Orap Fuerte 4 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orap Fuerte® 4 mg tablets

Pimozide

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Orap Fuerte is and what it is used for

Orap Fuerte belongs to a group of medicines called antipsychotics.

Orap Fuerte 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 Fuerte

Do not take Orap Fuerte if:

• You are allergic to pimozide or any of the other ingredients of this medicine (listed in section 6).
• You suffer from 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 taking other medicines).
• You have heart problems, particularly if your heartbeat is irregular, if there are abnormalities in the heart's electrical activity (sometimes called “QT interval prolongation”), a family history of abnormalities in the heart's electrical activity, or if you are taking medicines that may alter the heart's electrical activity.
• 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 deterioration with symptoms such as memory loss, reduced attention, and increasing difficulty speaking—taking Orap Fuerte 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 Fuerte if:

• You have any liver disease.
• You have severe agitation or anxiety.
• You or a family member has a history of blood clots, as these medicines may be associated with clot formation.
• You engage in intense physical exercise 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 Fuerte if your doctor specifically instructs you to do so. Stopping treatment too early, without your doctor’s advice, may cause symptoms to return. Therefore, stay in contact with your doctor when discontinuing 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 required.
• Involuntary rhythmic movements of the tongue, mouth, or face. In such cases, treatment with Orap Fuerte may need to be stopped.

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, mouth, or tongue, which may lead to 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 achieving an erection.

Taking Orap Fuerte with other medicines

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Do not combine Orap Fuerte with certain medicines such as:

• Certain antifungal medicines called azoles, such as ketoconazole, itraconazole, miconazole, and fluconazole.
• Macrolide antibiotics such as erythromycin, clarithromycin, dirithromycin, or troleandomycin. However, if these medicines are used as creams, lotions, or vaginal suppositories in combination with Orap Fuerte, this 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 Fuerte may alter the effect 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 used together with Orap Fuerte.

Taking Orap Fuerte with food, drinks, and alcohol

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

In addition, the combined use of grapefruit juice and Orap Fuerte 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 might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should take Orap Fuerte.

Newborn babies whose mothers have taken Orap Fuerte 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 Fuerte may pass into breast milk. If you are taking Orap Fuerte, you should not breastfeed.

Driving and using machines

Orap Fuerte 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 dangerous machinery or drive if your doctor permits it.

3. How to take Orap Fuerte

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

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

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

Adults

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

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

Elderly

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

Children

Orap Fuerte 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 depending on the results obtained.

The tablet may be divided into two equal parts.

Important:

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

If you take more Orap Fuerte than you should

If you think that you or someone else may have taken too many Orap Fuerte tablets immediately, contact your doctor, go to the nearest hospital, or contact the Toxicology Information Service, Telephone 915 620 420. Do this even if no discomfort or signs of poisoning are observed. Take the Orap Fuerte 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 is normal.
• Remember that Orap Fuerte is a prolonged-action drug.
• There is no specific antidote, but extrapyramidal reactions can be controlled by injection of an antiparkinsonian medication.

If you forget to take Orap Fuerte

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

4. Possible adverse effects

Like all medicines, Orap Fuerte can 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 production of saliva, vomiting, constipation
• Depression, difficulty falling asleep or staying awake, restlessness or agitation
• Coordination abnormalities 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 fatigue
• Difficulty remaining still

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

• Slow, rigid, 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
• Swelling of the face

Rare adverse 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 your blood, breast enlargement, even in men, discharge of fluid from the nipples, loss of libido
• Decrease in body temperature
• Low sodium levels in the blood
• Hives
• Skin rash, skin itching
• Stiffness of neck muscles
• Severe extrapyramidal syndromes associated with high fever
• Seizures
• Involuntary muscle movements of the face, eyes, mouth, and tongue. These effects may persist sometimes after stopping the medicine, particularly when used long-term, or may appear after discontinuation.
• Serious disturbances in heart rhythm resulting in 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 contact your doctor immediately if, during treatment with Orap Fuerte, 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Fuerte

Do not store at temperatures above 30°C.

Keep out of sight and reach of children.

Do not use Orap Fuerte 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 Fuerte

• Each tablet contains as the active substance: pimozide 4 milligrams.
• The other components are: calcium hydrogen phosphate dihydrate, gluten-free corn starch, microcrystalline cellulose, povidone K30, talc, hydrogenated cottonseed oil, and colouring agents (iron oxide yellow E172 and indigotine disodium sulfonate E132 aluminium lake).

Appearance of the product and contents of the pack

Orap Fuerte is available in boxes containing 20 tablets.

Orap Fuerte tablets are green, circular, biconvex, with the inscription “ORAP 4” on one side and scored on the other 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 revision of this leaflet: 09/2017

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