Metynor 10 mg & 20 mg & 30 mg & 40 mg & 50 mg & 60 mg modified -release Hard Capsules of Methylphenidate Hydrochloride
What Methynor Is And What Metynor Used For
What is it used for
Methynor is used to treat Attention Deficit Hyperactivity Disorder ( ADHD ). It contains the active substance methylphenidate.
- 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 behavioural therapy, which are not sufficient.
Methynor enhances activity in certain areas of the brain which are underactive. The drug can help to improve attention (to retain attention), the ability to concentrate and to reduce impulsive behaviour. The drug is given as part of a treatment program, which usually consists of psychological, educational, and social therapy. Using treatment programs as well as medications helps manage ADHD.
About ADHD
Children and adolescents with ADHD may experience difficulty in the:
- Sit still
- 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 intelligence.
Methylphenidate in Methynor may also be approved for treating other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Using Methynor
Do Not Use Methynor
- Is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6). If you think you or your child may be allergic, ask your doctor for advice
- Have problems with the thyroid gland
- Has increased pressure in the eye ( glaucoma )
- Has a tumour in the adrenal gland ( pheochromocytoma )
- Have an eating disorder that makes you not feel hungry or 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 part of blood vessels ( 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 Methynor
- Have mental health problems such as:
- Psychopathic or borderline personality disorder
- Abnormal thoughts or visions or 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 joyful, overactive and uninhibited.
Do not take methylphenidate if any of the above apply to you or your baby. If you have 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 or pharmacist before you or your child take Metynor if you or your child:
- Have liver or kidney problems
- Have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
- Have you ever abused or been addicted to alcohol, prescription drugs or drugs
- Is a woman 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 not mentioned in the above section, “Do not take Methynor if you or your child.”
- Have a mental health problem not mentioned in the section above, “Do not take Methynor if you or your child.” Other mental health problems can be:
- Mood swings (from being manic to becoming depressed, so-called “bipolar disorder”)
- Exhibits aggressive or hostile behaviour, or aggravated aggression
- See, hear or feel things that do not exist (hallucinations)
- Believe in things that are not true (delusions)
- Feels unusually suspicious ( paranoid )
- Feeling upset, anxious or tense
- Feeling depressed or having feelings of guilt.
If any of the above applies to you or your child, talk to a doctor or pharmacist before starting treatment. This is because methylphenidate can aggravate these problems. Your doctor will want to check how the medicine affects you or your child.
Checks that your doctor will do before you or your child start taking methylphenidate
These checks 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 unexplained 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. if you are elated or depressed, have strange thoughts, 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 behavioural 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.
Prolonged erection er
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 more than 2 hours, especially if it is painful.
Drug tests
This drug can give positive results in drug abuse tests.
Adults and the elderly
Methynor should not be used to treat ADHD in adults and the elderly over 18 years.
Children And Young People
Methynor is not indicated for treating ADHD in children under 6 years of age. It is unknown if it is safe or has any effect on children under 6 years of age.
Other Medicines And Methynor
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 take an MAOI for the last 14 days. Taking MAOIs together with methylphenidate can lead to a sudden increase in blood pressure.
If you or your child take other medicines, methylphenidate may affect how well they work or cause side effects. It may be necessary to change the dose of one of the medicines or stop treatment altogether. If you or your child are taking any of the following medicines, you must consult your doctor or pharmacist before taking methylphenidate:
- Other antidepressants
- Medicines for serious mental problems (e.g. schizophrenia)
- Antiepileptic drugs
- Medicines for high or low blood pressure
- Certain cough medicines and cold medicines 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 unsure if any of the medicines you or your child are taking are included in the list above, consult a physician or pharmacist before you or your child takes methylphenidate.
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 anaesthetic/anaesthetic is used. This is because there is a risk of sudden high blood pressure during surgery.
Methylphenidate 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 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. Your doctor will discuss contraception.
- Is pregnant or thinks you / your daughter may be pregnant? Your doctor will decide if methylphenidate should be used.
- Breastfeeding or planning to breastfeed. Methylphenidate may be transferred to breast milk. Therefore, your doctor will decide if you or your daughter can breastfeed during methylphenidate treatment.
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 drive vehicles, use machines, bike, ride, or climb trees.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
How To Use Methynor
The treatment may only be started by and used under the supervision of a doctor who specializes in treating ADHD, for example, a doctor who has experience with behavioural problems in children and adolescents or a child and adolescent psychiatrist. During treatment, careful examination and monitoring are required performed by this physician.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Methynor is a form of methylphenidate with “modified release”, which means that the drug is released gradually over 8 hours. It is intended to replace the same total daily dose of traditional methylphenidate (with immediate release ) taken at breakfast and lunch.
- If you or your child are already taking traditional methylphenidate tablets (with immediate release ), your doctor may prescribe a corresponding dose of Methynor instead.
- If you or your child have not taken methylphenidate before, your doctor will usually start treatment with traditional methylphenidate tablets (immediate release ). If your doctor thinks it is necessary, you can start treatment with methylphenidate with Metynor 10 mg once daily before breakfast.
- The doctor usually starts treatment with a low dose and gradually increases it as needed.
- The maximum daily dose is 60 mg.
How is it taken
Methynor should be swallowed. It should be given in the morning before breakfast. The capsules can be swallowed whole with a sip of water, alternatively opened, and the capsule contents poured into a small amount (tablespoon) of soft food (e.g. apple puree) and taken/given immediately. If the medicine is taken/given with soft food, some liquid, e.g. water, is taken afterwards.
How to open the child-resistant PP screw cap on the jar
Press the lid down and then turn it counterclockwise to open. The first time, a stronger force may be needed to turn the lid.
After the first opening, the ring will come loose from the bottom of the lid. Remove the loosened ring. Push the lid down again and turn it counterclockwise to further open the jar.
Long-term treatment
Methynor does not need to be taken forever. If you or your child have been taking Methynor for over a year, your doctor will discontinue treatment for a short time, e.g. under school law. This is to check if the medicine is still needed.
If you 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.
Not using Methynor properly
If Methynor is not used properly, it can lead to abnormal behavior. It can also mean that you or your child may become addicted to the drug. Tell your doctor if you or your child have ever abused or been addicted to alcohol, prescription drugs, or drugs.
Checks that your doctor will do during treatment
Your doctor will do some checks
- Before starting treatment, this is to ensure that Metynor is safe and that it will be useful.
- After you or your child has started treatment. Checks will be made at least every 6 months, possibly more often. Checks will also be made when dose one is changed.
- The controls 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 during the time Metynor was taken.
Possible Metynor Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Although some people get side effects, most 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 metynor side effects (may affect up to 1 in 10 people):
- Palpitations (irregular heartbeat)
- 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 disease)
- 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
- Seizures (seizures, epilepsy)
- Flaky skin or red, purple rash
- 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.
- Paralysis or difficulty moving, and visual or speech difficulties (may be a sign of a problem with the blood vessels in 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 (neuroleptic malignant 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 obsessions
- Unexplained fainting, chest pain or shortness of breath (may be a sign of heart problems).
- If you or your child get any of the above side effects, seek medical attention 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
- Dry mouth
- Fever
- Abnormal hair loss or thinning
- Abnormal fatigue or lethargy
- Loss of appetite or decreased appetite
- Itching, rash or raised, red itchy hives
- Cough, sore throat or nose and throat irritation
- High blood pressure, fast pulse ( tachycardia )
- Dizziness, uncontrollable movements, hyperactivity
- Feel aggressive, agitated, anxious, depressed, irritated and exhibit abnormal behaviour
- Severe gnashing of teeth (bruxism)
Uncommon (may affect up to 1 in 100 people):
- Constipation
- The feeling of discomfort in the chest
- Blood in the urine
- Double vision or blurred vision
- Muscle aches, muscle twitching
- Elevated liver values (detected by a blood test)
- Anger, restlessness or crying, excessive attention to the environment, difficulty sleeping
Rare (may affect up to 1 in 1,000 people):
- Altered sexual desire
- Cconfusion
- Dilated pupils, visual disturbances
- Swelling of the breasts in men
- Excessive sweating, reddening of the skin, red raised rash
Very rare (may affect up to 1 in 10,000 people):
- Myocardial infarction
- Sudden death
- Muscle cramps
- Small red spots on the skin
- Inflammation or clogging of blood vessels in the brain
- Abnormal liver function, including liver failure and coma
- Altered liver and blood levels
- Suicide attempts, suicide, abnormal thoughts, lack of emotions, repeated compulsions, fixation on individual things
- Loss of sensation in fingers and toes, tingling and change in colour (from white to blue, then red) on cold (Raynaud’s phenomenon).
Has been reported (occurs in an unknown number of users):
- Migraine
- Stuttering
- Excessive talkativeness
- Very high fever
- Slow, fast or extra heartbeat
- Severe seizures ( grand mal seizures)
- To believe in things that are not real (delusions), confusion
- 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 )
- Prolonged erections, sometimes painful, or increased number of erections, inability to get or keep an erection
- Problems in the blood vessels of the brain ( stroke, inflammation and blockage of the blood vessels of the brain)
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 and how well you or your child eats.
- If you or your child does not grow as expected, treatment with methylphenidate may be stopped for a short time.
How To Store Methynor
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if the capsules look damaged in any way.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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.
- Methynor 10 mg modified-release hard capsules contain 8.65 mg methylphenidate as 10 mg methylphenidate hydrochloride.
- Methynor 20 mg modified-release hard capsules contain 17.3 mg of methylphenidate as 20 mg of methylphenidate hydrochloride.
- Methynor 30 mg modified-release hard capsules contain 25.95 mg methylphenidate as 30 mg methylphenidate hydrochloride.
- Methynor 40 mg modified-release hard capsules contain 34.6 mg of methylphenidate as 40 mg of methylphenidate hydrochloride.
- Methynor 50 mg modified-release hard capsules contain 43.25 mg of methylphenidate as 50 mg of methylphenidate hydrochloride.
- Methynor 60 mg modified-release hard capsules contain 51.9 mg of methylphenidate as 60 mg of methylphenidate hydrochloride.
- Other ingredients are:
- Capsule contents: microcrystalline cellulose, hypromellose, ethylcellulose, hydroxypropyl cellulose, dibutyl sebacate, povidone (K30), talc.
- Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172) (only in Metynor 20 mg, 30 mg, 40 mg, and 50 mg), red iron oxide (E172) (only in Methynor 40 mg, 50 mg, and 60 mg)
- Ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520), potassium hydroxide (E525).
What The Medicine Looks Like And The Contents Of The Pack
- Capsule with a modified release, hard.
- Methynor 10 mg modified-release hard capsules.
- Opaque oblong hard capsule with white cap and white body marked “10” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 15.90 ± 0.30 mm, size 3.
- Methynor 20 mg modified-release hard capsules.
- Opaque oblong hard capsule with ivory-coloured cap and white body marked “20” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 15.90 ± 0.30 mm, size 3.
- Methynor 30 mg modified-release hard capsules.
- Opaque oblong hard capsule with yellow cap and white body marked “30” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 18.00 ± 0.30 mm, size 2.
- Methynor 40 mg modified-release hard capsules.
- Opaque oblong hard capsule with light orange cap and white body marked “40” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 19.40 ± 0.30 mm, size 1.
- Methynor 50 mg modified-release hard capsules.
- Opaque oblong hard capsule with orange cap and white body marked “50” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 21.70 ± 0.30 mm, size 0.
- Methynor 60 mg modified-release hard capsules.
- Opaque oblong hard capsule with orange cap and white body marked “60” with black ink on the body, filled with white to off-white spherical pellets. Capsule length: 21.70 ± 0.30 mm, size 0.
- Methynor 10 mg / 20 mg / 30 mg / 40 mg / 50 mg / 60 mg modified-release hard capsules are available in:
- HDPE jars with child-resistant PP screw caps containing a PP desiccant.
- Pack sizes: 28, 30, 50, 60, and 100 hard capsules with the modified release.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim
Germany
Local Representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark