SINOMIST 1MG/50MG/ML AER. 10ML Wick

ATC code: R01AB06 

Active substances: Xylometazolini Hydrochloridum, Dexpanthenolum

Vendor, principal: Wick. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

SINOMIST 1MG/+50MG/1ML 10ML

Package leaflet: Information for the patient

Sinomist 1 mg/ml + 50 mg/ml nasal spray, solution

xylometazoline hydrochloride/dexpanthenol For the use in children over 6 years of age and adults

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse
have told
you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.   What Sinomist is and what it is used for
2.   What you need to know before you use Sinomist
3.   How to use Sinomist
4.   Possible side effects
5.   How to store
6.   Contents of the pack and other information

1. What Sinomist is and what it is used for

Sinomist contains the active ingredients xylometazoline hydrochloride and dexpanthenol. Xylometazoline, which contricts the blood vessels, thereby reducing swelling of the nasal mucousa. It also contains the active substance dexpanthenol, a derivative of the vitamin pantothenic acid which promotes healing and protects the mucous membranes.
To reduce swelling of the nasal mucosa in rhinitis and as supportive treatment for healing of mucocutaneous lesions, paroxysmal rhinorrhea (vasomotor rhinitis) and for the treatment of obstructed nasal breathing arter surgery on the nose.
For the use in children over 6 years of age and adults
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you use Sinomist

Do not use Sinomist:

•   if you are allergic to xylometazoline hydrochloride or dexpanthenol or any of the other ingredients of this medicine (listed in section 6).
•   if you suffer from dry rhinitis (a form of chronic rhinitis that causes dry inflammation of the nasal mucous membrane with formation of crusts).
•   if you have recently had neurosurgery (transsphenoidal hypophysectomy or other surgery exposing the meninx).
•   in children 6 years old or younger.

Warnings and precautions

Talk to your doctor or pharmacist before using Sinomist
•   if you are being treated with certain medicinal products for depression known as monoamine oxidase inhibitors (MAO inhibitors) or other medicinal products that may increase blood pressure (e.g. doxapram, ergotamine, oxytocin).
•   if you are being treated with medicines that lower the blood pressure (e.g. methyldopa).
•   if you suffer from increased pressure inside the eye, particularly narrow-angle glaucoma.
•   if you suffer from coronary heart disease or high blood pressure (hypertension).
•   if you suffer from an adrenal tumour (phaeochromocytoma).
•   if you suffer from metabolic disorders such as thyroid hyperfunction (hyperthyroidism) and diabetes.
•   if you have a metabolic disease known as porphyria (a metabolic disorder that affects he skin and/or nervous system).
•   if you have an enlarged prostate (prostatic hyperplasia).
In chronic rhinitis, medical supervision is required when using this medicine, due to the wasting away of the nasal mucous membrane (tissue inside the nose).

Children

Sinomist must not be used in children 6 years of age or younger. For this age group of children between 2 and 6 years, appropriate nasal sprays with a lower content of xylometazoline hydrochloride (the active decongestant substance) are available.
Long-term use and overdose, especially in children, must be avoided. Use at higher doses must only take place under medical supervision.

Other medicines and Sinomist

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any ohter medicines.
When using Sinomist at the same time as certain medicinal products e.g. mood-enhancing substances (MAO inhibitors of the tranylcypromine-type or tricyclic antidepressants) or other medicines that can potentially increase the blood pressure (e.g. doxapram, ergotamine, oxytocin) an increase in blood pressure may occur due to effects on cardiovascular functions. This medicine should not be combined with medicines that lower blood pressure (e.g. methyldopa), due to the possible vasopressor (blood pressure-increasing) effect of xylometazoline.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Sinomist can be used during pregnancy according to instructions for not longer than one week duration.
Breast-feeding
It is not known whether xylometazoline and dexpanthenol are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Sinomist therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Driving and using machines

When used as directed, no adverse effects are to be expected.

3. How to use Sinomist

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose in adults and children above 6 years of age is 1 spray of Sinomist into each nostril, according to need, but up to a maximum of 3 times daily. The dosage depends on individual sensitivity and the clinical effect.

Method of administration

The medicinal product is for nasal use. After removing the protective cap, insert the spray aperture into the nostril and activate the pump once. Breathe gently through the nose during the spray procedure. After use, carefully wipe the nozzle with a clean paper tissue and replace the protective cap.

Notes:

Before the first use - and after interruption of treatment of more than 7 days - activate the pump several times until an even spray mist emerges. For subsequent applications, the metered-dose spray is ready for immediate use.
Before application of the nasal spray gently blow your nose. It is recommended to take the last dose of each day before you go to bed.
For hygienic reasons and to avoid infections, each spray bottle should only be used by the same person.

Duration of use

Sinomist should not be used for more than 7 days, unless further use is expressly instructed by your doctor.
There should be an interval of several days before using this product again.
For the duration of use in children, a doctor should always be consulted.
Continuous use of this medicine can lead to chronic swelling and ulimatively shrinkage of the nasal mucosa.
Patients with increased pressure inside the eye (glaucoma, particularly narrow-angle glaucoma) should consult their doctor before using this medicine.
If you have the impression that the effect of Sinomist is too strong or too weak, talk to your doctor or pharmacist.

If you use more Sinomist than you should

e.g. as a result of overdose or accidental ingestion the following effects may occur:
Contraction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, blue coloration of lips (cyanosis), nausea, seizures, cardiovascular disorders, e.g. heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); lung dysfunction (pulmonary oedema, respiratory disorders), mental disorders.
Furthermore, sleepiness, decrease in body temperature, decreased heart rate, a shock-like drop in blood pressure, cessation of breathing and unconsciousness (coma) can occur.
In case of suspected overdose, please inform your doctor immediately, who can initiate any measures that may be required.

If you forget to use Sinomist

Do not use a double dose at your next time. Just continue use as described in the dosage instructions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used for stating the frequency of side effects:

Very common:	more than 1 in 10 patients treated
Common:	1 to 10 in 100 patients treated
Uncommon:	1 to 10 in 1,000 patients treated
Rare:	1 to 10 in 10,000 patients treated
Very rare:	less than 1 in 10,000 patients treated
Not known:	cannot be estimated from the available data

Immune system disorders:
Uncommon:
allergic (hypersensitivity) reactions (swelling of the skin and mucous membranes, skin rash, itching)
Psychiatric disorders:
Very rare:
agitation, insomnia, hallucinations (especially in children)
Nervous system disorders:
Very rare:
fatigue (drowsiness, sedation), headache, convulsions (especially in children)
Cardiac disorders:
Rare:
palpitations, accelerated heart activity (tachycardia)
Very rare:
heart rhythm disorders (arrhythmia)
Vascular disorders:
Rare:
increased blood pressure (hypertension)
Respiratory, thoracic and mediastinal disorders:
Very rare:
after the effect has worn off, increased swelling of the mucous membranes, nosebleed Frequency not known:
burning and dryness of the nasal mucous membranes, sneezing

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sinomist

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After first opening, Sinomist should be used within 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Sinomist contains

The active substances are xylometazoline hydrochloride/dexpanthenol.
One spray (equivalent to 0.1 ml solution) contains 0.1 mg xylometazoline hydrochloride and 5 mg dexpanthenol. 1 ml of solution contains: xylometazoline hydrochloride 1 mg and dexpanthenol 50 mg. The other ingredients are:
Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections

What Sinomist looks like and contents of the pack

One bottle with 10 ml solution contains not less than 90 single sprays.
Sinomist is a clear, almost colourless solution available in an amber coloured glass bottle or 10 ml round plastic bottle containing 10 ml of solution sealed with a spray pump with a nose adapter and a protecting cap.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Wick Pharma Sulzbacher Strasse 40 65824 Schwalbach am Taunus Germany
Manufacturers
Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
TEVA Gyogyszergyar Zrt.
Debrecen, Pallagi ut 13,
H-4042
Hungary
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb 10000 Croatia
HBM Pharma s.r.o.
Sklabinska 30 03680 Martin Slovakia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Telephone: +372 6610801

This leaflet was last revised in August 2018.