LORAPAM 2.5 mg. 30 tablets

What LORAPAM and what it is used
The name of your medicine is LORAPAM.
The active substance is lorazepam, which is a type of medicine from the group of benzodiazepines. LORAPAM relieving the symptoms of anxiety and is used for short periods of time to alleviate the symptoms of anxiety, as they are heavy, or when a significant detrimental affect your everyday life, as well as for the treatment of sleep disorders caused by anxiety. LORAPAM may also be used as a sedative shortly before dental or surgical procedure.

2. What you need to know before taking LORAPAM
Do not take LORAPAM:
if you are allergic (hypersensitive) to lorazepam or any other benzodiazepine, or any of the other ingredients of this medicine (listed in section 6);
if you have difficulty breathing or chest pain;
if you feel tired or weak muscles, a condition called myasthenia gravis;
if you suffer from severe liver problems;
if you have difficulty breathing while you sleep, a condition called sleep apnea;
If abuse or are abused in the past with alcohol and / or drugs;
if you are breastfeeding, as lorazepam may be excreted in milk (see. section "Pregnancy and lactation").
If any of the above applies to you, do not take LORAPAM and return to your doctor.

Warnings and Precautions
Talk to your doctor or pharmacist before taking LORAPAM:
if you are pregnant or trying to become pregnant (see. section "Pregnancy and lactation");
if you suffer from personality disorder; it may mean that you are at greater risk of developing addiction lorazepam;
if you suffer from kidney or liver problems;
if you have previously suffered from depression, as it may be resumed during treatment with lorazepam;
if you suffer from depression as lorazepam can enhance suicidal thoughts;
if you have trouble breathing;
if you have impaired coordination or if you are taking a large number of drugs that affect the brain;
if you suffer from increased intraocular pressure, a condition called glaucoma;
if you are elderly patient, as the risk of falling may be increased.
However, LORAPAM may not be suitable for you, but you should discuss with your doctor or pharmacist if any of the above applies to you. Do this before you start taking LORAPAM.

Other medicines and LORAPAM
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. Other medicines may affect how lorazepam. Lorazepam may also affect the way other medicines.

Tell your doctor if you take:
Another drug which has a sedative effect or use in anxiety;
Antidepressants;
Strong painkillers such as tramadol, codeine, morphine, methadone;
Medicines to treat epilepsy, such as sodium valproate;
Antihistamines for allergies;
Drugs for the treatment of mood disorders, and disorders, such as chlorpromazine, clozapine, haloperidol, loxapine;
Medicines to treat asthma, such as theophylline or aminophylline;
Medications to relax the muscles;
Medicine for the treatment of gout called probenecid;
Drug called scopolamine, which can be used for intestinal problems, or before surgery.
LORAPAM with food and drink
Do not drink alcohol during treatment with lorazepam.
If you take the entire dose in the evening, it should not be taken less than four hours after eating. Otherwise, the next day you can have a sense of dehydration, fatigue, headache, nausea, difficulty concentrating, irritability, sensitivity to light and noise.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
LORAPAM should not be used during pregnancy. If you are pregnant or may become pregnant, do not take this medicine before you have consulted with your doctor. Lorazepam can cause birth defects if taken during pregnancy. If taking lorazepam in the last stages of pregnancy or during birth, after birth, the baby may be less active than other infants, there may be soft and relaxed muscles, low body temperature and / or low blood pressure, breathing difficulties or difficulty eating for a while, or be granted. Your baby may not respond normally to the cold for a while. If you are taking lorazepam regularly in the late stages of pregnancy, your baby may develop withdrawal symptoms after birth.
Lorazepam is excreted in human milk. For this reason should not be taken while breast-feeding unless the expected benefits of treatment outweigh the potential risk to the child. Otherwise your baby may seem sluggish or have difficulty breastfeeding. In this case it is advisable track of your baby.

Driving and using machines
Do not drive, operate machinery or perform any activities that require concentration, while taking lorazepam. Lorazepam may cause drowsiness and dizziness during the day and affect your concentration. These symptoms may worsen if you have not slept enough the night.

LORAPAM contains lactose monohydrate. If your doctor has told you that you suffer from an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take LORAPAM
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
LORAPAM should be taken with a glass of water.
Large dose administered at bedtime may cause drowsiness and dizziness the next day (symptoms such as dehydration, fatigue, headache, nausea, difficulty concentrating, irritability, sensitivity to light and noise), especially if you have not slept enough, it takes 7-8 hours of sleep (see. section "Driving and using machines").
If you are taking lorazepam for anxiety or sleep problems treatment usually lasts from a few days to four weeks and included gradual dose reduction at the end of treatment.

Adults (over 18 years):
Anxiety: The usual starting dose is 0.5 mg, administered 2 or 3 times daily, the dose may be increased to 2.5 mg daily (maintenance dose). The daily dose can be divided into 2 or 3 equal doses to be administered during the day, or can be administered as a single dose in the evening, 4 hours after a meal and 30 minutes before sleep. Your doctor will tell you how often to take the tablets. The maximum daily dose of 2.5 mg should not be exceeded.

Insomnia caused by anxiety: The usual starting dose is 1 mg at bedtime, it can be increased to 2 mg.

Before surgical or dental procedures: The usual dose is between 2 mg and 4 mg, taken two hours before the intervention.

In elderly patients and in patients with kidney or liver problems may be given a lower dose. The usual starting dose is usually half the adult dose. Your doctor will monitor your response to treatment and adjust the dose if necessary.

Use in children and adolescents:
LORAPAM should not be used in children and adolescents under 18 years of age, except in the following cases.

Children under 6 years of age:
Children under 6 years of age should not be treated with LORAPAM.

Children aged between 6 and 12 years:
Before surgical or dental procedure: The usual dose is 0.5 mg to 1 mg, depending on the weight of the child (the dose of 0.05 mg / kg of body weight should not be exceeded), received at least 1 hour prior to the procedure.

Children aged between 13 and 18 years:
Before surgical or dental procedures: The usual dose is 1 mg to 4 mg, taken one or two hours before the procedure.

LORAPAM 2.5 mg tablets can be divided into two equal halves. Each half tablet contains 1.25 mg lorazepam.

Your doctor may adjust the dose so that it is suitable for you, depending on your response to treatment. Your doctor will explain more. Always follow your doctor's instructions.

If you take more dose LORAPAM
Should immediately seek medical assistance, or contact your doctor or visit the emergency department of the nearest hospital. Do not drive - ask a friend or neighbor to take you or call an ambulance. Always carry a box of medicine with you, even if it is empty. So the doctor will know what medications you take.
Symptoms of mild overdose include: dizziness, confusion or lethargy. In more severe cases may occur difficult or slurred speech, clumsiness or instability, decreased muscle tone, dizziness and loss of balance or coordination.

If you forget to take LORAPAM
Do not take a double dose to make up the missed dose.
If you are treated for anxiety and have passed less than three hours than usual intake dose, take your dose as soon as you remember and then continue as usual. If more than 3 hours, do not worry and take the next dose at the usual time.
If you are being treated for sleep problems take a tablet if you slept enough time.

While taking LORAPAM
LORAPAM can affect your concentration and feel sleepy during the day.
Some elderly patients may feel dizzy after taking lorazepam and may be a danger of falling.
You can get used to lorazepam. The benefit of treatment may be more noticeable after a few weeks.
If you are prescribed lorazepam for more than 4 weeks, your doctor may appoint blood tests periodically to monitor your blood counts and liver function. LORAPAM can rarely affect liver function or blood.
After long term treatment may appear depending on lorazepam. Typically LORAPAM prescribed for short-term treatment, of a few days to 4 weeks, including a reduction in the dose at the end of treatment. This reduces the risk of addiction or lorazepam side effects following discontinuation of treatment. For additional information, see the next section.

If you stop taking LORAPAM
Once you have finished your treatment appointed LORAPAM Your doctor will decide whether you need additional treatment.
The number of tablets LORAPAM and frequency of administration should always be reduced gradually before stopping treatment altogether. This will help your body get used to the lack of lorazepam and reduce the risk of side effects when discontinuing treatment. Your doctor will give you guidelines on how to do this.
When stop taking LORAPAM may experience withdrawal symptoms such as headaches, muscle pain, anxiety, sleep disorders, stress, depression, restlessness, dizziness, nausea, diarrhea, loss of appetite, confusion, irritability, agitation, tremor, pain stomach and / or muscle, changes in heart rate, short-term memory loss, fever and sweating. Your original difficulty sleeping can resume.
If these symptoms occur, they usually do not last long. If you get any of these symptoms, talk to your doctor.
Do not stop taking LORAPAM suddenly. You may experience more severe withdrawal symptoms such as loss of sense of reality, a sense of unreality or detachment from life, inability to experience emotions. Some patients experienced numbness or tingling in the hands and feet, nausea, tinnitus, tremor, seeing or hearing things that are not there, seizures, hypersensitivity to touch, to sound and light. If you have any of these symptoms, consult your doctor.

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 everybody gets them.

Immediately contact your doctor if you experience any of the following symptoms:
Sudden, severe allergic reaction, causing difficulty breathing and dizziness;
Severe allergic reaction with swelling of the face, lips and throat;
Yellowing of the skin and whites of the eyes;
Difficulty breathing;
Thoughts of self harm and suicide;
Changes in mental status such as restlessness, agitation, irritability, aggression, hallucinations, abnormal behavior and delusions.
Tell your doctor or pharmacist if any of the following side effects:
Very common - affecting more than 1 patient in 10:
Drowsiness, sedation;
Fatigue.
Common - affects 1 to 10 patients in 100:
Confusion, depression, depression events, which have been masked;
Poor muscle control, dizziness;
Muscle weakness, loss of strength;
Lack of energy.
Uncommon - affects 1 to 10 patients in 1000:
Nausea;
Changes in sexual desire, impotence, decreased orgasm.
The following adverse reactions have been reported with the use of lorazepam, but their frequency can not be established from the available data:
Decreased levels of red blood cells, white blood cells and platelets, leading to unexplained bruising or bleeding, pale skin, weakness / shortness of breath and / or frequent infections;
Allergic skin reactions such as redness, rash, hair loss;
Low sodium levels in the blood, concentrated (very dark) urine;
Very low body temperature;
Loss of short term memory;
Muscle spasms, difficulty in fully opening the mouth, tendency to sticking out the tongue, slurred speech and abnormal changes in body posture, difficulty concentrating, dizziness, burning sensation, tremor, convulsions, loss of consciousness;
Blurred vision, double vision;
Low blood pressure;
Sexual arousal;
Anxiety, agitation, agitation, hostility, aggression, anger, sleep disorders, seeing or hearing things that are not there - these symptoms are more likely in children and the elderly;
Decreased breathing, shortness of breath, a temporary cessation of breathing, including sleep, worsening of asthma, or slurred speech;
Constipation;
Changes in liver function - Your doctor will check for it;
Changes in the blood - Your doctor will check for this.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report adverse events directly through the national reporting system:
Drug Agency,
str. "Damyan Gruev" № 8
1303 Sofia,
website: www.bda.bg.

As reported adverse reactions, you can do your bit to obtain more information on the safety of this medicine.

5. How to store LORAPAM
Keep at temperatures below 25 ° C. Store in the original container to protect from light.
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and the blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What LORAPAM
The active substance is lorazepam (lorazepam) 2.5 mg.
The other ingredients are lactose monohydrate, povidone (K30) crospovidone type A, corn starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate and polacrilin sodium.

LORAPAM looks like and contents of the pack
LORAPAM 2.5 mg: white, round, flat, beveled, scored tablets.
Blister packs containing 10, 14, 15, 20, 28, 30, 50, 60, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.