10 mg, 20 mg tablets
of methylphenidate hydrochloride
What Methylphenidate Alternova is and what it is used for
What is it used for
Methylphenidate Alternova 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 Alternova is not used to treat ADHD in children under 6 years of age or adults. The safety and benefits of treatment have not been established in these patient groups.
How it works
Methylphenidate Alternova 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
Methylphenidate Alternova is only prescribed by a behavioral disorder specialist who will follow up on your upcoming treatment. A thorough examination is necessary. Help in managing ADHD is provided through the use of treatment programs as well as medications.
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.
Not all patients with ADHD need to be treated with medication.
ADHD does not affect the intelligence of children or adolescents.
Investigations during treatment with Methylphenidate Alternova
Your doctor will check your or your child’s health regularly during treatment with Methylphenidate Alternova (carefully read section 3 “Checks on starting treatment”).
Methylphenidate hydrochloride contained in Methylphenidate Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you or your child take Methylphenidate Alternova
Do not take Methylphenidate Alternova 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 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 of 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 Alternova”
- have mental health problems such as:
- psychopathic or borderline personality disorder
- psychotic symptoms or schizophrenia
- suicidal thoughts
- severe depression, where you feel very sad, worthless or have feelings of hopelessness
- mania, where you feel unusually elated, overactive and have difficulty controlling your behavior.
Do not take Methylphenidate Alternova if any of the above apply to you / your child. If you have any further questions, ask your doctor or pharmacist before taking Methylphenidate Alternova. This is because methylphenidate can aggravate these problems.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before you or your child take Methylphenidate Alternova:
- have liver or kidney problems
- have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
- have ever abused or been addicted to alcohol, prescription drugs or “party drugs”
- is a girl and has started menstruating (see the section “Pregnancy and breastfeeding” 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 Alternova if you or your child:”
- have a mental health problem not mentioned in the section “Do not take Methylphenidate Alternova 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 behavior, or aggravated aggression
- see, hear or feel things that do not exist (hallucinations)
- believe in things that are not real (delusions)
- feels unusually suspicious ( paranoid )
- feeling agitated, anxious or tense
- feeling depressed or having unreasonable guilt feelings.
Tell a doctor or pharmacist, before you or your child start treatment if any of the above apply to you / your child. The reason for this is that methylphenidate can aggravate these problems. The doctor will want to follow up on how the medicine affects you / 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 starting treatment with Methylphenidate Alternova
These tests are needed to determine if Methylphenidate Alternova is a suitable drug for you / your child. Your doctor will talk to you about the following:
- if you or your child are taking any other medicine
- 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 or your child 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 is at risk of mood swings (from being manic to becoming depressed, so-called “bipolar disorder”). Your / your child’s previous mental health will be checked. It will also check if someone in your family has previously committed suicide, has bipolar disorder or depression.
You must provide as much information as you can. This will help your doctor decide if Methylphenidate Alternova is a suitable medicine for you / 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 Alternova
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 Alternova 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 .
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 Alternova:
- antidepressants
- medicines for serious mental problems
- 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 have any further questions on the use of this medicine, ask your doctor or pharmacist for advice before taking any medicine before you or your child take Methylphenidate Alternova.
Operation
Tell your doctor if you or your child will undergo surgery. Methylphenidate Alternova should not be taken on the day of surgery if anesthetics/anesthetics are used. This is because there is a risk of sudden high blood pressure and increased heart rate during surgery.
Drug tests
This drug can give positive results in drug abuse tests.
Methylphenidate Alternova 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 and breastfeeding
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.
Before you or your daughter use methylphenidate, tell your doctor or pharmacist if you or your daughter:
- is sexually active. The doctor will discuss contraception.
- is pregnant or if you think you / your daughter may be pregnant. Your doctor will decide if methylphenidate can be taken.
- breastfeeding or planning to breastfeed. It is possible that methylphenidate is transferred to breast milk. Therefore, your doctor will decide if you can breast-feed during treatment with Methylphenidate Alternova.
Driving and using machines
You or your child may feel dizzy, have difficulty focusing, or have blurred vision when using Methylphenidate Alternova. If this happens, it can be dangerous to do things like drive a car or other vehicles, use machines, ride a 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.
How you or your child use Methylphenidate Alternova
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.
The doctor usually starts the treatment with a low dose and increases gradually if necessary.
The highest recommended daily dose is 60 mg.
How to take the medicine
Methylphenidate Alternova should be taken 1-2 times daily (eg for breakfast and/or lunch).
The tablet should be swallowed with water.
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
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.
Not using Methylphenidate Alternova correctly
If Methylphenidate Alternova is not used properly, it can lead to abnormal behavior. It can also be a sign of tolerance development for the drug. Tell your doctor if you or your child have ever abused or been addicted to alcohol, prescription drugs, or drugs.
This medicine has been prescribed for you / your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to your / your child’s.
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):
- 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 e.g. 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, bluish 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, visual or speech difficulties (may be a sign of a problem with the blood vessels in the brain)
- reduced number of blood cells (red and white blood cells and platelets ), which can make one more susceptible to infection and make it easier to bleed 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).
- 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 are as follows. If they become serious, consult a doctor or pharmacist:
Very common (may affect more than 1 user in 10):
- decreased appetite
- headache
- nervousness
- difficulty sleeping
- nausea
- dry mouth
Common (may affect up to 1 in 10 people):
- joint pain
- fever
- abnormal hair loss or thinning
- abnormal fatigue or drowsiness
- loss of appetite
- panic attack
- decreased sexual desire
- toothache
- itching , rash or raised red itchy rash ( hives )
- excessive sweating
- cough, sore throat or irritation of the nose and throat, shortness of breath or chest pain
- high blood pressure , fast pulse ( tachycardia ), cold hands and feet
- shaking or trembling, dizziness, uncontrollable movements, feeling nervous, hyperactivity
- feeling aggressive, agitated, restless, anxious, depressed, stressed, irritated and exhibiting abnormal behavior, difficulty sleeping, fatigue
- stomach pain, diarrhea, stomach discomfort and vomiting. These usually occur at the beginning of treatment and can be reduced by taking the medicine with food
- indigestion, thirst
- severe gnashing of teeth (bruxism).
Uncommon (may affect up to 1 in 100 people):
- constipation
- feeling of discomfort in the chest
- blood in the urine
- double vision or blurred vision
- muscle aches, muscle twitching, muscle tension
- elevated liver values (detected by blood test)
- anger, weeping, excessive attention to the environment, tension
Rare (may affect up to 1 in 1,000 people):
- altered sexual desire
- confusion
- dilated pupils , visual disturbances
- swelling of the breasts in men
- 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, abnormal thoughts, lack of emotions, repeated compulsions, fixation on individual things (obsessions)
- 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
- very high fever
- slow, fast or extra heartbeat
- severe epileptic seizures ( grand mal seizures)
- to believe in things that are not real (delusions), confusion
- severe abdominal pain, usually with nausea and vomiting
- changes in the blood vessels of the brain ( stroke , inflammation and clogging of the blood vessels of the brain)
- impotence ( erectile dysfunction )
- excessive uncontrolled chatter
- 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
- 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 may be stopped for a short time
How to store Methylphenidate Alternova
Keep this medicine in a safe place so that no one else can take it. 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 after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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. 1 tablet contains 10 mg or 20 mg of methylphenidate hydrochloride.
- The other ingredients are microcrystalline cellulose, corn starch, calcium hydrogen phosphate dihydrate, magnesium stearate.
What the medicine looks like and contents of the pack
Blister pack of PVC / ALU.
Methylphenidate Alternova 10 mg: white, round, diameter 7 mm, flat tablet with a scoreline on one side, marked “RU 10” on the other side. Pack sizes: 30 and 100 tablets.
Methylphenidate Alternova 20 mg: white, round, diameter 9 mm, flat tablet with a scoreline on one side, marked “RU 20” on the other side. Pack sizes: 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer
Laboratorio Rubió SA, Industria, 29-Pol Ind. Comte de Sert, 08755 Castellbisbal-Barcelona, Spain