Soñodor diphenhydramine 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Soñodor diphenhydramine 50 mg tablets

Diphenhydramine hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

Contents of the leaflet

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

1. What Soñodor diphenhydramine is and what it is used for

Soñodor 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 awakening.

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

2. What you need to know before starting to take Soñodor diphenhydramine

Do not take Soñodor diphenhydramine:

• if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (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 Soñodor diphenhydramine.

Administration of the medicine is recommended only before going to bed. It should not be used for longer than 7 days, nor in individuals under 18 years of age, unless under medical advice or recommendation, as insomnia may be a symptom of a more serious underlying condition. If drowsiness occurs the following morning, reduce the dose.

Children and adolescents

Soñodor diphenhydramine may only be used in individuals aged 12 to 18 years under medical recommendation.

The safety and efficacy of Soñodor diphenhydramine have not been established in children under 12 years of age. No data are available.

Other medicines and Soñodor diphenhydramine

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Soñodor diphenhydramine should not be taken together 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; therefore, if you are being treated with any of these, you must consult your doctor before taking this medicine.

Interference with diagnosis: Soñodor diphenhydramine may interfere with skin tests using allergens. It is recommended to discontinue this medication at least 3 days before such tests and to inform your doctor.

Taking Soñodor diphenhydramine with food, drinks and alcohol

Consumption of alcohol together with Soñodor diphenhydramine may enhance the effect of the medicine.

Pregnancy, breastfeeding and fertility

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

Do not administer during pregnancy, especially during the first and last trimester, unless, according to medical judgment, the benefits outweigh the possible risks.

Do not administer during breastfeeding.

Driving and use of machines

Do not drive or operate tools or machinery while being treated with Soñodor diphenhydramine, as this medicine causes drowsiness.

Soñodor diphenhydramine contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Soñodor diphenhydramine

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

Soñodor diphenhydramine is administered orally. Swallow the tablets with liquid, 20-30 minutes before going to bed.

The recommended dose is:

• Adults: 1 tablet per day (50 mg)

Use in children and adolescents

• May only be used in adolescents between 12 and 18 years of age 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 may be divided into two equal halves.

• Do not administer to children under 12 years of age. The safety and efficacy of Soñodor diphenhydramine has not been established in children under 12 years of age. No data available.

If you take more Soñodor diphenhydramine than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medication and amount ingested.

If you forget to take Soñodor diphenhydramine

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 may produce adverse effects, although not everyone experiences them.

After administration of diphenhydramine hydrochloride, the following adverse reactions have been reported, although their frequency cannot be precisely determined:

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, and photosensitivity have been reported.

Very rarely, certain blood disorders have been reported, such as leucopenia, thrombocytopenia, and haemolytic anaemia.

In most cases, the adverse effects reported have been mild and have not required discontinuation of treatment.

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Soñodor Diphenhydramine

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Soñodor diphenhydramine

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

Appearance of the product and contents of the pack

Orally administered scored tablets.

The tablets can be divided into two equal halves.

Soñodor diphenhydramine is available in aluminum-polyethylene blisters, packed in cartons containing 10 and 16 tablets.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent revision of this leaflet: 05/2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/