Sinumedin

Package Leaflet: Information for the Patient

Sinumedin, (1.5 mg + 2.5 mg)/mL, nasal spray, solution
Mepyramine maleate + Phenylephrine hydrochloride

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is Sinumedin and what is it used for

Sinumedin contains two active substances: mepyramine maleate and phenylephrine hydrochloride.
Mepyramine has antihistamine and anti-allergic effects, and phenylephrine reduces congestion of the nasal mucosa and clears the nose and paranasal sinuses.
In addition, the excipient cetalkonium chloride has antibacterial properties.
Sinumedin relieves a runny nose, clears the nose and paranasal sinuses, facilitates breathing, and has antibacterial effects.
Sinumedin is indicated for the treatment of:

• rhinitis (runny nose) in nasal mucosa inflammation, including allergic rhinitis;
• sinusitis.

If there is no improvement or the patient feels worse after 3 days, they should consult their doctor.

2. Important information before using Sinumedin

When not to use Sinumedin

• if the patient is allergic to mepyramine maleate, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has asthma or atrophic rhinitis;
• in children under 6 years of age;
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting to use Sinumedin, the patient should discuss it with their doctor or pharmacist:

• if the patient is a child;
• if the patient is elderly;
• if the patient has heart disease;
• if the patient has high blood pressure;
• if the patient has diabetes;
• if the patient has a pheochromocytoma;
• if the patient has hyperthyroidism;
• if the patient has prostatic hyperplasia;
• if the patient has narrow-angle glaucoma;
• if the patient has taken medicines used to treat depression, called monoamine oxidase inhibitors (selegiline, moclobemide, amiflamine), Sinumedin can be used only after at least 14 days have passed since the last dose of these medicines, unless the doctor advises otherwise.

Children

Sinumedin should not be used in children under 6 years of age.

Sinumedin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, it may be necessary to change the dose or stop the treatment:

• barbiturates, sedatives, and hypnotics, atropine, tricyclic antidepressants (imipramine, opipramol, amitriptyline, doxepin, mianserin) - Sinumedin may enhance their effects;
• certain beta-adrenoreceptor blockers, such as esmolol, may enhance the effects of phenylephrine, a component of Sinumedin, which may cause severe hypertension in some patients;
• monoamine oxidase inhibitors, such as selegiline, moclobemide, and amiflamine, may prolong and enhance the effects of Sinumedin.

Sinumedin with food, drink, and alcohol

Sinumedin can be used independently of food and drink.
Sinumedin may enhance the effects of alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.
Sinumedin should not be used during pregnancy and breastfeeding.

Driving and using machines

Sinumedin has a minor or moderate influence on the ability to drive and use machines. Caution should be exercised.

Sinumedin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions). The medicine may cause minor skin, eye, and mucous membrane irritation.

3. How to use Sinumedin

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is administered intranasally.

Recommended dose

Adults, adolescents, and children over 6 years of age:
2 doses sprayed into each nostril every 4 to 6 hours.
Children under 6 years of age:
Sinumedin should not be used in children under 6 years of age.
A single dose sprayed contains 0.15 mg of mepyramine maleate and 0.25 mg of phenylephrine hydrochloride.

The medicine should not be used more than 5 times a day or for more than 3 days.

If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.
Prolonged use of the medicine may cause symptoms of nasal mucosa congestion.

Using more than the recommended dose of Sinumedin

In case of using more than the recommended dose of the medicine, the patient should contact their doctor.
In case of overdose, the following may occasionally occur: headaches, dizziness, sleep disturbances, difficulty urinating, heart rhythm disturbances.

Missing a dose of Sinumedin

A double dose should not be used to make up for a missed dose.
If there are any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinumedin can cause side effects, although not everybody gets them.
The following side effects may occur when using Sinumedin:

• tachycardia (rapid heart rate), palpitations, arrhythmia (heart rhythm disturbance);
• headache, dizziness, drowsiness, sedation, insomnia, weakness;
• diarrhea, nausea, constipation, vomiting;
• hypertension;
• irritation and congestion of the nasal mucosa, dryness of the mucous membranes.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sinumedin

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and label. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sinumedin contains

• The active substances of Sinumedin are mepyramine maleate and phenylephrine hydrochloride. 1 mL of nasal spray contains 1.5 mg of mepyramine maleate and 2.5 mg of phenylephrine hydrochloride.
• The other ingredients are glycerol, sodium chloride, cetalkonium chloride, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 20, purified water.

What Sinumedin looks like and contents of the pack

Sinumedin is a nasal spray.
A 30 mL polyethylene bottle with an atomizer in a carton containing 15 mL or 20 mL of the medicine, or a 20 mL polyethylene (HDPE) bottle with a pump spray (LDPE polyethylene, PP polypropylene, silicone, stainless steel) with a nasal applicator (PP polypropylene) in a carton containing 10 mL, 15 mL, or 20 mL of the medicine.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100
{marketing authorization holder's logo}

Date of last revision of the package leaflet: