Abik 10 mg tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Abik 10mg tablets EFG
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, because it could 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:
- What Abik is and what it is used for
- What you need to know before taking Abik
- How to take Abik
- Possible side effects
- How to store Abik
- Contents of the pack and other information
1. What Abik is and what it is used for
Abik contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older who have an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.
Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with aripiprazole.
2. What you need to know before taking Abik
Do not take Abik
- if you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before starting to take this medicine if you have:
- High blood sugar levels (characterized by symptoms such as excessive thirst, increased amount of urine, increased appetite, and feeling weak) or a family history of diabetes
- Seizures
- Irregular and involuntary muscle movements, especially in the face
- Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
- Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation
- A history of gambling addiction
If you notice that you are gaining weight, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.
If you have dementia (loss of memory and other mental abilities), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.
Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazole have been reported.
Speak to your doctor immediately if you notice numbness or stiffness of muscles with high fever, sweating, changes in mental state, or very rapid or irregular heartbeat.
Aripiprazole may cause drowsiness, drop in blood pressure when standing up, dizziness, and changes in ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are elderly or have some degree of weakness.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Taking Abik with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Medicines that lower blood pressure: aripiprazole may increase the effect of medicines used to lower blood pressure. Be sure to tell your doctor if you are taking any medicine to control blood pressure.
If you are taking this medicine together with any other medicine, you may need to adjust your dose of aripiprazole. It is especially important to tell your doctor about the following:
- Medicines to correct heart rhythm
- Antidepressants or herbal remedies used to treat depression and anxiety
- Antifungals
- Certain medicines to treat HIV infection
- Anticonvulsants used to treat epilepsy
Medicines that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), meperidine, St. John's wort, and venlafaxine. These medicines increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.
Taking Abik with food, drinks, and alcohol
Aripiprazole can be taken regardless of meals.
Alcohol consumption should be avoided while taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.
Be sure to inform your doctor immediately if you are breastfeeding.
If you are taking aripiprazole, you must not breastfeed.
Driving and using machines
Do not drive or operate tools or machinery until you know how this medicine affects you.
Abik contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Abik
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.
Use in children and adolescents
Aripiprazole should be initiated with the oral solution (liquid) at a low dose. The dose may gradually be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.
If you feel that the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.
Try to take the aripiprazole tablet at the same time each day. It does not matter whether you take it with or without food.
Always take the tablets with water and swallow them whole.
Even if you feel better, do not change or stop your daily dose of aripiprazole without first consulting your doctor.
If you take more Abik than you should
If you realize that you have taken more Abik than your doctor has prescribed (or if someone else has taken some of your Abik), contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount ingested.
It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Abik
If you miss a dose, take the missed dose as soon as you remember. However, do not take a double dose to make up for the missed dose.
If you stop taking Abik
Do not stop your treatment just because you feel better. It is important that you continue taking Abik for as long as your doctor has instructed.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 patients):
- diabetes mellitus;
- sleep disturbances;
- anxiety;
- feeling of restlessness and inability to stay still, difficulty remaining seated;
- uncontrollable twisting, writhing, or spasmodic movements, restless legs;
- tremor;
- headache;
- fatigue;
- somnolence;
- dizziness;
- shakiness and blurred vision;
- difficulty defecating or reduced frequency of bowel movements (constipation);
- indigestion;
- nausea;
- increased saliva production;
- vomiting;
- feeling of tiredness.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- increased levels of prolactin hormone in blood;
- excessively high blood sugar levels;
- depression;
- altered or increased sexual interest;
- uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
- muscular disorder causing twisting movements (dystonia);
- double vision;
- rapid heartbeat;
- drop in blood pressure upon standing causing dizziness, lightheadedness, or fainting;
- hiccups;
- ocular photosensitivity.
The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but their frequency is unknown:
- low white blood cell count;
- low platelet count;
- allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness);
- onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
- elevated blood sugar;
- low sodium levels in blood;
- loss of appetite (anorexia);
- weight loss;
- weight gain;
- suicidal thoughts, suicide attempt, and suicide;
- gambling addiction;
- aggression;
- agitation;
- nervousness;
- a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
- seizures;
- serotonin syndrome (a reaction that may cause intense feelings of well-being, somnolence, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
- speech disorder;
- fixation of the eyeballs in one position;
- unexplained sudden death;
- potentially life-threatening irregular heartbeat;
- heart attack;
- slower heartbeat;
- blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you experience any of these symptoms, contact your doctor immediately);
- elevated blood pressure;
- fainting;
- accidental inhalation of food with risk of pneumonia (lung infection);
- spasms of muscles around the glottis (a part of the larynx);
- inflammation of the pancreas;
- difficulty swallowing;
- diarrhea;
- abdominal discomfort;
- stomach upset;
- liver failure;
- inflammation of the liver;
- yellowing of the skin and whites of the eyes;
- abnormal liver function test results;
- rash;
- light sensitivity;
- hair loss;
- excessive sweating;
- abnormal muscle breakdown that may lead to kidney problems;
- muscle pain;
- stiffness;
- involuntary loss of urine (incontinence);
- difficulty urinating;
- withdrawal symptoms in newborns due to exposure to medication during pregnancy;
- prolonged and/or painful erection;
- difficulty controlling core body temperature or overheating;
- chest pain;
- swollen hands, ankles, or feet;
- in blood tests: fluctuation in blood sugar levels, increased glycated hemoglobin.
In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.
Other adverse effects in children and adolescents
Adolescents aged 13 years or older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affects more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness—especially when standing up after lying down or sitting—which were common (affects up to 1 in 10 patients).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Abik
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Abik
- The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
- The other components are monohydrate lactose, sodium croscarmellose, silicified microcrystalline cellulose, magnesium stearate and red iron oxide (E-172).
Appearance of the product and package contents
Abik 10 mg tablets are pink, round, biconvex tablets, marked with "10" on one side.
Each standard pack contains 28 tablets, packed in blisters.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of the most recent revision of this leaflet: June 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/