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Sinumedin Nasal Spray - 15ml

Sinumedin Nasal Spray - 15ml

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Sinumedin, (1.5 mg + 2.5 mg)/ml, nasal spray, solution

Mepyramini maleas + Phenylephrini hydrochloridum


Please read this leaflet carefully before taking this medicine because it contains: 
information important to the patient.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so you can read it again if you need to.
- If you need advice or additional information, please ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See point 4. 
- If you do not feel better or if you feel worse after 3 days, contact your doctor.


Table of contents of the leaflet
1. What Sinumedin is and what it is used for
2. Important information before using Sinumedin
3. How to use Sinumedin
4. Possible side effects
5. How to store Sinumedin
6. Package contents 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 antihistamine and antiallergic properties, and phenylephrine reduces mucosal congestion and clears the nose and openings of the paranasal sinuses. 
Additionally, the excipient cetalkonium chloride has antibacterial properties.

Sinumedin relieves a runny nose, clears the nose and the openings of the paranasal sinuses, facilitates breathing and has antibacterial properties.

Sinumedin is indicated for the treatment of:
- rhinitis (rhinitis) in inflammation of the nasal mucosa, including rhinitis occurring in case of
allergies (sensitivities); 
- sinusitis.


2. Important information before using Sinumedin

When not to use Sinumedin
- if you are allergic to the active substances or any of the other ingredients of the medicine (listed in section 6);
- in children under 6 years of age;
- during pregnancy and breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sinumedin: 
- if you are a child;
- if you are elderly;
- if you suffer from allergic diseases (e.g. asthma) or dry rhinitis;
- if you have heart failure; 
- if you have high blood pressure;
- if you have diabetes;
- if you have pheochromocytoma;
- if you have hyperthyroidism;
- if you have an enlarged prostate gland;
- if you have narrow angle glaucoma;
- if you have been taking medicines to treat depression called monoamine oxidase inhibitors (selegiline, moclobemide, amiflamine), you should only use Sinumedin at least 14 days after stopping treatment with these medicines, unless your doctor tells you otherwise.

Kids 
Do not use in children under 6 years of age.

Sinumedin and other medicines 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
If you are taking any of the medicines listed below, you may need to change them
dose or discontinuation of treatment:
- barbiturates, hypnotics and sedatives, atropine, tricyclic antidepressants (imipramine, opipramol, amitriptyline, doxepin, mianserin) - Sinumedin may intensify their effect;
- some beta-blockers, such as esmolol, may increase the effect of the phenylephrine component of Sinumedin, which may result in severe hypertension in some patients;
- monoamine oxidase inhibitors such as selegiline, moclobemide, amiflamine prolong and intensify the effect of Sinumedin.

Sinumedin with food, drink and alcohol
Sinumedin can be taken regardless of food or drink.
Sinumedin may enhance the effects of alcohol.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to be pregnant 
child, ask your doctor for advice before taking this medicine.
Sinumedin must not be used during pregnancy and breastfeeding.

Driving and using machines
Sinumedin has minor or moderate influence on the ability to drive and use machines. Be careful.

Sinumedin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate 
The medicine may cause allergic reactions (possibly delayed reactions). The drug may cause minor irritation to the skin, eyes and mucous membranes.


3. How to use Sinumedin

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The drug is administered intranasally.

The recommended dose is 
adults and children over 6 years old:
2 doses in each nasal passage every 4 to 6 hours. 

A single spray dose contains 0.15 mg of mepyramine maleinate 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 you take more Sinumedin than you should
If you use more than the recommended dose, contact your doctor. 
In case of overdose, the following may occasionally occur: headaches and dizziness, sleep disturbances, difficulty urinating, heart rhythm disturbances.

If you forget to take Sinumedin
Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following are the side effects that may occur when using Sinumedin:
- tachycardia, palpitations, arrhythmia;
- headache, dizziness, drowsiness, sedation, insomnia, weakness;
- diarrhea, nausea, constipation;
 hypertension;
- irritation and congestion of the nasal mucosa, dryness of the mucous membranes.

Reporting side effects
If you notice any side effects, including any side effects 
not listed in this leaflet, please tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Monitoring Department 
Adverse Effects of Medicinal Products of the Office for Registration of Medicinal Products, 
Medical Devices, Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warszawa
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the responsible entity.

By reporting side effects, more information can be gathered 
about the safety of using the drug.


5. How to store Sinumedin

Keep the medicine out of the sight and reach of children. Store at temperatures below 25°C.
Do not use this medicine after the expiry date which is stated on the package. The expiry date means the last day of the given month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such behavior will help to protect the environment.


6. Package contents 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.
- The other ingredients are: glycerol, sodium chloride, cetalkonium chloride, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 20, purified water.

What Sinumedin looks like and what the pack contains
Sinumedin is a nasal spray.
The spray bottle contains 10 ml, 15 ml or 20 ml of medicine in a cardboard box.


Responsible entity and manufacturer
Aflofarm Farmacja Polska Sp. z o. o.
Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

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