Prospect: Information for the Patient

Dormigen 25 mg Film-Coated Tablets

Hidrogenosuccinato de doxilamina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this prospect, 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 not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

1. What is Dormigen and for what it is used

2. What you need to know before starting to takeDormigen

3. How to takeDormigen

4. Possible adverse effects

5. Storage of Dormigen

6. Contents of the package and additional information

It is a medication that contains the active ingredient doxylamine hydrogenosuccinate.

Doxylamine belongs to a group of medications called antihistamines that have sedative properties.

This medication is indicated for the short-term symptomatic treatment of occasional insomnia in individuals over 18 years old.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Dormigen:

• If you are allergic to doxilamina or any of the other components of this medication (listed in section 6),
• If you are allergic to other antihistamines (antiallergics),
• If you are breastfeeding.
• If you suffer from respiratory disorders such as asthma, chronic bronchitis (persistent cough producing mucus and phlegm) or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (high eye pressure).
• If you have benign prostatic hyperplasia (abnormal enlargement of the prostate), urethral obstruction (disease of the urinary tract) or difficulty urinating.
• If you have gastric or intestinal wall erosion or pyloric duodenal obstruction (difficulty passing food from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors.
• If you are taking medications such as antidepressants, certain antibiotics, medications affecting the heart, such as those used to treat arrhythmias, certain antivirals and medications used to treat fungal infections, some medications that reduce lipid content (fats) in the blood or quinidine (a medication used to treat seizures).
• If you have severe kidney or liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormigen. You should consult a doctor before starting to take this medication if you have:

• Mild to moderate liver and kidney function impairment, as it may be necessary to adjust the dose.
• Epilepsy (in some cases, antihistamines can cause hyperexcitability and may therefore reduce the seizure threshold)
• Prolongation of the QT interval (a heart problem that causes a sudden change in heart rate during exercise or in situations of stress).
• Low potassium levels in the blood or other electrolyte imbalances,
• Heart disease and high blood pressure

If you experience daytime somnolence, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass before waking up.

- If you are taking other medications that cause ototoxicity, such as carboplatin or cisplatin (cancer medications), chloroquine (malaria treatment or prevention medication) and some antibiotics (infection medications), such as erythromycin or aminoglycosides, doxilamina may mask the toxic effects of these medications, so you should regularly check your ear status.

- Doxilamina may exacerbate dehydration and heatstroke symptoms due to decreased sweating, especially in hot weather.

- Avoid consuming alcoholic beverages during treatment.

- If you are over 65 years old, you may be more susceptible to side effects. Therefore, pay attention to the effects of treatment (see section 4).

- Avoid consuming grapefruits while taking doxilamina.

- Avoid taking medications such as phenytoin, digoxin, warfarin, lithium, aminoglycosides and vancomycin with doxilamina, as they may cause acute poisoning.

Children and adolescents

Do not recommend the administration of Doxilamina Dormigen to children under 18 years old.

Other medications and Dormigen

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

Do not take doxilamina with the following medications:

- Monoamine oxidase inhibitors (e.g., medications used to treat depression, Parkinson's disease or other diseases, such as moclobemide, phenelzine and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline and selegiline.

- Medications affecting the heart, such as those used to treat arrhythmias (amiodarone), some macrolide antibiotics (clarithromycin, erythromycin and telithromycin), certain medications used to reduce lipid content (fat) in the blood (gemfibrozil), some medications used to treat depression (antidepressants such as fluoxetine, fluvoxamine, paroxetine or bupropion), antiviral protease inhibitors (indinavir, ritonavir and telaprevir) and azole antifungals (fluconazole, ketoconazole and itraconazole).

You should avoid taking doxilamina with the following medications, as they may potentiate its action or adverse effects:

- Adrenaline (epinephrine) (for treating low blood pressure).

- Certain medications for malaria or some antihistamines.

- Some diuretics (medications that increase urine elimination).

- Alcohol or other central nervous system depressants, such as barbiturates, hypnotics, sedatives, other sleep or anxiety medications (alprazolam, diazepam and zolpidem), opioid analgesics (codeine), psychiatric medications (chlorpromazine, risperidone, amitriptyline and trazodone) or procarbazine.

- Anti-hypertensive medications (medications for treating high blood pressure) with central nervous system effects, such as guanabenz, clonidine or alpha-methyldopa.

- Other anticholinergic medications, such as neuroleptics (medications for treating mental disorders), medications for treating spasms (e.g., atropine and belladonna alkaloids) or disopyramide (for treating certain heart problems).

- Topical antihistamines (such as creams, ointments or aerosols of diphenhydramine) and scopolamine.

- Medications with a narrow therapeutic index (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides and vancomycin).

Interference with diagnostic tests

Doxilamina may interfere with skin allergy tests that use allergens. It is recommended to suspend treatment with Dormigen at least 3 days before starting these tests.

Taking Dormigen with food, drinks and alcohol

Do not consume alcoholic beverages during treatment with doxilamina. See section 3: How to take Dormigen.

Pregnancy, breastfeeding and fertility

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

No adequate data are available on the use of doxilamina in pregnant women, so it is recommended to avoid taking Dormigen during pregnancy.

Due to the risks associated with administering antihistamines to young children, women who are breastfeeding should not take Dormigen.

No data are available on the possible effects of Dormigen on human fertility.

Driving and operating machinery:

The effect of doxilamina on driving and operating machinery is important. Do not drive or operate hazardous machinery while taking this medication, at least during the first few days of treatment until you know how it affects you.

Dormigen contains lactose:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

There are other presentations of doxilamine to adapt to all dosages.

The recommended dose is:

Adults (over 18 years)

The recommended dose is 1 tablet (25 mg) per day, administered 30 minutes before bedtime.

If daytime somnolence occurs, it is recommended to reduce the dose to 1 tablet of 12.5 mg per day or to take it earlier to ensure that at least 8 hours pass until waking up.

Do not take more than 1 tablet (25 mg) per day.

Use in elderly patients

People over 65 years are more prone to suffering other pathologies that may recommend a dose reduction. The initial recommended dose is 1 tablet of 12.5 mg, administered 30 minutes before bedtime. The dose can be increased to 25 mg (1 tablet) if the initial dose does not sufficiently alleviate insomnia. In case of appearance of undesirable side effects, it is recommended to reduce the dose to 1 tablet of 12.5 mg per day..For this reason, pay attention to the effect caused by the treatment (see section 4).

Use in patients with some liver or kidney disease

In patients with renal or hepatic insufficiency, it is recommended to reduce the dose to a maximum daily intake of 12.5 mg.

Use in children and adolescents

Doxilamine is not recommended for use in minors under 18 years, so the medication should not be used in this population.

Administration form

Oral route.

The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).

Doxilamine can be taken before or after meals.

The groove of the tablets serves only tobreak the tablet if it is difficult to swallow it whole, but not to divide it into 2 equal doses.

Treatment duration

The treatment duration should be as short as possible. In general, the treatment duration can range from a few days to a week.

It should not be administered for a period exceeding 7 days, unless the doctor advises taking it for a longer period.

If you take more Dormigen than you should

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

The symptoms of an overdose are: somnolence, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), redness, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations.

Severe intoxication can cause delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, and coma, and may pose a risk to life.

A severe complication can be rhabdomyolysis (muscle injury), followed by renal failure.

There is no specific antidote for antihistamine overdose, so the treatment is symptomatic and supportive. Your doctor will evaluate the need to induce vomiting, perform a gastric lavage, or prescribe medications to increase blood pressure if necessary.

If you forgot to take Dormigen

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

Take your dose at the usual time the next day.

If you interrupt the treatment with Dormigen

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects of doxilamine are generally mild and transient, being more frequent in the first days of treatment.

Very common side effects (may affect more than 1 in 10 people): drowsiness.

Common side effects (may affect up to 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, vertigo, headache, upper abdominal pain, fatigue, insomnia, and nervousness.

Rare side effects (may affect up to 1 in 100 people): asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to changes in posture), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (respiratory difficulties).

Rare side effects (may affect up to 1 in 1,000 people): agitation (especially in elderly patients), tremor, convulsions, or blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (decrease in certain blood cells).

Side effects of unknown frequency (cannot be estimated from available data): general malaise.

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxilamine, are the following: arrhythmia (alteration of heart frequency), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (a cardiac alteration), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (sensory-motor coordination), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).

The frequency and magnitude of side effects may be reduced by decreasing the daily dose.

People over 65 years old have a higher risk of experiencing adverse reactions, as they may suffer from other diseases or be taking other medications simultaneously. These individuals also have a higher risk of experiencing a fall.

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus.

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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance 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.

No requires special conservation conditions.

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

Do not usethis medicationafter 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Dormigen:

• The active ingredient is doxylamine hydrochloride. Each tablet contains 25 mg of doxylamine hydrochloride.
• The other components (excipients) are:

Core: calcium dihydrogen phosphate, microcrystalline cellulose, sodium carboxymethylcellulose type A (potato), anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose (E-464), titanium dioxide (E-171), lactose monohydrate, macrogol 4000 (E-1521).

Appearance of the product and contents of the packaging:

Dormigen is presented in the form of coated tablets. The tablets are white, round, coated with a film, and scored on one side. The score is only for breaking the tablet when there are problems swallowing it, but not for dividing it into two equal doses.

Each package contains 14 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Laoratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Review date of this prospectus: July 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es