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What EXPLEMED is and what it is used for
EXPLEMED contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 and over who suffer from a condition characterized by symptoms such as hearing, seeing or feeling things that are not really there, suspicion, misconceptions, confused speech and behavior as well and boredom. People in such a state may experience depression, experience feelings of guilt, anxiety or tension.
Exxmedema is used to treat adults and adolescents aged 13 years or over who suffer from a condition characterized by symptoms such as a feeling of elevation, hypersensitivity, need for much less sleep than usual, very fast talking with racing thoughts, and sometimes strong irritability. In adults, this medicine also prevents the relapse of these symptoms in patients who have responded to Exxmedema treatment.
2. What you need to know before using EXPLEMED
Do not take EXPLEMED
if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking EXPLEMED if you suffer from:
high blood sugar (characterized by symptoms such as excessive thirst, excessive urine output, increased appetite and feeling of weakness), or have previous diabetes in the family;
involuntary, irregular movements of the muscles, especially the face;
cardiovascular diseases, previous cardiovascular diseases in the family, stroke or "microinvestig", impaired blood pressure;
the presence of blood clots or familial data on them, as the use of antipsychotic agents is associated with the formation of blood clots;
a strong passion for gambling in the past.
If you notice weight gain, develop unusual movements, experience somnolence that interferes with your normal daily activities, you have difficulty in swallowing or have allergic symptoms, tell your doctor.
If you are an adult patient and suffer from dementia (loss of memory or other mental abilities), you or your loved one should tell your doctor if you have had a stroke or a "microinn".
Tell your doctor immediately if you have thoughts or feelings that are directed to self-harm. There have been reports of thoughts and suicide attempts during treatment with aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or lack of flexibility accompanied by fever, sweating, altered mental state or accelerated irregular heartbeat.
Children and adolescents
EXPLEMED is not used in children and adolescents under the age of 13 years. Check with your doctor or pharmacist before taking EXPLEMED
Other Drugs and EXPLEMED
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Blood pressure lowering medications: EXPLEMED may increase the effect of medicines used to lower blood pressure. Make sure your doctor knows you are taking medicines to control your blood pressure.
Taking EXPLEMED with other medicines may require a change in Exsmedema dosage. It is especially important to tell your doctor about the following medicines:
medicines to correct heart rhythm;
antidepressants or herbal products used to treat depression and anxiety;
some medicines to treat HIV infection;
anticonvulsants used to treat epilepsy.
Serotonin uptake drugs: tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (eg paroxetine and fluoxetine), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John's wort and venlafaxine. These medicines increase the risk of side effects if you get an unusual symptom while you are taking any of these medicines in combination with Exspammed, talk to your doctor.
EXPLEMED with food, beverages and alcohol
EXPLEMED can be taken regardless of nutrition.
The use of alcohol should be avoided during treatment with Exxmedem.
Pregnancy and breastfeeding
You should not take Explemed if you are pregnant unless you have discussed it with your doctor. You should immediately inform your doctor if you are pregnant, think you may be pregnant or plan to become pregnant.
The following symptoms may occur in newborns whose mothers have used Exxmedem in the last trimester (the last three months of pregnancy): trembling, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and eating difficulties. If your baby has any of these symptoms, talk to your doctor.
Tell your doctor immediately if you are breast-feeding.
If you are taking Explemed , you should not breast-feed.
Driving and using machines
Do not drive or operate tools or machines before you know how Explimed affects you.
3. How to take Explemed
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
Use in children and adolescents over 13 years of age:
Treatment may be initiated at lower doses and gradually increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. Since doses of less than 5 mg are not available for Exspiramed tablets, your doctor may prescribe an oral solution that contains aripiprazole.
If you think the effect of Explemed is too strong or too weak, talk to your doctor or pharmacist.
Try taking Explemed at the same time each day. It does not matter if you take them with or without food. Always take the tablet with water and swallow it whole.
Even if you feel better, do not change or stop taking the daily dose of Exxmedema without first consulting your doctor.
If you take more Explemed than you should
If you find you have taken more Explemed than you should have prescribed (or if someone else has taken Exmesmed tablets), talk to your doctor straight away. If you can not contact your doctor, go to the nearest hospital and carry the medicine pack with you.
If you forget to take Explemed
If you miss a dose, take it as soon as you remember but do not take two doses in a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people):
uncontrolled twitching or abnormal movements, headache, fatigue, nausea, vomiting, nausea, constipation, increased saliva, dizziness, sleep problems, anxiety, anxiety, sleepiness, shakiness and blurred vision.
Uncommon side effects (may affect up to 1 in 100 people):
some patients may experience dizziness, especially when standing up or down, heart rate or double vision. Some patients may feel depressed.
The following undesirable effects have been reported following the marketing of aripiprazole but their frequency is not known (frequency can not be estimated from the available data):
Changes in the levels of some blood cells; abnormal heartbeat, sudden unexplained death, heart attack; an allergic reaction (eg swelling of the mouth, tongue, face and throat, itching, rash); high blood sugar, development or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low blood sodium; weight gain, weight loss, anorexia; nervousness, excitement, anxiety, strong gambling; suicidal thoughts, attempted suicide, suicide, aggression; (a reaction that may cause a feeling of excessive happiness, drowsiness, clumsiness, restlessness, wheezing, fever, sweating, or stiffness in the muscles), a combination of fever, muscle stiffness, rapid breathing, sweating , blurred consciousness and a sudden change in blood pressure and heart rate; high blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg) that can reach the lungs and cause chest pain and difficulty in breathing (if you notice any of these symptoms immediately contact a doctor); muscle spasm around the voice box, accidental inhalation of food at risk of pneumonia, difficulty in swallowing; inflammation of the pancreas; hepatic insufficiency
How to store EXPLEMED
This medicinal product does not require any special storage conditions.
Store in the original blister in order to protect from moisture.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What EXPLEMED contains
The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg or 30 mg of aripiprazole, respectively.
The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, anhydrous silica, magnesium stearate.
What EXPLEMED looks like and what the package contains
EXPLEMED 5 mg: White to off-white, round, flat, smudged, odorless or almost odor-shaped, bevelled edges with stylized "E" and code "561" on one side and smooth on the other side. The tablet diameter is about 6 mm.
EXPLEMED 10 mg: White to off-white, round, convex, odorless or almost odorless, stylish "E" and "562" on one side and smooth on the other side. The tablet diameter is about 7 mm.
EXPLEMED 15 mg: White to off-white, circular, flat, smudged edges, odorless or almost odorless, with stylized "E" and code "563" on one side and smooth on the other side. The tablet diameter is about 9 mm.
Exmeldom 30 mg: White to off-white, round, flat, odorless or almost odorless tablets with stylish "E" and code "564" on one side and smooth on the other side. The tablet diameter is about 11 mm.
Packages: 2 x 14, 4 x 14 or 6 x 14 tablets in ORA / Aluminum / PVC // Aluminum blister in folding carton.
Not all pack sizes may be marketed.
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