• What exactly is MERIDIA?

• Precisely how does MERIDIA work?

• How long will it take for MERIDIA to work on me?

• Who is an ideal candidate to take MERIDIA?

• How should I take MERIDIA and when?

• What do I do in the case of missing a dose?

• For what period of time should MERIDIA be used?

• Under what conditions should someone not take MERIDIA?

• What information about medical conditions should I give my doctor?

• What do I do about follow-up visits to my physician?

• What other medication might cause problems when taken in conjunction with MERIDIA?

• Under what circumstances should I call my doctor if I think I have a problem?

• Is MERIDIA considered to be a controlled substance?

• What kind of weight loss results have been seen with MERIDIA therapy?

• What are the more common side effects suffered with the use of MERIDIA?

• Does MERIDIA have an affect on blood pressure or heart rate?

• Are there any severe side effects that are worth taking special precautions for in the use of MERIDIA?

• Can MERIDIA cause any damage to the valves of the hearts?

• Will MERIDIA in any way alter the taking of nutritional supplements?

• What is advised when it comes to drinking alcoholic beverages?

• If I drink coffee, tea or caffeinated beverages, will it affect my MERIDIA therapy?

• What will occur if I develop an allergic reaction to MERIDIA?

• What about complications if I am pregnant or breastfeeding?

• Is there an affect on sexual activity or potential pregnancy?

• Does MERIDIA affect the efficiency of birth control prophylaxis?

• Is driving a car dangerous and what about work activities?

• How should MERIDIA be used and stored?

What exactly is MERIDIA?

 MERIDIA is a prescription drug taken orally and used for medical regulation of obesity, this includes weight loss and the maintenance of weight loss, this medication must be used together with  a diet that is reduced in calories.

MERIDIA is a prescription medication that can only ordered by a doctor. It is packaged in three strengths of capsule: 5, 10 and 15 mgs. The starting dose of MERIDIA is recommended at one 10 mg capsule daily. A doctor determines the commencing dose that is considered to be best for your circumstances.

Precisely how does MERIDIA work?

MERIDIA affects the appetite control center of the brain.

In clinical studies conducted on overweight people, MERIDIA, together with a diet that has been reduced in calories, caused a significant reduction in body weight.

It is imperative that MERIDIA be used as an aid in a program for weight-loss, controlled by your doctor. It includes a diet that is reduced in calories and supported by appropriate physical activity.

How long will it take for MERIDIA to work on me?

Everyone responds differently to MERIDIA therapy when it is utilized as part of a complete weight-loss program. You might lose 4 or even more pounds of body weight during the first month of therapy. Should you discover that you don’t lose at the very least 4lbs during your first month of therapy, you should definitely let your doctor know so they can re-evaluate the treatment. Your doctor might want to alter the dose of MERIDIA you are taking.

Many of the people who lose weight while using MERIDIA find that they lose that weight during the first 6 months of therapy. Scientific studies conducted over a two year time period, show that people who lost their weight and remained on MERIDIA therapy, easily maintained any weight loss.

Who is an ideal candidate to take MERIDIA?

Any a weight reduction program that incorporates a diet that is reduced in calories and correct physical activity might be sufficient for some people, but you must talk about whether MERIDIA ought to be added to such a regime with your doctor.

MERIDIA is highly recommended for obese people with a preliminary body mass index (BMI) of 30 or greater, or for overweight people with a BMI of 27 or more if they have risk factors present such as high blood pressure, high cholesterol or diabetes. Your doctor will decide your BMI based on results of measurement and make the decision if you meet these criteria.

How should I take MERIDIA and when?

Always follow any instruction given by your doctor instructions particularly concerning how and when to take MERIDIA. It is highly unlikely that your doctor will recommend that you take more than one (1) MERIDIA capsule per day and it can be taken either on an empty stomach or after a meal.

What do I do in the case of missing a dose?

Never take an extra dose to catch up with the dose you forgot. If you forget to take your MERIDIA, do not take another.

For what period of time should MERIDIA be used?

Only your doctor can decide for how long a period you should use MERIDIA therapy. Follow your doctor's advice for safety and effectiveness. To date MERIDIA results have not been determined beyond two years.

Under what conditions should someone not take MERIDIA?

MERIDIA should under no circumstances be used by people who:

• Suffer from high blood pressure that is uncontrolled or poorly controlled. It is important to note that MERIDIA can increase blood pressure substantially in some people.

• Take monoamine oxidase inhibitors (MAOIs) these are used principally for depression and  Parkinson’s Disease.Examples of this drug: Eldepryl®(selegiline hydrochoride), Parnate®(tranylcypromine sulfate), Nardil®(phenelzine sulfate)).

• Have been prescribed any other weight loss medication that acts on the brain. Example: Phentermine). This must also include over-the-counter and herbal products.

• Have experienced any allergic reaction to MERIDIA or sibutramine.

• Have been diagnosed with coronary artery disease or angina pectoris (heart-related chest pain).

• Suffer from arrhythmia (irregular heart beats).

• Have suffered a heart attack.

• Have been diagnosed with congestive heart failure.

• Suffer from severe kidney or liver disease.

• Have suffered a stroke or displayed symptoms of stroke (transient ischemic attacks [TIAs]).

• Are pregnant or planning to get pregnant.

• Breast-feeding mothers.

• Anyone suffering from any major eating ailment such as anorexia nervosa or bulimia nervosa.

• Anyone under the age of 16 years.

You should consult with your doctor if you have any more questions of concerns regarding your decision to take MERIDIA.

IMPORTANT NOTE: It is extremely important for you to ensure that all your healthcare providers are aware of what medications you might be taking and you medical condition and allergies.

What information about medical conditions should I give my doctor?

Your doctor should be told about your entire medical history; if you take or have taken weight loss drugs previously; any current medical problems or symptoms, what other medications you may be taking or have taken either prescription or over-the-counter medicines and herbal products, and any known allergies to medication.

It is also significant to ensure that your doctor is aware of your status in respect of heart disease of any description, migraine headaches, high blood pressure, gallstones, Parkinson’s disease, osteoporosis, stroke, angina pectoris, disorders of the thyroid,  liver or kidney disease, history of any serious eating disorder such as  anorexia nervosa or bulimia nervosa or any other medical problems you may have experienced.

You have to ensure that your doctor is made aware of any depression in your medical history or if you are using any medication prescribed for depression. For a patient suffering with depression the use of MERIDIA requires extra caution.

If you making use of medication that regulates the neurotransmitter serotonin in the brain e.g. Prozac®, Zoloft®, Effexor®, Luvox, Paxil, or Zyban). Please inform your doctor.

It is also vital if you have suffered seizures, either epilepsy or convulsions; that you inform your doctor as MERIDIA prescribed for patient with seizures requires additional caution. This applies to  glaucoma and any medication that might increase risk of bleeding for example aspirin, clopidogrel, ticlopidine and warfarin

What do I do about follow-up visits to my physician?

Your doctor will inform you of how often he would like see you in the case of regular follow-up visits. During these visits your doctor will monitor body weight and general health as you lose weight and maintain that weight loss.

What other medication might cause problems when taken in conjunction with MERIDIA?

It is not possible to use MERIDIA if you take a prescription medicine containing monoamine oxidase inhibitors (MAOIs). These are used to treat depression or Parkinson’s disease. Registered trade names of drugs containing MAOIs are: Eldepryl®(selegiline hydrochoride), Nardil®(phenelzine sulfate), Parnate®(tranylcypromine sulfate)). NOTE that this is very important as serious and even fatal reactions can occur if MERIDIA is used in conjunction with MAOIs. If you are currently MAOI drugs your doctor will need you to discontinue use for at least two full weeks before commencing MERIDIA therapy.

There is also a rare, but serious, medical condition which requires immediate medical attention, referred to as “serotonin syndrome” that has been reported when a medication such as MERIDIA is used together with drugs that modify serotonin activity, drugs such as: Desyrel®(trazodone hydrochloride) , Effexor®(venlafaxine hydrochloride), Eldepryl®(selegiline hydrochoride), Remeron®(mirtazapine), Serzone®(nefazodone hydrochloride), Wellbutrin®(bupropion hydrochloride), Nardil®(phenelzine sulfate), Parnate®(tranylcypromine sulfate), Paxil®(paroxetine hydrochloride), Prozac®(fluoxetine hydrochloride), Zoloft®(sertraline), Ludiomil®(maprotiline hydrochloride), Adapin®(doxepin hydrochloride), Asendin®(amoxapine), Elavil®(amitriptyline hydrochloride), Etrafon®(amitriptyline hydrochloride, perphenazine), Limbitrol®(chlordiazepoxide, amitriptyline hydrochloride), Norpramin®(desipramine hydrochloride), Pamelor®(nortriptyline hydrochloride), Sinequan®(doxepin hydrochloride), Surmontil®(trimipramine maleate), Tofranil®(imipramine hydrochloride), Triavil®(amitriptyline hydrochloride, perphenazine), Vivactil®(protriptyline hydrochloride), Luvox®(fluvoxamine maleate), Anafranil®(clomipramine hydrochloride)), drugs used for migraine headaches (Imitrex®[sumatriptan succinate]) and dihydroergotamine, pain medication such as Demerol®(meperidine), Duragesic®(fentanyl), and Talwin®(pentazocine); dextromethorphan found in cough medicine; lithium; and an amino acid called tryptophan. Symptoms of serotonin syndrome are: loss of consciousness, restlessness, anxiety or agitation, confusion and disorientation, weakness, tremor, fever, vomiting, shivering, sweating, and increase in heart rate.

MERIDIA’s metabolismcan be affected by ketoconazole (an anti-funga) and even erythromycin (antibiotic). You should ensure that your doctor is aware if you are taking any of these medications prior to using MERIDIA. If you are using MERIDIA therapy and your doctor wants you to use ketoconazole or erythromycin, you must remind him that you are also taking MERIDIA.

Phenylpropanolamine, ephedrine, or pseudoephedrine are contained in many over-the-counter cough and cold medications, and certain allergy products and decongestants, contain ingredients that can increase blood pressure and heart rate. So before you self medicate you must enquire from your doctor if it is suitable to take these particularly if you are taking MERIDIA. Your doctor can advise you what type of cough, cold, decongestant or allergy medicine  will not interact with MERIDIA.

Under what circumstances should I call my doctor if I think I have a problem?

You should call your doctor without delay if you have symptoms or feelings that give you concern for your health or you think it might be a possible side effect. If you experience any of the following symptoms, stop using the MERIDIA and notify your doctor at once: difficulty breathing, tremors, chest pain, angina, rapid or irregular heart beat, restlessness, depression, lightheadedness, blackouts, disorientation, confusion, anxiety, nervousness, loss of coordination, muscle stiffness or rigidity, fever, pain in the eyes or dilated pupils, sweating, abdominal pain, nausea or vomiting, or any other symptoms that may be of concern to you.

Is MERIDIA considered to be a controlled substance?

MERIDIA is definitely a controlled substance and appears on Schedule IV of the Controlled Substances Act (CSA).

What kind of weight loss results have been seen with MERIDIA therapy?

Patients demonstrated noteworthy weight loss in the first 6 months and this weight loss was sustained for one year when on MERIDIA therapy, together with a calorie reduced diet. In twelve month study, average weight loss for subjects using 10mg of MERIDIA daily, was approximately 10 lbs and for those taking 15 mg, also daily , weight loss was about 14 lbs. In comparison, weight loss was only 3Ѕ lbs for the subjects using only a calorie reduced diet.

What are the more common side effects suffered with the use of MERIDIA?

Like all medication, MERIDIA might trigger side effects. The most frequent side effects observed in the clinical studies were: constipation, dry mouth and insomnia. Others might include: headache, sweating, increase in blood pressure and heart rate. These on the whole appear to be mild, and have not made anyone stop MERIDIA treatment. If you develop any of these side effects it is wise to stop taking the MERIDIA and inform your doctor immediately so that they might advise you of what steps to take.

Does MERIDIA have an affect on blood pressure or heart rate?

IN CERTAIN PATIENTS, MERIDIA CAN SIGNIFICANTLY INCREASE BLOOD PRESSURE. IT IS ADVISABLE TO UNDERGO REGULAR BLOOD PRESSURE CHECKS WHEN TAKING MERIDIA.

In scientifically controlled studies, small rises in the blood pressure and heart rate were observed in overweight subjects taking MERIDIA. You must ensure that you visit your doctor for regular visits to monitor your blood pressure and pulse. This should also be measured before commencing MERIDIA treatment. Should an increase in blood pressure or heart rate be observed while taking MERIDIA, your doctor can make the decision to decrease the dose or stop MERIDIA therapy.

If your high blood pressure is controlled by medication or diet, your doctor might decide to prescribe MERIDIA as part of a complete weight-management regime. MERIDIA shouldn’t be used by people suffering from uncontrolled or badly controlled high blood pressure.

Are there any severe side effects that are worth taking special precautions for in the use of MERIDIA?

Some weight-loss medications have been linked to pulmonary hypertension (PPH), this is a rare but occasionally fatal illness. No cases of PPH have been reported from clinical studies conducted on MERIDIA. As this condition is rare, it is not known if MERIDIA is the cause of it.

Symptoms of PPH are shortness of breath. If you encounter new or deteriorating shortness of breath, or any chest pain, fainting, swelling of feet, ankles, or legs, immediately stop taking the MERIDIA, and alert your doctor.

Can MERIDIA cause any damage to the valves of the hearts?

Some drugs for weight loss have been connected with heart valve disease. Subjects in two studies were observed by doctors, and cardiac ultrasound testing was undertaken to investigate heart valve structure and performance. Twenty five patients on one study were examined prior to MERIDIA therapy and again after three months of MERIDIA treatment. None of these patients were suffering from heart valve disease. In a further study, patients were examined who had been treated with either MERIDIA or placebo for time periods of two weeks to 16 months. Three of the 132 subjects (2.3%) on MERIDIA and two out of the 77 subjects (2.6%) who had taken the placebo were discovered to be suffering from heart valve disease.

Will MERIDIA in any way alter the taking of nutritional supplements?

Nutritional supplements such as vitamins, minerals and amino acids (except for tryptophan) may be taken together with MERIDIA. As always your doctor must be advised regarding the nutritional supplements you are taking and the reason for them, and you should not use any herbal or over-the-counter weight-loss preparations.

What is advised when it comes to drinking alcoholic beverages?

MERIDIA might enhance the sedative effect of alcohol. Your doctor should be told what type of and how often, you drink alcoholic beverages. Your doctor will advise you as to whether you can or cannot drink alcohol while taking MERIDIA.

If I drink coffee, tea or caffeinated beverages, will it affect my MERIDIA therapy?

MERIDIA is safe for use with moderate amounts of coffee, tea or caffeinated drinks. Check with your doctor to make ensure that no medical condition exists that might be aggravated by these drinks independently of taking MERIDIA. You should also consult your doctor if you use a great deal of caffeinated drinks or over-the-counter pills containing caffeine.

What will occur if I develop an allergic reaction to MERIDIA

Immediately discontinue MERIDIA and notify your doctor if you develop a skin rash, hives or any allergic reaction.

What about complications if I am pregnant or breastfeeding?

MERIDIA should never be used by while pregnant or nursing. Notify your doctor immediately if are planning to become or become pregnant.

Is there an affect on sexual activity or potential pregnancy?

Women on MERIDIA should take effective birth control precautions. Consult your doctor ascertain whether you are using a  safe and effective birth control method.

Does MERIDIA affect the efficiency of birth control prophylaxis?

Absolutely not.

Is driving a car dangerous and what about work activities?

The ability to drive a car should not be affected by MERIDIA treatment. But you should take care and be alert for any signs of fatigue. Also be particularly careful about the use of alcohol before  driving as MERIDIA can enhance the sedative affect of alcohol.

MERIDIA has been studied in healthy people whose judgement and coordination was not impaired. However, MERIDIA does have the possibility to impair judgment, coordination and motor skills. Please check with your doctor for any questions regarding your work and use of MERIDIA.

How should MERIDIA be used and stored?

Never put MERIDIA in either hot or moist storage areas. It should be kept room temperature, approximately 60 to 85°F. IMPORTANT; keep MERIDIA safely away from children’s reach. Should your child accidentally swallow MERIDIA, immediately talk to your doctor and take the child to the nearest emergency room for urgent medical attention. If you are cannot reach an emergency room, call the poison control center at 1-800-222-1222.

No more MERIDIA, than prescribed by your doctor, should be taken.

Do not ever share MERIDIA with other people or friends.

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