Prospect: information for the user

Desarrol 50 mg/ml + 25mg/ml + 0,2 mg/ml oral solution

hydrochloride of carnitine / arginine aspartate / ciproheptadine hydrochloride

Read this prospect carefully before starting to take the medicine, as 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 to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they do not appear in this prospect. See section 4.

Content of theprospect:

1. What is Desarrol and for what it is used
2. What you need to know before starting to take Desarrol
3. How to take Desarrol
4. Possible adverse effects
5. Storage of Desarrol
6. Contents of the package and additional information

Desarrol belongs to a group of medications known as appetite stimulants.

This medication is indicated for the symptomatic treatment of loss of appetite in adults and children over 2 years old.

Do not take Desarrol

• If you are allergic to ciproheptadina, aspartate arginine, carnitine, or any of the other components of this medication (listed in section 6).
• In cases of asthma attack.
• In children under 2 years.
• If you are pregnant or breastfeeding your child.
• If you have glaucoma (increased pressure inside the eye), enlarged prostate, problems with bile or stomach emptying, or difficulty urinating.
• If you are taking a type of medication called "monoamine oxidase inhibitor" (MAOI) for depression or Parkinson's disease.
• If you have porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in urine and feces).
• If you have severe kidney or liver disease.
• If you have peptic ulcer disease (gastric ulcer).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desarrol.

Do not take this medication continuously for more than 8 weeks.

If symptoms worsen or persist after 4 weeks, stop taking the medication and consult your doctor.

Consult your doctor before starting to take Desarrol:

• If during treatment you experience bruises, bleeding, paleness, fever, or sore throat, consult your doctor.
• If you have ever had asthma, or if you have hypothyroidism, heart disease, hypertension, or increased intraocular pressure.
• If you are taking antibiotics, as antihistamines like ciproheptadina can mask the first signs of ototoxicity that some antibiotics have.
• Some antihistamines can decrease attention capacity, and in children, it may occasionally cause excitement.
• If you have kidney problems, you should consult your doctor because it may be necessary to monitor blood levels of a substance called carnitine.
• If you have kidney problems or are undergoing dialysis.
• If you are diabetic and are being treated with insulin or oral hypoglycemic agents (medications used to treat diabetes), because Desarrol may cause a greater reduction in blood sugar levels. In these cases, your doctor will ask you to perform frequent blood sugar level checks.
• If you are taking medications that reduce blood clotting (anticoagulants) (See section 2 "Other medications and Desarrol" and section 4 "Possible adverse effects").
• If you have a history of seizures.

Interference with diagnostic tests: false negatives may appear in allergy tests and an increase in triglycerides in the blood. If Desarrol is administered with antibiotics, they may interfere with the determination of vitamin B12 values and red blood cell counts, resulting in lower values.

Children

This medication is contraindicated in children under 2 years (see section 2 "Do not take Desarrol").

Special attention should be paid to determining the dose of Desarrol in children over 2 years due to their greater sensitivity to antihistamines.

Overdose of some antihistamines in children can cause nervous system alterations, respiratory and cardiac arrest, and even fatal outcome (see section "If you take more Desarrol than you should").

Other medications and Desarrol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inhibitors of monoamine oxidase (MAO) can potentiate the anticholinergic effects of ciproheptadina (see section "Do not take Desarrol").

Ciproheptadina can potentiate the toxicity of barbiturates, benzodiazepines, and alcohol, as well as other central nervous system depressants. Avoid consuming alcoholic beverages while taking Desarrol.

Ciproheptadina can potentiate the anticholinergic effects of anticholinergic medications (imipramine, clozapine, atropine).

Ciproheptadina can reduce the antidepressant effect of medications such as fluoxetine and paroxetine.

Alkalizing agents, such as ethylenediamine, can potentiate the antihistaminic action of ciproheptadina. Sympathomimetic agents (ephedrine, salbutamol, isoprenaline) inhibit the sedative action of ciproheptadina.

Oral anticoagulants, estrogens, progesterone, phenindione, griseofulvin, also inhibit the antihistaminic action.

The concomitant administration of L-carnitine with medications that induce hypocarnitinemia (e.g., valproic acid, pivoxic acid-containing prodrugs, cephalosporins, cisplatin, carboplatin, and ifosfamide) can reduce L-carnitine availability.

Desarrol may interact with potassium-sparing diuretics, such as amiloride, spironolactone, or triamterene. Arginine administration may produce high potassium levels in the blood, especially in patients with severe liver disease being treated with potassium-sparing diuretics.

In patients treated with coumarin anticoagulants and L-carnitase, isolated cases of increased INR have been reported.

Pregnancy and lactation

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

Do not use Desarrol during pregnancy or lactation.

Driving and operating machinery

Desarrol may cause drowsiness and therefore decrease concentration capacity and reflexes, although this effect usually disappears after a few days of continuous medication administration. Therefore, do not drive vehicles, or handle hazardous or precision machinery while taking this medication.

Desarrol contains sorbitol, sodium, parahydroxybenzoate (E-219), amaranth (E-123), and ethanol.

This medication contains 1750 mg of sorbitol in each 10 ml dose. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication contains 59.5 mg of sodium (main component of table salt/for cooking) in each 10 ml dose, which is equivalent to 3% of the maximum daily sodium intake recommended for an adult.

It may cause allergic reactions (possibly delayed).

It may cause allergic reactions.

This medication contains 4.88 mg of alcohol (ethanol) in each 10 ml dose, which is equivalent to 0.6% ethanol (alcohol). The amount in each 10 ml dose of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medication does not produce any noticeable effect.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is for oral administration.

The recommended dose is:

Adults and adolescents over 14 years:10 ml three times a day. (Equivalent to a total daily dose of ciproheptadina of 5.19 mg). Do not exceed 16 mg of ciproheptadina per day.

Use in children:

Children from2 to4 years:5 ml, three times a day(Equivalent to a total daily dose of ciproheptadina of 2.6 mg). Do not exceed 12 mg of ciproheptadina per day.

Children from4 to6 years:10 ml, two times a day(Equivalent to a total daily dose of ciproheptadina of 3.46 mg). Do not exceed 12 mg of ciproheptadina per day.

Children over 7 years and under 14:10 ml, three times a day(Equivalent to a total daily dose of ciproheptadina of 5.19 mg). Do not exceed 16 mg of ciproheptadina per day.

Patients with renal insufficiency

This medication is contraindicated in patients with severe renal insufficiency

Do not exceed the recommended daily doses.

Administration form

This medication should be administered preferably 30 minutes before the main meals.

If you take more Desarrol than you should

Overdose of some antihistamines in children may cause hallucinations, decreased nervous system function, seizures, respiratory or cardiac arrest, and even a fatal outcome.

In adults, excessive intake of this medication may cause intoxication, characterized by sedation, whose intensity may vary, from mild drowsiness to deep sleep, with muscle weakness and lack of coordination.

In children, intoxication may cause central nervous system stimulation between 30 minutes and 2 hours after ingestion of the product, with hallucinations or seizures and hyperpyrexia.

It may also present dry mouth, dilated pupils, and gastrointestinal alterations such as diarrhea.

Consult your doctor or pharmacist immediately or go to the nearest hospital emergency service. Bring this leaflet with you. You can also call the Toxicological Information Service at Teléfono 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Desarrol

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The adverse reactions are generally mild and transient and are mainly due to ciproheptadina and are characterized by drowsiness or sedation that can be avoided by reducing the dose. Adverse reactions observed with arginine aspartate are mainly gastrointestinal. Anticholinergic effects (dry mouth, constipation, blurred vision, worsening of glaucoma) are more frequent in elderly patients.

In general, after administration of Desarrol, the following side effects have been described:

Frequent (may affect up to 1 in 10 people)

• Effects on metabolism: Increased appetite/weight gain
• Effects on the nervous system: Sedation or drowsiness, more pronounced at the beginning of treatment.
• Gastrointestinal (or digestive) effects:Nausea, vomiting, diarrhea, abdominal pain.

Rare (may affect up to 1 in 1,000 people)

• Psychiatric effects: Excitement, nervousness, restlessness, mental confusion, visual hallucinations, and irritability more frequent in cases of overdose, euphoria.
• Effects on the skin: Erythema (redness of the skin), purpura, sweating, and photosensitivity.

Very rare (may affect up to 1 in 10,000 people)

• Effects on the immune system: In rare cases, angioedema (sudden swelling of the face and neck that can cause respiratory problems), anaphylactic shock (severe allergic reaction).
• Gastrointestinal (or digestive) effects:Abdominal cramps.
• General effects and changes at the administration site: Bad body odor.
• Examinations:Increased International Normalized Ratio in patients treated with coumarin drugs (anticoagulants). (See section 2 "Warnings and precautions" and "Other medicines and Desarrol).

Frequency unknown (cannot be estimated from available data)

• Effects on the blood and lymphatic system: Leukopenia (decrease in white blood cell count), neutropenia (decrease in a type of white blood cell), agranulocytosis (decrease in a type of white blood cell), thrombocytopenia (decrease in platelet count, a type of blood element), hemolytic anemia (decrease in red blood cell count) and thrombocytopenia (decrease in platelet count, a type of blood element) and hematuria (blood in the urine) have been reported.
• Effects on the immune system: Hypersensitivity to some of the components
• Psychiatric effects: Insomnia, agitation, aggressive behavior, altered concentration (decreased concentration), memory alterations (deficit).
• Effects on the nervous system: Motor incoordination, tremors, orthostatic hypotension (decrease in blood pressure when standing), sensation of dizziness, muscle weakness or fatigue (myasthenia), headache, paresthesia (tingling sensation), neuritis (inflammation of the nerves);inpatients with renal insufficiency, the administration of carnitine can cause myasthenia (a disease characterized by muscle weakness).
• Effects on the eyes: Excessive dilation of the pupils (mydriasis), visual accommodation alterations.
• Effects on the ear: Tinnitus (ringing in the ears, buzzing, internal sounds), vertigo (more frequent in elderly patients).
• Effects on the heart: Palpitations, tachycardia, abnormal heart contractions (extrasystoles)
• Respiratory, thoracic, and mediastinal effects: Thickening of bronchial secretions, dryness of mucous membranes (nasal, pharyngeal), nasal congestion.
• Gastrointestinal effects: Dry mouth, epigastric pain, constipation
• Effects on the liver:Liver function alteration (increase in transaminases), liver insufficiency, jaundice (yellow discoloration of the skin and eyes), cholestatic and/or cytolytic hepatitis.
• Effects on the skin:Urticaria
• Renal and urinary effects: Frequent urination, difficulty urinating, urinary retention.
• General effects and effects at the administration site: Fatigue, edema.

Reporting of adverse effects

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

Keep out of 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofDesarrol 50 mg/25mg/0.2 mg/ml oral solution

• The active principles are ciproheptadine hydrochloride, arginine aspartate, and hydrochloride carnitine. Each ml of solution contains 0.2 mg of ciproheptadine hydrochloride, 50 mg of hydrochloride carnitine, and 25 mg of arginine aspartate.
• The other components (excipients) are: sorbitol (E-420), sucrose, methyl parahydroxybenzoate (E-219),raspberry flavor (contains ethanol), sodium hydroxide, amaranth dye (E123), and purified water.

Appearance of the product and contents of the packaging

Desarrol is presented in a glass bottle with a polypropylene/polycarbonate high-density (PP/HDPE) cap with a child-resistant closure, containing 200 ml of oral solution and a dosing cup.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet:February 2025

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