Package leaflet: Information for the user

Doxypat, 25 mg, oral powder
Doxylamine hydrogen succinate
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for possible future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Doxypat is and what it is used for

Doxypat is a medicinal product containing doxylamine hydrogen succinate as the active substance.
The medicine is indicated for short-term, symptomatic treatment of occasional insomnia in adults.
Patients with persistent sleep disorders should consult their doctor.
If there is no improvement after 7 days of treatment, or if the patient feels worse, medical advice should be sought.

2. Important information before using Doxypat

When not to use Doxypat:

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 (antiallergic) medicines.
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 benign prostatic hyperplasia (enlarged prostate gland), 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).
If the patient is pregnant or breastfeeding.
If the patient is taking certain medicines, e.g. antidepressants, certain antibiotics, cardiac medicines such as those used to treat heart rhythm disorders, certain antiviral and antifungal medicines, certain lipid-lowering (fat-lowering) medicines, or quinidine (a medicine used to treat heart rhythm disorders).
If the patient is currently taking monoamine oxidase inhibitors (MAOIs).
If the patient has severe kidney or liver function impairment.

Warnings and precautions
Before starting treatment with Doxypat, consult your doctor or pharmacist:

If the patient has epilepsy.
If daytime drowsiness occurs, the dose may need to be reduced or the medicine taken earlier, ensuring at least an 8-hour interval between taking the medicine and planned waking time.
Alcohol must not be consumed during treatment.
Patients over 65 years of age may be more susceptible to adverse effects.
Doxylamine may worsen symptoms of dehydration and heat stroke due to reduced sweating.
If the patient has long QT syndrome (a heart rhythm disorder).
Caution is required in patients with hypokalaemia or other electrolyte imbalances.
This medicine should not be used for longer than 7 days without medical supervision. If symptoms persist, consult a doctor.

Doxypat with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription. In particular, inform the doctor if the patient is taking any of 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 (fat-lowering) medicines, and certain antipsychotics (used to treat psychiatric disorders).
Medicines that reduce the elimination of other medicines, such as azole derivatives or macrolides, as they may enhance the effect of Doxypat.
Certain diuretics (medicines that increase urine excretion).
Medicines with central nervous system depressant effects (barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
Antihypertensive medicines (blood pressure-lowering medicines) 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 to treat depression), antipsychotics (used to treat psychiatric disorders), antispasmodics (e.g. atropine), or disopyramide (used to treat certain heart conditions).
Other medicines that are ototoxic (toxic to the ear), such as carboplatin or cisplatin (used in cancer treatment), chloroquine (used in the treatment or prevention of malaria), and certain antibiotics used to treat infections, such as erythromycin or injectable aminoglycosides. Doxypat may mask the ototoxic effects of these medicines; therefore, hearing should be monitored periodically.

Effect on diagnostic tests
This medicine may affect the results of skin tests used in allergy diagnosis. Patients are advised to discontinue the medicine at least three days before testing and to inform their doctor.

Doxypat with food, drink, and alcohol
During treatment with doxylamine, consumption of grapefruit should be avoided.
There are no specific instructions regarding administration before or after meals. Alcohol consumption should be avoided during treatment.

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 her doctor or pharmacist before using this medicine.
Since doxylamine can cross the placenta, Doxypat is contraindicated during pregnancy.
Due to the passage of doxylamine succinate into breast milk and the risk associated with antihistamine use in infants, Doxypat is contraindicated during breastfeeding.
There is no data available on the effect of Doxypat on fertility.

Driving and operating machinery
Doxylamine may affect the ability to drive or operate machinery.
Driving vehicles or operating machinery is not recommended during treatment with Doxypat, especially during the first few days of treatment, until the patient knows how the medicine affects them.

Doxypat contains aspartame, sodium, and mannitol.
Doxypat 25 mg contains 23.1 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
The medicine contains 106.70 mg of sodium (the main component of table salt) per sachet. This corresponds to 5.33% of the maximum recommended daily sodium intake in the adult diet.
The medicine contains mannitol. The medicine may have a mild laxative effect.

3. How to take Doxypat

Always take this medicine exactly as directed by your doctor or pharmacist. If you are unsure,
consult your doctor or pharmacist.
Place the Doxypat tablet directly on the tongue and wait until it dissolves. Swallow after it has
dissolved. There is no need to take it with liquid. The medicine should be taken 30 minutes before
going to bed.
Adults (aged over 18 years)
The recommended daily dose is 1 sachet (25 mg) taken 30 minutes before sleep.
If daytime drowsiness occurs, it is recommended to reduce the dose from 25 mg to 12.5 mg (1
sachet of Doxypat 12.5 mg) or to take the dose earlier, ensuring at least an 8-hour interval between
taking the medicine and the planned time of waking up.
The maximum daily dose is 1 sachet of Doxypat 25 mg.
Use in elderly patients
Patients aged over 65 years are more likely to have other medical conditions that may require a
reduced dose. The recommended initial dose is 12.5 mg (1 sachet of Doxypat 12.5 mg), taken 30
minutes before sleep. The dose may be increased to 25 mg (1 sachet of Doxypat 25 mg) if the initial
dose proves ineffective in relieving insomnia. If adverse effects occur, the dose should be reduced
to 12.5 mg per day (1 sachet of Doxypat 12.5 mg). Therefore, the effects of treatment should be
closely monitored (see section 4).
Patients with renal or hepatic impairment
Doxypat is contraindicated in patients with severe renal or hepatic disease.
The use of Doxypat is not recommended in patients with moderate renal or hepatic disease.
In patients with mild renal or hepatic disease, the maximum daily dose should be reduced to one
12.5 mg tablet.
Use in children and adolescents
The use of doxylamine is not recommended in children and adolescents under 18 years of age. The medicine should not be used in this patient group.
Treatment duration
Treatment duration should be as short as possible. Treatment usually lasts from a few days to one
week. Do not take this medicine for longer than 7 days without prior consultation with your doctor.
Taking more Doxypat than recommended
Symptoms of overdose include drowsiness, central nervous system depression or stimulation,
anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal motility), hot flushes,
changes in heart rate, hypertension, nausea, vomiting, restlessness, ataxia, dizziness, irritability,
sedation, confusion, hallucinations. Patients may experience delirium, psychotic disturbances,
hypotension, seizures, respiratory distress, loss of consciousness, coma, and death. A serious
complication may be rhabdomyolysis (muscle damage), leading to renal failure.
There is no specific antidote in case of antihistamine overdose; therefore, treatment is symptomatic
and supportive. The physician will decide whether to induce vomiting, perform gastric lavage, or
prescribe medications to raise blood pressure, if necessary.
If you forget to take Doxypat
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time the following day.
Stopping Doxypat
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions caused by doxylamine are usually mild and transient.
They occur more frequently during the first few days of treatment.
Common (in 1 out of 10 patients): drowsiness and symptoms such as dry mouth, constipation, abdominal pain, blurred vision, urinary retention, increased bronchial secretion, dizziness, headache, fatigue, insomnia, and nervousness.
Uncommon (in 1 out of 100 patients): asthenia (weakness), peripheral edema (of hands and feet), nausea, vomiting, diarrhea, rash, tinnitus, orthostatic hypotension (low blood pressure following change in body position), double vision, dyspepsia (stomach disturbances), feeling of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare (in 1 out of 1,000 patients): 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: platelets or white blood cells).
Other adverse reactions with unknown frequency: malaise
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Doxypat

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date 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. Such measures help protect the environment.

6. Contents of the package and other information

What Doxypat contains

The active substance is doxylamine hydrogen succinate. Each sachet contains 25 mg of doxylamine hydrogen succinate.
Other ingredients are: mannitol, colloidal anhydrous silica, aspartame (E 951), sodium carboxymethyl starch type A, sodium hydrogen carbonate, citric acid, sodium citrate, calcium carbonate, strawberry flavour (flavouring agents, natural flavouring substances, flavour preparations, maltodextrin, gum arabic (E 414), triacetin, propylene glycol), masking flavour (potato maltodextrin, flavouring agents, flavour preparations, sugar, aspartame (E 951), acesulfame K (E 950)).

What Doxypat looks like and contents of the pack
Doxypat is a fine, white to slightly yellowish powder with a strawberry taste.
Doxypat is packed in sachets made of Polyester/Aluminium/PE, placed in a cardboard box.
Pack size: 10 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Geiser Pharma, S.L.
Polig Mutilva
Calle E, 5 bajo
Mutilva, Aranguren
31192 Navarre
Spain
Tel.: +34 948 229 090
E-mail: [email protected]
Manufacturer
Sincrofarm S.L.
C/ Mercurio, 10
Pol. Ind. Almeda (Cornellà de Llobregat)
08940 Barcelona
Spain
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products