Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to re-read it. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not give it to others. It can harm them, even if their symptoms are the same as yours.
In this respect:
1. WHAT ALPRAZOLAM NORMON IS 0.25 mg TABLETS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE ALPRAZOLAM NORMON 0.25 mg TABLETS
3. HOW TO TAKE ALPRAZOLAM NORMON 0.25 mg TABLETS
4. POSSIBLE ADVERSE EFFECTS
5. HOW TO STORE ALPRAZOLAM NORMON 0.25 mg TABLETS
ALPRAZOLAM NORMON 0.25 mg EFG TABLETS
The active substance is alprazolam. Each tablet contains 0.25 mg alprazolam (D.C.I.).
The other ingredients are: lactose monohydrate, polyvidone, corn starch and magnesium stearate.
1. WHAT ALPRAZOLAM NORMON IS 0.25 mg TABLETS AND WHAT IT IS USED FOR
Pharmaceutical form: Tablets. Container containing 30 tablets. Alprazolam belongs to a group of medicines called benzodiazepines, it is a tranquilizer drug.
It is indicated in the treatment of generalized anxiety disorders and in the treatment of agoraphobia with or without agoraphobia (open-space phobia very crowded).
2. BEFORE YOU TAKE ALPRAZOLAM NORMON 0.25 mg TABLETS
Do not take ALPRAZOLAM NORMON in the following cases: known hypersensitivity (allergy) to benzodiazepines, severe respiratory or liver failure, sleep apnea syndrome, myasthenia gravis (a form of muscle weakness) as it may aggravate this disease and in cases of Narrow-angle glaucoma (increased intraocular pressure).
Take special care with ALPRAZOLAM NORMON
* If you suffer from chronic respiratory failure, impaired renal or hepatic function. In these cases it is recommended to decrease the dose.
* The utility of alprazolam in hospitalized patients with severe depression has not been established.
* Dependence: The use of benzodiazepines can lead to a physical and psychic dependence. This occurs mainly after taking the drug continuously for a long time or with high doses of it. It is also greater in patients with a history of drug or alcohol abuse. To prevent these effects, the following recommendations should be taken into account:
- the taking of alprazolam will be done under medical prescription (never because it has given results to other patients) and should never be advised to other patients,
- never increase the dose prescribed by the doctor, or prolong the treatment longer than recommended,
- consult your doctor regularly to decide whether to continue treatment.
• Use in children: The use of alprazolam in patients under 18 years of age is not recommended.
• Pregnancy: Consult your doctor or pharmacist before taking a medicine. The use of alprazolam during pregnancy is not recommended since certain adverse effects have been observed in neonates of benzodiazepine-treated mothers and an increased risk of congenital malformations associated with benzodiazepine therapy in the first trimester of pregnancy.
Breast-feeding: Consult your doctor or pharmacist before taking a medicine. As a general rule, breastfeeding should be avoided while the patient is taking the medication, as benzodiazepines are excreted in breast milk.
§ Driving and using machines: Do not drive or use any dangerous tools or machinery, as alprazolam causes drowsiness and reduced reflexes.
• Using other medicines: Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription. Simultaneous administration of alcohol or other central nervous system depressant drugs should be avoided, since they may increase their action and their negative effects, such as dependence. Alprazolam increases blood concentrations of imipramine and desipramine when given together. Also, alprazolam interacts with the following drugs: narcotic analgesics, ketoconazole, itraconazole or other azole antifungals, nefazodone, fluvoxamine, cimetidine, fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem and macrolide antibiotics such as erythromycin and troleandomycin.
3. HOW TO TAKE ALPRAZOLAM NORMON 0.25 mg TABLETS
Follow these instructions unless your doctor has given you different directions.
Remember to take your medicine. If you think the action of ALPRAZOLAM NORMON is too strong or weak, tell your doctor or pharmacist.
Treatment should be as short as possible. The total duration of the same should not be longer than 8-12 weeks. In the treatment of distress disorders the mean total duration is 6 months.
Swallow the tablets with a sufficient amount of liquid.
Treatment of anxiety: The initial dose is 1 to 2 tablets (0.25 mg to 0.5 mg) 3 times a day. The usual range of doses ranges from 0.5 mg to 4 mg of alprazolam per day, divided into 3 or 4 doses.
Treatment of anxiety with or without agoraphobia: The initial dose is 2 to 4 tablets (0.5 mg to 1 mg) at bedtime. The dose will then be adjusted by the physician based on the response. The usual maintenance dose ranges from 5 mg to 6 mg daily, although in some cases up to 10 mg daily have been needed.
Use in elderly patients or debilitating diseases: The initial dose is 1 tablet (0.25 mg) 2 or 3 times a day. The usual dose ranges from 2 tablets per day (0.5 mg) to 3 tablets per day (0.75 mg) in divided doses. The doctor will reduce the dose to the lowest effective dose, especially in elderly patients or debilitating diseases, but may increase it gradually if necessary and tolerated.
§ If you take more ALPRAZOLAM NORMON than you should consult your doctor or pharmacist. Effects such as dizziness, mental confusion, lethargy (deep and continuous pathological sleep), ataxia (lack of muscle coordination), hypotonia (decreased tonicity), decreased tension, respiratory depression and, rarely, coma may occur. These effects are enhanced with alcohol. In case of overdose or accidental ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount ingested.
Information to physician: If conscious, induce vomiting and if unconscious, gastric lavage is recommended. If no benefit is seen in emptying the stomach, activated charcoal should be given to decrease absorption. Special attention should be given to respiratory and cardiac function: breathing, pulse and blood pressure should be controlled, taking the necessary general measures, such as intravenous administration of fluids, adequate pulmonary ventilation, etc.
§ If you forget to take ALPRAZOLAM NORMON do not take a double dose to make up for forgotten doses.
§ Effects on discontinuation of ALPRAZOLAM NORMON: If the dose of alprazolam is reduced rapidly or abruptly, abstinence syndrome may occur, with abdominal and muscle cramps, vomiting, sweating, tremor, and seizures. Therefore, it is not generally recommended to interrupt the medication abruptly, but to gradually reduce the dose, according to the doctor's instructions.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, ALPRAZOLAM NORMON can have side effects. If adverse effects occur, they are usually observed at the beginning of treatment and usually disappear during the treatment or with a decrease in dose.
In anxiety-treated patients, the most common reactions are: light-headedness or dizziness and drowsiness. Less frequently: depression, impaired memory or amnesia, coordination disorders, insomnia, nervousness, vegetative nervous system symptoms, dystonia (altered muscle tone), blurred vision, dysarthria (expression disorder), jaundice ( Yellowing of the skin and mucous membranes), incontinence, urinary retention, abnormal liver function, tremors, muscle weakness, changes in libido, anorexia, menstrual irregularities, weight changes, headache, fatigue, various gastrointestinal symptoms, irritability. An increase in intraocular pressure has rarely been reported.
The most common adverse reactions in patients treated for distress disorders are ataxia or impaired coordination, dysarthria, sedation or drowsiness and fatigue. Less frequently: memory problems, confusion, impaired intellectual functions, mood disturbances, sexual dysfunction, dermatitis (inflammation of the skin), and gastrointestinal symptoms.
As with other benzodiazepines, the following reactions have been observed: stimulation, agitation, difficulties in concentration, confusion, hallucinations and other negative effects on behavior, such as hostile or aggressive behavior. In the majority of cases, patients who experienced these effects were being treated in combination with other CNS depressant drugs.
5. HOW TO STORE ALPRAZOLAM NORMON 0.25 mg TABLETS
Keep ALPRAZOLAM NORMON out of the reach and sight of children.
Keep protected from light, keeping the tablets always inside the case.
Expiration: Do not use ALPRAZOLAM NORMON 0.25 mg TABLETS after the expiry date stated on the carton.
6. OTHER PRESENTATIONS
ALPRAZOLAM NORMON 0.5 mg TABLETS: Container containing 30 tablets.
ALPRAZOLAM NORMON 1 mg TABLETS: Container containing 30 tablets.
ALPRAZOLAM NORMON 2 mg TABLETS: Containers containing 30 and 50 tablets.
