SEPTANAZAL 50 mg. / Ml. 10 ml
Septanazal adult nasal spray containing xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride quickly shrinks blood vessels in the nasal mucosa and reduces swelling of the nasal mucosa and mucus secretion. Thus relieves the feeling of stuffy nose.
Dexpanthenol is a derivative of pantothenic acid, vitamin that helps heal damaged mucosa and has mukoprotektivno (protective mucous membranes) action.
Septanazal adult used:
To reduce swelling of the nasal mucosa during inflammation of the mucosa of the nose (rhinitis), and to assist the healing of lesions in the nasal mucosa and the surrounding skin areas;
To relieve symptoms of non-allergic inflammation of the nasal mucosa (vasomotor rhinitis);
For the treatment of impaired breathing through the nose after nasal surgery.
2. What you should know before using Septanazal adult
Do not use Septanazal for adults:
If you or your child is allergic to xylometazoline, dexpanthenol or any of the other ingredients of this medicine (listed in section 6);
If you or your child suffers from dry inflammation of the nasal mucosa with crusting (dry rhinitis);
Once done through the nose surgical removal of the pituitary gland of you or your child or other operational exposure to the meninges.
This medicine should not be used in children under 6 years.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Septanazal for adults:
If you or your child are taking monoamine oxidase (MAO) inhibitors or other drugs that have the ability to increase blood pressure;
If you or your child have increased intraocular pressure (glaucoma), in particular if you suffer from narrow-angle glaucoma;
If you or your child suffer from severe heart disease (eg. Coronary heart disease, high blood pressure);
If you or your child have an adrenal gland tumor (pheochromocytoma);
If you or your child suffer from metabolic disease (eg. Increased activity of the thyroid manifested by increased sweating, increased body temperature, increased heart rate or diabetes);
If you or your child suffer from a metabolic disorder called porphyria;
If you or your child have an enlarged prostate (prostatic hyperplasia).
The medicine may be used in chronic rhinitis only under medical supervision because of the risk of atrophy (decrease) in the nasal mucosa.
Misuse or use of excessive quantities of spray can cause systemic side effects, especially in children (see section "Undesirable effects").
Not recommended for use Septanazal if you or your child are already using:
Other medicines used to treat flu;
Other medicines for cough and cold products containing sympathomimetic agents (medicines used to treat stuffy nose as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tiaminoheptan).
Concomitant use of these drugs with Septanazal for adults can increase the risk of side effects of the cardiovascular system and central nervous system.
Avoid direct contact of this medicine with the eyes.
Do not use doses higher than recommended by your doctor. Please consult with your doctor about the duration of treatment and frequency of use in children.
Septanazal adult is suitable for use in children over 6 years of age. Available Septanazal children nasal spray with a lower concentration of the active substance.
Should monitor the use of this medicine in children under 12 years of age.
If the child does not feel better or worse after three days of treatment, please consult your doctor.
Other medicines and Septanazal adult
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of Septanazal for adults with some medicines to treat depression (monoamine oxidase inhibitors traniltsiprominovi or tricyclic antidepressants) may lead to increased blood pressure as a result of the effect of these substances on the cardiovascular system.
Use of Septanazal adult at the same time as other drugs for flu or cough and cold products containing sympathomimetic agents (medicines used to treat stuffy nose as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tiaminoheptan) may increase side effects of the cardiovascular system and central nervous system.
Consult a physician before using Septanazal adult if you or your child uses any of the above drugs.
Septanazal for adults with food and drink
You can use this medicine with or without food.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
This drug should be used during pregnancy because of the lack of data on safety in pregnant women.
This medicine should not be used in nursing mothers as it is not known whether xylometazoline hydrochloride passes into breast milk.
Driving and using machines
The use of this medicine in accordance with the instructions, do not expect events of any effect on the ability to drive or operate machinery.
3. How to use Septanazal adult
Always use this medicine exactly as described in this leaflet or as you have been told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended adult dose is one spray in each nostril 3 times daily if necessary. The dosage depends on individual susceptibility and clinical efficacy. Do not use this medicine for more than 7 days. The next use is possible only after a few days of rest.
Method of administration
First remove the protective cap from the spray.
Before the first use, or if the spray is not used for a long period of time, press the atomiser of the spray several times to yield a fine spray.
Insert tip into the nostril, the maximum vertical position and press the atomizer once. Gently inhale through the nose while spraying. If necessary, repeat this procedure for the other nostril.
After each use, wipe the tip with a tissue and put the cap back.
Prolonged use or use of higher doses of this drug may result in chronic swelling and possible thinning (damage) of the nasal mucosa.
Patients with increased intraocular pressure (glaucoma), especially narrow-angle glaucoma, you should consult a doctor before taking this medicine.
Use in children
The recommended dose for children over 6 years of age is one spray in each nostril up to 3 times a day if necessary. You should always consult a doctor regarding the duration of treatment in children.
If you use more than the required dose for adults Septanazal
If you use more than the amount Septanazal adult or if you accidentally ingested large amounts of the drug may occur following side effects: shrinking the eye pupil (miosis), widening of the eye pupil (mydriasis), fever, sweating, pale skin, bruising of the lips (cyanosis), nausea, convulsions, heart and vascular disorders (increased heart rate, slow heart rate, abnormal heart rhythm, circulatory failure, cardiac arrest, high blood pressure (hypertension)), respiratory disorders (swelling of the lungs , respiratory problems) and mental disorders.
Also, you may experience dizziness, reduced body temperature, slow heart rate and low blood pressure, respiratory arrest and coma.
Contact your doctor immediately if you notice any of these symptoms.
If you forget to take Septanazal adult
Do not take a double dose to make up the missed dose.
If you stop taking Septanazal adult
If you stop taking Septanazal adult as soon as you no longer need it.
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.
Uncommon (may affect up to 1 in 100 people):
Hypersensitivity reactions such as swelling of the skin and mucous membranes, skin rash, itching.
Rare (may affect up to 1 in 1000 people):
Palpitations (awareness of heart beat), tachycardia (rapid heartbeat), hypertension (high blood pressure).
Very rare (may affect up to 1 in 10,000 people):
Anxiety, sleep problems, nausea (dizziness, sedation), headache, hallucinations (especially in children);
Abnormal heart rhythms (arrhythmias);
Swelling of the nasal mucosa (after discontinuation of treatment), bleeding from the nose;
(Convulsions, especially in children).
Not known (frequency can not be estimated from the available data):
Burning and nasal dryness, sneezing.
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Septanazal adult
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging 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, the product should be used within 3 months.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Septanazal adult
The active substances are: xylometazoline hydrochloride and dexpanthenol.
Each spray of the nasal spray solution contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol.
One injection (0.1 ml of nasal spray solution) contains 0.1 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.
The other ingredients (excipients) are: potassium dihydrogen phosphate, disodium phosphate dodecahydrate and water, purified.
Looks Septanazal for adults and contents of the pack
Clear, colorless liquid solution.
Septanazal for adults are available in packs containing 10 ml nasal spray, solution in a plastic container with a pump spray.