Prospect: information for the user

DYNAMOGÉN 3 mg/1 g/10ml oral solution

?-cetoglutarato de ciproheptadina/aspartato de arginina

Read this prospect carefully before starting to take this medication, 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 medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect

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

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

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

Do not take Dynamogén

• if you are allergic to ciproheptadina, aspartate, arginine, or any of the other components of this medication (listed in section 6).
• in children under 2 years old.
• if you have a severe kidney or liver disease.
• in cases of asthma crisis.
• if you are pregnant or breastfeeding.
• 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dynamogén.

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

• if during treatment you experience bruises, bleeding, paleness, fever, or sore throat, consult your doctor.
• Consult your doctor if you are taking antibiotics, as antihistamines like ciproheptadina can mask the first signs of auditory toxicity that some antibiotics have.
• Consult your doctor before taking this medication if you have high pressure inside the eye (high intraocular pressure), an overactive thyroid gland, high blood pressure, heart problems, or asthma.
• Special attention should be paid to determining the dose of Dynamogén in children over 2 years old due to increased sensitivity to antihistamines in this population.
• Some antihistamines can decrease attention capacity, and in children, it may occasionally produce excitement.
• Overdose of some antihistamines in children can produce alterations in the nervous system, respiratory and cardiac arrest, and even fatal outcome (see the section “If you take more Dynamogén than you should”).

Other medications and Dynamogén

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even those purchased without a prescription.

Consult your doctor if you are taking a type of medication called “Monoamine Oxidase Inhibitors” (MAOI), oral contraceptives, or central nervous system depressants such as alcohol, benzodiazepines, or barbiturates.

Dynamogén may reduce the effect of some antidepressants.

Interference with diagnostic tests: may appear false negatives in allergy tests and an increase in blood triglycerides. If Dynamogén is administered with antibiotics, false negatives may appear in vitamin B12values and red blood cell count.

Pregnancy and lactation

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

Do not use Dynamogén during pregnancy or lactation.

Driving and operating machinery

Dynamogén 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 operate hazardous or precision machinery while on treatment with this medication.

Dynamogén contains sacarose, sorbitol (E-420) and amaranth colorant (E-123)

This medication contains sacarose and sorbitol (E-420). If your doctor has indicated 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 3.575g of sacarose per 10 ml ampoule.

It may cause a mild laxative effect because it contains 3.41g of sorbitol per 10ml ampoule.

Caloric value: 2.6Kcal/g of sorbitol.

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

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 administered orally.

The recommended dose is:

Adults and adolescents over 14 years old: 1 drinkable ampoule 3 times a day. Each ampoule contains 2mg of ciproheptadina which is equivalent to 6 mg per day. Do not exceed 16mg of ciproheptadina per day.

Use in children

Children from 2 to 6 years old: 1 drinkable ampoule 2 times a day (equivalent to a total daily dose of 4mg of ciproheptadina). Do not exceed 12mg of ciproheptadina per day.

Children over 7 years and under 14: 1 drinkable ampoule 2 or 3 times a day or distributed in several administrations (equivalent to a total daily dose of 4 or 6mg of ciproheptadina). Do not exceed 16mg of ciproheptadina per day.

Do not exceed the recommended daily doses.

Administration form

The ampoules should be administered preferably 30 minutes before the main meals. The content of the ampoule can be taken alone or with water or fruit juice.

To administer this medication correctly, follow the instructions indicated below:

If you take more Dynamogén than you should

The overdose of some antihistamines in children can produce hallucinations, decreased nervous system functions, convulsions, respiratory or cardiac arrest, and even a fatal outcome.

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

If you forgot to take Dynamogén

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

If you interrupt the treatment with Dynamogén

If you have any other doubt 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.

Adverse reactions are generally mild and transient and are mainly due to ciproheptadina. Adverse reactions observed with arginine aspartate are mainly gastrointestinal. Anticholinergic effects (dry mouth, constipation, blurred vision, worsening of glaucoma) are more frequent in elderly subjects.

After administration of Dynamogén, the following side effects have been described in general:

Frequent (can affect up to 1 in 10 people)

Rare (can affect up to 1 in 100 people)

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

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

Unknown frequency (cannot be estimated from available data)

Blood and lymphatic system disorders

Unknown frequency:

Immune system disorders

Unknown frequency:

Very rare:

Metabolism and nutrition disorders

Frequent:

Mental and behavioral disorders

Rare::

Unknown frequency:

Nervous system disorders

Frequent:

Unknown frequency::

Eye disorders

Unknown frequency:

Ear and labyrinth disorders

Unknown frequency:

Cardiac disorders

Unknown frequency:

Respiratory, thoracic, and mediastinal disorders

Unknown frequency:

Gastrointestinal disorders

Frequent:

Unknown frequency::

Hepatobiliary disorders

Unknown frequency:

Skin and subcutaneous tissue disorders

Rare:

Renal and urinary disorders

Unknown frequency:

General disorders and administration site conditions

Unknown frequency::

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Dynamogén 3 mg/1 g/10ml oral solution

• The active principles are arginine aspartate and ? -cetoglutarate of ciproheptadine. Each 10 ml ampoule contains 1 g of arginine aspartate and 3 mg of ( ? -cetoglutarate of ciproheptadine (equivalent to 2 mg of ciproheptadine).
• The other components are: sorbitol (E-420) (solution to 70%), sucrose, potassium sorbate (E-202), raspberry flavor, hydrochloric acid, amaranth colorant (E-123) and purified water.

Appearance of the product and content of the packaging

Dynamogén is presented in drinkable ampoules containing 10 ml of solution for oral administration. Each package contains 20 ampoules.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

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 2024

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/