5 mg tablets 
Dexamphetamine sulfate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to your child’s.

– If your child has any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Attentin is and what it is used for 
2. What you need to know before using Attentin 
3. How to use Attentin 
4. Possible side effects 
5. How to store Attentin 
6. Contents of the packaging and other information 

1. What Attentin is and what it is used for

Attentin 5 mg tablets contain the active substance dexamphetamine sulphate.

Attentin 5 mg is a psychostimulant that improves the activity in parts of the brain. The drug can help improve attention and concentration as well as reduce impulsive behavior.

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

• it is used for children and adolescents aged 6 to 17 years

• it is not intended for all children with ADHD

• it is used only after another medicine containing methylphenidate has not given sufficient effect

• is used as part of a treatment program that usually includes psychological therapy, education, and social therapy.

Treatment with Attentin may only be initiated by and under the supervision of a physician with specialist competence in the field of behavioral disorders in children and adolescents.

You must talk to a doctor if your child does not feel better or if he/she feels worse after one month. Your doctor may decide that another treatment is needed.

2. What you need to know before using Attentin

Do not use Attentin

• is allergic (hypersensitive) to dexamphetamine or other amphetamines 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 )

• has an eating disorder, does not feel hungry, or does not want to eat (eg anorexia nervosa )

• has very high blood pressure or has narrowing of the blood vessels, which can cause pain in the legs and arms

• has advanced arteriosclerosis (atherosclerosis)

• have or have had heart problems e.g. 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, e.g. stroke, dilated or weakened blood vessels in the brain ( aneurysm ), narrowing or blocked blood vessels, or inflammation of the blood vessels ( vasculitis )

• have mental problems such as: psychopathic or borderline – personality disorder, abnormal thoughts, hallucinations, schizophrenia, your signs of a severe emotional disorder such as suicidal thoughts, severe depression, mania

• is currently taking medicine for depression or has done so for the past 14 days (so-called monoamine oxidase inhibitors, MAO inhibitors ). See section ‘Other medicines and Attentin’ below

• have ever abused alcohol, prescription drugs, or “party drugs”

• or someone in your family has Tourette’s syndrome or other motor or verbal tics

• has difficult-to-control, repetitive twitches in any part of the body or repeats sounds and words

• has porphyria.

Do not use this medicine if any of the above apply to your child. If you feel unsure, talk to your doctor or pharmacist before taking your child with Attentin as this medicine may make these problems worse.

Warnings and cautions

Talk to your doctor or pharmacist before your child takes Attentin for your child

• have a blood, liver, or kidney disease

• easily becomes overexcited or has an unstable personality

• have had seizures (seizures, convulsions, epileptic seizures) or other abnormal findings when measuring brain activity ( EEG )

• is a woman and has started menstruating (see section ‘Pregnancy and breastfeeding’ below)

• has high blood pressure

• have a heart problem not mentioned in the section ‘Do not use …’

• has a mental illness that is not mentioned in the above section ‘Do not use …’. This can include mood swings, unusual aggression, hallucinations, delusions, paranoia, agitation (anxiety) and anxiety, guilt, and depression.

If any of the above applies to you or your child, tell your doctor or pharmacist before starting treatment. This is because this medicine may make these problems worse. Your doctor will want to check how the medicine is affecting your child.

Checks by your doctor before starting treatment with Attentin

These checks are to determine if Attentin is the right medicine for your child. Your doctor will talk to you about the following:

• if your child is taking other medicines

• if there have been sudden unexplained deaths in the family

• if you or someone in your family has any other medical condition (eg heart problem)

• how your child feels, e.g. if your child is elated or depressed has strange thoughts, or has previously had any such feelings

• if there have been tics in the family (difficult to control repeated twitches in any part of the body or repetition of sounds and words)

• if your child or other family member has or has had a problem related to mental health or behavioral disorder.

The doctor will discuss whether your child is at risk of mood swings (from being manic to becoming depressed, so-called bipolar disorder ). 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.

It is important that you provide as much information as you can. This will help your doctor decide if Attentin is the right medicine for your child. Your doctor may decide that more medical tests are needed before your child can start taking this medicine.

Effects on weight/growth

Attentin can cause weight loss in some children and adolescents.

• Failure to gain weight may occur

• The doctor will closely monitor your child’s development in terms of weight and height, as well as how well your child eats

• If your child does not grow as expected, your doctor may stop taking Attentin for a short time.

Operation

Tell your doctor if your child is having surgery. Attentin should not be taken on the day of surgery if a special type of anesthetic/anesthetic is used. This is because there is a risk of sudden high blood pressure during surgery.

Drug tests

This medicine may give positive results in drug abuse tests. Athletes need to know that this drug can give positive results on anti-doping tests.

Children and young people

Attentin should not be used to treat ADHD in children under 6 years of age or in adults. Efficacy and safety have not been established in these patient groups.

Other medicines and Attentin

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. This also applies to over-the-counter medicines.

MAO inhibitors

Do not use this medicine if your child is taking a so-called MAOI ( monoamine oxidase inhibitor ) for depression, or has taken an MAOI for the past 14 days. Concomitant use of an MAOI and dexamphetamine may cause a sudden drop in blood pressure.

If your child is taking other medicines, Attentin may affect how well they work or cause side effects.

If you are taking any of the following medicines, ask your doctor or pharmacist for advice before taking Attentin:

• other antidepressants e.g. tricyclic antidepressants and selective serotonin reuptake inhibitors

• medicines for serious mental problems, e.g. phenothiazines and haloperidol

• medicines for epilepsy, e.g. antiepileptics such as phenobarbital, phenytoin, primidone, and ethosuximide

• medicines that will make it easier to stop drinking alcohol, eg disulfiram

• medicines for high or low blood pressure, e.g. guanethidine, clonidine, reserpine or alpha-methyltyrosine or beta-blockers such as propanolol

• 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, e.g. coumarin anticoagulants

• medicine containing glutamic acid HCl, ascorbic acid, ammonium chloride, sodium phosphate, sodium bicarbonate, acetazolamide, thiazide s

Any of the following medicines: beta-blockers, antihistamines, lithium, norepinephrine, morphine, and meperidine.

If you are not sure if any of the medicines you are taking are included in this list, please consult your doctor or pharmacist before taking this medicine.

Attentin and alcohol

Do not drink alcohol during treatment with this medicine. Keep in mind that certain foods and medicines may contain alcohol.

Pregnancy and breastfeeding

Attentin can affect the unborn baby.

If your daughter is pregnant or breast-feeding, may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Your doctor will discuss contraception with you.

• If your daughter is pregnant, treatment with this medicine may need to be stopped.

• It is possible that this medicine passes into breast milk. Your doctor will therefore decide if your daughter should stop breast-feeding or stop taking this medicine.

Driving and using machines

Your child may feel dizzy, have difficulty focusing, or have blurred vision when using this medicine. If this happens, it can be risky to do things like driving, using machines, cycling, riding, or climbing trees.

You / your child is responsible for assessing whether your child is fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect the 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.

Attentin contains Isomalt (E935)

If your child does not tolerate certain sugars, consult a doctor before your child takes this medicine.

3. How to use Attentin

How much should your child take

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

The recommended dose is normally between 5 mg and 20 mg.

The doctor usually starts treatment with a low dose of a tablet of Attentin. This is gradually increased with a tablet at weekly intervals, as needed.

The highest recommended daily dose is 20 mg (in rare cases 40 mg may be needed).

How to take the medicine

The drug is intended to be swallowed.

Your child should take Attentin tablets with water, preferably with or immediately after a meal. Attentin tablets should be taken at the same time in relation to meals. The last dose should generally not be taken too late after lunch to avoid difficulty sleeping.

The tablets have a score line and can be divided if needed. The notch is only for you to be able to divide the tablet if your child has difficulty swallowing it whole. Divide the tablet by placing it on a hard surface with the smooth side with the crossed notch facing down, and then gently press with your index finger in the center of the top. The tablet is then divided into four parts.

Contact a doctor if the child does not feel better. The doctor may decide that the child needs another treatment.

Long-term use

The doctor decides how long the treatment should be given. If your child is taking this medicine for more than a year, your doctor should stop the treatment for a short time, e.g. during a school holiday. It shows if the drug is still needed.

Incorrect dosing of Attentin

Improper dosing of Attentin may cause abnormal behavior. It can also mean that your child develops an addiction to the drug. Tell your doctor if your child has ever been abused or addicted to alcohol, prescription drugs, or narcotics.

This medicine is for your child only. Do not give it to anyone else, even if they show signs of illness similar to your child’s.

Signs of overdose may include the following: agitation, hallucinations, muscle twitching that may turn into a coma, irregular heartbeat, and weaker breathing.

If your child forgets to take Attentin

Do not take a double dose to make up for a forgotten dose. If your child has forgotten to take a dose, wait until it is time for the next dose.

If your child stops taking Attentin

If your child suddenly stops taking this medicine, it may lead to extreme fatigue, depression, mood swings, severe anxiety, sleep disturbances, increased appetite, or involuntary movements. The doctor may choose to gradually reduce the daily dose one, before the medication is completely stopped. Talk to your doctor before stopping treatment with Attentin.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will talk about these side effects with you.

Very common: may affect more than 1 in 10 people

• Decreased appetite, decreased weight gain and weight loss with long-term use in children

• Difficulty sleeping

• Nervousness

Common: may affect up to 1 in 10 people

• Irregular heartbeats or increased heart rate, more noticeable heartbeats

• Abdominal pain and/or cramps, nausea, vomiting, dry mouth.

These usually occur at the beginning of treatment and can be alleviated by taking the medicine with a meal

• Changes in blood pressure and heart rate (usually increases)

• Joint pain

• Dizziness or intoxication, jerky or involuntary movements, headache, hyperactivity, abnormal behavior, aggression, agitation, loss of appetite, anxiety, depression, irritability.

Rare: may affect up to 1 in 1,000 people

• Angina pectoris ( Angina )

• Difficult to focus his eyes, blurred vision, dilated pupil s

Reduced length growth with long-term use in children

• Fatigue

• Skin rash, hives.

Very rare: may affect up to 1 in 10,000 people

Decreased number of red blood cells which can make the skin pale and cause weakness or shortness of breath, altered number of blood cells ( leukopenia, thrombocytopenia, thrombocytopenic purpura)

• Cardiac arrest

• Tourette’s syndrome

• Abnormal liver function from elevated liver function values ​​to liver coma

• Muscle cramps, involuntary movements (cordiform movements), bleeding inside the skull ( intracranial hemorrhage)

• Hallucinations, psychosis / psychotic reactions, suicidal behavior or suicide, tics, exacerbation of existing tics

Itchy red sores (erythema multiforme) or scaly skin spots (exfoliative dermatitis ), a recurrent skin rash that appears in the same place every time the drug is taken (fixed drug rash)

• Inflammation and/or obstruction of blood vessels in the spinal cord and brain (cerebral vasculitis )

No known frequency: (cannot be calculated from the available data)

• heart muscle disease ( cardiomyopathy ), heart attack

• inflammation in parts of the large intestine when blood flow is reduced (ischemic colitis )

• Chest pain, growth retardation with prolonged use, elevated body temperature, allergic reactions including severe allergic reactions that cause swelling of the face or throat ( angioedema ) and severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis ), sudden death

• disturbed acid-base balance in the body ( acidosis )

• abnormal muscle breakdown that can cause kidney problems ( rhabdomyolysis )

• difficulty controlling movements ( ataxia ), dizziness, abnormal or impaired sense of taste, difficulty concentrating, hyperreflexia (abnormally increased flexibility), stroke, tremors ( tremor )

• confusion, addiction, dysphoria (discomfort), emotional lability, euphoria (elation), impaired cognitive ability (rational thinking), altered libido (sexual drive), nightmares, compulsive behavior, panic disorder, paranoia, restlessness

• kidney damage

• impotence

• sweating, hair loss

• circulatory failure

Loss of sensation in fingers and toes, tingling and discoloration (from white to blue, then red) on cold (Raynaud’s phenomenon).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Attentin

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

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is dexamphetamine sulfate.

One tablet contains 5 mg dexamphetamine sulfate.

The other ingredients are: isomalt (E953), crospovidone, magnesium stearate

What the medicine looks like and the contents of the pack

Attentin 5 mg tablets

White, round, cloverleaf tablets with a diameter of 8.4 mm and a notched cross line on the top and a cross line with “S” embossed on each quarter on the bottom.

Pack sizes: 20, 30, 50 or 100 tablets.

Cartons containing tablets packed in blisters of PVC / PE / PVdC aluminum foil.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Agent:

Evolan Pharma AB

Box 120

182 12 Danderyd

Muhammad Nadeem

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