Leaflet: information for the user

Orap®1 mg tablets

Pimozide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Orap is and what it is used for

2. What you need to know before you start taking Orap

3. How to take Orap

4. Possible side effects

5. Storage of Orap

6. Contents of the pack and additional information

Orap belongs to a group of medications called antipsychotics.

Orap is used in the treatment of acute (at a specific time) and chronic (over prolonged periods) psychoses (loss of contact with reality) as well as anxiety disorder.

Do not take Orap if:

• You are allergic to pimozide or any of the other components of this medication (listed in section 6).
• You have depression.
• You have Parkinson's disease.
• You have heart arrhythmias (heart rhythm disturbances) or have had them.
• You have bradycardia (slow heart rate) with symptoms.
• You are taking other medications (see the section on taking other medications).
• You have heart problems, particularly if your heart rhythm is irregular, if there are abnormalities in the heart's electrical activity (sometimes called "Prolongation of the QT interval"), a family history of abnormalities in the heart's electrical activity, or if you are using medications that can change the heart's electrical activity.
• Your blood mineral levels (electrolytes) are below normal. Your doctor will warn you about this.

Patients with advanced age and dementia

If you are an elderly patient with dementia, which is a disease that causes mental deterioration with symptoms such as memory loss, loss of attention, and increased difficulty speaking, taking Orap may be associated with additional risks. Your doctor will discuss this with you.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Orap.

• If you have liver disease.
• If you have severe agitation or anxiety.
• If you or a family member has a history of blood clots, these medications may be associated with the formation of blood clots.
• If you engage in intense exercise in a hot place or cannot drink enough liquid.

You will need to wait some time before you start noticing the effects of the medication. Only if your doctor tells you to, stop taking Orap; if you interrupt treatment too soon, without your doctor's indication, the problems may return. Therefore, stay in touch with your doctor when you interrupt treatment.

Inform your doctor immediately if you experience:

• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Urgent medical treatment may be necessary.
• Involuntary rhythmic movements of the tongue, mouth, or face. In this case, treatment with Orap will need to be interrupted.

Inform your doctor if you experience:

• Abnormalities in coordination or involuntary muscle movements (also known as "extrapyramidal symptoms" {EPS} or parkinsonism). Symptoms may include slow movements, rigidity, or spasms of the limbs, neck, face, eyes, or mouth and tongue, which may result in an unusual, involuntary, or unusual facial expression. These adverse effects need to be stopped to start the medication.
• Changes in hormones that may cause:
• • Some women to produce milk unexpectedly;
  • Some women to experience breast swelling, irregular menstruation, infrequent or light menstruation, or no menstruation;
  • Some men to experience breast swelling or difficulty achieving an erection.

Use of Orap with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Do not combine Orap with certain medications such as:

• Certain medications called azoles used to treat fungal infections, such as ketoconazole, itraconazole, miconazole, and fluconazole.
• Macrolide antibiotics such as erythromycin, clarithromycin, dirithromycin, or troleandomycin. However, if these medications are used in the form of creams, lotions, or vaginal suppositories along with Orap, the combination will not pose a problem.
• Certain HIV medications such as ritonavir, saquinavir, indinavir, and nelfinavir.
• Certain antidepressants such as nefazodone, amitriptyline, maprotiline, sertraline, citalopram, escitalopram, fluoxetine, paroxetine, and fluvoxamine.
• Certain medications used to treat mental illnesses such as chlorpromazine and sertindol.
• Certain medications that affect the heart such as quinidine, disopyramide, procainamide, amiodarone, sotalol, and bepridil.
• Certain antihistamines such as astemizole and terfenadine.
• Cisapride, a medication used for certain digestive problems.
• The antimalarial halofantrine.
• The antibiotic enoxacin.
• Certain medications that alter the level of minerals (electrolytes) in your body and certain medications used to eliminate excess water in the body and increase urine production ("diuretics").

Orap may alter the effect of medications used to treat Parkinson's disease.

Inform your doctor if you are taking any of these medications. Your doctor will tell you which medications you can take with Orap.

Taking Orap with food, drinks, and alcohol

Orap increases the effect of alcohol, so you should avoid drinking alcohol while taking this medication.

Additionally, it is recommended to avoid using grapefruit juice and Orap together.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. They will tell you if you should take Orap.

Babies born to mothers who have taken Orap in the last trimester of pregnancy may experience tremors, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, or difficulty feeding. If your newborn baby experiences any of these symptoms, contact your doctor.

Breastfeeding

Small amounts of Orap may be found in breast milk. If you are taking Orap, do not breastfeed.

Driving and operating machinery

Orap may cause drowsiness, especially at the beginning of treatment. This may decrease your alertness and therefore your ability to drive or operate machinery, so you should only drive or operate machinery if your doctor allows it.

Important information about some of the components of Orap

This medication may cause allergic reactions because it contains yellow orange S (E110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for Orap indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is recommended for all patients to take a single dose, preferably in the morning.

Remember to take your medication.

It is very important that you take the correct dose of Orap. Your doctor will change the dose until finding the most suitable one for you. Your doctor will tell you exactly how many tablets you need.

Adults

Anxiety: the recommended dose is 2 milligrams (2 Orap 1 mg tablets) once a day.

Pschosis: the initial recommended dose is 2 to 4 milligrams (2 to 4 Orap 1 mg tablets) once a day. Your doctor may increase the dose gradually to achieve the desired effects. The maximum daily dose that can be taken is 20 milligrams.

Seniors

It is recommended to start treatment with half the initial dose recommended for adults. Your doctor may adjust the dose depending on the effect obtained.

Children

Orap has been mainly used in children over three years old.

Children should take doses lower than those of adults. Your doctor will determine the dose and adjust it depending on the results obtained.

Important:

Keep in mind that it takes some time to start noticing the effects of the medication, therefore do not interrupt treatment. Only if the doctor indicates, stop taking Orap; if treatment is interrupted too soon, without the doctor's consent, symptoms may reappear.

If you take more Orap than you should

If you believe you or someone else may have taken too many Orap tablets, contact your doctor, go to the nearest hospital, or consult the Toxicological Information Service, Phone 915 620 420. Do it even when you do not observe discomfort or signs of intoxication. Bring the Orap packaging if you visit the doctor or hospital.

The possible signs of an overdose are: unusual muscle stiffness, inability to move or sit, and irregular heartbeat.

Information for the doctor in case of overdose

• Consider gastric lavage and administration of activated charcoal.
• Establish a patent airway and apply supportive measures.
• Consider hospital transfer.
• Monitor ECG and vital signs until ECG is normal.
• Remember that Orap is a long-acting drug.
• There is no specific antidote, but extrapyramidal reactions can be controlled by injecting an antiparkinsonian medication.

If you forgot to take Orap

Do not take a double dose to compensate for the missed doses.

Like all medications, Orap may cause side effects, although not everyone will experience them.

The side effects include:

Very common side effects (may affect more than 1 in 10 patients):

• Dizziness, drowsiness, excessive sweating, excessive urination at night

Common side effects (may affect up to 1 in 10 patients):

• Loss of appetite, dry mouth, excessive saliva production, vomiting, constipation
• Depression, difficulty falling asleep or staying awake, restlessness or agitation
• Abnormal coordination or involuntary muscle movements (also known as "extrapyramidal symptoms" or parkinsonism), headache, tremor
• Slowness
• Rigidity, inflexible muscles
• Blurred vision
• Oily skin
• Frequent urination
• Impotence or erectile dysfunction ("ED")
• Extreme fatigue
• Difficulty remaining still

Rare side effects (may affect up to 1 in 100 patients):

• Slow, stiff, or spasmodic movements of the limbs, stiffness in the gear-like mechanism when trying to bend a limb, unusual posture, involuntary or rare facial expressions, difficulty speaking, spasmodic movement of the eyeballs in a fixed position, usually upwards.
• Loss of menstrual periods
• Swelling of the face

Very rare side effects (may affect up to 1 in 10,000 patients):

• High blood sugar in patients with diabetes, sugar in the urine
• Increased prolactin hormone in the blood, breast enlargement, even in men, discharge of fluid from the nipples, loss of libido
• Decreased body temperature
• Inadequate sodium levels in the blood
• Urticaria
• Skin rash, itching skin
• Stiffness of the neck muscles
• Severe extrapyramidal syndromes associated with high fever
• Seizures
• Involuntary muscle movements of the face, eyes, or mouth and tongue. These effects may continue, sometimes, after stopping the medication, when it is used for a long time, or appear after stopping the medication.
• Severe alterations in heart rhythm resulting in reduced heart pumping effectiveness
• Abnormalities in the electrocardiogram (ECG), electroencephalogram (EEG)
• Abnormalities in the brain electrical activity test (EEG).
• Weight gain

Side effects with an unknown frequency (cannot be estimated from available data):

Deep vein thrombosis, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

Important:

You must seek immediate medical attention if during treatment with Orap you experience any of the following symptoms: palpitations, dizziness, fainting, high fever, generalized muscle stiffness, rapid breathing, abnormal sweating, or decreased mental alertness.

Reporting side effects

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

Do not store at a temperature above 86°F (30°C).

Keep out of sight and reach of children.

Do not use Orap after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Orap

• Each tablet contains as active ingredient: pimozide 1 milligram.
• The other components are: calcium dihydrate acid phosphate, cornstarch without gluten, microcrystalline cellulose, polividone K30, talc, hydrogenated cottonseed oil, yellow iron oxide (E172), and yellow-orange S (E110).

Appearance of the product and content of the packaging

Orap is presented in boxes of 30 and 75 tablets.

Orap 1 mg tablets are orange, circular, biconvex, with the inscription “ORAP 1” on one side.

Holder of the marketing authorization and responsible for manufacturing

Holder: EUMEDICA N.V.

Winston Churchill Avenue 67

BE-1180 Brussels

Belgium

Responsible for manufacturing: Lusomedicamenta Sociedade Técnica Farmacêutica S.A.

Estrada Consiglieri Pedroso, 69 – B

Queluz de Baixo

2730 - 055 Barcarena

Portugal

or

Eumedica N.V.

Chemin de Nauwelette 1

BE-7170 Manage

Belgium

Last review date of this prospectus: 09/2017

Detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/