect more than 1 user in 10):<\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people):<\/p>\n\n\n\n The following side effect has been seen with the use of another drug called paliperidone<\/a> and is very similar to risperidone , so it can also be expected when treated with Risperidone Actavis: palpitations when standing up.<\/p>\n\n\n\n Additional side effects are in children and adolescents<\/strong><\/p>\n\n\n\n Side effects in children are generally expected to be similar to those in adults. The following side effects were reported more often in children and adolescents (5 to 17 years) than in adults: drowsiness or less alertness, fatigue, headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors, diarrhea and urinary incontinence.<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se<\/a>. By reporting side effects, you can help increase drug safety information.Postal address<\/a><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the blister, carton or tablet jar after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n 0.25 mg and 0.5 mg:<\/strong><\/p>\n\n\n\n Do not store above 25 \u00b0 C.<\/p>\n\n\n\n 1 mg, 2 mg, 3 mg, 4 mg and 6 mg:<\/strong><\/p>\n\n\n\n No special storage instructions.<\/p>\n\n\n\n Medicines 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 the environment.<\/p>\n\n\n\n 0.25 mg tablet: Light yellow, round, biconvex film-coated tablets, marked \u201cT\u201d, diameter 6 mm.<\/p>\n\n\n\n 0.5 mg tablet: Light yellow, oval, biconvex film-coated tablets, marked \u201cT\u201d with a score line, 8×5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n 1 mg tablet: White, oval, biconvex film-coated tablets, marked \u201cT1\u201d with a score line, 8×5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n 2 mg tablet: White, oval, biconvex film-coated tablets, marked \u201cT2\u201d with a score line, 10×5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n 3 mg tablet: White, oval, biconvex film-coated tablets, marked \u201cT3\u201d with a score line, 11×6.5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n 4 mg tablet: White, oval, biconvex film-coated tablets, marked \u201cT4\u201d with a score line, 14×7.5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n 6 mg tablet: White, oval, biconvex film-coated tablets, marked \u201cT\u201d with a score line, 16×8.5 mm.<\/p>\n\n\n\n The tablet can be divided into two equal doses .<\/p>\n\n\n\n Packaging:<\/em><\/p>\n\n\n\n Blister pack: 6, 10, 20, 28, 30, 50, 60, 98, 100 film-coated tablets.<\/p>\n\n\n\n Plastic jar: 100 and 500 film-coated tablets<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/em><\/p>\n\n\n\n Actavis Group PTC ehf.,<\/p>\n\n\n\n Reykjavikurvegur 76-78<\/p>\n\n\n\n IS-220 Hafnarfj\u00f6r\u00f0ur<\/p>\n\n\n\n Iceland<\/p>\n\n\n\n Manufacturer<\/em><\/p>\n\n\n\n Actavis Ltd.<\/p>\n\n\n\n BT16 Bulebel Industrial Estate<\/p>\n\n\n\n Newspaper<\/p>\n\n\n\n Malta<\/p>\n\n\n\n Balkanpharma – Dupnitsa AD<\/p>\n\n\n\n 3 Samokovsko Schosse Str.<\/p>\n\n\n\n Dupnitsa 2600<\/p>\n\n\n\n Bulgaria<\/p>\n\n\n\n Local representative<\/strong><\/p>\n\n\n\n Teva Sweden AB<\/p>\n\n\n\n Box 1070<\/p>\n\n\n\n 251 10 Helsingborg<\/p>\n","protected":false},"excerpt":{"rendered":" 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg film-coated tabletsrisperidone Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you. – Save this information, you may need to read it again. – If you have any further questions, ask your […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200],"tags":[],"class_list":["post-22244","post","type-post","status-publish","format-standard","hentry","category-medicines"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22244","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=22244"}],"version-history":[{"count":2,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22244\/revisions"}],"predecessor-version":[{"id":22291,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22244\/revisions\/22291"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22244"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22244"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22244"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other medicines and Risperidone Actavis<\/h2>\n\n\n\n
Risperidone Actavis with food and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Risperidone Actavis contains lactose<\/h2>\n\n\n\n
How to use Risperidone Actavis<\/h2>\n\n\n\n
If you use more Risperidone Actavis than you should <\/h2>\n\n\n\n
If you forget to use Risperidone Actavis<\/h2>\n\n\n\n
If you stop taking Risperidone Actavis<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Risperidone Actavis<\/h2>\n\n\n\n
6. Contents of the package and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer:<\/h2>\n\n\n\n