PRANZO 62.5 / 1.25 / 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Pranzo 62.5/1.25/0.5 mg/ml

oral solution

Carnitine hydrochloride

Lysine hydrochloride

Cyproheptadine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

You should consult a doctor if your symptoms worsen or do not improve after 30 days.

Contents of the Package Leaflet

1. What is Pranzo and what is it used for
2. What you need to know before taking Pranzo
3. How to take Pranzo
4. Possible side effects
5. Storage of Pranzo

1. Contents of the pack and further information

1. What is Pranzo and what is it used for

Pranzo is an appetite stimulant medication and is indicated for the symptomatic treatment of anorexia.

2. What you need to know before taking Pranzo

Do not take Pranzo

• If you are allergic to the active substances or to any of the other components of this medication (listed in section 6).
• In case of asthma attack.
• In case of porphyria (hereditary disorder of blood hemoglobin).
• In case of pregnancy or during the breastfeeding period.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pranzo.

• If you have a history of bronchial asthma, hyperthyroidism, cardiovascular disease, hypertension, and increased intraocular pressure.

The good taste of Pranzo may lead children to ingest excessive amounts of the medication, so it is advisable to keep it out of their reach.

Use in children:

Do not administer to children under 2 years of age.

Other medications and Pranzo

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

It is not advisable to take it in combination with barbiturates, benzodiazepines, and other central nervous system depressants, selective serotonin reuptake inhibitors such as fluoxetine, alkalizers, sympathomimetics, oral anticoagulants, estrogens, progesterone, diphenylhydantoin, griseofulvin, and monoamine oxidase inhibitors.

Taking Pranzo with food, drinks, and alcohol

It is not advisable to take this medication in combination with alcoholic beverages.

Pranzo should be taken before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Avoid administering this medication during pregnancy and breastfeeding.

Driving and using machines:

Driving vehicles or operating hazardous or precision machinery is not recommended (may reduce driving ability and reflexes).

Pranzo contains saccharose, ethanol, propyl hydroxybenzoate, sodium salt (E-217), amaranth (E-123), and sodium.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 0.6 g of saccharose per 2 ml dose, or 1.2 g of saccharose per 4 ml dose.

It may cause tooth decay.

This medication contains 97.8 mg of ethanol (alcohol) per 2 ml dose or 195.7 mg of ethanol (alcohol) per 4 ml dose, which is equivalent to 4.89%. The amount of 2 ml of this medication is equivalent to less than 2.5 ml of beer or 1 ml of wine. The amount of 4 ml of this medication is equivalent to 5 ml of beer or 2 ml of wine.

It is unlikely that the amount of alcohol in this medication will have any noticeable effect on adults or adolescents. It may have some effects on small children, such as drowsiness.

The amount of alcohol in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

It may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate, sodium salt (E-217).

This medication may cause allergic reactions because it contains amaranth (E-123). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1 mmol) per ml; that is, it is essentially "sodium-free".

3. How to take Pranzo

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medication is taken using the double dosing spoon of 2 ml and 4 ml.

Take this medication before meals.

Use in adults:

The recommended daily dose is 1 large spoon (4 ml) per 10 kg of body weight.

The total should be divided into 3 or 4 doses per day. Do not exceed more than 5 spoons of 4 ml per day (20 ml).

Use in children:

The recommended daily dose is 1 small spoon (2 ml) per 4 kg of body weight.

As a guideline, the following dosage is recommended:

If your symptoms worsen or persist after 30 days, you should consult a doctor.

If you take more Pranzo than you should

Intoxication, produced only by doses far above the therapeutic ones, causes lethargy and sometimes, on the contrary, convulsions. It should be treated by medical personnel with stomach lavage, sedatives if necessary, and respiratory stimulants.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pranzo

Do not take a double dose to make up for forgotten doses. Take it when you remember and the following doses with the indicated separation (3-4 doses per day).

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The side effects listed below are classified according to their frequency and the classification by organs and systems. The frequency categories are defined by the following convention: very common (affects more than 1 in 10 people); common (affects up to 1 in 100 people); uncommon (affects up to 1 in 1000 people); rare (affects between 1 and 10 in 10000 people); very rare (affects less than 1 in 10000 people); frequency not known (cannot be estimated from the available data).

Common: may affect up to 1 in 10 people:

Drowsiness and somnolence. In children, these effects could be desirable as they reduce emotional tension, often associated with anorexia.

Uncommon: may affect up to 1 in 100 people:

Dry mouth, dizziness, nervousness, weakness, dryness of the mucous membranes, headache, nausea, and allergic skin reactions such as rash and edema.

Rare: may affect up to 1 in 1000 people:

Stimulation of the central nervous system (such as agitation, confusion, visual hallucinations).

In patients with renal insufficiency, the administration of carnitine may cause myasthenia.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Pranzo

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration or if the bottle is open.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pranzo

• The active substances are carnitine hydrochloride, lysine hydrochloride, and cyproheptadine hydrochloride. Each ml of oral solution contains 62.50 mg of carnitine hydrochloride, 1.25 mg of lysine hydrochloride, and 0.50 mg of cyproheptadine hydrochloride.
• The other components (excipients) are: saccharose, 96% ethanol, sodium saccharin, raspberry flavor 5304-A, disodium edetate, potassium sorbate (E-202), propyl hydroxybenzoate, sodium salt (E-217), amaranth (E-123), and purified water.

Appearance of the product and pack contents

Pranzo is a pink oral solution.

It is presented in white opaque plastic bottles with a screw cap and seal, along with a double dosing spoon (2 ml and 4 ml).

The pack contents are 200 ml of oral solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 - Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrent d’en Vidalet, 29

08012 - Barcelona

Spain

Date of the last revision of this package leaflet:May 2010

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/