Methylphenidate Orifarm - Methylphenidate hydrochloride uses, dose and side effects

it is used in children and adolescents aged 6 to 18 years, and in adults
it is used only after other drug-free treatment methods have been tried, such as talk therapy and behavioral therapy, and these have not been sufficient.

Methylphenidate Orifarm is not used to treat ADHD in children under 6 years of age. The safety and benefits of treatment have not been established in children younger than 6 years.

How it works

Methylphenidate Orifarm improves the activity in certain areas of the brain that are underactive. The drug can contribute to improved attention (ability 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 .

Treatment with Methylphenidate Orifarm should only be initiated and used under the supervision of a doctor who specializes in the treatment of ADHD, such as a pediatrician, a child, an adolescent psychiatrist, or a psychiatrist. This doctor should perform a thorough examination. If you have not been treated before in adulthood, your doctor will perform tests to confirm that you have had ADHD since childhood. Treatment programs and the drug will help you manage ADHD.

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.

Adults with ADHD often find it difficult to concentrate. They often feel restless, impatient, and inattentive. They may have difficulty structuring their private and working lives.

Not all patients with ADHD need to be treated with medication.

For children, the decision to use a medicine must be based on a very careful assessment of the severity of the child’s symptoms and it must be determined whether these are chronic.

ADHD does not affect intelligence.

Methylphenidate hydrochloride contained in Methylphenidate Orifarm 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 use Methylphenidate Orifarm

Do not take Methylphenidate Orifarm if you or your child:

is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6). Ask your doctor if you think you may be allergic.
have problems with the thyroid gland
has increased pressure in the eye ( glaucoma )
has a tumor in the adrenal gland ( pheochromocytoma )
take a medicine called monoamine oxidase inhibitor ( MAOI ) for depression, or have done so for the last 14 days (see section “Other medicines and Methylphenidate Orifarm”)
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 )
have mental health problems such as:
- psychopathic or borderline personality disorder
- abnormal thoughts or hallucinations, or a disease called “schizophrenia”
- signs of serious mood 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 have difficulty controlling your behavior
  - mood changes from depression to mania.

Do not take methylphenidate if any of the above apply to you or your baby. 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 or pharmacist before taking Methylphenidate Orifarm if you or your child:

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 drugs
is a girl and has started menstruating (see section “Pregnancy, breast-feeding and fertility” below)
or someone else in your family has difficult-to-control repeated twitches in any part of the body or repeats sounds and words ( tics )
have high blood pressure
have a heart problem not mentioned in the section above “Do not take Methylphenidate Orifarm”
have a mental health problem which is not mentioned in the section “Do not take Methylphenidate Orifarm”. 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 upset, anxious or tense
- feeling depressed or having unreasonable guilt feelings.

If any of the above applies to you or your child, tell your doctor or pharmacist before starting treatment. The reason for this is that methylphenidate can aggravate these problems.

Your doctor will want to follow up on how the medicine affects you or your child.

During treatment, boys and men may unexpectedly get 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

These tests are needed to determine if methylphenidate is a suitable drug for you or your child.

Your doctor will talk to you:

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 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. Your 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 or 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. It will help your doctor decide if methylphenidate is a suitable 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.

Effects of substance abuse

The use of Methylphenidate Orifarm may lead to positive results in doping tests.

Misuse of Methylphenidate Orifarm for doping purposes may pose a health risk.

Other medicines and Methylphenidate Orifarm

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 MAO inhibitors with methylphenidate may lead to a sudden increase in blood pressure (see “Do not take Methylphenidate Orifarm”).

If you or your child are taking other medicines, methylphenidate may affect how well they work or cause side effects. It may therefore be necessary to change the dose of one of the medicines or to stop the 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 (eg schizophrenia)
antiepileptic drugs
medicines for high or low blood pressure
some cough medicines and medicines for colds 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 at all unsure whether 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 take 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 certain type of anesthetic/anesthetic is used. This is because there is a risk of sudden high blood pressure and increased heart rate during surgery.

Methylphenidate Orifarm with food, drink and 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.

Before you or your daughter use methylphenidate, tell your doctor or pharmacist if you or your daughter:

is sexually active. Your doctor will discuss contraception.
is pregnant, thinks you / your daughter may be pregnant or is planning to have a baby. Your doctor will decide if you should take methylphenidate or not.
breastfeeding or planning to breastfeed. It is possible that methylphenidate is transferred to breast milk. Therefore, your doctor will decide if it is appropriate to breast-feed during treatment with methylphenidate.

Driving and using machines

You or your child may feel dizzy or sleepy, have trouble focusing or have blurred vision, have hallucinations, or have other side effects in the central nervous system when taking methylphenidate. If this happens, it can be dangerous to do things like drive a car or other vehicle, use machinery, 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.

Methylphenidate Orifarm contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Methylphenidate Orifarm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

The doctor usually starts the treatment with a low dose and increases gradually if necessary.

Children (6 years and older) and adolescents

The recommended starting dose is 20 mg once daily. If your doctor thinks it is necessary, treatment with Methylphenidate Orifarm can be started with a dose of 10 mg. The maximum daily dose is 60 mg. Methylphenidate Orifarm is taken once daily in the morning by patients under 18 years of age.

Adults

If you have not taken Methylphenidate Orifarm before, your doctor will start treatment with 20 mg daily and then gradually increase the dose once a week in small steps.
If you have already been treated with modified -release methylphenidate during childhood and have recently turned 18, your doctor may continue treatment with the same dose . If you were treated with methylphenidate with immediate release in childhood, your doctor will prescribe the corresponding dose of Methylphenidate Orifarm.

The highest recommended daily dose is 80 mg.

For lower dose or smaller dose increases, other strengths of this medicine or other medicines containing methylphenidate may be available.

Your doctor will do some checks when you or your child are being treated:

before you or your child start treatment – to ensure that Methylphenidate Orifarm is safe and beneficial (listed in the section “Checks that your doctor will do before starting treatment with methylphenidate”)
after you or your child has started the treatment – they will be performed at least every 6 months, but 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 in children
- measurement of weight in adults
- 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 Orifarm has been taken.

How to take the medicine

Methylphenidate Orifarm should be swallowed.

Take Methylphenidate Orifarm once daily in the morning. Methylphenidate Orifarm should not be taken too late in the morning as it may cause sleep disturbances.

The capsule can be taken with or without food
Swallow the capsule whole with a glass of water
the capsule and the capsule contents must not be crushed, chewed or divided on several treatment occasions.

If you or your child can not swallow Methylphenidate Orifarm, you can sprinkle the contents of the capsule over some food, according to the following instructions:

Carefully open the capsule and sprinkle the grains on a small amount of liquid food (eg apple puree)
the food should not be hot as this may affect the special properties of the grains
immediately eat all of the medicine / food mixture

Do not save any medicine/food mixture for later use.

Opening instructions for blisters

This medicine is packaged in a child-resistant, perforated blister. Follow the instructions below to open the blister:

Do not push the capsule through the blister foil, as this will crush the capsule.
Hold the blister with the marked foil side up and bend it backwards along the perforated line. Bend the blister again in the opposite direction and tear along the cross perforation.
Separate a single dose by tearing along the perforated line on the blister, then pulling off the foil on the blister to obtain the capsule

Long-term treatment

Methylphenidate Orifarm does not need and should not be taken forever. If you or your child have been taking Methylphenidate Orifarm for more than a year, your doctor should stop the treatment for a short time at least once a year. For children, this can be done during a school holiday. This is to check if the medicine is still needed.

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 after 1 month of treatment. Your doctor may decide to use another treatment.

If Methylphenidate Orifarm is not used correctly

If Methylphenidate Orifarm is not used properly, it can lead to abnormal behavior. It can also mean that you or your child becomes addicted to the drug. Tell your doctor if you or your child have ever abused or been addicted to alcohol, prescription drugs, or drugs.

This medicine is for you or your child only. Do not give it to others, even if they have symptoms similar to yours.

If you or your child have taken too much Methylphenidate Orifarm

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, dry mucous membranes of the nose and mouth.

If you or your child have forgotten to take Methylphenidate Orifarm

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 Orifarm

If you or your child suddenly stop 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 Orifarm.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 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 and 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
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 (these may be signs of heart problems)

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
weight loss in adults
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
changes in blood pressure (mainly as 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, severe gnashing of teeth (bruxism)
stomach pain, diarrhea, stomach discomfort, indigestion, thirst and vomiting. These side effects occur mainly at the beginning of treatment and can be reduced by taking the medicine with food.

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 and clogging of the blood vessels of the brain
abnormal liver function, including liver failure and coma
altered liver and blood levels
suicide attempts and suicide, 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
problems with the blood vessels of the brain ( stroke , cerebral arthritis or cerebral occlusion )
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)
prolonged erections , sometimes painful, or increased number of erections
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 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 Orifarm

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 blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 Orifarm 10 mg modified -release hard capsules contain 10 mg methylphenidate hydrochloride (equivalent to 8.65 mg methylphenidate).
Methylphenidate Orifarm 20 mg modified -release hard capsules contain 20 mg methylphenidate hydrochloride (equivalent to 17.3 mg methylphenidate).
Methylphenidate Orifarm 30 mg modified -release hard capsules contain 30 mg methylphenidate hydrochloride (equivalent to 25.95 mg methylphenidate).
Methylphenidate Orifarm 40 mg modified -release hard capsules contain 40 mg methylphenidate hydrochloride (equivalent to 34.6 mg methylphenidate).
Methylphenidate Orifarm 60 mg modified -release hard capsules contain 60 mg methylphenidate hydrochloride (equivalent to 51.9 mg methylphenidate).

The other ingredients are:
Capsule content: ammonio methacrylate copolymer (type B), methacrylic acid – methyl methacrylate copolymer (1: 1), povidone 30, sugar spheres (containing sucrose and corn starch), talc, triethyl
citrate Capsule shell: gelatin, titanium dioxide (E171).

In addition, Methylphenidate Orifarm contains 10 mg, 30 mg, 40 mg and 60 mg modified-release hard capsules: yellow iron oxide (E172).

Printing ink
Potassium hydroxide
Propylene glycol
Red iron oxide (E172)
Shellack glaze
Ammonia, concentrated

What the medicine looks like and contents of the pack

Methylphenidate Orifarm 10 mg modified-release hard capsules

Hard gelatin capsule (size 2) with a dark yellow, opaque, capsule top embossed “RUB” with red ink and a white, opaque, capsule bottom embossed “M10” with red ink. The capsule is filled with white to off-white spherical pellets. Capsule length: 18 mm.

Methylphenidate Orifarm 20 mg modified-release hard capsules

Hard gelatin capsule (size 2) with a white, opaque, capsule top embossed “RUB” with red ink, and a white, opaque, capsule bottom embossed “M20” with red ink. The capsule is filled with white to off-white spherical pellets. Capsule length: 18 mm.

Methylphenidate Orifarm 30 mg modified-release hard capsules

Hard gelatin capsule (size 2) with an ivory colored, opaque, capsule top embossed “RUB” with red ink, and an ivory capsule bottom embossed “M30” with red ink. The capsule is filled with white to off-white spherical pellets. Capsule length: 18 mm.

Methylphenidate Orifarm 40 mg modified-release hard capsules

Hard gelatin capsule (size 1) with a dark yellow, opaque, capsule top embossed “RUB” with red ink, and a dark yellow capsule bottom embossed “M40” with red ink. The capsule is filled with white to off-white spherical pellets. Capsule length: 20 mm.

Methylphenidate Orifarm 60 mg modified-release hard capsules

Hard gelatin capsule (size 0) with a dark yellow, opaque, capsule top embossed “RUB” with red ink, and an ivory capsule bottom embossed “M60” with red ink. The capsule is filled with white to off-white spherical pellets. Capsule length: 22 mm.

Child-resistant blister (Aclar / PVC / Al / PET) in cardboard.

Pack sizes:

10 mg: 28, 30, 50, 56, 60, 100 capsules.

20 mg: 28, 30, 50, 56, 60, 84, 100 capsules.

30 mg: 28, 30, 50, 56, 60, 100 capsules.

40 mg: 28, 30, 50, 56, 60, 100 capsules.

60 mg: 28, 30, 40, 50, 56, 60, 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Manufacturer

Laboratorios Rubió, SA

Industria, 29. Pol. Ind. Count of Sert

08755 Castellbisbal (Barcelona)

Spain