DESARROL 50 mg/mL + 25 mg/mL + 0.2 mg/mL ORAL SOLUTION

2. What you need to know before taking Desarrol

Do not take Desarrol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desarrol.

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

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

Consult your doctor before starting to take Desarrol:

• If during treatment you experience bruising, bleeding, pallor, 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 cyproheptadine can mask the first signs of auditory toxicity (ototoxicity) that some antibiotics have.
• Some antihistamines can decrease attention and, in children, can sometimes 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 hypoglycemics (medicines used to treat diabetes), as Desarrol may cause a greater reduction in blood sugar levels. In these cases, your doctor will ask you to perform frequent checks on your blood sugar levels.
• If you are taking medicines that reduce blood coagulation (anticoagulants) (see section 2 "Other medicines and Desarrol" and section 4 "Possible side 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, it may interfere with the determination of vitamin B12 and red blood cell values, resulting in lower values.

Children

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

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

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

Other medicines and Desarrol

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

Monoamine oxidase inhibitors (MAOIs) may potentiate the anticholinergic effects of cyproheptadine (see section "Do not take Desarrol").

Cyproheptadine may potentiate the toxicity of barbiturates, benzodiazepines, and alcohol, as well as other central nervous system depressants. Avoid consuming alcoholic beverages while being treated with Desarrol.

Cyproheptadine may potentiate the anticholinergic effects of anticholinergic drugs (imipramine, clozapine, atropine).

Cyproheptadine may reduce the antidepressant effect of medicines such as fluoxetine and paroxetine.

Alkalizing drugs, such as ethylenediamine, may potentiate the antihistamine action of cyproheptadine. Sympathomimetic drugs (ephedrine, salbutamol, isoprenaline) inhibit the sedative action of cyproheptadine.

Oral anticoagulants, estrogens, progesterone, diphenylhydantoin, griseofulvin also inhibit the antihistamine action.

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

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

In patients treated with coumarin anticoagulants and L-carnitine, isolated cases of increased International Normalized Ratio (INR) have been reported.

Pregnancy and breastfeeding

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

Do not use Desarrol during pregnancy or breastfeeding.

Driving and using machines

Desarrol may cause drowsiness and therefore decrease concentration and reflexes, although this effect usually disappears after a few days of continuous administration of the medicine. Therefore, driving vehicles or operating hazardous machinery or precision machinery is not recommended while being treated with this medicine.

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

This medicine contains 1750 mg of sorbitol in each 10 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 your doctor before taking this medicine.

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

It can cause allergic reactions (possibly delayed).

It can cause allergic-type reactions.

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

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

3. How to take Desarrol

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

This medicine 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 cyproheptadine of 5.19 mg). Do not exceed 16 mg of cyproheptadine per day.

Use in children:

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

Children from4 to6 years: 10 ml, twice a day (equivalent to a total daily dose of cyproheptadine of 3.46 mg). Do not exceed 12 mg of cyproheptadine per day.

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

Patient with renal insufficiency

This medicine is contraindicated in patients with severe renal insufficiency.

Do not exceed the recommended daily doses.

Method of administration

This medicine should be administered preferably 30 minutes before main meals.

If you take more Desarrol than you should

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

In adults, excessive intake of this medicine can cause intoxication, characterized by sedation, whose intensity can be variable, from mild drowsiness to deep sleep, with muscle weakness and lack of coordination.

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

It can also cause dry mouth, dilated pupils, and gastrointestinal alterations such as diarrhea.

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Bring this package leaflet with you. You can also call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Desarrol

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Adverse reactions are generally mild and transient and are mainly due to cyproheptadine 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, intestinal 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)

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

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

• Psychiatric effects: Excitement, nervousness, restlessness, mental confusion, hallucinations (visual) 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 effects (or digestive): abdominal cramps.
• General and administration site effects: Body odor.
• Investigations: increased International Normalized Ratio in patients treated with coumarin anticoagulants (see section 2 "Warnings and precautions" and "Other medicines and Desarrol").

Frequency not known (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), hemolytic anemia (decrease in red blood cell count), and some cases of thrombocytopenia (decrease in platelet count) 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 up), dizziness, muscle weakness or fatigue (myasthenia), headache, paresthesia (tingling sensation), neuritis (inflammation of the nerves); in patients with renal insufficiency, the administration of carnitine may cause myasthenia (a disease characterized by muscle weakness).
• Effects on the eyes: Excessive dilation of the pupils (mydriasis), alterations in visual accommodation.
• Effects on the ear: Tinnitus (ringing in the ears, buzzing, internal noises), 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: Alteration of liver function (increase in transaminases), liver failure, jaundice (yellowing 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 and administration site effects: Fatigue, edema.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Desarrol

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofDesarrol 50 mg/25mg/0.2 mg/ml Oral Solution

• The active ingredients are cyproheptadine hydrochloride, arginine aspartate, and carnitine hydrochloride. Each ml of solution contains 0.2 mg of cyproheptadine hydrochloride, 50 mg of carnitine hydrochloride, and 25 mg of arginine aspartate.
• The other ingredients (excipients) are: sorbitol (E-420), sucralose (E-955), methylparaben (E-219), raspberry flavor (contains ethanol), sodium hydroxide, amaranth dye (E123), and purified water.

Appearance of the product and package contents

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

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this package leaflet:February 2025

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.gob.es/