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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 or pharmacist has 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 3-5 days.
What is in this leaflet
1. What Galazolin is and what it is used for 2. What you need to know before you use Galazolin 3. How to use Galazolin 4. Possible side effects 5. How to store Galazolin 6. Contents of the pack and other information
1. What Galazolin is and what it is used for
Galazolin is a nasal drop preparation; the active ingredient is xylomethazoline hydrochloride, a drug of the sympathomimetic group. When administered onto the nasal mucous membrane, Galazolin reduces swelling and hyperaemia, as well as the quantity of secretions and facilitates the clearance of secretions from the nasal sinuses, thereby relieving nasal congestion and the sensation of pressure in the sinuses, which accompany allergies and colds. Galazolin is used to reduce the swelling of the nasal mucous membrane in case of rhinitis.
2. What you need to know before you use Galazolin Do not use Galazolin
- if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6); - if you have undergone hypophysectomy or any other neurosurgical procedure; - if you have defects or damage of the nasal mucous membrane.
Warnings and precautions
Talk to your doctor or pharmacist before using Galazolin. - Stop using this medicine if the child receiving the medicine becomes restless or has trouble falling asleep. - Stop taking this medicine if you have symptoms, such as dizziness, insomnia, tremors, irregular heart rate, especially if said symptoms have occurred after using other similar medicines. - Talk to your doctor before using this medicine, if you have: - hypertension; - stenocardia (i.e. pain in the chest during exertion); - diabetes (high blood sugar); - glaucoma (increased intra-ocular pressure); - enlarged prostate; - hyperthyroidism; - adrenal gland pheochromocytoma (tumour of the gland above the kidneys). - Do not use Galazolin for longer than 5 days, as the treatment of nasal mucous membrane changes can become difficult as a result of longer-term use.
Other medicines and Galazolin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. - Do not use Galazolin during treatment with antidepressants also known as tricyclic antidepressants or MAO inhibitors. Also do not use Galazolin within 2 weeks from taking the last MAO inhibitor dose. - Do not use Galazolin concomitantly with ergotamine (a medicine used in the treatment of migraines and as a delivery aid). - Avoid using Galazolin concomitantly with medicines, such as ephedrine and pseudoephedrine (ingredients of cold medicines).
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. Do not use Galazolin during pregnancy. Women who are breast-feeding should talk to their doctor before using Galazolin.
Driving and using machines
When used by following the information presented in this leaflet, Galazolin will in general have no effect on your ability to drive or use machines. However, if you get symptoms described in section 4 (e.g. drowsiness), avoid driving or using machines until the symptoms have receded.
Galazolin contains benzalkonium chloride
The preservative benzalkonium chloride can cause nasal mucous membrane irritation.
3. How to use Galazolin
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. - Only administer this medicine nasally (incl. in case of otitis media). - Due to reasons of hygiene, one package of medicine should only be used by one patient. - Do not use Galazolin for longer than 3 to 5 days. - Do not use larger doses than described below.
Galazolin 1 mg/mL
1 drop contains 0.05 mg of xylometazoline hydrochloride. Galazolin 1 mg/mL is used only in adults and children over 12 years of age. Adults and children over the age of 12: 2 to 3 drops in each nostril once every 8 to 10 hours. Do not exceed 3 doses in each nostril per day.
Galazolin 0.5 mg/mL
1 drop contains 0.025 mg of xylometazoline hydrochloride. Galazolin 0.5 mg/mL is meant for use in children from 2 to 12 years of age. Children aged 2 to 12: 1 or 2 drops in each nostril once or twice per day, every 8 to 10 hours. Do not use more than 3 doses in each nostril per day.
If you use more Galazolin than you should
Immediately talk to your doctor if someone has taken a larger than recommended dose (overdose) or has swallowed the medicine by accident, especially if this has happened to a child. Immediatly talk to your doctor if you get any of the symptoms below, as these could be a sign of an overdose or accidental ingestion of the medicine by a child: - fast and irregular heart rate; - hypertension (with symptoms, such as persistent strong headache, especially in the back of the head; fatigue, feeling unwell); - excessive drowsiness; - irregular or laboured breathing; - disorders of consciousness; - excessive sedation.
If you forget to use Galazolin
Do not administer a double dose if you missed the previous application of drops, and do not exceed the daily maximum of 3 doses in each nostril.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get an allergic reaction, such as facial, lip or tongue swelling causing difficulties breathing or swallowing, stop using the medicine and immediately talk to a doctor. These reactions are very rare. Very rare (occurs in less than 1 person in 10,000): nausea, headache, fatigue, weariness, drowsiness, impaired vision, irregular heart rate, fast heart rate, hypertension (especially in people with cardiovascular diseases). Side effects can also include irritation and dryness in the nose, as well as burning sensation in the nose and pharynx, sneezing. Long-term use of the medicine and/or using larger than recommended doses can complicate the treatment of changes in the nasal mucous membrane.
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 Galazolin
Keep this medicine out of the sight and reach of children. Do not store at a temperature higher than 25 °C and protect from light. Keep the bottle tightly sealed and inside the external package. Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month. Do not use the medicine for longer than 12 weeks after the first opening of the bottle. 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 Galazolin 1 mg/mL contains
- The active ingredient is xylometazoline hydrochloride. One millilitre contains 1 mg of xylometazoline hydrochloride. - The other ingredients are disodium phosphate dodecahydrate, sodium dihydrophosphate monohydrate, sodium chloride, sorbitol, disodium edetate, benzalkonium chloride solution, purified water.
What Galazolin 0.5 mg/mL contains
- The active ingredient is xylometazoline hydrochloride. One millilitre contains 0.5 mg of xylometazoline hydrochloride. - The other ingredients are disodium phosphate dodecahydrate, sodium dihydrophosphate monohydrate, sodium chloride, sorbitol, disodium edetate, benzalkonium chloride solution, purified water.
What Galazolin looks like and contents of the pack
Galazolin 1 mg/mL and Galazolin 0.5 mg/mL nasal drops are colourless or nearly colourless transparent liquids. Galazolin 1 mg/mL and Galazolin 0.5 mg/mL are available in polyethylene bottles with a dropper and a measuring device. Each bottle contains 10 mL of solution and is packaged in a carton.
Marketing Authorisation Holder and Manufacturer
Warsaw Pharmaceutical Works Polfa S.A. ul. Karolkowa 22/24 01-207 Warszawa Poland