Package leaflet: Information for the user

Doxypat, 12.5 mg, oral powder
Doxylamini hydrogenosuccinas
Read this leaflet carefully before taking this medicine because it contains important information for you.

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

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 a doctor.
If there is no improvement after 7 days, 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 hydrogen 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 associated with sputum and mucus production), or pulmonary 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 urination due to urinary retention (urinary tract disorder), or difficulty passing urine.
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 medications (e.g. used to treat heart rhythm disorders), certain antiviral and antifungal medicines, certain lipid-lowering (fat-lowering) agents, or quinidine (a medicine used to treat heart rhythm disorders).
If the patient is concurrently taking monoamine oxidase inhibitors (MAOIs).
If the patient has severe kidney or liver function impairment.

Warnings and precautions
Before starting Doxypat, discuss this with your doctor or pharmacist:

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

Doxypat with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those obtained without a prescription. In particular, inform your 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) agents, 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 Doxypat.
Certain diuretics (medicines that increase urine excretion).
Medicines with central nervous system depressant effects, 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 alpha-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 ototoxic medicines, 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, periodic monitoring of hearing function is recommended.

Effect on diagnostic tests
The 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 with or without food. Alcohol should be avoided during treatment.

Pregnancy, breastfeeding and 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 hydrogen succinate into breast milk and the risk associated with antihistamine use in young children, 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 and operate machinery.
Driving vehicles or operating machinery is not recommended during treatment with Doxypat, at least during the first few days of treatment, until the patient knows how the medicine affects them.

Doxypat contains aspartame, sodium and mannitol.
Doxypat 12.5 mg contains 11.25 mg of aspartame in each 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 53.35 mg of sodium (the main component of table salt) in each sachet. This corresponds to 2.66% of the maximum recommended daily intake of sodium in the adult diet.
The medicine contains mannitol. It may have a mild laxative effect.

3. How to use Doxypat

The medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Place the Doxypat medicine 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 dose is 12.5 mg to 25 mg (1 or 2 sachets) taken 30 minutes before sleep.
If daytime drowsiness occurs, it is recommended to reduce the dose from 2 sachets to 1 sachet (12.5 mg) or to take the dose earlier to ensure at least an 8-hour interval between taking the medicine and the planned time of waking up.
The maximum daily dose is 25 mg (2 sachets).

Use in elderly patients
Patients aged over 65 years are more susceptible to other diseases which may require dose reduction. The recommended initial dose is 12.5 mg (1 sachet), taken 30 minutes before sleep. The dose may be increased to 25 mg (2 sachets) 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). Therefore, the effects of treatment should be carefully 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 sachet of 12.5 mg.

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
The treatment period should be as short as possible. Treatment usually lasts from several days to one week.
The medicine should not be used for longer than 7 days without prior consultation with a doctor.

Taking more Doxypat than recommended
Symptoms of overdose include drowsiness, central nervous system depression or excitation, 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, 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 overdose with antihistamines; therefore, treatment is symptomatic and supportive. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medications to increase blood pressure if necessary.

Missed dose of 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 everybody experiences them.
Adverse reactions caused by doxylamine are usually mild and transient.
They occur more frequently during the first few days of treatment.
Common (affects 1 in 10 people): drowsiness and symptoms such as dry mouth, constipation, epigastric pain, blurred vision, urinary retention, increased bronchial secretion, dizziness, headache, fatigue, insomnia, and nervousness.
Uncommon (affects 1 in 100 people): asthenia (weakness), peripheral oedema (of hands and feet), nausea, vomiting, diarrhoea, rash, tinnitus, orthostatic hypotension (low blood pressure following a change in body position), double vision, dyspepsia (stomach disturbances), feeling of relaxation, nightmares, and dyspnoea (breathing difficulties).
Rare (affects 1 in 1,000 people): excitation (especially in children and elderly people), tremor, convulsions, blood disorders such as haemolytic anaemia, 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 symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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. This will help protect the environment.

6. Contents of the pack and other information

What Doxypat contains

The active substance is doxylamine hydrogen succinate. Each sachet contains 12.5 mg of doxylamine hydrogen succinate.
Other components 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 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