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What Clonarex is 2.5 mg / ml oral drops, solution and what it is used for
Clonarex 2.5 mg / ml oral drops solution contains a medicine called clonazepam. It belongs to the group of benzodiazepine derivatives with anticonvulsive action.
Clonarex is used to treat epilepsy in infants, children and adults.
Clonarx reduces the number of seizures you receive;
If you get a fainting, it will not be so serious.
2. What you need to know before you take Clonarex 2.5 mg / ml oral solution
Do not take Clonarex:
If you are allergic (hypersensitive) to clonazepam, other benzodiazepines or to any of the other ingredients of this medicine (listed in section 6).
Clonarx is contraindicated in:
Patients with severe liver disease;
Severe renal insufficiency or severe pulmonary insufficiency;
Cryo-angle glaucoma (Clonarex can be used in patients with open-angle glaucoma who undergo appropriate treatment);
Myasthenia gravis (a disease where your muscles weaken and easily get tired)
Patients in coma;
Sleep apnea (a condition where your breathing stops during sleep)
Patients who abuse drugs, drugs or alcohol.
Do not take Clonarax if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clonarex.
Warnings and precautions
Patients treated with antiepileptics have reported suicidal and suicidal behaviors. The mechanism of this risk is unknown and the available data do not exclude the possibility of an increased risk of treatment with clonazepam. If such thoughts occur, contact your doctor immediately.
Talk to your doctor or pharmacist before taking Clonarex:
If you have had a depression, have attempted suicide, or a friend or close relative has recently died;
If you have problems with the liver, kidneys or lungs;
If you regularly take alcohol or drugs, or have had problems with alcohol or medicines in the past;
If you have spinal or cerebellar ataxia (a condition where movements may become uncertain and unstable, speech is unclear or rapid eye movements occur);
If you have a rare, innate blood problem called porphyria;
If you have sleep apnea (sleep disorder associated with sleep disturbance during sleep);
If you are over 65 years of age or your body has become weak due to severe and / or prolonged illness. Your doctor may need to adjust your dose;
If you have increased salivation. In babies and young children, clonazepam may cause increased saliva and bronchial secretion.
If any of the above applies to you or you are not sure, talk to your doctor or pharmacist before taking Clonarax.
Treatment with anticonvulsant medicines, including clonazepam, should not be stopped abruptly in patients with epilepsy, as this may provoke a seizure disorder. When there is a need for dose reduction or discontinuation of treatment, it should be done gradually, at the discretion of the treating physician. In such cases, combination with other antiepileptic drugs is recommended.
Other medicines and Clonarex 2.5 mg / ml oral solution, solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes both medicines you bought without a prescription, as well as herbal medicines. This is because Clonarax may affect the action of some other medicines. Also, some other medicines may affect the action of Clonarax.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Other medicines for the treatment of epilepsy, such as carbamazepine, hydantoin derivatives, phenobarbital, phenytoin, primidone or sodium valproate;
Cimetidine (used to treat stomach problems and heartburn);
Rifampicin (an antibiotic used to treat infections);
Drugs used for sleeping (sleeping);
Anxiety medications (tranquilizers);
Painkillers (analgesics) and muscle relaxants (muscle relaxants).
If you are going to have anesthesia (anesthesia) for surgery or dental treatment, it is important to tell your doctor or dentist that you are taking Clonarex.
Clonarex with food, beverages and alcohol
Never drink alcohol during treatment with Clonarax. In combination with clonazepam, alcohol can modify the effects of the drug, compromise treatment success, and cause unpredictable side effects.
Pregnancy, breastfeeding and fertility
Do not take Clonarex if you are pregnant, think you may be pregnant or plan to become pregnant unless your doctor tells you to. This is because Clonarax can cause damage to the fetus or baby.
Driving and using machines
Ask your doctor about driving and using machines while taking Clonarax. This is necessary because Clonarax may slow your reactions, especially when you start taking it. Talk to your doctor if you have a doubt as to whether you can do a certain activity.
When taking this medicine, there is a risk of mental and physical dependence, which increases with increasing dose and duration of treatment, as well as in patients with a history of alcohol and / or drug abuse.
3. How to take Clonarx 2.5 mg / ml oral drops, solution
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The dose should be determined individually for each patient, depending on the response and tolerability. To avoid undesirable effects at the start of treatment, treatment should be started at a low dose that is gradually increased to a maintenance dose tailored to the individual patient's needs.
Recommended starting and maintenance doses. Supportive doses could be increased if necessary:
Age Recommended starting dose (mg) Daily maintenance dose
Infants (0 to 1 year) 0.25 mg (or less) 0.5 - 1 mg 5 - 10 drops
Small children (1 to 5 years) 0.25 mg (or less) 1 - 3 mg 15 - 30 drops
Larger children (5 to 12 years) 0.5 mg (or less) 3-6 mg 30 - 60 drops
Adults and children over 12 years 1 mg (or less) 4-8 mg 40 - 80 drops
When possible, your doctor will divide the total daily dose into three or four doses to be taken at regular intervals throughout the day. The maintenance dose is reached after 3-4 weeks of treatment.
The drops should be taken in a spoon and can be mixed with water, tea or fruit juice.
The bottle should be kept upright, with the opening down. If the liquid does not come out of the dropper, the bottle should overturn several times or shake gently.
If you take more Clonarex than you should 2.5 mg / ml oral drops, a solution
If you take more Clonarax than you should, or someone else has accidentally taken your Clonarix drops, contact your doctor or go to the hospital immediately. Take the medicine pack with you.
If you take too many drops, you may feel drowsiness, tiredness, dizziness, impaired coordination of movements, weakness or no reaction.
If you forget to take Clonarx 2.5 mg / ml oral drops, solution
If you forget to take a dose, skip the missed dose and take the next one at the usual time.
Do not take a double dose (two doses at the same time) to compensate for the missed dose.
If you stop taking Clonarex 2.5 mg / ml oral drops, a solution
If you are being treated with Clonarx for a long time, you may become addicted to it and get withdrawal symptoms (see section 4, "Possible side effects"):
Do not stop taking the medicine without consulting your doctor. If you do, seizures may recur and you may experience withdrawal symptoms (see section 4);
If the dose of Clonarax you are taking should be reduced or stopped, this should be gradual. Your doctor will advise you on how to do this.
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.
Serious undesirable effects to be monitored:
If you get an allergic reaction, contact your doctor immediately. Symptoms may include:
Sudden swelling of the throat, face, lips and mouth. This may cause difficulty in breathing or swallowing;
Sudden swelling of the hands, feet and ankles;
Skin rash or itching.
Side effects from the heart
If you notice any of the following side effects, talk to your doctor straight away. Symptoms may include:
Shortness of breath, swelling of the ankles, cough, fatigue and palpitations;
Chest pain that can spread to the neck, shoulders and left hand.
Side effects related to behavior
Talk to your doctor if you notice any of the following side effects, as you may need to stop taking Clonarax. Symptoms may include:
Aggression, agitation, irritability, nervousness or anxiety;
Sleep problems, nightmares and vivid dreams;
Psychic problems such as seeing or hearing things that are not real (hallucinations), delusions (belief in things that are not real), and speech problems;
Types of seizures (convulsions) you did not have before.
Adverse reactions in children and adolescents
Infants and young children who receive Clonarex should be monitored very carefully. This is because,
Psychiatric disorders and nervous system disorders:
Disturbed concentration, confusion and disorientation;
Difficulty in remembering new things;
Delay or delay of speech;
Distorted coordination, including a sense of walking instability;
In some forms of epilepsy, an increase in seizure frequency.
Renal, liver and blood disorders:
Hepatic impairment (found in blood tests);
Incontinence (discharge of urine);
Blood problems. Symptoms include fatigue, bruising, shortness of breath and bleeding from the nose. Your doctor may appoint recurrent examinations.
Changes in appetite.
Metabolism and nutrition disorders:
Sharp eye movements (nystagmus).
Respiratory problems (respiratory depression). Early symptoms include suddenly noisy, difficult and uneven breathing. Your skin may bloom.
Skin and hair:
Skin rashes, urticaria (rash with raised strides) and itchy skin;
Changes in skin color;
Hair loss (hair usually grows again).
Loss of sexual desire;
Difficulty receiving or maintaining an erection (erectile dysfunction).
Symptoms of withdrawal
The use of benzodiazepines, such as Clonarax, may make you dependent on the medicine. This means that if you stop the treatment suddenly or reduce the dose too quickly, you may experience withdrawal symptoms. Symptoms may include:
Muscle pain, tremor (tremor) and anxiety;
Strong anxiety, tension, confusion, irritability or excitement, or mood swings;
Less common withdrawal symptoms include:
Sensitivity to light, noise and physical contact;
Seeing or hearing things that are not real (hallucinations);
Numbness and stiffness of the hands and feet;
A sense of loss of contact with reality.
Adverse reactions associated with injuries
Patients taking drugs from the benzodiazepine group are at risk of falling and breaking the bones. The risk is higher when benzodiazepines are used concomitantly with sedatives, including alcoholic beverages, as well as in the elderly.
How to store Clonarex 2.5 mg / ml oral drops, solution
Keep out of the reach and sight of children.
Store below 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Period of use after first opening - 1 month.
Do not dispose of medicines in the sewage system 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 Clonarex contains 2.5 mg / ml oral drops, solution
The active substance is clonazepam.
1 ml (25 drops) contains 2.5 mg of clonazepam.
The other ingredients are: saccharin sodium, glacial acetic acid, orange flavor - lemon - caramel, propylene glycol.
What Clonarex 2.5 mg / ml oral drops, solution and what the pack contains, looks like
Clonarex 2.5 mg / ml oral drops, solution is clear, pale yellow, with a sweet citrus flavor. It is packed in a dark glass bottle of 15 ml capacity with a low density polyethylene dropper applicator and a polypropylene cap with a child-proof inner seal.
Solution volume in vial: 10 ml. The glass bottle is placed in a cardboard box.
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