Restigulin 15 mg. 28 tablets


RESTIGULIN contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.


Restigulin 15 mg. 28 tablets

What REGEGULIN is and what it is used for

RESTIGULIN 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 disease characterized by symptoms such as hearing, seeing or feeling things that are not really there, suspicion, misconceptions, confused (unrelated) speech and behavior, and boredom. People in such a state may experience depression, feeling guilty, anxious or tense.

RESTIGULIN is used to treat adults and adolescents aged 13 and over who suffer from a condition characterized by symptoms such as a feeling of elevation, excess energy, need for much less sleep than usual, very fast talking with racing ideas, and sometimes severe irritability. In adults, it also prevents these symptoms from resuming in patients who have responded to treatment with RESTIGULIN.

2. What you need to know before you take RESTIGULIN

Do not take RESTIGULIN

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 RESTIGULIN if you suffer from it

- high blood sugar (characterized by symptoms such as excessive thirst, excessive urine output, increased appetite, feeling weak) or have previous diabetes in the family.

- seizures.

- involuntary, irregular movements of the muscles, especially the face.

- cardiovascular disease, previous cardiovascular disease in the family, stroke or "micro" stroke, abnormal blood pressure.

- the presence of blood clots or family history of these, 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, have somnolence that interferes with your normal daily activities, have difficulty in swallowing or allergic symptoms, please 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 whether you have had a stroke or a "micro" stroke.

Tell your doctor immediately if you have thoughts or feelings that are aimed at 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 status, or an accelerated or uneven heartbeat.

Children and adolescents

Do not use this medicine in children and adolescents under the age of 13 years. It is not known whether it is safe and effective in these patients.

Other medicines and RESTIGULIN

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

Blood pressure lowering medicines: RESTIGULIN 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 RESTIGULIN together with other medicines may require a change in the dose of RESTIGULIN. It is especially important to tell your doctor about the following medicines:

- Medicines to correct heart rhythm

- Antidepressants or herbal preparations used to treat depression and anxiety

- Antifungal agents

- Some medicines to treat HIV infection

- Anticonvulsants used to treat epilepsy

Serotonin elevators: tryptans, tramadol, tryptophan, SSRI (for example paroxetine and fluoxetine), tricyclic antidepressants (eg clomipramine, amitriptyline)
St. John's wort, St. John's wort, and venlafaxine. As these medicines increase the risk of side effects, if you get any unusual symptoms while taking any of these medicines in combination with RETISIGULIN, talk to your doctor.

RESTAUGULIN with food, beverages and alcohol

RESTIGULIN can be taken regardless of the diet regimen. Alcohol should be avoided.

Pregnancy, breastfeeding and fertility

If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor before taking this medicine.

The following symptoms may occur in newborns whose mothers have used RESTIGULIN during the last trimester (the last three months of pregnancy): tremor, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and eating difficulties. If any of these symptoms occur with your baby, contact your doctor.

When breastfeeding, tell your doctor immediately. If you are taking RESTIGULIN, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines before you know how RESTIGULIN affects you.

RESTIGULIN contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take RESTIGULIN

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 to a maximum of 30 mg once a day.

Use in children and adolescents

Aripiprazole may initially be given at lower doses (2 mg) for 2 days. For this initial dose, you should use aripiprazole containing 1 mg / ml oral solution. A suitable preparation (eg 1 mg / ml solution) of RESTIGULIN is not available. It is necessary to use an alternative product with the same active substance.

The dose may be progressively increased to 10 mg daily, which is the recommended dose for adolescents. Your doctor may prescribe a lower or higher dose, but not more than 30 mg daily.

In case the correct dose of RESTIGULIN 15 mg tablets can not be obtained, an alternative product with the same active ingredient should be used.

If you think the effect of RESTIGULIN is too strong or too weak for you, talk to your doctor or pharmacist. Try to take your RESTIGULIN tablets at the same time each day. It does not matter if you take them with or without food. Always take the tablets whole with water. Even if you feel better, do not change the dose of RESTIGULIN and do not stop treatment without first consulting your doctor.

If you take more RESTIGULIN than you should

If you find that you have taken more RESTIGULIN tablets than prescribed (or if someone else has taken your RESTIGULIN tablets), contact your doctor immediately. If you can not find it, go to the nearest hospital and carry the medicine pack with you.

If you forget to take RESTIGULIN

If you miss a dose, take it as soon as you remember, but do not take two doses on the same day.

If you stop using RESTOGULIN tablets

Do not stop your treatment just because you feel better. It is important to continue using RESTIGULIN tablets for as long as your doctor has told you.

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 patients):

sleep problems, anxiety,
a feeling of restlessness and inability to sit in one place, sitting problems in one place,
uncontrolled twitching, convulsive movements or soreness, restless legs syndrome,
trembling and blurred vision,
reduced number of bowel movements or difficulty,
indigestion, nausea,
more saliva in the mouth than usual, vomiting,
feeling fatigued
Uncommon side effects (may affect up to 100 patients):

- increased blood levels of the hormone prolactin,

- increased blood sugar,

- depression,

- changed or increased sexual interest,

- uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia)

- muscle disorder causing spastic movements (dystonia),

- double vision,

- rapid heartbeat,

drop in blood pressure when straightening, causing dizziness, dizziness or dizziness



The following undesirable effects have been reported during marketing of aripiprazole, but their frequency is unknown (frequency not
suicidal thoughts, attempted suicide and suicide, strong gambling,

- a sense of aggression, excitement,

- nervousness,

- a combination of high fever, muscle stiffness, rapid breathing, sweating, blurred consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome)

- a convulsion,

- serotonin syndrome (a reaction that can cause a feeling of excessive happiness,

- drowsiness, clumsiness, restlessness, feeling of being intoxicated, fever, sweating or stiffness in the muscles),

- speech disorders,

- sudden unexplained death,

- life-threatening irregular heart rhythm, heart attack (heart attack), slow heart rate,

- Blood clots in the veins, especially in the legs (symptoms include limb swelling, pain and redness) that can get through the blood vessels to the lungs and cause chest pain and difficulty in breathing (in the presence of these symptoms, immediately seek medical attention), high blood pressure,

- fainting,

- accidental inhalation of food at risk of pneumonia (pulmonary infection), spasm of the muscles around the voice box,

- inflammation of the pancreas, difficulty in swallowing, diarrhea,

- abdominal discomfort,

- stomach discomfort,

- hepatic failure,

- inflammation of the liver,

- yellowing of the skin and white eyes,

- reports of liver function test abnormalities, skin rash,

- sensitivity to light,

- Baldness,

- increased sweating,

- abnormal muscle breakdown that can cause kidney problems,

- muscle pain,

- stiffness,

- involuntary urine discharge (incontinence), difficulty urinating,

- withdrawal symptoms in newborns in case of exposure during pregnancy,

- prolonged and / or painful erection,

- problems in the body's thermoregulation or overheating,

- chest pain,

- swelling of the hands, ankles or legs,

- in blood tests: changing blood sugar levels, elevated glycated hemoglobin.

In elderly patients with dementia, more cases of fatal outcome have been reported during aripiprazole administration. In addition, cases of stroke or "micro" stroke have also been reported.

Additional side effects in children and adolescents

Adverse reactions in adolescents at or above 13 years of age are similar in frequency and type to those in adult patients, except for insomnia, uncontrolled convulsions and tingling, restlessness and tiredness, which are very common (more than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable movements of the limbs, dizziness, especially when getting up from a lying or sitting position, which are common side effects more frequent than 1 n 100 patients).
How to store RESTIGULIN

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.

This medicinal product does not require any special storage conditions. Store the blister card in the carton to protect from light.

Do not dispose of medicines in the sewer 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 RESTIGULIN contains

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.

The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

What Retiggulin looks like and contents of the pack

RESTIGULIN 15 mg tablets are white or almost white, round, biconvex tablets, embossed "N75" on one side and smooth on the other side with a diameter of 7 mm.

28, 30 or 60 tablets packed in PA / Aluminum / Rubber / Aluminum blisters. Blister packs are packed in cardboard boxes with attached leaflet.



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