When to use
For adults from 18 years old and above. Otrivin Dual relief Nasal Spray is indicated for the symptomatic treatment of nasal congestion and rhinorrhoea associated with common cold. Otrivin Dual Relief is not recommended for use in children and adolescents below 18 years of age.
Precautions
Talk to your doctor or pharmacist before using Otrivin Dual Relief.
Otrivin Dual Relief must be administered with caution to patients with:
- Hypertension, cardiovascular diseases
- Hyperthyroidism, diabetes mellitus
- Hypertrophy of the prostate, stenosis of the bladder bar
- Pheochromocytoma
Caution is recommended in patients predisposed to:
- Angle closure glaucoma
- Epistaxis (e.g. elderly)
- Paralytic ileus
- Cystic fibrosis
Immediate hypersensitivity including urticaria, angioedema, rash, bronchospasm, pharyngeal oedema and anaphylaxis may occur. These symptoms may appear individually or all combined as a severe allergic reaction. If this occurs, immediately STOP using Otrivin Dual Relief.
The medicinal product must be used with caution in patients who are sensitive to adrenergic substances, which may give symptoms such as sleeping disturbances, dizziness, tremor, cardiac arrythmias or elevated blood pressure.
The treatment duration should not exceed 7 days, as chronic treatment with xylometazoline hydrochloride may cause swelling of the nasal mucosa and hypersecretion because of increased sensibility in the cells, ”rebound effect” (rhinitis medicamentosa).
Patients should be instructed to avoid spraying Otrivin Dual Relief in or around the eye. If Otrivin Dual Relief gets in contact with the eyes, the following may occur: temporary blurred vision, irritation, pain, red eyes. Aggravation of angle closure glaucoma may also develop.
The patient should be instructed to rinse their eyes with cold water if Otrivin Dual Relief gets in direct contact with the eyes and to contact a doctor if they experience pain in the eyes or blurred vision.
There are no adequate data from the use of Otrivin Dual Relief in pregnant women. If you are pregnant or breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Further information
Keep out of reach of children. Seek medical advice before using if you are breastfeeding. Do not use after the expiry date stated on the bottle.
Always read the patient information leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP using Otrivin Dual Relief and seek medical help immediately if you have any of the following:
- Palpitations and increased heart rate (affects less than 1 in 100 people)
- Sign of an allergic reaction as difficulty breathing, speaking or swallowing; swelling of the face, lips, tongue or throat; severe itching of the skin, with a red rash or raised bumps (frequency not known cannot be estimated from available data).
- Disturbances of vision (including blurred vision, worsening of glaucoma or increased pressure in the eye), rainbow-colored circles/haloes around bright lights and/or severe eye pain (frequency not known cannot be estimated from available data).
The most commonly reported adverse reactions are nose bleeding occuring in 14.8% and nasal dryness occurring in 11.3 % of patients many of the side effects reported are also symptoms of common cold.
Very common side effects (may affect more than 1 in 10 people):
- Nose bleeding, nasal dryness
Common side effects (may affect up to 1 in 10 people):
- Nasal discomfort, congestion of the nose, dry and irritated throat, pain in the nose
- Dry mouth
- Altered taste sensation, headache
Uncommon (may affect up to 1 in 100 people):
- Nasal ulcer, sneezing, pain in the throat, cough, hoarseness
- Stomach upsets, nausea
- Altered smell sensation, dizziness, shakiness
- Discomfort, tiredness
- Sleeplessness
- Irritation of the eyes, dry eyes
Rare (may affect up to 1 in 1,000 people):
Frequency not known (cannot be estimated from available data):
- Rash, hives
- Discomfort around the nose
- Discomfort in the chest, thirst
- Sudden spam of throat muscle
- Irregular pulse
- Difficulties focusing with the eyes, dilation of the pupils
- Itching
- Difficulties emptying the bladder
- Atrial fibrillation
- Paranasal sinus discomfort
- Pharyngeal oedema
In order to minimize the risk of side effects such as nose bleeding and other effects on the nose, it is recommended that you stop treatment with Otrivin Dual Relief when your symptoms improve even if this is sooner than 7 days.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not use Otrivin Dual Relief
- In children below 18 years of age, as sufficient documentation in children is not available.
- If you are allergic (hypersensitive) to xylometazoline hydrochloride and ipratropium bromide or any of the other excipients of Otrivin Dual Relief.
- If you are hypersensitive to atropine or similar substances, e.g. hyoscyamine and scopolamine.
- After surgical operations where dura mater have been penetrated e.g (transphenoidal hypophysectomy or other transnasal operations).
- If you suffer from Glaucoma.
- If you have a very dry nose (inflammatory nasal dryness, rhinitis sicca).
