ORAP 1 mg TABLETS

2. What you need to know before you take Orap

Do not take Orap if:

• You are allergic to pimozide or any of the other ingredients of this medicine (listed in section 6).
• You suffer from depression.
• You suffer from Parkinson's disease.
• You have or have had heart rhythm disorders (arrhythmias) or other heart problems.
• You have a slow heart rate (bradycardia) with symptoms.
• You are taking other medicines (see section "Taking other medicines").
• You have heart problems, especially if your heart rhythm is irregular, if there are abnormalities in your heart's electrical activity (sometimes called "QT interval prolongation"), a family history of heart rhythm abnormalities, or if you are taking medicines that can affect your heart's electrical activity.
• If the levels of minerals in your blood (electrolytes) are below normal. Your doctor will advise you about this.

Elderly patients with 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 a state of severe agitation or anxiety.
• If you or a family member have a history of blood clots, these medicines may be associated with the formation of blood clots.
• If you engage in intense exercise in a hot place or cannot drink enough fluids.

You will need to wait some time before you start to notice the effects of the medicine. Only stop taking Orap if your doctor tells you to; if you interrupt treatment too early, without your doctor's advice, your problems may come back. Therefore, stay in touch with your doctor when you stop treatment.

Tell your doctor immediately if you experience:

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

Tell your doctor if you experience:

• Abnormalities in coordination or involuntary muscle movements (also known as "extrapyramidal symptoms" or parkinsonism). Symptoms may include slow movements, stiffness, or spasms of the limbs, neck, face, eyes, or mouth and tongue, which can result in an unusual posture, involuntary or rare facial expressions. It is necessary to stop these side effects to start the medication.
• Hormonal changes that can cause:
• • Some women to produce milk unexpectedly;
  • Some women to experience breast swelling, irregular periods, infrequent or very light periods, or no periods;
  • Some men to experience breast swelling or difficulty getting an erection.

Using Orap with other medicines

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

Do not combine Orap with certain medicines such as:

• Certain medicines called azoles used to treat fungal infections, such as ketoconazole, itraconazole, miconazole, and fluconazole.
• Antibiotics called macrolides, such as erythromycin, clarithromycin, dirithromycin, or troleandomycin. However, if these medicines are used in the form of creams, lotions, or vaginal suppositories with Orap, the combination would not pose any problems.
• 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 for the treatment of 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 level of minerals (electrolytes) in your body and certain medicines used to eliminate excess water in the body and increase urine production ("diuretics").

Orap may alter the effect of medicines for the treatment of Parkinson's disease.

Tell your doctor if you are taking any of these medicines. Your doctor will advise you which medicines you can use with Orap.

Taking Orap with food, drinks, and alcohol

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

Additionally, the use of grapefruit juice with Orap should be avoided.

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. He will advise you whether you should take Orap.

Tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, or difficulty feeding may occur in newborns whose mother has used Orap in the last trimester of pregnancy. If your newborn has any of these symptoms, contact your doctor.

Breastfeeding

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

Driving and using machines

Orap can cause drowsiness, especially at the start of treatment. This can reduce your alertness and ability to drive, so you should only operate hazardous machinery or drive if your doctor allows it.

Important information about some of the ingredients of Orap

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

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

3. How to take Orap

Follow your doctor's instructions for taking Orap exactly. If you are unsure, consult your doctor or pharmacist again.

A single 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 they find the most suitable one for you. Your doctor will tell you exactly how many tablets you need to take.

Adults

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

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

Elderly

Treatment should be started with half the recommended initial dose for adults. Your doctor may adjust the dose depending on the effect obtained.

Children

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

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

Important:

Keep in mind that it takes some time before you start to notice the effects of the medicine, so do not interrupt treatment. Only stop taking Orap if your doctor tells you to; if you interrupt treatment too early, without your doctor's consent, your problems may come back.

If you take more Orap than you should

If you think you or someone else may have taken too many Orap tablets, contact your doctor, go to the nearest hospital, or consult the Toxicology Information Service, Telephone 915 620 420, immediately. Do this even if you do not notice any discomfort or signs of poisoning. Take the Orap packaging with you if you go to the doctor or hospital.

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 hospitalization.
• Monitor the ECG and vital signs until the ECG is normal.
• Remember that Orap is a long-acting medicine.
• There is no specific antidote, but extrapyramidal reactions can be controlled with an antiparkinsonian injection.

If you forget to take Orap

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

4. Possible side effects

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

Side effects include:

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

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

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

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

Uncommon side effects (may affect up to 1 in 100 people):

• Slow, stiff, or spastic movements of the limbs, stiffness when trying to bend a limb, unusual posture, involuntary or rare facial expressions, difficulty speaking, spastic movement of the eyeballs in a fixed position, usually upwards.
• Loss of menstrual periods
• Facial swelling

Rare side effects (may affect up to 1 in 10,000 people):

• High blood sugar in diabetic patients, 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
• Insufficient sodium in the blood
• Hives
• Skin rash, itching
• 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 can continue, sometimes, after stopping the medicine, when it is used for a long time, or appear after stopping the medicine.
• Severe heart rhythm disorders that result in loss of effectiveness in pumping blood
• Abnormalities in the heart rate record (electrocardiogram), in the electroencephalogram
• Abnormalities in the test of brain electrical activity (EEG).
• Weight gain

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

Blood clots in the veins, 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, go to your doctor immediately.

Important:

You should go to the doctor immediately 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es/. By reporting side 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 is 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 medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orap

• Each tablet contains as active ingredient: pimozide 1 milligram.
• The other ingredients are: calcium phosphate dihydrate, cornstarch, microcrystalline cellulose, povidone K30, talc, hydrogenated cottonseed oil, yellow iron oxide (E172), orange yellow S (E110).

Appearance of the product and pack contents

Orap is available in boxes of 30 and 75 tablets.

The 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 last revision of this leaflet: 09/2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/