SOÑODOR DIPHENHYDRAMINE 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sonodor Diphenhydramine 50 mg Tablets

Diphenhydramine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Sonodor Diphenhydramine is and what it is used for
2. What you need to know before taking Sonodor Diphenhydramine
3. How to take Sonodor Diphenhydramine
4. Possible side effects

5 Conservation of Sonodor Diphenhydramine

1. Package Contents and Additional Information

1. What Sonodor Diphenhydramine is and what it is used for

Sonodor Diphenhydramine 50 mg tablets are indicated in adults for the symptomatic treatment of occasional insomnia, particularly when there is difficulty falling asleep, such as in situations of restlessness, frequent interruptions during sleep, or early morning waking.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before starting to take Sonodor Diphenhydramine

Do not take Sonodor Diphenhydramine:

• if you are allergic to diphenhydramine hydrochloride or any of the other components of this medication (listed in section 6),
• if you have asthma,
• if you have difficulty breathing,
• if you have chronic pulmonary emphysema (severe lung disease),
• if you have glaucoma (increased intraocular pressure),
• if you have difficulty urinating due to prostate problems,
• if you are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Sonodor Diphenhydramine.

It is recommended to administer the medication only before bedtime. It should not be administered for a period exceeding 7 days, nor to minors under 18 years, unless with medical knowledge or recommendation, as insomnia may be a symptom of a more important disease. If morning somnolence appears, reduce the dose.

Children and Adolescents

Sonodor Diphenhydramine can only be used in young people between 12 and 18 years under medical recommendation.

The safety and efficacy of Sonodor Diphenhydramine have not been established in children under 12 years. No data are available.

Other Medications and Sonodor Diphenhydramine

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

Sonodor Diphenhydramine should not be administered concomitantly with alcohol, sedatives, tranquilizers, or other central nervous system depressants, due to a possible additive effect. MAOI antidepressants (monoamine oxidase inhibitors) may prolong and intensify the anticholinergic effects of diphenhydramine, so if you are being treated with any of them, you should consult your doctor before taking this medication.

Interference with diagnosis: Sonodor Diphenhydramine may interfere with skin tests using allergens. It is recommended to discontinue this medication at least 3 days before starting such tests and inform the doctor.

Taking Sonodor Diphenhydramine with Food, Beverages, and Alcohol

Consuming alcohol along with Sonodor Diphenhydramine may intensify the effect of the medication.

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.

Do not administer during pregnancy, especially during the first and last trimester, unless, in the medical opinion, the benefits justify the potential risks.

Do not administer during breastfeeding.

Driving and Using Machines

Do not drive or operate tools or machines during treatment with Sonodor Diphenhydramine because this medication produces somnolence.

Sonodor Diphenhydramine contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Sonodor Diphenhydramine

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

Sonodor Diphenhydramine is administered orally. Swallow the tablets with the help of some liquid, 20-30 minutes before bedtime.

The recommended dose is:

• Adults: 1 tablet per day (50 mg)

Use in Children and Adolescents

• It can only be used in adolescents between 12 and 18 years under medical recommendation.

Adolescents between 12 and 18 years: The recommended dose is half a tablet per day (25 mg), always under medical recommendation.

The tablets can be divided into two equal halves.

• Do not administer to children under 12 years. The safety and efficacy of Sonodor Diphenhydramine have not been established in children under 12 years. No data are available.

If you take more Sonodor Diphenhydramine than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and quantity ingested.

If you forget to take Sonodor Diphenhydramine

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

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

4. Possible Side Effects

Like all medications, this medication can produce side effects, although not all people experience them.

After administration of diphenhydramine hydrochloride, the following adverse reactions have been reported, whose frequency cannot be established with precision:

Occasionally, diarrhea, anorexia (loss of appetite), stomach discomfort or pain, constipation, difficulty urinating, dizziness, confusion, dry mouth, and blurred vision may occur.

Rarely, tremors, skin rash (skin eruption), and photosensitivity have been described.

Exceptionally, certain blood disorders such as leukopenia, thrombocytopenia, and hemolytic anemia have been described.

In most cases, the reported side effects were mild and did not require discontinuation of treatment.

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 Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sonodor Diphenhydramine

Keep this medication 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 after CAD.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sonodor Diphenhydramine

• The active ingredient is diphenhydramine hydrochloride. Each tablet contains 50 mg of diphenhydramine hydrochloride.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, stearic acid, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Scored tablets for oral administration.

The tablets can be divided into two equal halves.

Sonodor Diphenhydramine is presented in aluminum-polyethylene strips in boxes with 10 and 16 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Urgo S.L. - C/Florida, 29 - 20120 HERNANI (Guipúzcoa) Spain

Date of the Last Revision of this Package Leaflet: 05/2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/