Patient Information Leaflet: Information for the Patient

Sinumedin, (1.5 mg + 2.5 mg)/mL, nasal spray, solution
Mepyramini maleas + Phenylephrini hydrochloridum
Please read this 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 patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your physician or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, consult your physician.

Table of Contents

What Sinumedin is and what it is used for
Important information before using Sinumedin
How to use Sinumedin
Possible side effects
How to store Sinumedin
Contents of the pack and other information

1. What Sinumedin is and what it is used for

Sinumedin contains two active substances: mepyramine maleate and phenylephrine hydrochloride.
Mepyramine has antihistaminic and anti-allergic effects, while phenylephrine reduces congestion of the mucous membrane, clears the nasal passages and the openings of the paranasal sinuses.
Additionally, the excipient cetalkonium chloride has antibacterial properties.
Sinumedin relieves nasal discharge, clears the nose and the openings of the paranasal sinuses, facilitates breathing, and exerts antibacterial action.
Sinumedin is indicated for the treatment of:

Nasal catarrh (rhinitis) in inflammation of the nasal mucosa, including rhinitis associated with allergies (hypersensitivity);
Sinusitis.

If there is no improvement after 3 days, or if you feel worse, consult your physician.

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 drying rhinitis;
in children under 6 years of age;
during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Sinumedin, discuss this with a doctor or pharmacist:

if the patient is a child;
if the patient is elderly;
if the patient has heart disease;
if the patient has arterial hypertension;
if the patient has diabetes;
if the patient has a pheochromocytoma;
if the patient has hyperthyroidism;
if the patient has benign prostatic hyperplasia;
if the patient has narrow-angle glaucoma;
if the patient has been taking medicines used to treat depression called monoamine oxidase inhibitors (selegiline, moclobemide, amiflamine), Sinumedin may be used only after at least 14 days have passed since stopping treatment with these medicines, unless otherwise advised by a doctor.

Children
Do not use in children under 6 years of age.
Sinumedin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

barbiturates, sedatives and tranquilizers, atropine, tricyclic antidepressants (imipramine, opipramol, amitriptyline, doxepin, mianserin) – Sinumedin may enhance their effects;
certain β-blockers, such as esmolol, which may enhance the effect of phenylephrine, a component of Sinumedin, potentially causing severe hypertension in some patients;
monoamine oxidase inhibitors, such as selegiline, moclobemide, amiflamine, which prolong and intensify the effect of Sinumedin.

Sinumedin with food, drink and alcohol
Sinumedin may be taken regardless of food or drink intake.
Sinumedin may intensify the effects of alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Sinumedin must not be used during pregnancy or while breastfeeding.
Driving and operating machinery
Sinumedin has a minor or moderate effect on the ability to drive and operate machinery. Caution is advised.
Sinumedin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions). It may cause mild irritation of the skin, eyes, and mucous membranes.

3. How to use Sinumedin

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is administered intranasally.
Recommended dose
Adults, adolescents and children over 6 years of age:
2 sprays sprayed into each nostril every 4 to 6 hours.
Children under 6 years of age:
Do not use this medicine in children under 6 years of age.
A single sprayed dose contains 0.15 mg of mepyramine maleate and 0.25 mg of phenylephrine hydrochloride.
Do not use the medicine more than 5 times a day or for longer than 3 days.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.
Prolonged use of the medicine may cause symptoms of nasal mucosa hyperaemia.
Use of a higher than recommended dose of Sinumedin
If a higher than recommended dose is used, consult a doctor.
In case of overdose, the following may occur occasionally: headache, dizziness, sleep disturbances, difficulty in urination, cardiac rhythm disturbances.
Missed dose of Sinumedin
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur during treatment with Sinumedin:

tachycardia (rapid heartbeat), palpitations, arrhythmia (irregular heart rhythm);
headache, dizziness, drowsiness, sedation, insomnia, fatigue;
diarrhoea, nausea, constipation, vomiting;
hypertension;
irritation and congestion of the nasal mucosa, dryness of mucous membranes.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
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.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on the safe use of the medicine.

5. How to store the medicine Sinumedin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle label. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Sinumedin contains

The active substances 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.
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 polyethylene bottle with a capacity of 30 mL with an atomizer in a cardboard box containing 15 mL
or 20 mL of the medicinal product, or a polyethylene (HDPE) bottle of 20 mL with a spray pump
(LDPE polyethylene, polypropylene PP, silicone, stainless steel) and a nasal applicator (polypropylene PP)
in a cardboard box containing 10 mL, 15 mL or 20 mL of the medicinal product.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
{logo of the marketing authorisation holder}