Licensed Products - Medikinet XL Capsules [PIL]

What you should know about:

Medikinet® XL 10 mg prolonged-release capsules
Medikinet® XL 20 mg prolonged-release capsules
Medikinet® XL 30 mg prolonged-release capsules
Medikinet® XL 40 mg prolonged-release capsules

Active substance: methylphenidate hydrochloride

Read all of this leaflet carefully before you or your child start(s) taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your/your child's doctor or pharmacist.
• This medicine has been prescribed for you or your child. Do not pass it on to others.
(It may harm them, even if their symptoms are the same as yours or your child's).
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell  your/your child's doctor or pharmacist.

In this leaflet:

1. What Medikinet® XL is and what it is used for
2. Before you or your child takes Medikinet® XL
3. How to take Medikinet® XL
4. Possible side effects
5. How to store Medikinet® XL
6. Further information

1. What Medikinet® XL is and what it is used for:
Medikinet® XL contains methylphenidate hydrochloride which enhances the activity of certain underactive parts of the brain.

Methylphenidate is used to treat a behavioural disorder in children over 6 years of age known as Attention Deficit
Hyperactivity Disorder (ADHD). It should be given under the supervision of a specialist in this condition. Children with
ADHD tend to be restless or hyperactive and find it difficult to concentrate.

Methylphenidate is used together with other forms of treatment in ADHD, as part of a comprehensive treatment programme.

2. Before you or your child take(s) Medikinet® XL
Do not take Medikinet® XL

If you or your child:

1. are/is allergic (hypersensitive) to methylphenidate or to any of the other ingredients of Medikinet® XL
2. are/is taking any medicine from a group of drugs known as non-selective irreversible Monoamine OxidaseInhibitors (MAOI) or within a minimum of 14 days following discontinuation of use
3. are/is very anxious or agitated or depressed
4. suffer(s) from glaucoma (increased pressure in the eye)
5. suffer(s) from any heart or thyroid problems
6. have/has very high blood pressure
7. suffer(s) from psychotic symptoms or psychopathological personality disorder
8. have/has a history of aggression or suicidal tendency
9. are/is drug dependent or alcoholic
10. suffer(s) from tics or a condition called Tourette's syndrome, or if there is a family history of these problems
11. are/is or could be pregnant
12. have/has a history of pronounced anacidity of the stomach (lack of gastric acid) with a pH value above 5.5
13. are/is taking H2-receptor blocker or antacid treatment (medicines to reduce secretion of gastric acid or to treat excessive acidity of the stomach).

Take special care with Medikinet® XL if you or your child:

1. have/has high blood pressure
2. suffer(s) from anorexia nervosa
3. suffer(s) from epilepsy (fits/seizures)
4. suffer(s) from severe depression or suicidal thoughts or actions, because there is a risk of aggravation of this condition.

Medikinet® XL should not be used in children under 6 years of age.

While you are/your child are/is taking Medikinet® XL, your/your child's doctor will probably want to carry out blood tests and will monitor your/your child's height, weight and blood pressure from time to time.

There is no experience with the use of Medikinet® XL in patients with kidney or liver disease.

The active ingredient of Medikinet® XL may interfere with results of drug testing in athletes or sportsmen and women.

Taking other medicines

Before you start/your child starts taking Medikinet® XL please tell your/your child's doctor or pharmacist if you/your
child are/is taking any of the medicines below, since dose adjustment and/or blood monitoring may be necessary.

1. Any medicines for depression, for example amitriptyline or imipramine, ('tricyclics'), or selective serotonin reuptake inhibitors (SSRS) for example fluoxetine, paroxetine
2. Any medicines for epilepsy (anticonvulsants), for example phenobarbital, phenytoin and primidone
3. Any medicines increasing blood pressure. N.B. some cough and cold remedies may also contain ingredients which can affect blood pressure, so it is important to check with your/your child's pharmacist when you or your child buy(s) any of these products.
4. Anticoagulants (blood thinning tablets, like warfarin)
5. Guanethidine or Clonidine (drugs used to lower high blood pressure)
6. Haloperidol or Thioridazine (antipsychotics)
7. Some anaesthetics used during surgery

Medikinet® XL must not be taken together with medicines for the treatment of depression known as non-selective
irreversible Monoamine Oxidase Inhibitors (MAOIs), or within 14 days of discontinuation of treatment with MAOIs.
The combination of methylphenidate and MAOIs is potentially dangerous.

Medikinet® XL must not be taken together with H2 receptor blockers or antacids (drugs used to reduce gastric acid secretion or to counteract excessive acitity in the stomach), as this could lead to a faster release of the total amount of active substance.

Please tell your/your child's doctor or pharmacist if you are/your child is taking or have/has recently taken any other
medicines, including medicines obtained without a prescription.

Taking Medikinet® XL with food and drink:
You/your child must not drink alcohol while taking this medicine.

Pregnancy and breast-feeding:
Ask your/your child's doctor or pharmacist for advice before taking any medicine.

It is possible that this drug causes abnormalities in the unborn baby and therefore it should not be used in pregnancy.

Breast feeding mothers should not take Medikinet® XL or should discontinue breastfeeding while taking Medikinet® XL.

Please tell your/your child's doctor, if you/your child are/is known or suspected or planning to be pregnant.

Driving and using machines:
When you/your child first start(s) to take methylphenidate, you/your child may feel slightly dizzy or sleepy. If so, make  sure you/your child avoid(s) activities where this could be dangerous, for example, working machinery, driving
your/its car or other vehicle, until these effects wear off.

Important information about some of the ingredients of Medikinet® XL
These capsules contain sucrose, if you have been told by your/your child's doctor that you have/your child has an
intolerance to some sugars contact your/your child's doctor before taking this medicinal product.

3. How to take Medikinet® XL
Medikinet® XL can be used in children aged 6 years and over.

You/Your child should always take Medikinet® XL exactly as your/your child's doctor has advised. You should check
with your/your child's doctor if you are not sure.

It is important that you take/your child takes the capsules at the right times.

Medikinet® XL is a “modified release” form of methylphenidate which releases the medicine gradually over a time
period corresponding to the school day. It is intended to take the place of the same total daily dose of traditional
(immediate release) methylphenidate taken at breakfast and lunchtime.

If you/your child is already taking traditional (immediate release) methylphenidate, your/your child's doctor may prescribe an equivalent dose of Medikinet® XL instead.

If you or your child have/has not taken methylphenidate before, your/your child's doctor will normally start treatment with traditional (immediate release) methylphenidate tablets. If your/your child's doctor feels it is necessary methylphenidate treatment may be started with Medikinet® XL 10 mg once daily after breakfast.
If the effect of the capsules wears off too early in the late afternoon or evening, your/your child's doctor may
decide whether a small additional dose of traditional methylphenidate hydrochloride can be taken in the evening.

The maximum daily dose is 60 mg.

Method of administration

The medicinal product is intended for oral use.

Medikinet® XL has to be given in the morning with or after breakfast. This is very important in order to obtain sufficiently prolonged action.

The capsules may be swallowed whole with a drink of water, or alternatively, may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce intaken/given immediately to your child, and not stored for future use.

The capsules and the capsule contents must not be crushed or chewed.

Your/Your child's doctor will tell you if you/your child should stop taking the capsules. If you have/your child has been  taking them for a long time, it is important that the intake of the capsules is not stopped abruptly without your/your  child's doctor knowing.

As a general rule, if no improvement is seen after the dose has been adjusted over a one month period, then the medicine should be stopped on the advice of your/your child's doctor.

Your/Your child's doctor may suggest stopping the treatment periodically to see how your/your child's condition is progressing.

Methylphenidate treatment is usually stopped during or after puberty.

If you/your child take(s) more Medikinet® XL than you/your child should:
If you/your child, or anyone else, accidentally takes too much of Medikinet® XL, tell your/your child's doctor at once
or contact your nearest hospital casualty department.

If you/your child forget(s) to take Medikinet® XL:
If you/your child forget(s) to take a dose, you/your child should take the next dose at the usual time. You/Your child  must NOT take a double dose.

If you/your child stop(s) taking Medikinet® XL:
Always tell your/your child's doctor if you/your child stop(s) taking Medikinet® XL.

If you have any further questions about the use of this product, ask your/your child's doctor or pharmacist.

4. Possible side effects
Like all medicines, Medikinet® XL can cause side effects, although not everybody gets them. For example:

very common (more than 1 out of 10 persons)
common (more than 1 out of 100 persons and less than 1 out of 10 persons)
uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons)
very rare (less than 1 out of 10,000 persons)

The very common side effects are:

• Nervousness
• Sleeplessness (insomnia)

Common side effects are:

• Skin rash
• Itching
• Increased heart rate, palpitations, changes in heart rhythm or blood pressure
• Hair loss
• Headache, dizziness or drowsiness/difficulty co-ordinating, hyperactivity
• Dry mouth
• Reduced appetite, stomach pain or feeling sick and being sick. Taking the capsules together with food may help.
• Painful joints
• Abnormal behavior, aggression, agitation, anxiety, depression, irritability

Rare side effects are:

• Some children taking methylphenidate for a long period of time may have slower than normal growth and reduced weight gain, but they usually catch up when the intake of methylphenidate is stopped.
• Blurred vision
• Chest pain with a feeling of pressure and suffocation behind the breast bone

Very rare side effects are:

• Muscle cramps.
• Uncontrolled movements, tics.
• Severe or unusual mood changes, delusions and hallucinations, suicidal behavior and suicide.
• Abnormal, involuntary movements of muscles of the head, limbs and trunk, convulsions (fits).
• Inflammation of blood vessels to the brain.
• Blood disorders resulting in increased susceptibility to infections, tiredness, bruising or unusual bleeding.
• Liver blood tests may be altered, ranging from simple elevation of blood values to coma.
• Skin peeling or purplish red patches.
• Sudden death

If one or more of the following symptoms occur please seek medical attention immediately:

• Heart attack.
• Continuous muscle cramps, trembling of a body part, sudden rapid increase in body temperature
• Sweating, high blood pressure and memory problems.

If the capsules upset you/your child in any way, inform your/your child's doctor.

If any of the side effects become serious, or if you or your child notice(s) any side effects not listed in this leaflet, please tell your/your child's doctor or pharmacist.

5. How to store Medikinet® XL
Keep out of the reach and sight of children.

Do not use Medikinet® XL after the expiry date which is stated on the blister and the box. The expiry date refers to thelast day of that month.

Storage conditions:

Do not store above 30 °C.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your/your child's pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
What Medikinet® XL contains:
The active substance is methylphenidate hydrochloride.

Medikinet® XL 10 mg prolonged-release capsules
One prolonged-release capsule contains 10 mg methylphenidate hydrochloride equivalent to 8.65 mg methylphenidate.

Medikinet® XL 20 mg prolonged-release capsule
One prolonged-release capsule contains 20 mg methylphenidate hydrochloride equivalent to 17.30 mg methylphenidate.

Medikinet® XL 30 mg prolonged-release capsules
One prolonged-release capsule contains 30 mg methylphenidate hydrochloride equivalent to 26.10 mg methylphenidate.

Medikinet® XL 40 mg prolonged-release capsules
One prolonged-release capsule contains 40 mg methylphenidate hydrochloride equivalent to 34.80 mg methylphenidate.

The other ingredients are:
Sucrose
Gelatin
Maize starch
Methacrylic acid-ethylacrylate-copolymer (1:1) (Ph. Eur.)
Talcum
Triethylcitrate
Titanium dioxide (E 171)
Poly(vinylalcohol)
Macrogol 3350
Polysorbate 80
Sodium hydroxide
Sodium laurilsulfate
Simeticone
Silica colloidal anhydrous
Indigo carmine, aluminium salt (E 132)
Erythrosine (E 127)
Methylcellulose
Sorbic acid (Ph. Eur.)
Purified water
additional in Medikinet® XL 10 mg and 20 mg: Patent blue V (E 131)
additional in Medikinet® XL 30 mg and 40 mg: Iron (II, III) oxide (E172)

What Medikinet® XL looks like and contents of the pack:

Medikinet® XL 10 mg prolonged-release capsules (colours: mauve/white)

Medikinet® XL 20 mg prolonged-release capsules (colours: mauve/mauve)

Medikinet® XL 30 mg prolonged-release capsules (colours: deep violet/light grey)

Medikinet® XL 40 mg prolonged-release capsules (colours: deep violet/grey)

Pack sizes:
Boxes containing 28 prolonged-release capsules packed in blisters made of PVC/PVdC aluminium foil.

Marketing authorisation holder and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

DE: Medikinet® retard 10 mg, Medikinet® retard 20 mg, Medikinet® retard 30 mg, Medikinet® retard 40 mg
AT: Medikinet® 10 mg- retardierte Hartkapsel, Medikinet® 20 mg- retardierte Hartkapsel, Medikinet® 30 mg- retardierte Hartkapsel, Medikinet® 40 mg- retardierte Hartkapsel
DK: Medikinet® CR 10 mg, Medikinet® CR 20 mg, Medikinet® CR 30 mg, Medikinet® CR 40 mg
ES: Medikinet® 10 mg cápsulas de liberación prolongada, Medikinet® 20 mg cápsulas de liberación prolongada, Medikinet® 30 mg cápsulas de liberación prolongada, Medikinet® 40 mg cápsulas de liberación prolongada
FI: Medikinet® CR 10 mg, Medikinet® CR 20 mg, Medikinet® CR 30 mg, Medikinet® CR 40 mg
LU: Medikinet® CR 10 mg, Medikinet® CR 20 mg, Medikinet® CR 30 mg, Medikinet® CR 40 mg
NL: Medikinet® CR 10 mg, Medikinet® CR 20 mg, Medikinet® CR 30 mg, Medikinet® CR 40 mg
NO: Medikinet® 10 mg depotkapsler, harde, Medikinet® 20 mg depotkapsler, harde, Medikinet® 30 mg depotkapsler, harde, Medikinet® 40 mg depotkapsler, harde
PL: Medikinet® CR 10 mg, Medikinet® CR 20 mg, Medikinet® CR 30 mg, Medikinet® CR 40 mg
SE: Medikinet® 10 mg depotkapslar, hårda, Medikinet® 20 mg depotkapslar, hårda, Medikinet® 30 mg depotkapslar, hårda, Medikinet® 40 mg depotkapslar, hårda
UK: Medikinet® XL 10 mg prolonged-release capsules, Medikinet® XL 20 mg prolonged-release capsules,
Medikinet® XL 30 mg prolonged-release capsules, Medikinet® XL 40 mg prolonged-release capsules

This leaflet was last approved in Dec 2007