RONYDAL solution 1 mg. / Ml. 100 ml.

WHAT RONYDAL AND WHAT IT IS USED
RONYDAL be used in the treatment of mental disorders group called psychoses. These are disorders in the brain that affect thinking, feelings and / or actions, such as confusion, hallucinations, disturbances in perception (hearing the voice of someone who is absent at the moment), excessive suspiciousness, social alienation and conditions of excessive self-absorption, excitability and tension.
RONYDAL can be used for both acute and chronic. In addition, after the relief of symptoms, Ronidal is applied to keep under control the disease, and to prevent the exacerbation.
Another condition which can be taken Ronidal is mania, which is characterized by symptoms such as elevated, expansive mood and irritability, increased self-esteem, decreased need for sleep, tense speech, racing thoughts, abducted or scarce judgments, destructive or aggressive behavior.
Ronidal may be used alone or together with another type of medicine, referring to the group of mood stabilizers.

2. BEFORE YOU TAKE RONYDAL
Do not take RONYDAL
If you know that you are hypersensitive to it.
Anaphylaxis can be recognized as skin rash, itching, shortness of breath and sweating in the face.
If you get any of these symptoms, contact your doctor promptly.

Take special care with Ronidal
Studies in elderly patients with dementia show that intake Ronidal alone or furosemide was observed with a higher incidence of mortality. Tell your doctor if you are taking furosemide. Furosemide is a medicine that is sometimes used for the treatment of high blood pressure, for the treatment of edema of various parts of the body, caused by too much collection liquid. In elderly patients with dementia was observed sudden onset of weakness or numbness of the face, arms or legs, especially on one or slurred speech. If you observe any of these conditions for even a short time, contact your doctor immediately.
With prolonged acceptance Ronidal can cause uncontrolled twitching of facial muscles. If this happens, consult your doctor.
Very rarely can occur states of confusion, the level of consciousness, fever, or muscle stiffness.
If they occur, consult a doctor promptly and informed him that taking Ronidal.
In very rare cases of elevated blood sugar levels. Contact your doctor if you experience symptoms such as excessive thirst or urination.

If you have any of the following conditions inform your doctor as soon as possible:
Weight gain - Eat moderate as Ronidal can cause weight gain;
Cardiovascular diseases, renal and liver function, Parkinson's disease, Lewy-Body dementia or epilepsy - If you suffer from any of these diseases, report this to your doctor. You may need to be kept under medical observation or dosage to be adjusted;
Elderly - Elderly should take Ronidal in lower doses than recommended for other adults.
Taking other medicines
Take other medicines during treatment with Ronidal only if your doctor has told you that this is possible. If you are taking other medicines, tell your doctor about it. He will tell you what medicines you can take simultaneously with Ronidal.
Ronidal enhances the effect of alcohol and drugs, delaying responses (tranquilizers, narcotic analgesics, some antihistamines, some antidepressants). You are advised not to drink alcohol and to consume such drugs only on prescription.
Some drugs for the treatment of Parkinson's disease (dopamine agonists, e. Levodopa) may exert an effect opposite to that of Ronidal.
The effect of Ronidal could change and carbamazepine, which is used mainly for epilepsy and trigeminal neuralgia nerve (acute attacks of pain in the face).
Therefore you must tell your doctor if the start or stop treatment with carbamazepine.
Fluoxetine and paroxetine - drugs that are used primarily for the treatment of depression - may cause an increase in the level of Ronidal in your blood. Therefore, tell your doctor if you start and / or stop taking fluoxetine or paroxetine.
Cimetidine and ranitidine - two drugs that are used to reduce stomach acidity - may slightly increase the level of Ronidal in your blood, but they usually do not change the effect of Ronidal.
Erythromycin, an antibiotic, has no effect on the level of Ronidal blood.
Topiramate, a medicine used for the treatment of epilepsy and migraine, no significant effect on the level of Ronidal blood.
Galantamine and donepezil - medicines used for the treatment of dementia - no effect on Ronidal.
Ronidal showed no effect on lithium or valproate - two drugs that are used for the treatment of mania; no impact on Digoxin - a heart medicine.
Co-administration of furosemide Ronidal - a drug which is used for conditions such as heart failure and high blood pressure - may be associated with adverse effects. Tell your doctor if you are taking furosemide.

Taking RONYDAL with food and drink
Ronidal enhances the effect of alcohol.
Do not drink alcohol during treatment with Ronidal.
Ronidal oral solution should be taken with tea due to incompatibility.

Pregnancy and lactation
If you are pregnant or plan to become pregnant, you should report it to your doctor who will decide whether you can take Ronidal or not. In newborns of mothers taking Ronidal during the last trimester of pregnancy were observed tremor, stiffness and difficulty in feeding, these symptoms were reversible.
If you take Ronidal should not breastfeed. In this case we advise you to contact your doctor.

Driving and using machines
It is RONYDAL affect attention and your ability to drive. You are advised not to drive or operate machinery until your doctor to assess your individual sensitivity to Ronidal.

Important information about some of the ingredients of RONYDAL
This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars (eg. Lactose), contact him before taking this medicine.

3. HOW TO TAKE RONYDAL
Always take Ronidal just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Your doctor will tell you how Ronidal tablets to take and how long to take them. Consult your doctor if your symptoms do not improve or return but do not stop taking Ronidal until your doctor tells you to do.

RONYDAL is available in tablets and solution for oral administration.
It can take RONYDAL as during meals and between meals.
Tablets may be made with a certain amount of liquid.

The solution may be mixed with the soft drink, except tea.
It is very important to take the correct dose Ronidal, but it is different for different people. For this reason, your doctor will adjust the dosage until the desired effect is obtained. Strictly follow the instructions of your doctor and do not alter or stop the prescribed dosage without being consulted him.

In adults and adolescents 15 years of psychosis treatment gradually.
For example: the first day was given 2 mg, the second day - 4 mg. Hereinafter, the dose can not be changed, or if necessary, be further adjusted.
For long-term treatment are sufficient 4 to 6 mg per day. It may be sufficient and a lower dose.
The total amount per day can be taken in one or two doses - in the morning and evening. Your doctor should advise you what is best for you.
Your doctor will tell you how many tablets or how much solution is necessary in your case.
Generally in elderly patients with psychosis is best taken half the dose recommended for adults, divided into two doses. During prolonged treatment the total dose for the day can also be taken at once. Your doctor will inform you how many tablets or how much solution is most suitable for you.
For the treatment of manic disorders recommended starting dose of 2 mg once daily. This dose may be increased gradually in steps of 1 mg, but no more frequently than every other day. Most patients feel better with doses between 1 and 6 mg per day. Your doctor will tell you how many tablets or oral solution are suitable for your particular case. Ronidal may be administered alone or in combination with another type of medicine known as a mood stabilizer.
In patients with reduced liver or kidney function, your doctor will tell you how many tablets or oral solution you should take in your case.

Oral solution RONYDAL
The solution is available in a 100 ml glass vial with a plastic child-resistant cap and dosing pipette with which you can download the exact amount of the vial.
Pipette accompanying vials 100 ml graduated in milligrams and milliliters of 0,25 ml minimum volume and maximum volume of 3 ml. Pipette indicia every 0,25 ml to 3 ml.

One ml is equivalent to one milligram RONYDAL

Instructions for opening the container and use of pipette:
1. The bottle comes with a child-resistant cap.
2. Press down the plastic cap and by turning counterclockwise.
3. Open the cap.
4. The pipette is inserted into the vial.
5. By adhering the lower ring, the upper ring is pulled up to the mark corresponding to the number of milliliters or milligrams, are necessary.
6. Keeping the lower ring filled pipette is removed from the vial.
7. The content of the pipette is poured into a non-alcoholic drink, except tea by sliding the upper ring down.
8. The vial was closed.
9. The pipette was rinsed with water.

If you take more dose RONYDAL
Patients received more than the required amount RONYDAL experienced the following symptoms: disturbances in consciousness, drowsiness, severe shaking or stiff muscles. In such cases, contact your doctor.
Contact your doctor or go straight to the nearest hospital. Show your doctor your pack of tablets.
Meanwhile, the removal of these complaints can take activated charcoal, which absorbs the drug present in your stomach.

Information for the doctor in case of overdose
Loss of consciousness, restore and maintain airway of the patient;
If blood pressure is low, inject suitable sympathomimetic;
We are ECG monitoring. Consider the need for admission to hospital.
If you forget to take RONYDAL
During the initial treatment period:
Take the missed dose as soon as possible, instead of the next dose. Then continue to take the remaining doses in the above order.

Then:
Do not take the missed dose and take the dose that is as usual and continue the course of treatment.
IMPORTANT! Never take more than 16 mg per day.
There are different types of tablets that differ in the amount of risperidone in them. You can distinguish tablets Ronidal the color and shape (see. "Ronidal looks like and contents of the pack").

If you stop taking RONYDAL
Do not stop taking your tablets just because you feel better. It is important to continue taking RONYDAL as long as your doctor prescribes. If you suddenly stop taking Ronidal may experience adverse signs. Your doctor may propose to reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, RONYDAL can cause side effects, although not everybody gets them.
RONYDAL usually well tolerated by the body and is often difficult to distinguish adverse events from symptoms of the disease.
In some cases, they may experience the following side effects: drowsiness, nervousness, anxiety, headaches. Very rarely can occur: lethargy, fatigue, concentration problems, blurred vision, dizziness, indigestion, nausea, vomiting, abdominal pain, constipation, impaired potency, dropping a small need, nasal congestion. Sedation usually mild and transient, may occur more often in children than in adults. Although these symptoms are usually harmless if they bother you too much, contact your doctor;
Sometimes a slight drop in blood pressure at the beginning of treatment, accompanied by dizziness. Most often, this condition resolves spontaneously. In the later stages of treatment can be observed increase in blood pressure, but this happens very rarely;
During treatment, your weight could be increased slightly and may be some violations of motility, as tremor, mild muscle stiffness, twitching legs. These symptoms are usually not dangerous and disappear after a doctor to reduce the dose or prescribe Ronidal adoption of additional medicine;
Although rare, it can occur swelling of the ankles, but they are harmless;
In elderly patients with dementia was observed sudden onset of weakness or numbness of the face, arms or legs, especially unilateral, or slurred speech. If you observe any of the above symptoms, contact your doctor;
Hypersensitivity to Ronidal is rare. It can be expressed as skin rash, itching, a feeling of suffocation or swelling of the face, lips or tongue. The appearance of these symptoms, call a doctor as quickly as possible;
Very rarely can occur confusional state, abnormal clarity of consciousness, fever or severe muscle spasms;
In very rare cases reported to increase blood sugar levels. Talk to your doctor if you experience symptoms such as strengthening the feeling of thirst or frequent urination;
In extremely rare cases, most often under the influence of some factors, such as high or low temperatures may have been significant changes in body temperature. If this happens, call the doctor;
In long-term treatment could occur twitching of the tongue, face, mouth or jaw. In case you observe similar effects, you should contact your doctor;
After prolonged treatment in some patients can be established breast enlargement, separation of milky discharge from the breast or menstrual disorders. It should be noted, however, that most patients will not show any of these complications.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RONYDAL
Keep out of reach of children.
Do not use RONYDAL after the expiry date stated on the carton and vial label after "EXP". The expiry date refers to the last day of that month.
Shelf life after first opening the package - 3 months.