Pranzo 62,5 / 1,25 / 0,5 mg/ml solucion oral

Label: information for the user

Pranzo 62.5/1.25/0.5 mg/ml

oral solution

Hydrochloride carnitine

Lysine hydrochloride

Ciproheptadine hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

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

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

6. Contents of the pack and additional information

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

Do not take Pranzo

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• In case of asthma attack.
• In case of porphyria (a hereditary disorder of the blood's hemoglobin).
• During pregnancy or while breastfeeding.
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pranzo.

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

The good taste of Pranzo may induce 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 old.

Other medications and Pranzo

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

It is not advisable to take it together with barbiturates, benzodiazepines, and other central nervous system depressants, selective serotonin reuptake inhibitors such as fluoxetine, alkalinizers, sympathomimetics, oral anticoagulants, estrogens, progesterone, phenytoin, griseofulvin, and MAO inhibitors.

Pranzo intake with food, drinks, and alcohol

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

Pranzo should be taken before meals.

Pregnancy, breastfeeding, and fertility

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

Avoid administering this medication during pregnancy and breastfeeding.

Driving and operating machinery:

It is not recommended to drive vehicles, or operate hazardous or precision machinery (it may reduce driving ability and reflexes).

Pranzo contains saccharose, ethanol, propylparaben, sodium chloride (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 him before taking this medication.

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

It may cause tooth decay.

This medication contains 97.8 mg of ethanol (alcohol) per dose of 2 ml or 195.7 mg of ethanol (alcohol) per dose of 4 ml, which is equivalent to a 4.89% concentration.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 contained in this medication will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

The amount of alcohol contained 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 propylparaben, sodium chloride (E-217).

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

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

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

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

Take this medication before meals.

Use in adults:

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

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

Use in children:

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

As a guideline, the following dosing schedule is recommended:

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

If you take more than you should

Intoxication, produced only by very high doses above the therapeutic dose, causes drowsiness and sometimes, contrarily, convulsions. It must be treated by qualified personnel with stomach washes, sedatives if necessary, and respiratory stimulants.

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

If you forgot to take Pranzo

Do not take a double dose to compensate for the missed doses. Take it when you remember and the next 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.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The adverse effects listed below are classified according to their frequency and by organ and system. 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 10,000 people); very rare (affects fewer than 1 in 10,000 people); frequency not known (cannot be estimated from available data).

Common: may affect up to 1 in 10 people:

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

Uncommon: may affect up to 1 in 100 people:

Mouth dryness, dizziness, nervousness, weakness, dry mucous membranes, headache, nausea, and dermatological allergic manifestations such as rash and edema.

Rare: may affect up to 1 in 1000 people:

Central nervous system stimulation (such as agitation, confusion, visual hallucinations).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pranzo

• The active principles are hydrochloride of carnitine, hydrochloride of lysine and hydrochloride of ciproheptadine. Each milliliter of oral solution contains 62.50 mg of hydrochloride of carnitine, 1.25 mg of hydrochloride of lysine and 0.50 mg of hydrochloride of ciproheptadine.
• The other components (excipients) are: saccharose, ethanol at 96 percent, sodium saccharin, raspberry essence 5304-A, disodium edetate, potassium sorbate (E-202), propyl parahydroxybenzoate, sodium chloride (E-217), amaranth (E-123) and purified water.

Appearance of the product and contents of the packaging

Pranzo is an oral solution of pink color.

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 contents of the packaging are 200 ml of oral solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Viñas, S.A.

Provenza, 386

08025 - Barcelona

Spain

Responsible for manufacturing

Laboratorios Viñas, S.A.

Torrent d’en Vidalet, 29

08012 - Barcelona

Spain

Last review date of this prospectus:May 2010

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