Mosegor jarabe 200 ml

 1. What it is Mosegor and what it is used
The active ingredient is pizotifen Mosegor, which has a stimulating effect on appetite that promotes weight gain in patients with low body weight (whose appetite has been reduced or lost).
Mosegor used to treat loss of appetite in patients with low body weight as an adjunct to treatment of disease causing weight loss.

 2. What you need to know before you start taking Mosegor
Carefully follow the instructions of your doctor. they may differ from the general information in this leaflet.
Do not take Mosegor if you are allergic (hypersensitive) to pizotifen or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Tell your doctor if you have liver problems. This medicine has been associated with some cases of abnormal test results of liver function. You may not notice any symptoms but if you notice that your skin or whites of the eyes turn yellow, urine darkens or have nausea, vomiting and fatigue, tell your doctor immediately. Your doctor may ask you to do a blood test to check and monitor liver function and may tell you to stop treatment if the problem is severe.
If while taking Mosegor the symptoms described above, tell your doctor immediately presented.
- If you have impaired vision due to increased pressure in the eye (signs of narrow-angle glaucoma), unless it has been operated successfully.
- If you suffer from urinary retention (difficulty urinating as in the case of prostate hypertrophy).
- If you have seizures.
If you are in any of the situations described, tell your doctor before taking the medicine.
Mosegor contains ethanol
This product contains 2% of ethanol (alcohol), which corresponds to an amount of 200 mg per 10 ml, equivalent to 4 ml of beer or wine 1.7ml. This medicine is harmful for those suffering from alcoholism. The alcohol content should be considered in the case of pregnant or breastfeeding, children and high-risk populations such as patients with liver disease or epilepsy.

Mosegor contains sucrose
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.

Mosegor contains propyl parahydroxybenzoate and methyl parahydroxybenzoate
It can cause allergic reactions (possibly delayed).

Mosegor contains sorbitol
If your doctor has told you have an intolerance to some sugars, contact your doctor before using this medicine.

Children and adolescents
Mosegor not be given to children under 2 years old.

Mosegor interaction with other medicines
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

It is important that your doctor knows if you are taking:
- Sedatives and hypnotics (tranquilizers, or sleeping medications to treat anxiety) as they may increase the sedative effects of Mosegor.
- Antihistamines (medicines used against allergies or the common cold) as they may increase the sedative effects of Mosegor.
- Cisapride (a medicine used to treat heartburn).

Mosegor with food, drink and alcohol use
Drinking alcohol can increase the sedative effects of this medicine.

Pregnancy
Tell your doctor if you are or plan to become pregnant.
Experience with Mosegor in pregnancy is limited and should only be used in special circumstances, your doctor will discuss with you.

Lactation
You do not take this medication while breastfeeding.

Driving and using machines
This medicine may cause drowsiness, dizziness and other effects on the brain so it should drive and operate machines with caution. If you are sleepy, do not drive or do any activity that requires alert (eg using tools or machines) until you feel well to avoid any risk to you and others.

 3. How to take Mosegor
Follow the instructions exactly Mosegor management provided by your doctor. If in doubt, refer back to your doctor or pharmacist. Do not take a larger dose than prescribed by your doctor.
The initial adult dose is 0.5 mg (10 ml solution) per day, which can gradually be increased to 0.5 mg (10 ml solution) three times a day.

Use in children (aged 2 to 12 years old)
The initial low dose will be increased gradually until a maintenance dose of 0.025 mg / kg per day. The resulting total dose may be divided into 2 or 3 doses a day as prescribed by your doctor.

These are approximate daily dosages:
- Children from 2 to 6 years old: from 5 to 10 ml of solution (0.25 mg to 0.5 mg) in divided doses (over 2 or 3 doses, as directed by your doctor). For example, for children 2 years or 14 kg, 7 ml; for children 3 years or 16 kg, 8 ml; for children 4 years old or 18 kg, 9 ml; for children 5 years or 20 kg, 10 ml; for children 6 years old and weighing less than 23 kg, 10 ml weight.
- Children 6 to 12 years old: from 10 to 20 ml of solution (0.5 mg to 1 mg) in divided doses.
For example, for children 6 years old or over 23 kg, 11 ml; Children 7 years old and weight 26 kg, 13 ml; for children 8 years or 30 kg, 15 ml; for children 9 years or 35 kg, 17 ml; for children 10 to 12 years and weighing about 40 kg, 20 ml.
- In adolescents over 13 years old with a greater than 40 kg body weight, may be administered the same dose as an adult, that is, start with 0.5 mg daily and gradually increase the dose up to 0.5 mg three times a day.

If you take more than you should Mosegor
If accidentally taken too much Mosegor solution, contact your doctor immediately as they may be needed medical care. You can also call the poison control center telephone +34 91 562 04 20 indicating the medicine and the amount taken.

If you forget to take Mosegor
If you miss a dose of Mosegor, it should be taken as soon as possible. If only missing 4 hours or less for the next shot must wait until that meets the time and take the medicine according to the initial regimen. They should not take double dose to make up for a forgotten dose. If in doubt, consult your doctor.

If you stop taking Mosegor
Do not change or stop your medicine without asking your doctor. Your doctor may recommend reducing the dose gradually before stopping treatment. This is done to avoid a worsening of the health and reduce the risk of withdrawal symptoms such as depression, tremors, nausea, anxiety, feeling unwell, dizziness, sleep disorders and weight loss.

 4. Possible side effects
Like all medicines, Mosegor can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are described below:

Some side effects can be serious. If you notice any of these, tell your doctor immediately:
Rare:
· Signs of allergy such as itching, itching or blisters on the skin; swelling of the face.
Very rare:
· Convulsions.
· The skin or whites of the eyes turn yellow, urine darkens and nausea, vomiting and tiredness (signs of jaundice or hepatitis) appear.
Other adverse effects:
Very common:
- Increased appetite, weight gain.
common:
- Drowsiness, fatigue, dizziness, dry mouth, nausea.
Uncommon:
- Constipation.
Rare:
- Depression, excitability, hallucinations (hearing, seeing or hearing things not real), difficulty sleeping, anxiety, feeling insensibility and tingling in the hands and feet, muscle pain.
Not known:
- Muscle cramps.
If you experience side effects, consult your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.

 5. Conservation Mosegor
Keep out of the reach and sight of children.
· Do not use this medicine after the expiry date shown on the box. The expiry date is the last day of that month.
· It does not require any special storage conditions.
· Do not use this medicine if you notice any visible signs of deterioration.

 6. Contents of the pack and other information
Composition Mosegor
- The active substance is pizotifen. 10 ml of solution containing 0.5 mg of pizotifen.
- The other ingredients are: Propyl parahydroxybenzoate (E216) methyl parahydroxybenzoate (E218), citric acid, disodium hydrogen phosphate, 96% ethanol, sucrose, sorbitol 70%, raspberry flavor, aroma of maraschino and purified water.

Looks like and contents of the pack
200 ml bottle and measuring cup.

Holder of the marketing authorization
Artis Pharma, S.L.
Gran Via de les Corts Catalanes, 764 08013 Barcelona

Responsible for manufacturing Novartis Pharmaceuticals, S.A. Santa Maria Ronda, 158
08210 Barcelona

Marketed by
Novartis Pharmaceuticals, S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona

Source: Spanish Agency for Medicines and Health Products

LEAFLET