Package Insert: Information for the User

Neosayomol 20 mg/g Cream

Difenhidramina Hydrochloride

Read this entire package insert carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, 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 package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Neosayomol is a cream composed of an antihistamine, diphenhydramine, which by its mode of action is effective in relieving itching in allergic episodes.

This medication is indicated in adults and children over 6 years old for local symptomatic relief of skin itching and stinging of allergic origin, produced by insect bites, nettles or jellyfish.

Do not use Neosayomol

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Children

Its use should be evaluated in children under 6 years old, as although absorption is very scarce, it may cause dry skin and mouth, pupil dilation, urinary retention, increased heart rate, tremors, speech disorders, hyperactivity, and somnolence.

Older adults (65 years and older)

Its use should be evaluated in people over 65 years old, as they are more sensitive to the adverse effects of this medication.

Use of Neosayomol with other medications

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

Do not use with other medications on the same skin area, or with those known to cause skin allergic reactions (photo-sensitivity and phototoxicity) without consulting your doctor.

Although not expected to be absorbed in large amounts, part of this medication may pass into the bloodstream, so the use of this medication simultaneously with ototoxic medications (such as some antibiotics) may mask the sensation of vertigo and dizziness.

Do not consume alcoholic beverages during treatment, as simultaneous use may increase sedative effects.

The use of this medication with anticholinergic medications (such as antiparkinsonian, some antidepressants, neuroleptics, and belladonna) and with a medication called metoprolol (to reduce blood pressure and heart disease) may increase adverse effects.

The use of this medication with sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics) may cause somnolence.

Interference with laboratory tests

If you are to undergo any laboratory test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Pregnancy, breastfeeding, and fertility

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

Although not expected to be absorbed systemically and pass into breast milk, pregnant women and breastfeeding women should consult their doctor before using this medication.

Driving and operating machinery

Under approved use conditions, it is not expected that this medication will have an influence on the ability to drive and operate machinery.

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

The recommended dose is:

Adults and children over 6 years old

Apply a small amount of medication to the affected area up to a maximum of 3-4 times a day.

If symptoms persist for more than 5 days or worsen, discontinue treatment and consult a doctor.

Use in children

Children 2 to 6 years old:

Children are more prone to the appearance of adverse effects, so consult with your doctor about the use of this medication in children 2 to 6 years old.

Children under 2 years old

Do not use this medication in children under 2 years old.

If you use more Neosayomol than you should

It is very unlikely to experience an overdose with this medication, given its presentation and dosage. However, in the event of excessive or very frequent application, you may notice: dry skin and mouth, pupil dilation, urinary retention, increased heart rate, tremors, speech disorders, psychomotor hyperactivity, sedation, and drowsiness. At high doses, coma, ataxia (coordination problems), increased muscle reflexes, and seizures may appear.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

If you forgot to use Neosayomol

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

Use the dose as soon as possible, or if it is close to the next dose, use it at your regular time, following the normal course of treatment.

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

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

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

During the period of use of difenhidramine in topical use, the following adverse effects have been observed, whose frequency has not been established with exactness:

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medications for Human Use: https://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.

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.

This medication does not require special storage conditions.

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

Composition of Neosayomol

• The active ingredient isdifenhydramine hydrochloride.
• The other components are: menthol, Sepineo P600 (compound consisting of: acrylamide/copolymer of acryloyldimethyltaurate sodium, isohexadecane, polysorbate 80 and purified water), glycerol,isopropyl myristate, calendula oil(compound consisting of: oil of Prunus armeniaca kernel, extract of Calendula officinalis flower and mineral oil),sodium hydroxide and purified water.

Appearance of the product and contents of the packaging

Neosayomol is a bright white cream with a menthol odor.

This medication is presented in a tube containing 30 grams or 60 grams of cream.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

BOHM, S.A.

Molinaseca, 23. Cobo Industrial Estate

28947 Fuenlabrada (Madrid) - Spain

Last review date of this leaflet: February 2022

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

www.aemps.gob.es/