Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - keppra

Document Subject

Generated Narrative: MedicinalProductDefinition mpd21a665ebc1011132a02f9a335304090

identifier: http://ema.europa.eu/identifier/EU/1/00/146/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Keppra 250 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d21a665ebc1011132a02f9a335304090

identifier: http://ema.europa.eu/identifier/EU/1/00/146/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - keppra

Attesters

What is in this leaflet

1. What Keppra is and what it is used for
2. What you need to know before you take Keppra
3. How to take Keppra
4. Possible side effects
5. How to store Keppra
6. Contents of the pack and other information

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.
• as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;

primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Do not take Keppra

• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions Talk to your doctor before taking Keppra

• If you suffer from kidney problems, follow your doctor s instructions. He/she may decide if your dose should be adjusted.
• If you notice any slowdown in the growth or unexpected puberty development of your child, please contact your doctor.
• A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
• Aggravation of epilepsy: Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose.
  In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills you may notice that the seizures remain present or are becoming worse during your treatment.

If you experience any of these new symptoms while taking Keppra, see a doctor as soon as possible.

Children and adolescents

• Keppra is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Keppra Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor. You should not stop your treatment without discussing this with your doctor. A risk of birth defects for your unborn child cannot be completely excluded.
Breast-feeding is not recommended during treatment.

Driving and using machines Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra 750 mg tablets contain Sunset Yellow FCF (E110).
Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor s instructions. Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Adjunctive Therapy and monotherapy (from 16 years of age)

• Adults ( 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg each day. When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest daily dose. Example: if your daily dose is intended to be 1000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually incremented to reach 1000 mg daily after 2 weeks.

• Adolescents (12 to 17 years) weighing 50 kg or less: Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to weight and dose.

• Dose in infants (1 month to 23 months) and children (2 to 11 years) weighing less than kg: Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to the age, weight and dose.

Keppra 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don t allow accurate dosage.

Method of administration Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Keppra with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Duration of treatment

• Keppra is used as a chronic treatment. You should continue Keppra treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor s advice as this could increase your seizures.

If you take more Keppra than you should The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Keppra: Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Keppra: If stopping treatment, Keppra should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue and throat (Quincke s oedema)
• flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (sleepiness), headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), vision blurred;
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1000 people

• infection;
• decreased number of all blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke s oedema [swelling of the face, lips, tongue and throat]);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• delirium;
• encephalopathy (see sub-section Tell your doctor immediately for a detailed description of symptoms);
• seizures may become worse or happen more often;
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• change of the heart rhythm (Electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and
  genitals (Stevens Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
• limp or difficulty walking;
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.

Very rare: may affect up to 1 in 10000 people

• repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).

Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date stated on the carton box and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Keppra contains The active substance is called levetiracetam.
One tablet of Keppra 250 mg contains 250 mg of levetiracetam. One tablet of Keppra 500 mg contains 500 mg of levetiracetam. One tablet of Keppra 750 mg contains 750 mg of levetiracetam. One tablet of Keppra 1000 mg contains 1000 mg of levetiracetam.

The other ingredients are:
Tablet core: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate. Film-coating: Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.

• The colourants are: 250 mg tablet: indigo carmine aluminium lake (E132) 500 mg tablet: iron oxide yellow (E172) 750 mg tablet: sunset yellow FCF aluminium lake (E110), iron oxide red (E172)

What Keppra looks like and contents of the pack Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code ucb
and 250 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code ucb and 500 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code ucb and 750 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code ucb and 1000 on one side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:

• 250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

• 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multipacks containing (2 packs of 100) film-coated tablets

• 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

• 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

The 100 x 1 tablet packs are available in aluminium/PVC perforated unit dose blisters. All other packs are available in standard aluminium/PVC blisters.

Not all pack sizes may be marketed. Marketing Authorisation Holder UCB Pharma SA, All e de la Recherche 60, B-1070 Brussels, Belgium. Manufacturer

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l Alleud, Belgium. or

Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien UCB Pharma SA/NV Tel/T l: + 32 / (0)2 559 92 Lietuva UCB Pharma Oy Finland Tel: +358 9 2514 4231 (Suomija)

Te .: + 359 (0) 2 962 30 Luxembourg/Luxemburg UCB Pharma SA/NV T l/Tel: + 32 / (0)2 559 92 esk republika UCB s.r.o. Tel: + 420 221 773 Magyarorsz g UCB Magyarorsz g Kft. Tel.: + 36-(1) 391 0Danmark UCB Nordic A/S Tlf: + 45 / 32 46 24 Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 Deutschland UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4Nederland UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 Eesti UCB Pharma Oy Finland
Tel: +358 9 2514 4231 (Soome)

Norge UCB Nordic A/S Tlf: + 45 / 32 46 24
UCB . .
: + 30 / 2109974 sterreich UCB Pharma GmbH Tel: + 43 (0)1 291 80 Espa a UCB Pharma, S.A. Tel: + 34 / 91 570 34 Polska UCB Pharma Sp. z o.o. Tel: + 48 22 696 99 France UCB Pharma S.A. T l: + 33 / (0)1 47 29 44 Portugal UCB Pharma (Produtos Farmac uticos), Lda Tel: + 351 / 21 302 5Hrvatska Medis Adria d.o.o. Tel: +385 (0) 1 230 34 Rom nia UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 Slovenija Medis, d.o.o. Tel: + 386 1 589 69 sland Vistor hf. Tel: + 354 535 7Slovensk republika UCB s.r.o., organiza n zlo ka Tel: + 421 (0) 2 5920 2Italia UCB Pharma S.p.A. Tel: + 39 / 02 300 Suomi/Finland UCB Pharma Oy Finland Puh/Tel: +358 9 2514 4
Lifepharma (Z.A.M.) Ltd : + 357 22 34 74 Sverige UCB Nordic A/S Tel: + 46 / (0) 40 29 49 Latvija UCB Pharma Oy Finland Tel: +358 9 2514 4231 (Somija)

United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd Tel: + 353 / (0)1-46 37 This leaflet was last revised in {month/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package Leaflet: Information for the patient

Keppra 100 mg/ml oral solution Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet: