MOSEGOR 0.5 mg/10 ml ORAL SOLUTION

2. What you need to know before taking Mosegor

Follow your doctor's instructions carefully. These may differ from the general information included 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 or have had any of these conditions:

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

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

• if you have vision problems due to increased pressure in the eye (signs of narrow-angle glaucoma), except if you have been successfully operated on.
• if you have 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.

Children and adolescents

Mosegor should not be given to children under 2 years of age.

Interaction of Mosegor with other medicines

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

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

• Sedatives or hypnotics (tranquilizers, sleeping pills, or medications for 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 acidity).

Mosegor with food, drink, and alcohol

Consuming alcohol may increase the sedative effects of this medicine.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are or think you may be pregnant.

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

Breastfeeding

Do not take the medicine while breastfeeding.

Driving and using machines

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

Mosegor contains ethanol

• This medicine 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 medicine is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk populations, such as patients with liver disease or epilepsy.

Mosegor contains sucrose

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

Mosegor contains propyl parahydroxybenzoate and methyl parahydroxybenzoate

• May cause allergic reactions (possibly delayed).

Mosegor contains sorbitol

This medicine 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 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 medicine. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

3. How to take Mosegor

Follow your doctor's instructions for taking Mosegor exactly. If you are unsure, consult your doctor or pharmacist again. Do not take a higher dose than your doctor has indicated.

The initial dose in adults is 0.5 mg (10 ml of the solution) per day, which may 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 may be divided into 2 or 3 daily doses, as prescribed by your doctor.

These are the approximate daily doses:

• Children from 2 to 6 years: 5 to 10 ml of solution (0.25 mg to 0.5 mg) in divided doses (split 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 under 23 kg in weight, 10 ml.
• Children from 6 to 12 years: 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 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 old with a body weight over 40 kg, the same dose as for an adult can be administered, i.e., starting with 0.5 mg per day and gradually increasing the dose to 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 attention may be necessary. You can also call the Toxicology Information Service, phone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mosegor

If you forget to take a dose of Mosegor, take it as soon as possible. If it is only 4 hours or less until the next dose, wait until the scheduled time and take the medicine according to the initial schedule. Do not take a double dose to make up for forgotten doses. If you are unsure, consult your doctor.

If you stop taking Mosegor

Do not change or stop your medication without asking your doctor. Your doctor may recommend gradually reducing the dose before stopping treatment. This is done to avoid worsening your health condition 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 medicine, ask your doctor or pharmacist.

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 may be serious. If you notice any of them, tell your doctor immediately:

Rare:

• Signs of allergy such as itching, pruritus, or blisters on the skin; swelling of the face.

Very rare:

• Seizures.

Frequency not known:

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

Other side effects:

Very common:

• Increased appetite, weight gain.

Common:

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

Uncommon:

• Constipation.

Rare:

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

Frequency not known:

• Muscle cramps.

If you experience side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Mosegor

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month stated.
• No special storage conditions are required.
• Do not use this medicine if you notice visible signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mosegor

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

Appearance of the product and pack contents

Bottle with 200 ml and dosing cup.

Marketing authorization holder

ETHYX PHARMACEUTICALS

19 rue Duquesne

69006 Lyon

France

Manufacturer

DELPHARM ORLEANS

5 avenue de concyr

45071 Orleans

France

This leaflet was approved in

May 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/