Prospect: information for the user

Mosegor0.5 mg/10 ml oral solution

pizotifeno

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they present the same symptoms of illness as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What is Mosegor and for what it is used

2.What you need to know before starting to take Mosegor

3.How to take Mosegor

4.Possible adverse effects

5.Storage of Mosegor

6.Contents of the package and additional information

The active ingredient of Mosegor is pizotifeno, which has a stimulating effect on appetite that promotes weight gain in patients with low body weight (whose appetite has decreased or they have lost it).

Mosegor is used for the treatment of appetite loss in patients with low body weight as a complement to the treatment of the disease that causes weight loss.

Follow your doctor's instructions carefully. These may differ from the general information included in this prospectus.

Do not take Mosegor

• if you are allergic (hypersensitive) to pizotifeno or any of the other components of this medication (listed in section 6).

Warnings and precautions

Inform your doctor if you have or have had any of the following conditions:

• if you have liver problems. This medication has been associated with some abnormal results in liver function tests. You may not notice any symptoms, but if you observe that your skin or the white of your eyes turn yellow, your urine darkens, or you experience nausea, vomiting, and fatigue, inform your doctor immediately. Your doctor may ask you to have a blood test to check and monitor liver function and may tell you to discontinue treatment if the problem is severe.

If you experience the symptoms described above while taking Mosegor,inform your doctor immediately.

• if you have vision problems due to increased eye pressure (signs of narrow-angle glaucoma), except if you have been successfully operated on.
• if you have urinary retention (difficulty urinating, such as in the case of prostate hypertrophy).
• if you experience seizures.

If you find yourself in any of the described situations, inform your doctor before taking the medication.

Children and adolescents

Mosegor should not be administered to children under 2 years old.

Mosegor interactions with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is essential that your doctor knows if you are taking:

• Sedatives or hypnotics (tranquilizers, sleep medications, or anxiety medications) as they may increase the sedative effects of Mosegor.
• Antihistamines (medications used to treat allergies or the common cold) as they may increase the sedative effects of Mosegor.
• Cisaprida (medication used to treat acid reflux).

Mosegor with food, drink, and alcohol

Consuming alcohol may increase the sedative effects of this medication.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are or think you may become pregnant.

The experience with Mosegor in pregnancy is limited, so it should only be used in special circumstances, which your doctor will discuss with you.

Breastfeeding

You should not take the medication while breastfeeding.

Driving and operating machinery

This medication may cause drowsiness, dizziness, and other effects on the brain, so you should drive and operate machinery with caution. If you feel sleepy, do not drive or perform any activity that requires alertness (such as using tools or machinery) until you feel well to avoid any risk to yourself and others.

Mosegor contains ethanol

• This medication contains 2% ethanol (alcohol), which corresponds to 200 mg per 10 ml, equivalent to 4 ml of beer or 1.7 ml of wine. This medication is harmful to people with alcoholism.The ethanol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk populations, such as patients with liver disease or epilepsy.

Mosegor contains saccharose

• If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

Mosegor contains propylparahydroxybenzoate and methylparahydroxybenzoate

• It may cause allergic reactions (possibly delayed).

Mosegor contains sorbitol

This medication contains 10 g of sorbitol per 20 ml dose. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Follow exactly the administration instructions for Mosegor indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take a dose greater than the one your doctor has indicated.

The initial dose in adults is 0.5 mg (10 ml of the solution) per day, which can be gradually increased to 0.5 mg (10 ml of the solution) three times a day.

Use in children (from 2 to 12 years)

Low initial doses will be gradually increased to reach a maintenance dose of 0.025 mg/kg per day. The resulting total dose can be divided into 2 or 3 doses per day, as prescribed by your doctor.

These are the approximate daily doses:

• Children from 2 to 6 years: from 5 to 10 ml of solution (0.25 mg to 0.5 mg) in divided doses (divided into 2 or 3 doses, as indicated by the doctor). For example, for children 2 years old or 14 kg in weight, 7 ml; for children 3 years old or 16 kg in weight, 8 ml; for children 4 years old or 18 kg in weight, 9 ml; for children 5 years old or 20 kg in weight, 10 ml; for children 6 years old and weighing less than 23 kg, 10 ml.
• Children from 6 to 12 years: from 10 to 20 ml of solution (0.5 mg to 1 mg) in divided doses. For example, for children 6 years old or more than 23 kg in weight, 11 ml; for children 7 years old or 26 kg in weight, 13 ml; for children 8 years old or 30 kg in weight, 15 ml; for children 9 years old or 35 kg in weight, 17 ml; for children 10 to 12 years old or approximately 40 kg in weight, 20 ml.

In adolescents over 13 years with a body weight greater than 40 kg, the same dose as an adult can be administered, i.e., start with 0.5 mg per day and gradually increase the dose to reach 0.5 mg three times a day.

If you take more Mosegor than you should

If you have accidentally taken too much Mosegor solution, contact your doctor immediately, as medical care may be necessary. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Mosegor

If you forget to take a dose of Mosegor, it should be taken as soon as possible. If only 4 hours or less remain until the next dose, wait until the hour is up and take the medication according to the initial schedule. Do not take double doses to compensate for the missed doses. If you have doubts, consult your doctor.

If you interrupt the treatment with Mosegor

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

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Mosegor can produce adverse effects, although not everyone will experience them.

These adverse effects may occur at certain frequencies, which are described below:

Some adverse effects may be severe. If you notice any of them, inform your doctor immediately:

Rare:

• Allergic symptoms such as itching, prickling, or blisters on the skin; facial swelling.

Very Rare:

• Seizures.

Unknown Frequency:

• The skin or the whites of the eyes turn yellow, urine darkens, and nausea, vomiting, and fatigue occur (signs of jaundice or hepatitis).

Other Adverse Effects:

Very Frequent:

• Increased appetite, weight gain.

Frequent:

• Drowsiness, fatigue, dizziness, dry mouth, nausea.

Infrequent:

• Constipation.

Rare:

• Depression, excitability, hallucinations (hearing, seeing, or feeling things that are not real), difficulty sleeping, anxiety, tingling and numbness in the hands and feet, muscle pain.

Unknown Frequency:

• Muscle cramps.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

• Keep out of reach and sight of children.
• Do not usethis medicationafter the expiration date that appears onthe box. Theexpiration date is the last day of the month indicated.
• No special storage conditions are required.
• Do not use this medication if you observe visible signs of deterioration.
• Medicines should not be throwndown the drains or intothe trash. Disposeof the packaging and unused medications at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofMosegor

• The active principle is pizotifeno. Each 10 ml of solution contains 0.5 mg of pizotifeno.
• The other components are:propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), citric acid, disodium hydrogen phosphate, 96% ethanol, sucrose, 70% sorbitol, raspberry flavor, cherry flavor, and purified water.

Appearance of the product and contents of the packaging

Bottle with 200 ml and measuring cup.

Holder of the marketing authorization

ETHYX PHARMACEUTICALS

19 rue Duquesne

69006 Lyon

France

Responsible for manufacturing

DELPHARM ORLEANS

5 avenue de concyr

45071 Orleans

France

This leaflet has been approved in

May 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http:/www.aemps.es/