ALONET . 400 mg. 30 tablets 

ALONET WHAT IS AND WHAT IT IS USED

Amisulpride belongs to a group of medicines called antipsychotics, which help control the symptoms of the mental disorder called schizophrenia. Symptoms include delusions (strange or unusual thoughts), hallucinations seeing or hearing things) have unusual behavior, which could be aggressive (this is called. Positive symptoms) and a sense of withdrawal and depression (the . negative symptoms).

 BEFORE YOU TAKE ALONET

Do not take Alonet

 if you are allergic (hypersensitive) to amisulpride or any of the other ingredients of Alonet

 if you are taking medicines containing levodopa (for Parkinson's disease) (see "Taking other medicines" section below).

 If you have a tumor of the adrenal gland called phaeochromocytoma.

 are breast-feeding

 suffer from prolactin-producing tumors or breast cancer

 if you have severe kidney disease

 if you are taking medicines to treat abnormal heart rhythms such as quinidine, disopyramide, procainamide, miksiletin, flecainide, propafenone, amiodarone, sotalol. See also "Taking other medicines" below.

 if you are taking medicines that may cause irregular heartbeat, when you use them together with amisulpride (such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin, imidazole antifungals). Consult your doctor before taking any other medicine poodukt. See also "Taking other medicines" below.

 if you are under 18 years of age

Take special care with Alonet

 if you are elderly Alonet may cause sedation or low blood pressure, and generally not recommended, as experience is limited.

 If you suffer from mild to moderate renal insufficiency, your doctor will reduce the dosage

 treatment with Alonet may occur muscle stiffness, impaired consciousness, accompanied by undue fever, sweating, palpitations, drowsiness or confusion. This requires discontinuation and consultation with your doctor.

 epilepsy and Parkinson's disease

 if you have or have had heart disease, irregular heart rhythm (QT prolongation) or very slow heartbeat (less than 55 beats per minute) or taking other medicines that may have such side effects.

 if you have electrolyte imbalance, mainly very low levels of potassium, calcium or magnesium, or taking medications that may cause these side effects.

 if you are taking other medications that could affect your heart function, consult your doctor before taking any medicine. See also "Taking other medicines" below.

If you have an increased risk of stroke or transient ischemic attack (temporary reduction in blood flow to the brain).

 if you have diabetes or know that you are at risk to develop diabetes. You must control your levels of the blood sugar because they may increase during treatment with amisulpride (hyperglycemia).

Taking other medicines

Consult your doctor before taking on any medication.

You should not take Alonet tablets at the same time with the following medications:

 some medicines used to treat irregular heart rhythm (eg quinidine, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol) or angina (bepridil).

 antipsychotics thioridazine and sultopride

 some antibiotics (such as pentamidine, sparfloxacin, erythromycin (administered intravenously), medications for malaria (halofantrine) or medicines for fungal infections (such as clotrimazole)

 cisapride (for indigestion or heartburn), methadone (for pain and drug addiction), intravenous vincamine (to dilate blood vessels)

 "Dopamine agonists" as levodopa for Parkinson's disease Alonet tablets are not recommended with the following medications:

 medicines for heart conditions and migraine, which could slow heartbeat (eg, beta-blockers, diltiazem, verapamil, clonidine, guanfacin, digitalis)

 medicines that cause loss of potassium in the body (eg the so-called. "Water tablets", some laxatives, intravenous amphotericin B for the treatment of infections, glucocorticoids used for conditions such as asthma or rheumatoid arthritis tetracosactide that can used in clinical studies)

 antipsychotics haloperidol and pimozide, certain antidepressants (such as imipramine, lithium)

 some antihistamines for allergies (eg, astemizole, terfenadine).

The effect of these Alonet tablets or drugs could be increased if used at the same time:

  drugs used to relieve pain, anesthetics, anti-allergy antihistamines that cause drowsiness, barbiturates and benzodiazepines (sleeping pills) or other medicines for anxiety.

 medicines that lower blood pressure (eg, clonidine).

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

Taking Alonet with food and drink

Alcoholic beverages and drugs containing alcohol should be avoided during treatment. The sedative effect of neuroleptics is enhanced by alcohol.

Pregnancy and lactation

Ask your doctor before taking any medicine.

Pregnancy

There was a decrease in fertility. The safety of amisulpride during pregnancy has not been established. It is therefore not recommended for use by pregnant women unless specifically directed by your doctor.

Lactation

There are no data on the excretion of amisulpride in human milk and therefore its use during lactation is contraindicated.

Driving and operating machinery

Drivers and people working with machines should be informed of the risk of drowsiness.

Important information about some of the ingredients of Alonet

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Alonet.

 HOW TO TAKE ALONET

Always Alonet exactly as your doctor has told you. If you're not sure, ask your doctor. At a daily dose below 400 mg dosing is once daily. In daily dose exceeds 400 mg, the drug twice daily.

Acute psychotic episodes

In patients with acute psychotic episodes recommended oral doses of 400 mg and 800 mg daily. The maximum daily dose should not exceed 1200 mg amisulpride.

The dose is adjusted according to individual response.

In all cases, maintenance treatment is determined individually using the minimum effective dose.

If negative symptoms:

With regard to patients with predominantly negative symptoms is recommended oral doses of 50 mg to 300 mg daily. Determine the dosage is done individually. The optimal dose is 100 mg daily.

When positive symptoms

With regard to patients with predominantly positive symptoms is recommended oral doses of 400 mg to 800 mg daily.

If you have both positive and negative symptoms, your doctor will adjust your dosage so as to ensure adequate control of positive symptoms.

Maintenance treatment should be individually adjusted to individual response, using the minimum effective dose.

Elderly:

Amisulpride should be used with caution because of possible risk of hypotension or sedation.

Children:

Amisulpride is contraindicated in children under 18 - the age, as safety has not been well studied.

Renal failure:

If you have kidney disease, your doctor will determine the dose you should take. It can be reduced to half or a third of the normal dose.

Hepatic Insufficiency:

Given the low level of metabolism of amisulpride in the liver is not necessary dose reduction.

The tablets should be taken with enough fluid to not chew regardless of food intake.

If you take more than the dose Alonet

If you take more tablets than you should immediately seek medical attention. Overdose may cause drowsiness, coma, low blood pressure, and abnormal movements. Bring remaining tablets and the container with you to the doctor.

If you forget to take Alonet

Do not take a double dose to make up for a missed dose. Take your next dose at the regular time.

If you stop taking the tablets Alonet

Your doctor will decide how long you should take Alonet tablets. Do not stop taking your tablets just because you feel better. It is important to continue taking tablets Alonet as long as your doctor tells you. If you stop taking the tablets Alonet, you should do it gradually, especially if you take high dose, unless your doctor recommends otherwise. Abrupt withdrawal can cause effects such as nausea, vomiting and insomnia can get return on your main symptoms of disease.

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

 POSSIBLE SIDE EFFECTS

Like all medicines, Alonet can cause side effects, although not everybody gets them.

There have been reports of neuroleptic malignant sinrom, which is characterized by high fever, sweating, muscle cramps, rapid heart rate, rapid breathing and drowsiness or confusion. If you develop these symptoms, stop taking the tablets Alonet and seek immediate medical attention.

They were the following side effects:

Very common (occurring in more than 1 patient in 10):

Tremors, muscle rigidity expressed or spasm, brake, excess salivation or anxiety that usually decrease if your doctor Alonet reduce the dose of tablets or prescribe additional drugs.

Common (occurring in more than 1 in 100 patients but less than 1 in 10 patients)

 obesity

 abnormal movements such as tics or spasms of the neck muscles, eyes or jaw, which can be reduced if your doctor prescribe additional drugs, drowsiness, dizziness

 constipation, nausea, vomiting, dry mouth

 increased levels of the hormone prolactin, which can result in the release of milk from the breasts, chest pain or increase them, menstrual disorders, impotence, which gradually disappear once you stop taking the tablets Alonet. Can also occur and prolactin - dependent tumors.

 low blood pressure (causing dizziness)

 insomnia, anxiety, agitation, abnormal orgasm.

Uncommon (occurring in more than 1 in 1,000 patients but less than 1 in 100 patients)

  increased levels of liver enzymes, elevated blood sugar (hyperglycemia)

 slow heartbeat

 uncontrollable movements mainly of the face and tongue (usually after prolonged treatment), convulsions (fits)

 allergic reactions like skin rash, itching or swelling.

Not known (can not be estimated from available data)

 abnormal heart rhythms that could be life-threatening and may lead to cardiac arrest and sudden death.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 HOW TO STORE ALONET

 Do not store above 25 ° C.

  Keep out of reach of children.

  Do not use Alonet after the expiry date stated on the carton. The expiry date refers to the last day of that month.

  Medicines should not be disposed of via wastewater or household waste. Stagger your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 ADDITIONAL INFORMATION

What Alonet

  The active substance is amisulpride

  The other ingredients are lactose monohydrate, sodium starch glycolate, methylcellulose, magnesium stearate, microcrystalline cellulose, basic butylated methacrylate copolymer, titanium dioxide, magnesium stearate, talc, macrogol 6000, isopropyl alcohol.