DOPRILTEN 54 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Doprilten 18 mg prolonged-release tablets EFG

Doprilten 27 mg prolonged-release tablets EFG

Doprilten 36 mg prolonged-release tablets EFG

Doprilten 54 mg prolonged-release tablets EFG

methylphenidate hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours or your child's.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Doprilten and what is it used for
2. What you need to know before you or your child take Doprilten
3. How to take Doprilten
4. Possible side effects
5. Storing Doprilten
6. Package contents and further information

1. What is Doprilten and what is it used for

What is it used for

Doprilten is used to treat "Attention Deficit Hyperactivity Disorder" (ADHD).

• It is used in children from 6 years of age and adults.
• It is used only after non-medication treatments, such as behavioral therapy and counseling, have been tried first.

Doprilten is not indicated for the treatment of ADHD in children under 6 years of age.

How it works

Doprilten improves the activity of certain parts of the brain that are underactive. The medication may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medication is given as part of a comprehensive treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy.

It is only prescribed by doctors who have experience in behavioral problems in children, adolescents, or adults. If you are an adult and have not received treatment before, the specialist will perform tests to confirm that you have had ADHD since childhood. Although ADHD has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still and
• focusing

It is not their fault that they cannot do these things.

Many children and adolescents struggle to do these things. However, ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, and in other places.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and distracted. They may have difficulty organizing their private life and work.

Not all patients with ADHD need treatment with medication.

ADHD does not affect intelligence.

2. What you need to know before you or your child take Doprilten

Do not take Doprilten if you or your child:

• are allergic to methylphenidate or any of the other ingredients of this medicine (see section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have an eating disorder, loss of appetite, or do not want to eat, such as in "anorexia nervosa"
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a heart problem at birth
• have had a problem with the blood vessels in the brain, such as a stroke, widening or weakness of part of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis)
• are taking or have taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see "Other medicines and Doprilten"
• have mental health problems such as:

• a "psychopathic" or "borderline personality" disorder
• abnormal thoughts or visions or a disease called "schizophrenia"
• signs of a severe mood disorder such as:

• suicidal thoughts
• severe depression, feeling very sad, worthless, and desperate
• mania, feeling exceptionally elated, more active than usual, and uninhibited.

Do not take methylphenidate if you or your child have any of the above. If you are not sure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these problems.

Warnings and precautions

Talk to your doctor before starting Doprilten if you or your child:

• have liver or kidney problems
• have problems swallowing or swallowing whole tablets
• have had seizures (fits, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG)
• have abused or been dependent on alcohol, prescription drugs, or drugs
• are female and have started your period (see below the section on "Pregnancy and breastfeeding")
• have difficulty controlling repetitive movements of some parts of the body or repeat sounds and words
• have high blood pressure
• have a heart problem not included in the previous "Do not take" section
• have a mental health problem not included in the previous "Do not take" section.

Other mental health problems include:

• mood changes (from being manic to being depressed, known as "bipolar disorder")
• feeling aggressive or hostile
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing things that are not real (delusions)
• feeling strangely suspicious (paranoia)
• feeling agitated, anxious, or tense
• feeling depressed or guilty

Tell your doctor or pharmacist if you or your child have any of the above before starting treatment. This is because methylphenidate may worsen these problems. Your doctor will want to monitor how the medication affects you or your child.

During treatment, male patients may experience unexpected prolonged erections. The erections can be painful and occur at any time. It is essential to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks that your doctor will make before you or your child start taking Doprilten

To decide if methylphenidate is the right medicine for you or your child, your doctor will talk to you about:

• any medicine that you or your child are taking
• if you or your child have a family history of sudden unexplained death
• other illnesses that you or your family (such as heart problems) may have
• how you or your child are feeling, if you or your child have mood swings, have had strange thoughts or have had these feelings in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeated sounds and words)
• possible behavioral or mental health problems that you or your child or other family members have had.

Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, known as bipolar disorder). He will check your or your child's mental health history and check if any family members have a history of suicide, bipolar disorder, or depression.

It is essential to provide all the information you can. This will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need other medical tests before starting this medicine. For adults starting Doprilten, your doctor may refer you to a cardiologist.

Other medicines and Doprilten

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:

• are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used for depression or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate can cause a sudden increase in blood pressure (see "Do not take Doprilten").

Tell your doctor or pharmacist if you or your child are taking any of the following medicines for depression or anxiety:

• tricyclic antidepressant
• selective serotonin reuptake inhibitor (SSRI)
• serotonin and noradrenaline reuptake inhibitor (SNRI)

Taking methylphenidate with these types of medicines can cause a potentially life-threatening increase in "serotonin" in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, seek medical attention immediately.

If you or your child are taking other medicines, methylphenidate may affect how they work or cause side effects. If you or your child are taking any of the following medicines, talk to your doctor or pharmacist before taking methylphenidate:

• medicines for severe mental health problems
• medicines for Parkinson's disease (such as levodopa)
• medicines for epilepsy
• medicines used to lower or increase blood pressure
• some cough and cold remedies that contain medicines that can affect blood pressure. It is essential to talk to your pharmacist when you buy any of these medicines
• medicines that thin the blood to prevent blood clots.

If you are unsure if any of the medicines you or your child are taking are included in the list above, talk to your doctor or pharmacist for advice before taking methylphenidate.

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as it can cause a sudden increase in blood pressure during the procedure.

Drug tests

This medicine may give a positive result in drug tests, even in tests used in sports.

Doprilten with alcohol

Do not drink alcohol while taking this medicine. Alcohol can worsen the side effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and contraception

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine.

Available data do not suggest an increased risk of total congenital anomalies, although a small increase in the risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide more information about this risk.

Talk to your doctor or pharmacist before using methylphenidate if you or your daughter:

• are having sex. Your doctor will discuss contraception with you
• are pregnant or think you may be pregnant. Your doctor will decide if you should use methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Your doctor will decide if you or your daughter should breastfeed while using methylphenidate.

Driving and using machines

You or your child may feel dizzy, have problems focusing, or have blurred vision when taking methylphenidate. If this happens, it can be dangerous to perform certain activities such as driving, operating machinery, riding a bike or horse, or climbing trees.

This medicine may affect your ability to drive.

Doprilten contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Doprilten

How much to take

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, talk to your doctor or pharmacist again.

• Your doctor will usually start treatment with a low dose and increase the daily dose by 18 mg no sooner than once a week if necessary. The goal should be the lowest dose that is effective for you. Your doctor will decide the maximum daily dose for you or your child.
• Doprilten is for oral use. You should take the tablet once a day in the morning with a glass of water.

The tablet should be swallowed whole and not chewed, broken, or crushed. The tablet can be taken with or without food.

Use in children from 6 years of age

The recommended initial dose of Doprilten is 18 mg once a day for children who are not currently taking methylphenidate or for children who are switching from another stimulant to methylphenidate.

The maximum daily dose is 54 mg.

Use in adults

• For adults who have taken Doprilten before:

• adult patients may need a higher daily dose, but the doctor will try to give you the lowest dose that is effective.

• For adults who have not taken Doprilten before:

• The recommended initial dose is 18 mg a day.
• The maximum daily dose is 72 mg in adults.

If you or your child do not feel better after 1 month of treatment

Tell your doctor. Your doctor may decide that you or your child need a different treatment.

What your doctor will do while you or your child are on treatment

Your doctor will perform some tests

• before you or your child start treatment to ensure that Doprilten is safe and beneficial
• once treatment has started, at least every 6 months and even more often. They will also be performed when the dose is changed
• these tests will include:
• • appetite control
  • height and weight measurement
  • blood pressure and heart rate measurement
  • evaluation of mood-related problems, mental state, or any other unusual feelings. Or if these have worsened while taking Doprilten.

Long-term treatment

Doprilten does not need to be taken indefinitely. If you or your child take Doprilten for more than a year, your doctor should interrupt treatment for a short period, which may be during school holidays. This allows your doctor to determine if the medicine is still needed.

Incorrect use of Doprilten

If Doprilten is not used correctly, it can cause abnormal behavior. This can also mean that you or your child start to depend on the medicine. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription drugs, or drugs.

This medicine is only for you or your child. Do not give this medicine to anyone else, even if they have similar symptoms.

If you or your child take more Doprilten than you should

If you or your child take too many tablets, talk to your doctor or go to the nearest hospital emergency department immediately and tell them how many tablets were taken. Medical treatment may be necessary.

Signs of overdose may include: being sick, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which can be followed by coma), feeling very happy, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle inflammation, weakness, sensitivity, and muscle pain, and dark urine.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you or your child forget to take Doprilten

Do not take a double dose to make up for forgotten doses. If you or your child forget a dose, wait and take the next dose at the scheduled time.

If you or your child stop taking Doprilten

If you or your child stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may return. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping it completely. Talk to your doctor before stopping treatment with Doprilten.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Although some people present adverse effects, most people are helped by methylphenidate. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you or your child have any of the following adverse effects, go to your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• irregular heartbeats (palpitations)
• changes or alterations in mood or personality changes.

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or feelings
• seeing, feeling, or hearing things that are not real, symptoms of psychosis
• uncontrolled speech and body movements (Tourette's syndrome)
• allergy signs such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty or problems breathing.

Rare (may affect up to 1 in 1,000 people)

• feeling exceptionally excited, more active than normal, and uninhibited (mania).

Very Rare (may affect up to 1 in 10,000 people)

• heart attack
• sudden death
• suicidal intention
• seizures (attacks, convulsions, epilepsy)
• skin peeling or red purpuric spots
• inflammation or blockage of the arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may be related to problems with blood vessels in the brain)
• uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets) that can cause a higher risk of infections and easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Frequency Not Known (frequency cannot be estimated from available data)

• unwanted recurring thoughts
• unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)
• prolonged erections, sometimes painful, or increased number of erections.

If you or your child have any of the above adverse effects, go to your doctor immediately.

Other adverse effects are indicated below, and if they become severe, please inform your doctor or pharmacist:

Very Common (may affect more than 1 in 10 people)

• headache
• feeling of nervousness
• difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• problem staying asleep
• high temperature (fever)
• decreased sexual desire
• hair loss or decreased hair thickness (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or decreased appetite
• inability to have or maintain an erection
• itching, rash, or red eruptions that itch (hives)
• excessive sleepiness or drowsiness, feeling tired
• excessive teeth grinding (bruxism)
• panic feeling
• tingling, itching, or numbness of the skin
• increased levels of alanine aminotransferase in blood (liver enzyme)
• cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection, sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness (vertigo), feeling of weakness, uncontrolled movements, abnormal activity
• aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior
• stomach discomfort or indigestion, stomach pain, diarrhea, feeling nauseous, stomach upset, and vomiting. excessive sweating
• weight loss

Uncommon (may affect up to 1 in 100 people)

• dry eyes
• constipation
• chest discomfort
• blood in the urine
• apathy
• agitation or tremor
• increased need to urinate
• muscle pain, muscle twitches
• shortness of breath or chest pain
• feeling of heat
• increased liver test results (seen in a blood test)
• anger reaction (angry), restless, or tearful, excessive awareness of the environment, sleep problems.

Rare (may affect up to 1 in 1,000 people)

• changes in sexual desire
• feeling disoriented or confused
• vision problems or double vision
• breast enlargement in men
• skin redness, increased redness of skin rashes.

Very Rare (may affect up to 1 in 10,000 people)

• muscle cramps
• small red spots on the skin
• abnormal liver function, including sudden liver failure and coma
• changes in test results, including liver and blood tests
• abnormal thinking, absence of feelings or emotion, doing things over and over, obsession with something
• fingers and toes numbness, tingling, and color change with cold (from white to blue to red) ("Raynaud's phenomenon").

Frequency Not Known (frequency cannot be estimated from available data)

• migraine
• dilated pupils
• very high fever
• slow, fast, or irregular heartbeats
• major epileptic seizure ("grand mal" convulsions)
• believing things that are not true
• severe stomach pain with feeling of discomfort and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• inability to control urine elimination (incontinence)
• jaw muscle spasm that makes it difficult to open the mouth (trismus)
• stuttering
• nosebleed

Effects on Growth

When used for more than a year, methylphenidate may reduce growth in some children. This affects less than 1 in 10 children.

• may prevent weight or height gain
• your doctor will carefully check the height and weight of you or your child, as well as nutrition

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Doprilten

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Validity period after the first opening of the bottle:

18 mg prolonged-release tablets: 3 months

27, 36, 54 mg prolonged-release tablets: 6 months

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Doprilten

The active ingredient is methylphenidate hydrochloride

Doprilten 18 mg prolonged-release tablets: each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride, equivalent to 15.6 mg of methylphenidate.

Doprilten 27 mg prolonged-release tablets: each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride, equivalent to 23.3 mg of methylphenidate.

Doprilten 36 mg prolonged-release tablets: each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride, equivalent to 31.1 mg of methylphenidate.

Doprilten 54 mg prolonged-release tablets: each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride, equivalent to 46.7 mg of methylphenidate.

Other ingredients are:

Tablet core

Lactose monohydrate, hypromellose, anhydrous colloidal silica, magnesium stearate, fumaric acid, methacrylic acid copolymer, and methyl methacrylate (1:1), methacrylic acid copolymer, and methyl methacrylate (1:2), triethyl citrate, talc.

Tablet coating

18 mg prolonged-release tablets:partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

27 mg prolonged-release tablets:partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172), aluminum lake carmine indigo (E132), black iron oxide (E172)

36 mg prolonged-release tablets:partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171)

54 mg prolonged-release tablets:partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), red iron oxide (E172)

Printing ink

Lacquer, black iron oxide (E172), propylene glycol.

Appearance of the Product and Package Contents

Doprilten 18 mg prolonged-release tablets: yellow, capsule-shaped, biconvex, 6.6 mm x 11.9 mm, with "2392" printed on one side with black ink.

Doprilten 27 mg prolonged-release tablets: gray, capsule-shaped, biconvex, 6.7 mm x 12.0 mm, with "2393" printed on one side with black ink.

Doprilten 36 mg prolonged-release tablets: white, capsule-shaped, biconvex, 6.7 mm x 12.0 mm, with "2394" printed on one side with black ink.

Doprilten 54 mg prolonged-release tablets: brown-red, capsule-shaped, biconvex, 6.8 mm x 12.0 mm, with "2395" printed on one side with black ink.

Doprilten is available in high-density polyethylene (HDPE) bottles with a child-resistant polypropylene cap with an integrated silica gel desiccant.

Package sizes:

Contains 28, 30, and 90 prolonged-release tablets.

Only some package sizes may be marketed

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

Or

Merckle GmbH

Ludwig-Merckle-Strasse 3

Blaubeuren

89143

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

This medicine is authorized in the Member States of the European Economic Area with the following names:

Denmark Methylphenidate Actavis

Germany: Methylphenidat AbZ 18 mg Retardtabletten

Methylphenidat AbZ 27 mg Retardtabletten

Methylphenidat AbZ 36 mg Retardtabletten

Methylphenidat AbZ 54 mg Retardtabletten

Iceland Metylfenidat Actavis

Netherlands Methylfenidaat HCl retard Teva 18 mg, tabletten met verlengde afgifte

Methylfenidaat HCl retard Teva 27 mg, tabletten met verlengde afgifte

Methylfenidaat HCl retard Teva 36 mg, tabletten met verlengde afgifte

Methylfenidaat HCl retard Teva 54 mg, tabletten met verlengde afgifte

Norway Delmosart

Sweden Metylfenidat Actavis

Spain: Doprilten 18 mg prolonged-release tablets EFG

Doprilten 27 mg prolonged-release tablets EFG

Doprilten 36 mg prolonged-release tablets EFG

Doprilten 54 mg prolonged-release tablets EFG

Date of the Last Revision of this Leaflet: December 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es