18 mg, 36 mg, and 54 mg prolonged-release tablets are
methylphenidate hydrochloride
What Methylphenidate Sandoz is and what it is used for
What is it used for
Sandoz Methylphenidate is used to treat ADHD (Attention Deficit Hyperactivity Disorders).
- It is used in children and adolescents aged 6 to 18 years.
- It is used only after other drug-free treatment methods have been tried, such as talk therapy and behavioral therapy.
Methylphenidate Sandoz should not be used to treat ADHD in children under 6 years of age or to start treatment in adults. If treatment is started at a younger age, it may be appropriate to continue Methylphenidate Sandoz when you grow up. Your doctor will advise you on this.
How it works
Methylphenidate Sandoz 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 consists of:
- psychological therapy
- training
- 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 with the help of treatment programs.
About ADHD
Children and adolescents with ADHD may have:
- 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 Sandoz 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 Sandoz
Do not take Methylphenidate Sandoz if you
- 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 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, chest pain or discomfort, 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 )
- is currently taking an antidepressant, or has been doing so for the past 14 days (known as monoamine oxidase inhibitors – MAOIs ). See section “Other medicines and Methylphenidate Sandoz”.
- have mental health problems such as:- psychopathic or borderline personality disorder- divergent thoughts or visual experiences, or a disease called schizophreniasigns of serious mental problems, such as
- suicidal thoughts
- severe depression, when you feel very sad, useless and have no hope
- mania, when you are abnormally eager, overactive and uninhibited.
Do not take methylphenidate if any of the above apply to you. If you have any further questions, ask your doctor or pharmacist before taking methylphenidate. This is because methylphenidate can aggravate these problems.
Warnings and cautions
Talk to your doctor before taking Methylphenidate Sandoz if you:
- have liver or kidney problems
- have difficulty swallowing or have difficulty swallowing whole tablets
- have a narrowing or obstruction in the gastrointestinal tract or esophagus
- 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 contraception” 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 not mentioned in the section above “Do not take Methylphenidate Sandoz if you”
- have a mental health problem which is not mentioned in the above section “Do not take Methylphenidate Sandoz if you”.Other mental health problems can be:
- mood swings (from mania to depression, so-called “bipolar disorder”)
- incipient aggression or hostility, or aggravated aggression
- that you see, hear or feel things that do not exist (hallucinations)
- believe in things that are not true (delusions)
- excessive suspicion ( paranoid )
- excitement, anxiety or nervousness
- depression or guilt.
If any of the above applies to you, tell your doctor or pharmacist before starting treatment. This is because Methylphenidate Sandoz can make these problems worse. Your doctor will want to check how the medicine is affecting you.
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 starting treatment with Methylphenidate Sandoz
These checks are to determine if Methylphenidate Sandoz is the right drug for you. Your doctor will talk to you about the following:
- if you 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 feel, e.g. if you are 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. Your doctor will discuss whether you 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. Your doctor may decide that more medical examinations are needed before you can start taking this medicine.
Other medicines and Methylphenidate Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take methylphenidate if you:
- take a medicine called “monoamine oxidase inhibitor” ( MAOI ) for depression, or have taken 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 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 develop these side effects, consult your doctor immediately.
If you are taking other medicines, methylphenidate may affect how well they work or cause side effects.
If you 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 for high or low blood pressure
- certain cough medicines and cold medicines that can affect blood pressure . 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 are taking are included in the list above, consult your doctor or pharmacist before taking methylphenidate.
Operation
Tell your doctor if you will have 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 a sudden increase in blood pressure and a sudden increase in the number of heartbeats during the operation.
Drug tests
This drug can give positive results in drug abuse tests. This also applies to tests performed at sports events.
Methylphenidate Sandoz 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 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 Sandoz if you:
- 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 passes into breast milk. Therefore, your doctor will decide if you are breast-feeding during treatment with methylphenidate.
Driving and using machines
You may feel dizzy, have trouble focusing, or have blurred vision when using methylphenidate. If this happens, it can be risky to do things like drive a vehicle and use machines, bike, ride, or climb 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 Sandoz contains lactose and sodium
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Methylphenidate Sandoz 18 mg prolonged-release tablets:
This medicine contains 7.8 mg sodium (the main ingredient in table salt/table salt) per prolonged-release tablet. This corresponds to 0.39% of the maximum recommended daily sodium intake for adults.
Methylphenidate Sandoz 36 mg prolonged-release tablets:
This medicine contains 15.6 mg sodium (the main ingredient in table salt/table salt) per prolonged-release tablet. This corresponds to 0.78% of the maximum recommended daily sodium intake for adults.
Methylphenidate Sandoz 54 mg prolonged-release tablets:
This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, ie it is essentially ‘sodium-free’.
How to take Methylphenidate Sandoz
How much medicine to take
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- usually the doctor starts the treatment with a low dose and increases gradually if necessary.
- The highest recommended daily dose is 54 mg.
- You should take Methylphenidate Sandoz 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.
The tablet does not dissolve completely after all the active substance has been released. Sometimes the tablet shell can accompany the stool out. This is normal.
If you do not feel better after 1 month of treatment
Tell your doctor if you do not feel better. Your doctor may decide to use another treatment.
Not using Methylphenidate Sandoz properly
If Methylphenidate Sandoz is not used properly, it can lead to abnormal behavior. It may also mean that you may 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.
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 get 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. This is a sign 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) :
- 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 (seizures, epilepsy)
- flaky skin or red, bluish rash
- inflammation or clogging of blood vessels in the brain
- temporary paralysis or difficulty moving, vision problems, speech difficulties (these can be signs of problems with the blood vessels in the brain)
- uncontrollable muscle cramps that affect the eyes, head, neck, body and nervous system. This is 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 or get bruised more easily
- a sudden increase in body temperature, very high blood pressure and severe seizures (malignant neuroleptic syndrome). It is uncertain whether this side effect is caused by methylphenidate or by other medicines that may have been taken in combination with methylphenidate.
Has been reported (occurs in the unknown number of users):
- recurring unwanted thoughts
- 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 get any of the above side effects, seek medical advice immediately.
Other side effects are as follows. 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 drowsiness or drowsiness, fatigue
- 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 )
- dizziness ( vertigo ), weakness, jerky, uncontrollable movements, hyperactivity
- feel aggressive, agitated, anxious, depressed, irritated, tense, nervous and exhibit abnormal behavior
- Stomach upset or indigestion, stomach pain, diarrhea, nausea, upset stomach and vomiting
- toothache
- excessive sweating.
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 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 (may affect up to 1 in 1,000 people) :
- feel disoriented or confused
- visual disturbances or double vision
- swelling of the breasts in men
- 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 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 the unknown number of users):
- migraine
- dilated pupil is
- very high fever
- slow, fast or extra heartbeat
- severe seizures ( grand mal cramps)
- believe in things that do not exist
- severe abdominal pain, usually with nausea and vomiting
- spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
- inability to control urinary incontinence ( incontinence )
- stuttering.
Effects on growth
When 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 progress in terms of weight and height, as well as how well you eat.
- If you do not grow as expected, treatment with methylphenidate may be stopped for a short time.
How to store Methylphenidate Sandoz
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.
Storage instructions after first opening:
Do not store above 25 ° C.
Shelf life after first opening:
6 months.
The package contains a puck with desiccant that protects the prolonged-release tablets from moisture. The puck with desiccant must not be swallowed.
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 package and other information
Content declaration
The active substance is methylphenidate hydrochloride.
One prolonged-release tablet contains 18 mg of methylphenidate hydrochloride.
One prolonged-release tablet contains 36 mg of methylphenidate hydrochloride.
One prolonged-release tablet contains 54 mg of methylphenidate hydrochloride.
Other ingredients are:
Stocks containing active substances: polyethylene oxide, succinic acid, povidone (K25), butylhydroxytoluene, stearic acid
Active substance release layer: polyethylene oxide, sodium chloride, povidone (K25), butylhydroxytoluene, red iron oxide (E172), stearic acid
Membrane layer: cellulose acetate, poloxamer 188
Active substance coating: hypromellose, succinic acid
Film coating: film coating containing lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000.
In addition, 18 mg prolonged-release tablets contain:
Yellow iron oxide (E172)
In addition, 54 mg prolonged-release tablets contain :
Red iron oxide (E172)
Yellow iron oxide (E172)
What the medicine looks like and contents of the pack
18 mg prolonged-release tablets are :
Light yellow, round, film-coated tablet (diameter 8 mm) with a release opening (visible, small, round opening) on one side.
36 mg prolonged-release tablets are :
White, round, film-coated tablet (diameter 10 mm) with a release opening (visible, small, round opening) on one side.
54 mg prolonged-release tablets are :
Red, round, film-coated tablet (diameter 10 mm) with a release opening (visible, small, round opening) on one side.
The prolonged-release tablets are packed in HDPE jars with a child-resistant polypropylene closure (PP screw cap) with a drying capsule.
Pack sizes:
28 or 30 prolonged-release tablets or multiple packs: 60 (2×30) or 90 (3×30) prolonged-release tablets .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany