PACKAGE LEAFLET:

Information for the user
Doksylamina Geiser, 25 mg, coated tablets
Doxylamini hydrogenosuccinas
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of the leaflet

What Doksylamina Geiser is and what it is used for
Important information before taking Doksylamina Geiser
How to take Doksylamina Geiser
Possible side effects
How to store Doksylamina Geiser
Contents of the pack and other information

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

Doksylamina Geiser is a medicine containing doxylamine hydrogen succinate as the active substance.
This 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 symptoms worsen, consult a doctor.

2. Important information before using Doksylamina Geiser

When not to use Doksylamina Geiser:

If the patient is allergic to doxylamine 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 disorders such as asthma, chronic bronchitis (persistent cough accompanied by sputum and mucus production), or emphysema (difficulty breathing).
If the patient has glaucoma (increased pressure in the eye).
If the patient has prostate enlargement (benign prostatic hyperplasia), difficulty in passing urine from the bladder (urinary tract disorder), or problems with urination.
If the patient has gastric ulcer, duodenal ulcer, or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
Severe liver or kidney impairment;
If the patient is concurrently taking monoamine oxidase inhibitors (MAOIs).
If the patient is taking certain medicines, such as antidepressants, certain antibiotics, cardiac medications including those used to treat cardiac arrhythmias, certain antiviral and antifungal drugs, certain lipid-lowering agents, or quinidine (an anticonvulsant drug).

Warnings and precautions
Before starting treatment with Doksylamina Geiser, discuss this with your doctor or
pharmacist:

If the patient has epilepsy.
If daytime drowsiness occurs, it may be necessary to reduce the dose or take the medicine earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
Alcohol must not be consumed during treatment.
Patients over 65 years of age may be more susceptible to adverse effects.
Doksylamina Geiser may exacerbate symptoms of dehydration and heat stroke due to reduced sweating.
If the patient has long QT syndrome (a heart rhythm disorder).
The medicine should not be used for longer than 7 days without medical supervision. If symptoms persist, consult a doctor.

Doksylamina Geiser and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, including those available without prescription. In particular, inform your doctor if you are taking the following medicines:

Epinephrine (a medicine used to treat low blood pressure).
Cardiac medicines, including antiarrhythmics, certain antibiotics, certain antimalarials, certain antihistamines, certain lipid-lowering agents (fats in the blood), and certain antipsychotics (used to treat psychiatric disorders).
Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, as they may enhance the effect of doxylamine.
Certain diuretics (medicines that increase urine production).
Central nervous system depressants, such as barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine.
Antihypertensive medicines (lowering blood pressure) acting on the central nervous system, such as guanabenz, clonidine, or methyldopa.
Other anticholinergic medicines, including those used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (used in depression treatment), antipsychotics (used in psychiatric disorders),
antispasmodics (e.g. atropine), or disopyramide (used in treating
certain heart conditions).
Other ototoxic medicines, such as carboplatin or cisplatin (used in cancer treatment), chloroquine (used in treatment or prevention of malaria), and certain antibiotics (used to treat infections), such as erythromycin or aminoglycosides administered by injection. Doksylamina Geiser may mask the ototoxic effects of these medicines; therefore, hearing should be monitored periodically.

Effect on diagnostic test results
Doksylamina Geiser may affect the results of skin allergy tests using allergens. It is recommended to discontinue Doksylamina Geiser at least three days before undergoing such tests.
Doksylamina Geiser with food, drink, and alcohol
Alcohol consumption should be avoided during treatment with Doksylamina Geiser.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Since doxylamine may cross the placenta, as a precautionary measure, the use of Doksylamina Geiser during pregnancy is not recommended unless the potential benefit to the mother outweighs the potential risk to the developing fetus.
Due to the passage of doxylamine succinate into breast milk and the risk associated with antihistamine use in young children, Doksylamina Geiser is contraindicated during breastfeeding.
There is no data available regarding the effect of Doksylamina Geiser on fertility.
Driving and operating machinery
Doksylamina Geiser affects the ability to drive and operate machinery. Do not drive or operate machinery during treatment, at least for the first few days, to determine how the medicine affects your body.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Doksylamina Geiser

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults (aged over 18 years)
The recommended daily dose is 1 tablet (25 mg).
If daytime drowsiness occurs, it is recommended to reduce the dose from 25 mg to 12.5 mg or
to take the dose earlier, ensuring at least an 8-hour interval between taking the medicine and
waking up. Do not use more than 1 tablet (25 mg) per day.
Use in elderly patients
Patients aged over 65 years are more susceptible to other diseases which may require dose
adjustment. The recommended initial dose is 12.5 mg (1 tablet of 12.5 mg), administered
30 minutes before bedtime. The dose may be increased to 25 mg (1 tablet) if the initial dose
proves ineffective in relieving insomnia. If adverse effects occur, the dose should be reduced to
12.5 mg per day.
Use in patients with hepatic or renal impairment
Patients with these conditions require individual dose adjustment by a doctor depending on
the degree of impairment.
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 going to bed, with an adequate amount of liquid
(preferably water).
Doksylamina Geiser may be taken before or after a meal.
The break line on the tablet is intended only to facilitate splitting the tablet if the patient has
difficulty swallowing it whole.
Treatment duration
The treatment period should be as short as possible. Treatment usually lasts from several
days to one week.
The medicine should not be taken for longer than 7 days without prior consultation with a
doctor.
Taking more than the recommended dose of Doksylamina Geiser
Symptoms of overdose include drowsiness, central nervous system depression or stimulation,
anticholinergic effects (dilated pupils, fever, dry mouth, reduced intestinal motility), hot flushes,
changes in heart rate, hypertension, nausea, vomiting, restlessness, ataxia, dizziness,
irritability, sedation, confusion and hallucinations. Patients may experience delirium,
psychotic disorders, hypotension, seizures, respiratory distress, loss of consciousness, coma
and death.
A serious complication may be rhabdomyolysis (muscle damage), leading to renal failure.
The lack of a specific antidote in case of antihistamine overdose means that treatment is
symptomatic and supportive. The doctor will decide whether to induce vomiting, perform
gastric lavage, or prescribe medications to raise blood pressure if necessary.
Missed dose of Doksylamina Geiser
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time
on the following day.
Discontinuation of Doksylamina Geiser
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions caused by doxylamine are usually mild and transient. They occur more frequently during the first few days of treatment.
Common adverse reactions (may occur in fewer than 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 nervousness.
Uncommon adverse reactions (may occur in fewer than 1 in 100 people): asthenia (weakness), peripheral edema (of hands and feet), nausea, vomiting, diarrhea, rash, tinnitus, orthostatic hypotension (low blood pressure following a change in body position), double vision, dyspepsia (stomach disturbances), feeling of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare adverse reactions (may occur in fewer than 1 in 1000 people): excitation (especially in children and elderly patients), tremor, convulsions, blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (reduction in the number of certain types of blood cells).
Other adverse reactions with unknown frequency: malaise
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Doksylamina Geiser

Keep this medicine out of sight and reach of children.
Do not use Doksylamina Geiser after the expiry date stated on the blister pack and carton.
The expiry date (EXP) refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This helps protect the environment.
Store in the original packaging.

6. Contents of the pack and other information

What Doksylamina Geiser contains
The active substance is 25 mg of doxylamine hydrogen succinate.
The other ingredients are:
Core excipients:
Mannitol
Microcrystalline cellulose
Sodium carboxymethyl starch (type A)
Anhydrous colloidal silicon dioxide
Magnesium stearate
Coating excipients:
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Indigo carmine, aluminium 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 score line.
The medicine is packed in aluminium blisters containing 7, 10, 14 or 20 tablets, all within a cardboard box.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Geiser Pharma S.L.
Camino Labiano 45B
31192 Mutilva (Navarra)
Spain
Tel: +34 948 10 19 43
E-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area under the following names:
Spain: Doxilamina Geiser 25 mg comprimidos recubiertos con película