OTRIVIN PLUS 1mg/ml/50mg/ml nasa spray 10ml
OTRIVIN PLUS spray 10 ml. / OTRIVIN PLUS spray 10 ml.
Leaflet: user information
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Xylometazoline Hydrochloride / Dexpanthenol
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Xylometazoline hydrochloride / Dexpanthenol
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.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is and what it is used for
2. What you need to know before you use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
3. How to use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
4. Possible side effects
5. How to store Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
6. Contents of the package and additional information
1. What Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is and what it is used for
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is a nasal spray.
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution contains the active ingredient xylometazoline hydrochloride, which constricts blood vessels, leading to a reduction in swelling of the nasal mucosa.
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution also contains the active ingredient dexpanthenol - a derivative of the vitamin pantothenic acid. It helps heal wounds and protects the mucous membrane.
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is used in adults and adolescents aged 12 years and over for:
reducing swelling of the nasal mucosa in rhinitis and as an adjunctive treatment for the healing of wounds on the skin and mucous membranes, for the relief of runny nose (upper rhinitis) and for the treatment of nasal congestion after nasal surgery;
reduction of swelling of the nasal mucosa in rhinitis associated with acute inflammation of the sinuses (rhinosinusitis).
2. What you need to know before you use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Do not use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution:
if you are allergic to the active substances xylometazoline hydrochloride and dexpanthenol or to any of the other ingredients of this medicine (listed in point 6);
if you have inflammation characterized by dry nasal mucosa, including the formation of crusts (crusts) in the nose (dry rhinitis or atrophic rhinitis);
after surgical removal of the pituitary gland through the nose (transsphenoidal hypophysectomy) or during other surgical interventions leading to exposure of the cerebral membrane;
if you have increased intraocular pressure, especially in cases of angle-closure glaucoma;
in infants and children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution if:
you have been treated with monoamine oxidase (MAO) inhibitors or have taken them in the last two weeks or other medicines that may lead to an increase in blood pressure;
you have severe cardiovascular disease (eg coronary heart disease) or high blood pressure (hypertension);
you have a tumor of the adrenal gland (phaeochromocytoma);
you have a metabolic disorder such as an overactive thyroid gland (hyperthyroidism) or diabetes mellitus;
you have a metabolic disease (porphyria);
you have an enlarged prostate (prostatic hyperplasia).
To reduce the risk of spreading infection, the medicinal product should not be used by more than one patient and the tip should be rinsed after use.
Xylometazoline can very rarely cause insomnia. If insomnia occurs, avoid application late in the evening or at night.
Elderly patients:
Elderly patients may be more sensitive to the side effects of Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution.
Due to the risk of thinning of the nasal mucosa, the use of the product in chronic runny nose should only be carried out under medical supervision.
Children and adolescents:
Long-term use (more than 10 consecutive days) and use in doses higher than recommended should be avoided, especially in children, because it can cause nasal congestion and narrowing of the airways. Prolonged use has resulted in secondary nasal obstruction and atrophy of the nasal mucosa.
The concentration of active substances in Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is tailored for adults and adolescents aged 12 and over, therefore it is not suitable for babies and children under 12 years of age.
Nasal sprays are available with a suitable, lower dose of the active nasal decongestant xylometazoline hydrochloride for children between 1 and 11 years of age.
Other medicines and Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The simultaneous use of Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution with antidepressants (monoamine oxidase inhibitors or tri- and tetracyclic antidepressants) and with drugs that increase blood pressure can lead to an increase in blood pressure due to cardiovascular effects of these substances.
Pregnancy, lactation and fertility
Pregnancy
Due to insufficient information on the use of xylometazoline hydrochloride and dexpanthenol in pregnant women, Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution should not be used during pregnancy.
Breastfeeding
It is not known whether xylometazoline hydrochloride or dexpanthenol is excreted in human milk, therefore Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution should not be used during breast-feeding.
Fertility
Adequate data on the effects of xylometazoline hydrochloride and/or dexpanthenol on human fertility are lacking.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
No adverse effects are expected with proper use of the medicinal product, but if you feel dizzy or drowsy, you should not drive or operate machinery.
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution contains benzalkonium chloride.
Benzalkonium chloride may cause irritation or swelling of the nasal mucosa if used for a long time.
Contact your doctor if you feel any discomfort while using Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution.
3. How to use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Application method:
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is a nasal spray, solution and is used in the nose.
1) Remove the protective cap from the nozzle.
2) Before initial use, the pump must be activated by pressing the dispenser three times until a fine spray appears.
This step does not need to be repeated for subsequent use.
Once activated, the pump normally remains charged for the duration of the usual treatment period. If the spray pump was not fully activated initially or the spray has not been used for several days, the pump must be activated again with a double push.
Be careful not to get spray in the eyes.
3) Clean your nose.
4) Hold the bottle upright with the thumb at the base and the tip between the two fingers.
5) Tilt your head slightly forward and insert the tip into one nostril.
6) Spray while inhaling gently through the nose. Repeat the same procedure for the other nostril.
7) Dry the tip and put the protective cap on it immediately after use.
8) To avoid the possible spread of infection, the spray should only be used by one person.
Dosage
In adults and adolescents - one spray of Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution in each nostril up to 3 times a day, as needed, unless otherwise prescribed by a doctor. The dose depends on individual sensitivity to the product and response to treatment. Do not exceed more than 3 sprays per day in each nostril.
Duration of treatment
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution should not be used for more than 7 days, unless a doctor prescribes a longer treatment.
Prolonged use of this product may lead to chronic edema and subsequent damage to the nasal mucosa.
Application in children
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is contraindicated in children under 12 years of age (see point 2).
If you have used more than the required dose of Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
In case of overdose or accidental ingestion, the following effects may occur: contraction (miosis) or dilation of the pupil (mydriasis), fever, sweating, paleness, blue lips (cyanosis), nausea, cramps, cardiovascular disorders such as heart rhythm disturbances ( tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension), lung disorders (pulmonary edema, breathing problems), mental disorders.
Drowsiness, lowering of body temperature, slowing of heart rate, lowering of blood pressure to a shock-like state, respiratory failure and loss of consciousness (coma) are also possible.
If you suspect an overdose, contact your doctor immediately. Appropriate measures may need to be taken.
If you forget to use Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Do not take a double dose to make up for a missed dose. Continue use as described in the leaflet.
Consult your doctor or pharmacist if you have any other questions related to the use of Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people):
allergic reactions (rash, itching, swelling of the skin and mucous membrane).
Rare side effects (may affect up to 1 in 1,000 people):
palpitations;
fast heart rate (tachycardia);
increase in blood pressure (hypertension).
Very rare side effects (may affect up to 1 in 10,000 people):
anxiety;
insomnia;
fatigue (drowsiness, sedation);
headache;
hallucinations (mainly in children);
heart rhythm disorder (arrhythmias);
increased swelling of the mucous membrane, due to the weakening of the effect of the drug;
nosebleeds;
cramps (mainly in children).
Not known (frequency cannot be estimated from the available data):
burning or dryness of the nasal mucosa;
sneezing.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Bulgaria,
Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
Phone: +359 2 8903417,
Website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. It corresponds to the last day of the specified month.
To be stored below 25 °C.
Shelf life after first opening: 24 weeks.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution contains;
Active substances: xylometazoline hydrochloride and dexpanthenol.
A single dose of 0.1 ml spray contains 0.1 mg xylometazoline hydrochloride and 5 mg dexpanthenol.
Excipients: benzalkonium chloride, potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified water (Ph. Eur.).
What Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution looks like and contents of the pack
Otrivin Plus 1 mg/ml + 50 mg/ml nasal spray, solution is a colorless, clear solution in a 15 ml plastic bottle equipped with a dosing pump and a tip with a protective cap, placed in a cardboard package.
The bottle contains 10 ml of solution.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder: GlaxoSmithKline Dungarvan Limited, Ireland.
Manufacturers:
MEDANA PHARMA SA, Poland
GlaxoSmithKline Consumer Healthcare GmbH, Germany.
