18 mg prolonged-release tablets, 27 mg prolonged-release tablets, 36 mg prolonged-release tablets, 54 mg prolonged-release tablets are
methylphenidate hydrochloride
What Methylphenidate Mylan is and what it is used for
What is it used for
Methylphenidate Mylan is used to treat ADHD ( Attention Deficit Hyperactivity Disorder ).
- It is used in children and adolescents aged 6 to 18 years.
- It is used only after treatment methods other than drug treatment have been tried, such as talk therapy and behavioral therapy.
Methylphenidate Mylan is not used to treat ADHD in children under 6 years of age or to start treatment in adults. If treatment was started at a younger age, it may be appropriate to continue Methylphenidate Mylan even in adulthood. Your doctor will advise you on this.
How it works
Methylphenidate Mylan improves the activity in certain areas of the brain, which are underactive. The drug can help to improve attention (to retain attention), ability to concentrate, and to reduce impulsive behavior.
The drug is given as part of a treatment program, which usually includes:
- psychological therapy
- education, and
- social therapy
It is prescribed only by doctors with experience of behavioral problems in children and adolescents. Although there is no cure for ADHD, the condition can be managed by using treatment programs.
About ADHD
Children and adolescents with ADHD experience difficulty in:
- sit still, and
- concentrate
It’s not their fault that they can not do these things.
Many children and young people are struggling to cope with these things. In people with ADHD, problems in everyday life can occur. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere. ADHD does not affect the intelligence of a child or adolescent.
Methylphenidate contained in Methylphenidate Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you or your child take Methylphenidate Mylan
Do not take Methylphenidate Mylan if you or your child
- is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
- have problems with the thyroid gland
- has increased pressure in the eye ( glaucoma )
- has a tumor in the adrenal gland ( pheochromocytoma )
- have an eating disorder that makes you or your child not feel hungry or unwilling to eat, such as “anorexia nervosa”
- have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
- have or have had heart problems, such as heart attack, irregular heartbeat, chest pain and discomfort, heart failure , heart disease or have a congenital heart problem
- have or have had problems with the blood vessels in the brain, such as a stroke , dilated or weakened blood vessels ( aneurysm ), narrowing or blocked blood vessels or inflammation of the blood vessels ( vasculitis )
- is currently taking or has been taking an antidepressant (called a monoamine oxidase inhibitor ) for the past 14 days. See section “Other medicines and Methylphenidate Mylan”
- have or have had mental problems such as
- psychopathic or borderline personality disorder
- abnormal thoughts or visions or a disease called schizophrenia
- signs of severe mental health problems such as:
- suicidal thoughts
- severe depression, where you feel very sad, useless and have feelings of hopelessness
- mania, where you feel unusually elated, overactive and uninhibited
Do not take methylphenidate if any of the above apply to you or your baby. If you are not sure, talk to your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate can aggravate these problems.
Warnings and cautions
Talk to your doctor or pharmacist before you or your child take Methylphenidate Mylan if you or your child
- have liver or kidney problems
- have difficulty swallowing or have difficulty swallowing whole tablets
- have a narrowing or obstruction in the intestine or esophagus
- have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
- is a woman and has started menstruating (see section “Pregnancy, breast-feeding and fertility”)
- have ever abused or been addicted to alcohol, prescription drugs or drugs
- have difficult-to-control, repeated twitches in any part of the body or repeat sounds and words ( tics )
- have high blood pressure
- have a heart problem that is not mentioned in the section “Do not take Methylphenidate Mylan if you or your child”.
- have a mental health problem which is not mentioned in the section “Do not take Methylphenidate Mylan if you or your child”.Other mental health problems include:
- mood swings (from being manic to becoming depressed, so-called bipolar disorder )
- incipient aggression or hostility or if aggression worsens
- to see, hear or feel things that do not exist (hallucinations)
- to believe in things that are not true (delusions)
- to feel unusually suspicious ( paranoid )
- to feel anxious, anxious or tense
- to feel depressed or to have feelings of guilt
If any of the above applies to you or your child, tell your doctor or pharmacist before starting treatment. This is because methylphenidate can aggravate these problems. Your doctor will want to monitor how the medicine is affecting you or your child.
Checks that your doctor will do before you or your child start taking methylphenidate
These checks are to determine if methylphenidate is the right drug for you or your child. Your doctor will talk to you about the following:
- if you or your child are taking other medicines
- if there have been any sudden unresolved deaths in the family
- presence of other possible medical problems (such as heart problems) in you, your child or other people in your family
- how you or your child feel, e.g. if you are elated or depressed, have strange thoughts or if you or your child have had any such feelings in the past
- if there have been “tics” within the family (difficult-to-control repeated twitches in any part of the body or repetition of sounds and words)
- if you or your child or other family member has or has had a problem related to mental health or behavioral disorder. The doctor will discuss whether you or your child are at risk of mood swings (from being manic to becoming depressed, so-called “bipolar disorder”). Your or your child’s previous mental health will be checked. It will also be checked if there has been suicide, bipolar disorder or depression in your family.
You must provide as much information as you can. It will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide that more medical tests are needed before you or your child can start taking this medicine.
During treatment, boys and adolescents may unexpectedly experience prolonged erections. It can be a painful condition that can occur at any time. You must contact your doctor immediately if an erection lasts for more than 2 hours, especially if it is painful.
Other medicines and Methylphenidate Mylan
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Do not take methylphenidate if you or your child:
- take a medicine called monoamine oxidase inhibitor ( MAOI ) for depression, or have been taking an MAOI for the last 14 days. Taking MAOIs together with methylphenidate can lead to a sudden increase in blood pressure .
Tell your doctor or pharmacist if you or your child are taking any of the following medicines for depression or anxiety:
- tricyclic antidepressant drugs
- selective serotonin reuptake inhibitors ( SSRIs )
- serotonin and norepinephrine reuptake inhibitors ( SNRIs ).
Taking methylphenidate with these types of drugs can result in a life-threatening increase in serotonin in the brain (serotonergic syndrome), which can lead to a feeling of confusion or restlessness, sweating, tremors, muscle twitching, or rapid heartbeat. If you or your child develop these side effects, consult a doctor immediately.
If you or your child are taking other medicines, methylphenidate may affect how well they work or cause side effects. If you or your child take any of the following medicines, talk to your doctor or pharmacist before taking methylphenidate:
- other antidepressants
- medicines for serious mental problems
- antiepileptic drugs
- medicines used to lower or raise blood pressure
- certain preparations for coughs or colds, which contain substances which may affect blood pressure . It is important to consult the pharmacy staff before buying any such product.
- drugs that thin the blood to prevent blood clots.
If you are not sure if any of the medicines you or your child are taking are listed above, talk to your doctor or pharmacist before taking this medicine.
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Operation
Tell your doctor if you or your child will undergo surgery. Methylphenidate should not be taken on the day of surgery if a special type of anesthetic/anesthetic is used. This is because there is a risk of sudden high blood pressure during surgery.
Drug tests
This drug can give positive results in drug abuse tests.
Methylphenidate Mylan with alcohol
Do not drink alcohol while using this medicine. Alcohol can aggravate the side effects of the drug. Keep in mind that some dishes and medicines may contain alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Available data do not indicate an increased risk of malformations overall. However, it can not be ruled out that there is a small increase in the risk of heart defects when used during the first three months of pregnancy. Your doctor can provide more information about this risk. Tell your doctor or pharmacist before using methylphenidate if you or your daughter:
- is sexually active. The doctor will discuss contraception.
- is pregnant or thinks you may be pregnant. Your doctor will decide if methylphenidate should be used.
- breastfeeding or planning to breastfeed. It is possible that methylphenidate is transferred to breast milk. Therefore, your doctor will decide if you or your daughter should breast-feed during treatment with methylphenidate.
Driving and using machines
You or your child may feel dizzy, have difficulty focusing, or have blurred vision when using methylphenidate. If this happens, it can be risky to do things like driving a vehicle, using machines, riding a bike, riding a horse, or climbing trees.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Methylphenidate Mylan contains sucrose and sodium
If you or your child cannot tolerate certain sugars, you should consult your doctor before you or your child takes this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Methylphenidate Mylan
How much to take
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The doctor usually starts treatment with a low dose that is increased gradually and as needed.
- The highest recommended daily dose is 54 mg.
Methylphenidate Mylan 18 mg prolonged-release tablet
- You or your child should take Methylphenidate Mylan once a day, in the morning with a glass of water. The tablet should be swallowed whole and must not be chewed or crushed. The tablet can be taken with or without food.
Methylphenidate Mylan 27 mg, 36 mg, and 54 mg prolonged-release tablets
- You or your child should take Methylphenidate Mylan once a day, in the morning with a glass of water. The tablet can be divided into two equal doses . The tablet (or half the tablet) must not be chewed or crushed. The tablet can be taken with or without food.
If you or your child does not feel better after 1 month of treatment
Tell your doctor if you or your child does not feel better. Your doctor may decide to use another treatment.
Checks when starting treatment
The doctor will do some checks
- before you or your child start treatment to ensure that Methylphenidate Mylan is safe and that it will be beneficial
- after you or your child has started treatment. These will be done at least every 6 months, possibly more often. They will also be done when dose one is changed.
- These checks will include:
- control of appetite
- measurement of height and weight
- measurement of blood pressure and heart rate
- control of mood, mood or other unusual emotions. Your doctor will also check to see if these feelings have worsened while Methylphenidate Mylan has been taken.
Long-term treatment
Methylphenidate Mylan does not need to be taken forever. If you or your child have been taking Methylphenidate Mylan for over a year, your doctor will discontinue treatment for a short time. This can be done e.g. during a school holiday. This is to check if the medicine is still needed.
Not using Methylphenidate Mylan properly
If Methylphenidate Mylan is not used properly, it can lead to abnormal behavior. It can also mean that you / your child may become addicted to the drug. Tell your doctor if you / your child has ever abused or been addicted to alcohol, prescription drugs, or drugs.
This medicine has been prescribed for you or your child. Do not give it to others even if they have symptoms similar to yours or your child’s.
If you or your child have taken too much Methylphenidate Mylan
Signs of overdose may include the following: nausea, feeling of arousal, tremors, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma ), feeling of happiness, confusion, seeing, feeling or hearing things that do not exist (hallucinations), sweating, redness of the skin, headache, high fever, changes in heart rate (slow, fast or uneven), high blood pressure, dilated pupils or dry mucous membranes of the nose and mouth.
If you or your child have forgotten to take Methylphenidate Mylan
Do not take a double dose to make up for a forgotten dose. If you or your child misses a dose, wait until it is time for the next dose.
If you or your child stop taking Methylphenidate Mylan
If you or your child suddenly stops taking this medicine, symptoms of ADHD may return or side effects such as depression may occur. Your doctor may choose to gradually reduce the daily dose one before the medication completely stops. Talk to your doctor before stopping Methylphenidate Mylan.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Although some people experience side effects, most people find that methylphenidate helps them. Your doctor will talk to you about these side effects.
Some side effects can be serious. If you or your child experience any of the side effects listed below, contact a doctor immediately:
Common (may affect up to 1 in 10 people)
- irregular heartbeat (palpitations)
- mood swings, mood swings or personality changes
Uncommon (may affect up to 1 in 100 people)
- suicidal thoughts or feelings
- see, feel or hear things that do not exist, these are signs of psychosis
- uncontrollable speech or movement ( Tourette’s syndrome )
- signs of allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing
Rare (may affect up to 1 in 1,000 people)
- feeling unusually excited, overactive or uninhibited (mania).
Very rare (may affect up to 1 in 10,000 people )
- myocardial infarction
- sudden death
- suicide attempt
- seizures (epilepsy seizures, seizures, epilepsy )
- flaky skin or reddish-purple skin blemishes
- inflammation or clogging of blood vessels in the brain
- uncontrollable muscle cramps that affect the eyes, head, neck, body and nervous system. Due to a temporary lack of blood supply to the brain.
- decreased number of blood cells (red and white blood cells and platelets ), which can make you more susceptible to infections and make you bleed more easily or get bruises
- a sudden increase in body temperature, very high blood pressure and severe seizures (malignant neuroleptic syndrome). This side effect may not be caused by methylphenidate or by other medicines that may have been taken in combination with methylphenidate
Has been reported (occurs in an unknown number of users)
- recurring unwanted thoughts
- unexplained fainting, chest pain or shortness of breath (these may be signs of heart problems)
- paralysis or difficulty moving, seeing or speaking (may be a sign of a problem with the blood vessels in the brain)
- prolonged erections , sometimes painful, or increased number of erections
Other side effects include the following. If they become serious, consult a doctor or pharmacist:
Very common (may affect more than 1 user in 10)
- headache
- nervousness
- insomnia
Common (may affect up to 1 in 10 people)
- joint pain
- dimsyn
- tension headache
- dry mouth , thirst
- difficulty falling asleep
- fever
- problems with sex drive
- abnormal hair loss or thinning
- muscle tension, muscle cramps
- lost or decreased appetite
- inability to get or maintain an erection
- itching , rash or raised red itchy rash ( hives )
- abnormal fatigue or drowsiness, feeling tired
- severe gnashing of teeth (bruxism), feeling of panic
- irritating, stinging sensation or numbness in the skin
- increased level of alanine aminotransferase (liver enzyme) in the blood
- cough, sore throat or nose and throat irritation, inflammation of the upper respiratory tract, sinusitis
- high blood pressure , fast heartbeat ( tachycardia )
- vertigo , feeling weak, uncontrollable movements, hyperactivity
- feel aggressive, agitated, anxious, depressed, irritated, tense, nervous and exhibit abnormal behavior
- upset stomach or indigestion, abdominal pain, diarrhea, nausea, stomach discomfort and vomiting
Uncommon (may affect up to 1 in 100 people)
- dry eyes
- constipation
- feeling of discomfort in the chest
- blood in the urine
- lethargy
- shaking or trembling
- increased need to urinate
- muscle pain, muscle twitching
- shortness of breath or chest pain
- feeling of warmth
- elevated liver values (detected by blood test)
- anger, restlessness or crying, talking too much, excessive attention to the environment, difficulty sleeping
Rare (may affect up to 1 in 1,000 people)
- feel disoriented or confused
- visual disturbances or double vision
- swelling of the breasts in men
- heavy sweating, reddening of the skin, red raised rash.
Very rare (may affect up to 1 in 10,000 people)
- muscle cramps
- small red spots on the skin
- abnormal liver function, including liver failure and coma
- changes in test results, including liver and blood values
- abnormal thoughts, lack of emotions, doing things repeatedly (compulsions), being obsessed with a thing (obsessions)
- numbness, tingling and change in color (from white to blue, then red) in fingers and toes on cold (Raynaud’s phenomenon).
Has been reported (occurs in an unknown number of users)
- migraine
- dilated pupil is
- very high fever
- slow, fast or extra heartbeat
- severe seizures ( grand mal seizures)
- believe in things that do not exist
- severe abdominal pain, usually with nausea and vomiting
- inability to control urinary incontinence ( incontinence )
- spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
- stuttering.
Effects on growth
As methylphenidate has been used for over a year, it can lead to slower growth in some children. This occurs in less than 1 in 10 children.
- Lack of weight gain and height growth may occur.
- Your doctor will closely monitor your or your child’s weight and height, as well as how well you or your child are eating.
- If you or your child does not grow as expected, treatment with methylphenidate may be stopped for a short time.
How to store Methylphenidate Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions. The prolonged-release tablets should be stored in the original child-resistant pack.
Do not use this medicine if you notice that the tablet is damaged.
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.
Contents of the pack and other information
Content declaration
- Methylphenidate Mylan 18 mg prolonged-release tablet isThe active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride equivalent to 15.57 mg of methylphenidate).
- Methylphenidate Mylan 27 mg prolonged-release tablet isThe active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride equivalent to 23.35 mg of methylphenidate.
- Methylphenidate Mylan 36 mg prolonged-release tablet isThe active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride (equivalent to 31.13 mg of methylphenidate).
- Methylphenidate Mylan 54 mg prolonged-release tablet isThe active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride (equivalent to 46.7 mg of methylphenidate)
- Other ingredients are:
Tablet core:sugar spheres (sucrose [see section 2 Methylphenidate Mylan contains sucrose], maize starch ) , hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hypromellose acetate succinate, carmellose sodium, microcrystalline cellulose , hydrochloride , anhydrous stearate
Tablet coating:polyvinyl alcohol, macrogol 3350, talc, hydrochloric acid (for pH adjustment ), titanium dioxide (E171) (not 27 mg tablets), yellow iron oxide (E172) (only 18 mg and 27 mg tablets), red iron oxide (E172) (only 54 mg tablets).
What the medicine looks like and contents of the pack
Methylphenidate Mylan 18 mg prolonged-release tablet is
Yellowish to yellow, round, biconvex 6.3 mm film-coated tablets. The tablet can not be divided into two equal doses.
Methylphenidate Mylan 27 mg prolonged-release tablet is
Yellow, oblong, biconvex film-coated tablets of 10.3 x 4.8 mm with a break notch on both sides. The tablet can be divided into two equal doses.
Methylphenidate Mylan 36 mg prolonged-release tablet is
White to off-white, oblong, biconvex film-coated tablets of 11.3 x 5.3 mm with a notch on both sides. The tablet can be divided into two equal doses.
Methylphenidate Mylan 54 mg prolonged-release tablet is
Reddish to red, oblong, biconvex film-coated tablets of 13.3 x 6.4 mm with a scoreline on both sides. The tablet can be divided into two equal doses.
The prolonged-release tablets are available in jars with child-resistant screw caps.
Pack sizes:
28 prolonged-release tablets (not Methylphenidate Mylan 27 mg prolonged-release tablets )
30 prolonged-release tablets are
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim, Germany
McDermott Laboratories Ltd t / a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Generics [UK] Limited
Station Close
Potters Bar
EN6 1TL
UK
Mylan UK Healthcare Limited,
Building 20, Station Close, Potters Bar,
EN6 1TL,
UK