Orap 1 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Orap® 1 mg tablets

Pimozide

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Orap is and what it is used for

Orap belongs to a group of medicines called antipsychotics.

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

2. What you need to know before taking Orap

Do not take Orap if:

• You are allergic to pimozide or to any of the other ingredients of this medicine (listed in section 6).
• You have depression.
• You have Parkinson's disease.
• You have cardiac arrhythmias (abnormal heart rhythms) or have had them in the past.
• You suffer from symptomatic bradycardia (slow heart rate).
• You are taking other medicines (see section on use with other medicines).
• You have heart problems, particularly if your heartbeat is irregular, if there are abnormalities in the heart's electrical activity (sometimes referred to as "QT interval prolongation"), if you have a family history of heart electrical abnormalities, or if you are taking medicines that may alter the heart's electrical activity.
• If your blood mineral levels (electrolytes) are below normal. Your doctor will advise you about this.

Elderly patients with dementia

If you are an elderly patient with dementia—a condition causing mental decline with symptoms such as memory loss, reduced attention, and increasing difficulty speaking—taking Orap may be associated with additional risks. Your doctor will discuss this with you.

Warnings and precautions

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

• If you have any liver disease.
• If you have a state of severe agitation or anxiety.
• If you or a family member has a history of blood clots, as these medicines may be associated with clot formation.
• If you engage in intense physical activity in hot environments or are unable to drink enough fluids.

You will need to wait some time before noticing the effects of the medicine. Only stop taking Orap if your doctor specifically instructs you to do so. Stopping treatment too early, without medical advice, may cause your symptoms to return. Therefore, maintain contact with your doctor when stopping treatment.

Contact 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 such cases, treatment with Orap must be discontinued.

Inform your doctor if you experience:

• Coordination problems or involuntary muscle movements (also known as "extrapyramidal symptoms" {EPS} or parkinsonism). Symptoms may include slow movements, stiffness, or spasms in the limbs, neck, face, eyes, or mouth and tongue, which may result in unusual, involuntary postures or strange facial expressions. These adverse effects must be managed before continuing medication.
• Hormonal changes that may cause:
  • Some women to produce breast milk unexpectedly;
  • Some women to experience breast swelling, irregular menstruation, infrequent or very light periods, or absence of menstruation;
  • Some men to experience breast swelling or difficulty with erection.

Using Orap with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

You must not combine Orap with certain medicines such as:

• Certain antifungal drugs known as azoles, such as ketoconazole, itraconazole, miconazole, and fluconazole.
• Antibiotics known as macrolides, such as erythromycin, clarithromycin, dirithromycin, or troleandomycin. However, if these medicines are used as creams, lotions, or vaginal suppositories together with Orap, the combination would not pose a problem.
• Certain anti-HIV medicines such as ritonavir, saquinavir, indinavir, and nelfinavir.
• Certain antidepressants such as nefazodone, amitriptyline, maprotiline, sertraline, citalopram, escitalopram, fluoxetine, paroxetine, and fluvoxamine.
• Certain medicines used to treat mental illnesses such as chlorpromazine and sertindole.
• Certain medicines that affect the heart such as quinidine, disopyramide, procainamide, amiodarone, sotalol, and bepridil.
• Certain antihistamines such as astemizole and terfenadine.
• Cisapride, a medicine used for certain digestive problems.
• The antimalarial halofantrine.
• The antibiotic sparfloxacin.
• Certain medicines that alter the levels of minerals (electrolytes) in your body and certain medicines used to remove excess fluid from the body and increase urine output ("diuretics").

Orap may interfere with the effects of medicines used to treat Parkinson's disease.

Inform your doctor if you are taking any of these medicines. Your doctor will advise you which medicines can be taken together with Orap.

Taking Orap with food, drinks, and alcohol

Orap increases the effects of alcohol. Therefore, you should avoid alcohol while taking this medicine.

In addition, grapefruit juice should not be used together with Orap.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should take Orap.

Newborns whose mothers have taken Orap during the last trimester of pregnancy may experience tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, or feeding difficulties. If your newborn shows any of these symptoms, contact your doctor immediately.

Breastfeeding

Small amounts of Orap may pass into breast milk. If you are taking Orap, you should not breastfeed.

Driving and using machines

Orap may cause drowsiness, especially at the beginning of treatment. This may reduce your level of alertness and thus your ability to drive. Therefore, you should only operate heavy machinery or drive if your doctor permits it.

Important information about some of the ingredients of Orap

This medicine may cause allergic reactions as it contains Sunset Yellow FCF (E110).

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

3. How to take Orap

Follow exactly the instructions for administering Orap given by your doctor. If in doubt, consult your doctor or pharmacist again.

A single daily dose is recommended for all patients, preferably in the morning.

Remember to take your medicine.

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

Adults

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

Psychosis: the recommended initial dose is 2 to 4 milligrams (2 to 4 tablets of Orap 1 mg) once daily. Your doctor may gradually increase the dose until the desired effects are achieved. The maximum daily dose is 20 milligrams.

Elderly

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

Children

Orap has mainly been used in children over three years of age.

Children should take lower doses than adults. Your doctor will determine the dose and adjust it according to the results obtained.

Important:

Please note that it may take some time before you start noticing the effects of the medication; therefore, do not interrupt the treatment. Only stop taking Orap if your doctor instructs you to do so. If treatment is stopped too early without the doctor's consent, symptoms may reappear.

If you take more Orap than you should

If you think that you or someone else may have taken too many Orap tablets immediately, contact your doctor, go to the nearest hospital, or call the Toxicology Information Service at telephone number 915 620 420. Do this even if you do not observe any discomfort or signs of poisoning. Bring the Orap packaging with you if you go to the doctor or hospital.

Possible signs of overdose include: unusual muscle stiffness, inability to move or sit still, 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 transferring the patient to hospital.
• Monitor ECG and vital signs until the ECG returns to normal.
• Remember that Orap is a prolonged-action drug.
• There is no specific antidote, but extrapyramidal reactions can be controlled by injection of an anti-Parkinsonian medication.

If you forget to take Orap

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, Orap may cause adverse effects, although not everyone experiences them.

Adverse effects include:

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

• Dizziness, drowsiness, excessive sweating, excessive urination during the night

Common adverse 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
• Coordination problems or involuntary muscle movements (also known as “extrapyramidal symptoms” or parkinsonism), headache, tremor
• Slowness
• Stiffness, inflexible muscles
• Blurred vision
• Oily skin
• Frequent urination
• Impotence or erectile dysfunction (“ED”)
• Extreme tiredness
• Difficulty remaining still

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Slow, stiff, or spasmodic movements of the limbs, cogwheel rigidity when attempting to bend a limb, unusual involuntary postures or strange facial expressions, difficulty speaking, spastic eye movements fixed in one position, usually upwards
• Loss of menstrual periods
• Facial swelling

Rare adverse effects (may affect up to 1 in 10,000 patients):

• High blood sugar in diabetic patients, sugar in urine
• Increased prolactin hormone levels in your blood, breast enlargement (even in men), nipple discharge, loss of libido
• Decreased body temperature
• Low sodium levels in the blood
• Hives
• Skin rash, skin itching
• Neck muscle stiffness
• Severe extrapyramidal syndromes associated with high fever
• Seizures
• Involuntary muscle movements of the face, eyes, or mouth and tongue. These effects may persist, sometimes, after stopping the medication, particularly when used long-term, or may appear after discontinuation of the medication.
• Serious disturbances in heart rhythm leading to reduced effectiveness of the heart's pumping action
• Abnormalities in the heart tracing (electrocardiogram), in the electroencephalogram
• Abnormalities in the test of electrical activity of your brain (EEG)
• Weight gain

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

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg); these clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

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 rigidity, rapid breathing, abnormal sweating, or decreased mental alertness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Orap

Do not store above 30°C.

Keep out of the sight and reach of children.

Do not use Orap after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orap

• Each tablet contains as the active substance: pimozide 1 milligram.
• The other components are: calcium hydrogen phosphate dihydrate, gluten-free corn starch, microcrystalline cellulose, polyvinylpyrrolidone K30, talc, hydrogenated cottonseed oil, yellow iron oxide (E172), orange yellow S (E110).

Appearance of the product and pack contents

Orap is available in packs of 30 and 75 tablets.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: EUMEDICA N.V.

Winston Churchill Avenue 67

BE-1180 Brussels

Belgium

Manufacturer: 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

Date of the most recent review of this summary: 09/2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/