Desarrol 50 mg/ml + 25 mg/ml + 0.2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desarrol 50 mg/ml + 25 mg/ml + 0.2 mg/ml oral solution

hydrochloride carnitine / arginine aspartate / ciproheptadine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Desarrol is and what it is used for
2. What you need to know before taking Desarrol
3. How to take Desarrol
4. Possible adverse effects
5. How to store Desarrol
6. Contents of the pack and other information

1. What Desarrol is and what it is used for

Desarrol belongs to a group of medicines called appetite stimulants.

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

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 ingredients of this medicine (listed in section 6).
• During an asthma attack.
• 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 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 disorder, usually inherited, in which large amounts of porphyrins are excreted in urine and feces).
• If you have severe kidney or liver disease.
• If you have peptic ulcer disease (peptic ulcer).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Desarrol.

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

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

Talk to your doctor before starting Desarrol if:

• During treatment you develop bruising, bleeding, paleness, fever, or sore throat, consult your doctor.
• You have ever had asthma, or if you have hypothyroidism, heart disease, hypertension, or increased intraocular pressure.
• You are taking antibiotics, as antihistamines such as cyproheptadine may mask the early signs of auditory toxicity (ototoxicity) caused by some antibiotics.
• Some antihistamines may reduce attention span, and in children, may occasionally cause excitation.
• If you have kidney problems, you should consult your doctor, as it may be necessary to monitor blood levels of a substance called carnitine.
• If you have renal problems or are undergoing dialysis.
• If you are diabetic and are being treated with insulin or oral hypoglycemics (medicines used to treat diabetes), because Desarrol could cause a greater reduction in blood sugar levels. In these cases, your doctor may ask you to perform frequent blood sugar monitoring.
• If you are taking medicines that reduce blood clotting (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 occur in allergy tests, and an increase in blood triglycerides may be observed. If Desarrol is administered with antibiotics, it may interfere with the determination of vitamin B12 levels and red blood cell count, leading to lower values.

Children

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

Special care must be taken when determining the dose of Desarrol in children over 2 years of age due to their increased sensitivity to antihistamines.

Overdose of some antihistamines in children may cause disturbances of the nervous system, respiratory and cardiac arrest, even resulting in death (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 might need to use any other medicines.

Monoamine oxidase inhibitors (MAOIs) may enhance the anticholinergic effects of cyproheptadine (see section “Do not take Desarrol”).

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

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

Alkalinizing agents such as ethylenediamine may enhance the antihistaminic action of cyproheptadine. Sympathomimetic drugs (ephedrine, salbutamol, isoprenaline) inhibit the sedative effect of cyproheptadine.

Oral anticoagulants, estrogens, progesterone, phenytoin, and griseofulvin may also inhibit the antihistaminic effect.

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 could interact with potassium-sparing diuretics such as amiloride, spironolactone, or triamterene. Administration of arginine could lead to high blood potassium levels, especially in patients with severe liver disease who are being treated with potassium-sparing diuretics.

In patients treated with coumarin anticoagulants and L-carnitinase, 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 while breastfeeding.

Driving and using machines

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

Desarrol contains sorbitol, sodium, methyl parahydroxybenzoate (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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder 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/cooking salt) in each 10 ml dose. This corresponds to 3% of the maximum daily sodium intake recommended for an adult.

It may cause allergic reactions (possibly delayed).

It may 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 contained in this medicine does not produce any noticeable effect.

3. How to take Desarrol

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is for oral administration.

The recommended dose is:

Adults and adolescents over 14 years of age: 10 ml three times a day (equivalent to a total daily dose of ciproheptadine of 5.19 mg). Daily doses must not exceed 16 mg of ciproheptadine.

Use in children:

Children aged 2 to 4 years: 5 ml, three times a day (equivalent to a total daily dose of ciproheptadine of 2.6 mg). Daily doses must not exceed 12 mg of ciproheptadine.

Children aged 4 to 6 years: 10 ml, twice a day (equivalent to a total daily dose of ciproheptadine of 3.46 mg). Daily doses must not exceed 12 mg of ciproheptadine.

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

Patients with renal impairment

This medicine is contraindicated in patients with severe renal impairment.

Recommended daily doses must not be exceeded.

Method of administration

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

If you take more Desarrol than you should

Overdose of some antihistamines in children may cause hallucinations, depression of central nervous system functions, seizures, respiratory or cardiac arrest, and may even be fatal.

In adults, excessive intake of this medicine may cause intoxication characterized by sedation, which may vary in intensity from mild drowsiness to deep sleep, accompanied by muscle weakness and lack of coordination.

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

Dry mouth, dilated pupils, and gastrointestinal disturbances such as diarrhea may also occur.

Seek immediate advice from your doctor or pharmacist, or go to the nearest hospital emergency department. Take this leaflet with you. You may also call the Toxicology Information Service at telephone number 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse reactions are generally mild and transient, mainly due to ciproheptadine, and are characterized by drowsiness or sedation, which 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, following administration of Desarrol, the following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people)

• Effect 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: Excitation, nervousness, restlessness, confusion, hallucinations (visual), irritability—more frequent in cases of overdose—and euphoria
• Skin reactions: Erythema (redness of the skin), purpura, sweating, photosensitivity

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

• Effects on the immune system: In very rare cases, angioedema (sudden swelling of the face and neck that may cause breathing difficulties), anaphylactic shock (severe allergic reaction)
• Gastrointestinal (or digestive) effects: Abdominal cramps
• General effects and administration site alterations: Body odor
• Investigations: Increase in International Normalized Ratio (INR) in patients treated with coumarin drugs (anticoagulants). (See section 2 “Warnings and precautions” and “Other medicines and Desarrol”)

Frequency not known (cannot be estimated from available data)

• Effects on blood and lymphatic system: Leucopenia (decreased number of white blood cells), neutropenia (decrease in a type of white blood cells), agranulocytosis (decrease in a type of white blood cells), thrombocytopenia (decreased number of platelets, components of blood), hemolytic anemia (decreased number of red blood cells), and cases of thrombocytopenia (decreased number of platelets, components of blood) and hematuria (blood in urine) have been reported
• Effects on the immune system: Hypersensitivity to some of the components
• Psychiatric effects: Insomnia, agitation, aggressive behavior, altered concentration (decreased attention), memory disturbances (deficit)
• Effects on the nervous system: Motor incoordination, tremors, orthostatic hypotension (drop in blood pressure upon standing), dizziness, muscle weakness or fatigue (myasthenia), headache, paresthesia (tingling sensation), neuritis (nerve inflammation); in patients with renal insufficiency, administration of carnitine may cause myasthenia (a disease characterized by muscle weakness)
• Eye effects: Excessive pupil dilation (mydriasis), disturbances in visual accommodation
• Ear effects: Tinnitus (ringing in the ears, buzzing, internal noises), vertigo (more frequent in elderly patients)
• Heart effects: Palpitations, tachycardia, abnormal heartbeats (extrasystoles)
• Respiratory, thoracic and mediastinal effects: Thickening of bronchial secretions, dryness of mucous membranes (nasal, pharyngeal), nasal congestion
• Gastrointestinal effects: Dry mouth, stomach discomfort (epigastric pain), constipation
• Liver effects: Liver function abnormalities (increased transaminases), liver failure, jaundice (yellowing of the skin and eyes), cholestatic and/or cytolytic hepatitis
• Skin effects: Urticaria
• Renal and urinary effects: Urinary frequency, difficulty urinating, urinary retention
• General effects and administration site reactions: 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desarrol

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desarrol 50 mg/25 mg/0.2 mg/ml oral solution

• The active substances are ciproheptadine hydrochloride, arginine aspartate and carnitine hydrochloride. Each ml of solution contains 0.2 mg of ciproheptadine hydrochloride, 50 mg of carnitine hydrochloride and 25 mg of arginine aspartate.
• The other components (excipients) are: sorbitol (E-420), sucralose (E-955), methyl parahydroxybenzoate (E-219), raspberry flavour (containing ethanol), sodium hydroxide, amaranth dye (E123) and purified water.

Appearance of the product and contents of the pack

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

Marketing Authorisation Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Scientific and Technological Park of Bizkaia

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/