403006061409 GI Medikinet XL 5-60 capsules GB.qxp_20070124 BPZ UK XL Variation 11.09.20 08:39 Seite 1
Package Leaflet: Information for the user Tell your doctor or pharmacist if any of the above apply to you or your child before starting treat- ment. Methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you or your child. B G modified-release capsules, hard
s Checks that your doctor will make before you start taking methylphenidate e l These checks are to decide if methylphenidate is the correct medicine for you or your child. Your u modified-release capsules, hard doctor will talk to you about: s
p • any other medicines you or your child is taking a modified-release capsules, hard • whether there is any family history of sudden unexplained death c
• any other medical problems (such as heart problems) you or your family may have 0 modified-release capsules, hard • how you or your child is feeling, such as feeling high or low, having strange thoughts and if you 6 - or your child has had any of these feelings in the past 5 modified-release capsules, hard • whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the L 9
X body or repeating sounds and words)
m 0 t modified-release capsules, hard • any mental health or behavioural problems you or your child or other family members have ever 4 e m 0 1
z had. n r i 2 6 0 k a
0 modified-release capsules, hard 0 5 i 2 w 6 9
d Your doctor will discuss whether you or your child is at risk of having mood swings (from being manic - Methylphenidate hydrochloride h 0 e
x to being depressed - called ‘bipolar disorder’). They will check you or your child’s mental health 9 c 0
0 M history, and check if any of your family have a history of suicide, bipolar disorder or depression. 3 2 S
- I 0 8
1 This medicine is subject to additional monitoring. This will allow quick identification of new safety 1 4 G 2 I information. You can help by reporting any side effects you may get. See the end of section 4 for how It is important that you provide as much information as you can. This will help your doctor decide if
: to report side effects. methylphenidate is the correct medicine for you or your child. Your doctor may decide that other
medical tests are needed before you or your child start taking this medicine. m : . a
: z
. : t : r l e The name of your medicine is Medikinet XL, it contains the active substance During treatment, boys and adolescents may unexpectedly experience prolonged erections. This l e e N B e ß
- - ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used may be painful and can occur at any time. It is important to contact your doctor straight away if your t b . . r ö s t t
r erection lasts for longer than 2 hours, particularly if this is painful. r r r a in the leaflet. E A A G F Drug testing This medicine may give a positive result when testing for drug use. Athletes must be aware that this medicinal product may cause a positive reaction to ‘anti-doping’ tests. • The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’. Other medicines and MEDIKINET XL • The medicine helps with your brain activity. It can help improve your attention, help Please tell your doctor or pharmacist if you or your child is taking, has recently taken or may take you concentrate, and make you less impulsive. any other medicines. • You need to have other treatments for ADHD as well as this medicine. Read section 1 for more information. Do not take methylphenidate if you or your child: • is taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or has taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden • You have heart, circulation, or mental health problems - you may not be able to take increase in blood pressure. this medicine. • You are taking any other medicines - this is because methylphenidate can affect how If you or your child is taking other medicines, methylphenidate may affect how well they work or other medicines work. may cause side effects. Tell your doctor if you or your child is taking medicines to treat: Read section 2 for more information. • depression • mental health problems • epilepsy • blood pressure problems • See your doctor regularly. This is because your doctor will want to check how the • cough and colds. Some remedies contain medicines that can affect blood pressure. It is impor- medicine is working. tant to check with your pharmacist when you buy any of these products. • Do not stop taking the medicine without first talking to your doctor. • medicines that thin the blood to prevent blood clots. • Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year. MEDIKINET XL must not be taken together with H2 receptor blockers, proton pump inhibitors or • The most common side effects are feeling nervous, not being able to sleep or having a antacids which are used to reduce gastric acid secretion or to counteract excessive acitity in the headache. stomach, as this could lead to a faster release of the total amount of active substance. Read sections 3 and 4 for more information. If you are in any doubt about whether any medicines you or your child is taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate. • Your mood and how you feel changes. Having an operation • You feel any problems with your heart. Tell your doctor if you or your child is going to have an operation. Methylphenidate should not be Read section 4 for more information. taken on the day of surgery if a certain type of anaesthetic is used. This is because there is a chan- ce of a sudden rise in blood pressure during the operation. Taking methylphenidate with alcohol Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine • Keep this leaflet. You may need to read it again. worse. Remember that some foods and medicines contain alcohol. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you or your child. Do not pass it on to others. Pregnancy and breast-feeding It may harm them, even if their symptoms are the same as yours. Available data do not suggest an increased risk of overall birth defects, whilst a small increase in • If you get any side effects talk to your doctor or pharmacist. This includes any possi- the risk of malformations of the heart when used during the first three months of pregnancy could ble side effects not listed in this leaflet. not be ruled out. Your doctor will be able to give you more information about this risk. Tell your doc- See section 4. tor or pharmacist before using methylphenidate if you or your daughter: • is having sex. Your doctor will discuss contraception. • is pregnant or think she might be pregnant. Your doctor will decide whether methylphenidate should be taken. - Sections 1 to 6 are for parents and carers (sometimes called ‘your guardians’). • is breast-feeding or planning to breast-feed. It is possible that methylphenidate is passed into - The last section is a special section for a child or young person to read. human breast milk. Therefore, your doctor will decide whether you or your daughter should However, all sections are written as though the child or young person taking the medicine breast-feed while taking methylphenidate. is reading them. Driving and using machines What is in this leaflet: You or your child may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.