What are the side effects of Otrivin
Otrivin 0.05% - nasal drops
|Marketing authorization holder||GSK-Gebro Consumer Healthcare GmbH|
How does the remedy work?
Otrivin contains the active substance xylometazoline. It quickly clears the blocked nose and facilitates the drainage of secretions; this allows you to breathe freely through your nose.
Otrivin starts working within 2 minutes and lasts for up to 12 hours. Otrivin, used in the nose, also supports the decongestion of the mucous membrane in the nasopharynx in the case of otitis media.
If you don't feel better or even worse after 1 week, contact your doctor.
Otrivin 0.05% - nasal drops contains benzalkonium chloride.
In which areas of application is the product used?
Otrivin 0.05% - nasal drops are used for colds of various types in children in the age group from 2 to 12 years, under the supervision of an adult.
Otrivin is used to treat nasal congestion caused by colds, hay fever, allergic rhinitis, or sinus infections.
It may also be prescribed by your doctor to facilitate rhinoscopy (examination of the inside of the nose).
how do you apply the product?
Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has discussed. Check with your doctor or pharmacist if you are not sure.
Otrivin 0.05% nasal drops are suitable for children in the age group of 2 to 12 years. Other Otrivin preparations (Otrivin 0.1% - nasal spray without preservatives, Otrivin Menthol 0.1% - nasal spray, Otrivin 0.1% - nasal gel) are available for adolescents from 12 years of age and adults.
Otrivin 0.05% nasal drops should not be used in newborns, infants and young children under 2 years of age.
Unless otherwise prescribed by the doctor:
- Children from 2 to 6 years: 1 - 2 times, but no more than 3 times a day, 1 drop,
- Children from 7 to 12 years: 1 - 2 times, but no more than 3 times a day 1 - 2 drops.
Last application in the evening, generally just before bedtime.
In general, there should be an interval of at least 8 hours between two applications.
Use in children from 2 to 6 years of age may only be carried out on the express medical recommendation.
Children under 2 years: see also "Otrivin 0.05% - nasal drops must not be used"
Use in children should be supervised by parents or adults.
Type of application:
- For nasal use.
- Thoroughly clean your nose (blowing your nose) before use.
- Then put your head back and instill drops into one nostril; Close the other nostril with your finger and breathe in quickly with your mouth closed.
- The process is repeated on the other nostril.
For reasons of hygiene and to avoid infections, please note that each dosing pipette may only be used by one and the same person.
Duration of treatment:
Otrivin 0.05% nasal drops should not be used for more than 7 days unless directed to do so by a doctor.
After 1 week of treatment, a break of several days must be taken.
If you use more Otrivin 0.05%, nasal drops than you should
In case of overdose
or accidental ingestion of the entire content of the 10 ml bottle can lead to an acceleration and irregularity of the pulse, an increase in blood pressure, possible clouding of consciousness, cramps, restlessness, insomnia, tiredness (drowsiness) and hallucinations, especially in childhood.
In the event of such symptoms, seek medical advice immediately.
If you forget to use Otrivin 0.05%, nasal drops
Do not use double the amount to make up for a forgotten application. Instead, if necessary, continue treatment as usual.
If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.
When should the product not be used?
Otrivin 0.05% nasal drops must not be used
- if your child is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- with dry rhinitis.
- for chronic rhinitis, which has led to a thinning of the nasal mucosa.
- After operations in the nose and throat area (removal of the pituitary gland or surgical interventions in which the meninges were exposed), Otrivin, like other decongestants, must not be used.
- if you are taking MAO inhibitors (medicines for depression) at the same time, even within the last 14 days.
- in glaucoma (narrow-angle glaucoma).
- in newborns, infants and toddlers under 2 years of age.
Tell your doctor or pharmacist if any of the above applies to you as Otrivin is not suitable in these circumstances.
Can the product be used by pregnant and breastfeeding women?
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
Because of its vasoconstricting properties, Otrivin should not be used as a precaution during pregnancy and breastfeeding.
Which side effects can occur?
With prolonged use, abuse of the drug and overdosage of nasal mucous membrane decongestants (even after discontinuation):
- drug-induced swelling of the nasal mucous membrane, a so-called rhinitis medicamentosa (the symptoms of which are very similar to a runny nose),
- Dehydration of the nasal mucous membrane (rhinitis sicca),
- Swelling of the nasal mucosa as a counter-reaction after stopping or
- Decrease in effectiveness
These reactions can in turn make nasal breathing difficult and lead to incorrect long-term use of the drug.
May cause skin irritation.
Like all medicines, this medicine can Side effects that do not have to occur with everyone.
Stop using Otrivin and seek medical help immediately if you experience any of the following, which may be a sign of an allergic reaction:
- Difficulty breathing or swallowing
- Swelling of the face, lips, tongue, or throat
- Severe itching of the skin, with a red rash or raised bumps.
Frequency of side effects:
Nervous system disorders:
- Common: headache
- Very rare: restlessness, insomnia, tiredness (sleepiness, sedation), hallucinations (primarily in children)
- Very rare: temporary visual disturbances
- Rare: palpitations, rapid heart activity, increased blood pressure
- Very rare: irregular heartbeat
Respiratory and chest disorders:
- Common: dryness of the lining of the nose and throat, sneezing
- Uncommon: After the effects have subsided, increased swelling of the mucous membranes, nosebleeds
Digestive system disorders:
Musculoskeletal, connective tissue and bone diseases:
- Very rare: seizures (especially in children)
Immune system disorders:
- Very rare: hypersensitivity reactions (rash, itching, allergic painful swelling of the skin and mucous membranes, especially in the face area)
General disorders and administration site conditions:
- Common: burning sensation at the application site.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
Federal Office for Safety in Health Care Traisengasse 5
AT-1200 VIENNA AUSTRIA
Fax: + 43 (0) 50 555 36207 Website: http://www.basg.gv.at/
By reporting side effects you can help provide more information on the safety of this medicine.
Interactions are known with the following substances:
Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.
Medicines that are taken at the same time and have a stimulating effect on the nervous system (sympathomimetics) can be more effective, while those with the opposite effect can be weakened.
The effect of Otrivin on the entire organism can be increased by certain mood-enhancing drugs (MAO inhibitors also within the last 14 days, tricyclic or tetracyclic antidepressants), especially in the event of an overdose.
If beta blockers are taken at the same time, the amount of otivin should be kept as low as possible, as in very rare cases temporary shortness of breath due to narrowing of the lower airways and an increase in blood pressure can occur.
You should therefore tell your doctor or pharmacist which medicines you are taking in addition to using Otrivin.
Talk to your doctor or pharmacist before using Otrivin 0.05% nasal drops.
Take special care when using Otrivin 0.05% nasal drops
- with high blood pressure,
- in diseases of the coronary arteries (e.g. angina pectoris),
- with enlarged prostate,
- with certain metabolic disorders, such as diabetes mellitus, overactive thyroid gland (hyperthyroidism) or porphyria (disorders of the red blood pigment),
- if you have a tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline (pheochromocytoma).
Tell your doctor or pharmacist if you:
- suffer from other diseases or allergies,
- use / take other medicines, including those you have bought yourself,
- are pregnant or breastfeeding.
At the first signs of side effects, please talk to your doctor.
If the symptoms persist or if the expected success from the application does not occur within a week, medical advice is required as soon as possible.
If you react to drugs that stimulate the nervous system (sympathomimetics) with signs of insomnia, dizziness, tremors, etc., you should use Otrivin with caution, like all preparations of the same class of active substances.
Otrivin is not for use in the eyes or mouth.
Do not exceed the recommended dose, especially in children.
Note: The list of drugs does not in any way represent a recommendation, sales promotion or advertising of the individual drugs in any way.
The information is by no means conclusive and is not a substitute for medical or other specialist advice.
In particular with regard to side effects, contraindications and other information, the attending doctor or pharmacist should be consulted.
Status of information: September 2017
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