Doksilamina Geiser

LEAFLET INCLUDED IN THE PACKAGING:

Information for the user

Doksylamina Geiser, 25 mg, coated tablets

Doxylamini hydrogenosuccinas

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Doksylamina Geiser and what is it used for
• 2. Important information before taking Doksylamina Geiser
• 3. How to take Doksylamina Geiser
• 4. Possible side effects
• 5. How to store Doksylamina Geiser
• 6. Contents of the pack and other information

1. What is Doksylamina Geiser and what is it used for

Doksylamina Geiser is a medicine that contains doxylamine hydrogen succinate as the active substance.
The medicine is indicated for short-term, symptomatic treatment of occasional insomnia in adults over 18 years of age.
Patients with persistent sleep disorders should consult a doctor.
If there is no improvement after 7 days or if the patient feels worse, they should consult a doctor.

2. Important information before taking Doksylamina Geiser

When not to take Doksylamina Geiser:

• If the patient is allergic to doxylamine hydrogen succinate or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other antihistamine medicines.
• If the patient is breastfeeding.
• If the patient has respiratory diseases such as asthma, chronic bronchitis (persistent cough with sputum production) or chronic obstructive pulmonary disease (difficulty breathing).
• If the patient has glaucoma (increased eye pressure).
• If the patient has prostate enlargement (enlargement of the prostate gland), difficulty urinating, or urinary retention (urinary tract disease) or difficulty urinating.
• If the patient has stomach ulcers or narrowing of the stomach or duodenum (difficulty passing food from the stomach to the intestine).
• Severe liver or kidney failure;
• If the patient is taking monoamine oxidase inhibitors.
• If the patient is taking certain medicines, such as antidepressants, some antibiotics, heart medicines, including those used to treat heart rhythm disorders, some antiviral and antifungal medicines, some cholesterol-lowering medicines, or quinidine (an antiepileptic medicine).

Warnings and precautions

Before taking Doksylamina Geiser, the patient should discuss it with their doctor or pharmacist:

• If the patient has epilepsy.
• In case of daytime drowsiness, it may be necessary to reduce the dose or take the medicine earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
• Alcohol should not be consumed during treatment.
• Patient over 65 years of age may be more prone to side effects.
• Doksylamina Geiser may exacerbate dehydration and heat stroke due to decreased sweat production.
• If the patient has a prolonged QT interval (heart rhythm disorder).
• The medicine should not be taken for more than 7 days without medical supervision. If symptoms persist, the patient should consult a doctor.

Doksylamina Geiser and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, including those obtained without a prescription. In particular, the patient should inform their doctor about taking the following medicines:

• Epinephrine (a medicine used to treat low blood pressure).
• Heart medicines, including anti-arrhythmic medicines, some antibiotics, some antimalarial medicines, some antihistamines, some cholesterol-lowering medicines, and some antipsychotic medicines (used to treat mental disorders).
• Medicines that reduce the elimination of other medicines, such as azole derivatives or macrolides, as they may enhance the effect of doxylamine.
• Certain diuretics (medicines that increase urine production).
• Medicines that act on the central nervous system (barbiturates, sedatives, anxiolytics, opioid analgesics, antipsychotic medicines, or procarbazine).
• Antihypertensive medicines that act on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medicines, including those used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (used to treat depression), antipsychotic medicines (used to treat mental disorders),

antispasmodic medicines (atropine) or disopyramide (used to treat certain heart diseases).

• Other medicines that are toxic to the ear, such as carboplatin or cisplatin (used to treat cancer), chloroquine (used to treat or prevent malaria), and certain antibiotics (used to treat infections), such as erythromycin or aminoglycosides in injectable form. Doksylamina Geiser may mask the toxic effects of these medicines, so the patient's hearing should be monitored periodically.

Effect on diagnostic test results

Doksylamina Geiser may affect the results of allergic skin tests using allergens. It is recommended to stop taking Doksylamina Geiser at least 3 days before undergoing such tests.

Doksylamina Geiser with food, drink, and alcohol

During treatment with Doksylamina Geiser, the patient should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Since doxylamine can pass through the placenta, as a precautionary measure, Doksylamina Geiser should not be taken during pregnancy, unless the potential benefit to the mother outweighs the potential risk to the fetus.
Due to the passage of doxylamine into breast milk and the risk associated with the use of antihistamines in young children, Doksylamina Geiser is contraindicated during breastfeeding.
There is no data on the effect of Doksylamina Geiser on fertility.

Driving and using machines

Doksylamina Geiser affects the ability to drive and use machines.
The patient should not drive or operate machinery during treatment, at least for the first few days, to determine how the medicine affects them.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Doksylamina Geiser

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Adults (over 18 years of age)
The recommended daily dose is 1 tablet (25 mg).
In case of daytime drowsiness, it is recommended to reduce the dose to 12.5 mg or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up. Do not take more than 1 tablet (25 mg) per day.
Use in the elderly
Patient over 65 years of age are more prone to other diseases that may require dose reduction. The recommended initial dose is 12.5 mg (1 tablet of 12.5 mg), taken 30 minutes before bedtime. The dose can be increased to 25 mg (1 tablet), if the initial dose proves ineffective in relieving insomnia. If side effects occur, the dose should be reduced to 12.5 mg per day.
Use in patients with liver or kidney failure
Patient with these diseases require individual dose adjustment by the doctor, depending on the degree of failure.
Use in children and adolescents
Doksylamina Geiser is not recommended for use in children and adolescents under 18 years of age. The medicine should not be used in this patient group.
Route and method of administration
Oral administration.
Tablets should be taken 30 minutes before bedtime, with a sufficient amount of liquid (preferably water).
Doksylamina Geiser can be taken before or after a meal.
The dividing line on the tablet is only to facilitate breaking the tablet, if the patient has difficulty swallowing it whole.
Duration of treatment
The duration of treatment should be as short as possible. Treatment usually lasts from a few days to one week.
The medicine should not be taken for more than 7 days without prior consultation with a doctor.

Taking a higher dose of Doksylamina Geiser than recommended

Symptoms of overdose include drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal motility), heat stroke, changes in heart rate, hypertension, nausea, vomiting, stimulation, unsteady gait, dizziness, irritability, sedation, confusion, and hallucinations.
In patients, delirium, psychotic disorders, hypotension, seizures, dyspnea, loss of consciousness, coma, and death may occur.
A serious complication can be rhabdomyolysis (muscle damage), followed by kidney failure.
There is no specific antidote in case of overdose of antihistamines, so treatment is symptomatic and supportive. The doctor decides whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase blood pressure, if necessary.

Missing a dose of Doksylamina Geiser

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time the next day.

Stopping treatment with Doksylamina Geiser

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Doksylamina Geiser can cause side effects, although not everybody gets them.
The side effects of doxylamine are usually mild and transient. They occur more frequently during the first few days of treatment.
Common side effects (may affect up to 1 in 10 people):drowsiness and symptoms such as dry mouth, constipation, abdominal pain, blurred vision, urinary retention, increased bronchial secretion, dizziness, headache, fatigue, insomnia, and irritability.
Uncommon side effects (may affect up to 1 in 100 people):asthenia (fatigue), peripheral edema (hands and feet), nausea, vomiting, diarrhea, rash, tinnitus, orthostatic hypotension (decrease in blood pressure when changing body position), double vision, dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare side effects (may affect up to 1 in 1,000 people):stimulation (especially in children and the elderly), tremors, seizures, blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in the number of certain types of blood cells).
Other side effects of unknown frequency:malaise

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Doksylamina Geiser

The medicine should be stored out of sight and reach of children.
Doksylamina Geiser should not be taken after the expiry date stated on the blister pack and carton. The expiry date (EXP) is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.
Store in the original packaging.

6. Contents of the pack and other information

What Doksylamina Geiser contains

The active substance of the medicine is 25 mg of doxylamine hydrogen succinate.
The other ingredients of the medicine are:
Core excipients:
Mannitol
Microcrystalline cellulose
Sodium carboxymethylcellulose (type A)
Colloidal anhydrous silica
Magnesium stearate
Coating excipients:
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Indigo carmine, lake (E 132)

What Doksylamina Geiser looks like and contents of the pack

Doksylamina Geiser is a blue, cylindrical, biconvex, coated tablet with a dividing line.
The medicine is packaged in aluminum blisters containing 7, 10, 14, or 20 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Geiser Pharma S.L.
Camino Labiano 45B
31192 Mutilva (Navarra)
Spain
Phone: +34 948 10 19 43
Email: phvigilance@geiserpharma.com

Manufacturer:

Industria Química y Farmacéutica Vir S.A.
C/Laguna 66-68-70, Poligono Industrial Urtinsa II
28923 Alcorcón
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain, Doxilamina Geiser 25 mg comprimidos recubiertos con película

Date of last revision of the leaflet: