18 mg, 27 mg, 36 mg, 54 mg prolonged-release tablets are
methylphenidate hydrochloride
What Methylphenidate Actavis is and what it is used for
What is it used for
Methylphenidate Actavis 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 Actavis 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 taking Methylphenidate Actavis in adulthood. Your doctor will advise you on this.
How it works
Methylphenidate Actavis improves the activity in certain areas of the brain that 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 consists of:
- psychological therapy
- education and
- social therapy
It is only prescribed by doctors who have experience with 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 may experience:
- difficulty sitting still
- difficulty concentrating
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 hydrochloride contained in Methylphenidate Actavis 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 take Methylphenidate Actavis
Do not take Methylphenidate Actavis if you or your child
- is allergic to methylphenidate hydrochloride 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 not feel hungry or do not want to eat, such as “anorexia nervosa”
- have very high blood pressure or have narrowing of the blood vessels, which can cause pain in the legs and arms
- have or have had heart problems, such as heart attack, irregular heartbeat, pain or discomfort in the chest, heart failure , heart disease or have a congenital heart problem
- have had problems with the blood vessels in the brain, such as stroke , dilated or weakened blood vessels in the brain ( aneurysm ), narrowing or blocked blood vessels, or inflammation of the blood vessels ( vasculitis )
- currently taking an antidepressant, or have been doing so for the past 14 days (called monoamine oxidase inhibitors ). See section “Other medicines and Methylphenidate Actavis”
- have mental health problems such as:
- psychopathic or borderline personality disorder
- abnormal thoughts or visions or a disease called schizophrenia
- signs of serious mental problems such as:
- suicidal thoughts
- severe depression, where you feel very sad, useless or have feelings of hopelessness
- mania, where you feel unusually elated, overactive and uninhibited
Do not take Methylphenidate Actavis if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before taking Methylphenidate Actavis before you or your child. This is because methylphenidate can aggravate these problems.
Warnings and cautions
Talk to a doctor before you or your child take Methylphenidate Actavis if you or your child:
- have liver or kidney problems
- have difficulty swallowing whole tablets
- have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
- have ever abused or been addicted to alcohol, prescription drugs or drugs
- is a girl and has started menstruating (see section “Pregnancy, breast-feeding and fertility” below)
- 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 above section “Do not take Methylphenidate Actavis if you or your child”
- have a mental health problem which is not mentioned in the above section “Do not take Methylphenidate Actavis if you or your child”.
Other mental health problems can be:
- mood swings (from being manic to becoming depressed, so-called “bipolar disorder”)
- feeling aggressive or hostile
- see, hear or feel things that do not exist (hallucinations)
- believe in things that are not true (delusions)
- feels unusually suspicious ( paranoid )
- feeling anxious, anxious or tense
- feeling depressed or 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 check how the medicine is affecting you or your child.
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.
Checks that your doctor will do before you or your child start taking Methylphenidate Actavis
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
- if there is any other medical condition (such as heart problems) in you or other people in your family
- how you or your child feel, e.g. feel elated or depressed, have strange thoughts or if you 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 another 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 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.
Other medicines and Methylphenidate Actavis
Tell your doctor 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’ (MAO inhibitor) for depression, or have been taking an MAO inhibitor for the last 14 days. Taking MAOIs together with methylphenidate may 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 medicines 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 are taking any of the following medicines, you must consult your doctor or pharmacist before taking methylphenidate:
- medicines for serious mental problems
- medicines for Parkinson’s disease (such as levodopa )
- antiepileptic drugs
- medicines used to lower or raise blood pressure
- certain preparations for coughs and colds containing substances which may affect blood pressure et. It is important to consult the pharmacy staff before buying any such product.
- blood-thinning drugs that 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.
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 Actavis with alcohol
Do not drink alcohol during treatment with this medicine. Alcohol can aggravate the side effects of the drug. Keep in mind that certain foods and medicines may contain alcohol.
Pregnancy, breastfeeding and contraception
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using 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 child:
- is sexually active. Your 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. Methylphenidate is transferred to breast milk. Therefore, your doctor will decide if you are breast-feeding 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 Actavis contains lactose
This medicine contains lactose. If you or your child do not tolerate certain sugars, you should consult your or your child’s doctor before you or your child takes this medicine.
How to take Methylphenidate Actavis
How much medicine to take
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The doctor usually starts the treatment with a low dose and increases gradually if necessary.
- The highest recommended daily dose is 54 mg.
- Methylphenidate Actavis should be swallowed. The tablet is taken once daily in the morning with a glass of water. The tablet should be swallowed whole and not chewed, divided or crushed. The tablet can be taken with or without food.
If you or your child do 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
Your doctor will do some checks
- before starting treatment to ensure that Methylphenidate Actavis is safe and useful.
- after starting treatment. These will be done at least every 6 months, but possibly more often. They will also be done when dose one is changed.
- These checks include the following:
- 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 if these feelings have worsened while Methylphenidate Actavis has been taken.
Long-term treatment
Methylphenidate Actavis does not need to be taken forever. If you or your child have been taking Methylphenidate Actavis for more than a year, your doctor will stop the 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 Actavis correctly
If methylphenidate Actavis is not used properly, it can lead to abnormal behavior. It could also be a sign that you are starting to become addicted to the drug. Tell your doctor if you have ever abused or been addicted to alcohol, prescription drugs, or drugs.
This medicine is for you only. Do not give it to others, even if they have symptoms similar to yours.
If you use more Methylphenidate Actavis than you should
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 Actavis
Do not take a double dose to make up for a forgotten dose. If you miss a dose, wait until the next dose.
If you stop using Methylphenidate Actavis
If you or your child suddenly stop taking this medicine, the symptoms of ADHD may come back 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 Actavis.
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 get 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 your healthcare provider 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 allergy 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)
- feel unusually excited, overactive or uninhibited (mania)
Very rare (may affect up to 1 in 10,000 people)
- myocardial infarction
- sudden death
- suicide attempt
- seizures (seizures, epilepsy)
- flaky skin or reddish-purple skin spots
- inflammation or clogging of blood vessels in the brain
- temporary paralysis or difficulty moving, vision problems, speech difficulties (this may be a sign of a problem with the blood vessels in the brain)
- uncontrollable muscle cramps that affect the eyes, head, neck, body and nervous system.
- 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 at the same time as methylphenidate.
Has been reported (occurs in an unknown number of users)
- recurring delusions
- unexplained fainting, chest pain or shortness of breath (may be a sign of heart problems).
- paralysis or difficulty moving, visual or speech difficulties (may be a sign of a problem with the blood vessels in the brain)
- prolonged erections , sometimes painful, or increased number of erections
If you or your child get any of the above side effects, seek medical attention immediately.
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
- difficulty sleeping
Common (may affect up to 1 in 10 people)
- joint pain
- dimsyn
- tension headache
- dry mouth , thirst
- insomnia
- fever
- problems with sex drive
- abnormal hair loss or thinning
- muscle tension, muscle cramps
- loss of appetite or decreased appetite
- inability to get or maintain an erection
- itching , rash or raised red itchy hives
- abnormal fatigue or lethargy, 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; upper respiratory tract infection, sinusitis
- high blood pressure , fast pulse ( tachycardia )
- vertigo , feeling weak, uncontrollable movements, hyperactivity
- feel aggressive, agitated, anxious, depressed, irritated, tense, nervous and exhibit abnormal behavior
- stomach upset or digestive problems, stomach pain, diarrhea, nausea, stomach upset and vomiting.
Uncommon (affects less than 1 user in 100)
- dry eyes
- constipation
- feeling of discomfort in the chest
- blood in the urine
- lethargy
- shaking or trembling
- increased need to urinate
- muscle aches, muscle twitching
- shortness of breath or chest pain
- feeling of warmth
- elevated liver values (detected by blood test)
- anger, restlessness or weeping, talking too much, excessive attention to the environment, difficulty sleeping
Rare (affects less than 1 user in 1,000)
- feel disoriented or confused
- visual disturbances or double vision
- swelling of the breasts in men
- excessive sweating, reddening of the skin, red raised rash
Very rare (affects less than 1 user in 10,000)
- muscle cramps
- small red spots on the skin
- abnormal liver function, including acute liver failure and coma
- altered liver and blood levels
- abnormal thoughts, lack of emotions, repeated compulsions, obsessions about individual things
- loss of sensation in fingers and toes, tingling and change in color (from white to blue, then red) on cold (Raynaud’s phenomenon)
Has been reported (occurs in an unknown number of users)
- migraine
- dilated pupil is
- inability to control urinary incontinence ( incontinence )
- spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
- very high fever
- slow, fast or extra heartbeat
- severe seizures ( grand mal seizures)
- stuttering
- delusions
- severe abdominal pain, usually with nausea and vomiting
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
- The doctor will closely monitor your or your child’s development in terms of weight and height, as well as how well you or your child eats.
- If you or your child does not grow as expected, treatment with methylphenidate can be stopped for a short time.
How to store Methylphenidate Actavis
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 carton and label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after first opening the jar:
18 mg tablets: 3 months
27 mg tablets: 6 months
36 mg tablets: 6 months
54 mg tablets: 6 months
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
The active substance is methylphenidate hydrochloride.
Methylphenidate Actavis 18 mg: One prolonged-release tablet contains 18 mg of methylphenidate hydrochloride, equivalent to 15.6 mg of methylphenidate.
Methylphenidate Actavis 27 mg: One prolonged-release tablet contains 27 mg of methylphenidate hydrochloride, equivalent to 23.3 mg of methylphenidate.
Methylphenidate Actavis 36 mg: A prolonged-release tablet contains 36 mg of methylphenidate hydrochloride equivalent to 31.1 mg of methylphenidate.
Methylphenidate Actavis 54 mg: One prolonged-release tablet contains 54 mg of methylphenidate hydrochloride, equivalent to 46.7 mg of methylphenidate.
Other ingredients are:
Tablet core
Lactose monohydrate, hypromellose, silica ( colloidal, anhydrous), magnesium stearate, fumaric acid, methacrylic acid – methyl methacrylate copolymer (1: 1), methacrylic acid – methyl methacrylate copolymer (1: 2), triethyl citrate, talc.
Tablet coating
18 mg tablets: Polyvinyl alcohol (partially hydrolyzed), macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
27 mg tablets: Polyvinyl alcohol (partially hydrolyzed), macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), black iron oxide (E172).
36 mg tablets: Polyvinyl alcohol (partially hydrolyzed), macrogol (3350), talc, titanium dioxide (E171).
54 mg tablets: Polyvinyl alcohol (partially hydrolyzed), macrogol (3350), talc, titanium dioxide (E171), red iron oxide (E172).
Ink: Shellac, black iron oxide (E172), propylene glycol.
What the medicine looks like and contents of the pack
18 mg tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9 mm, with, “2392”, printed in black on one side.
27 mg tablet: Capsule-shaped, biconvex, gray tablet, 6.7 mm x 12.0 mm, with “2393”, printed in black on one side.
36 mg tablet: Capsule-shaped, biconvex, white tablet, 6.7 mm x 12.0 mm, with “2394”, printed in black on one side.
54 mg tablet: Capsule-shaped, biconvex, brown-red tablet, 6.8 mm x 12.0 mm, with “2395”, printed in black on one side.
Methylphenidate Actavis is available in cans with a child-resistant closure and silica gel desiccant integrated into the lid. The jars contain 28, 30 or 90 prolonged-release tablets (18 mg tablets) or 28, 30 or 100 prolonged-release tablets (27 mg, 36 mg and 54 mg tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Street
Dupnitsa, 2600
Bulgaria