Otrivin Comp - Xylometazoline hydrochloride / Ipratroprium bromide uses, dose and side effects

Otrivin Comp is a combination drug that consists of two different substances. One active substance helps with colds, the other has a decongestant effect.

Otrivin Comp is used for nasal congestion and runny nose ( rhinorrhea ) in connection with common colds.

What you need to know before using Otrivin Comp

Do not use Otrivin Comp

to children under 18 years of age as sufficient information describing safety and efficacy is not available

– if you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6)

– if you are hypersensitive to atropine or similar atropine-like substances, e.g. such as hyoscyamine and scopolamine

– if you have had a pituitary gland removed by surgery through your nose

– if you have had an operation on your brain and the operation was performed through your nose or mouth

– if you have glaucoma (increased pressure in the eye)

– if you have a very dry nose ( inflammatory dry nose, rhinitis sicca, or atrophic rhinitis )

Warnings and cautions

Otrivin Comp may cause you to have sleep disturbances, dizziness, tremor, irregular heartbeat, or increased blood pressure if you are sensitive to medicines that relieve nasal congestion. Consult your doctor if these symptoms occur and are troublesome.

Talk to your doctor or pharmacist before using Otrivin Comp if you suffer from:

– heart disease (eg long QT syndrome)

– high blood pressure

– diabetes

– increased release of thyroid hormone ( hyperthyroidism )

– difficulty urinating and/or enlarged prostate

– glaucoma with narrow ventricular angle

– to easily suffer from nosebleeds

– intestinal upset (paralytic ileus )

– cystic fibrosis

a benign adrenal tumor ( pheochromocytoma ) that produces large amounts of adrenaline and norepinephrine, or a particular sensitivity to adrenaline and norepinephrine

Rapid hypersensitivity reaction ( allergic reaction ) may occur. This can be experienced as an itchy red inflamed rash on the skin ( hives ), difficulty breathing or speaking, difficulty swallowing due to swollen lips, or swelling of the face or throat. These symptoms may occur individually or together as a severe allergic reaction. If this happens, STOP using Otrivin Comp immediately (see section 4).

Otrivin Comp should not be used for more than 7 consecutive days. If symptoms persist, consult a physician for advice. Prolonged or excessive use may cause nasal congestion to recur or worsen as well as swelling of the nasal mucosa.

Avoid spraying Otrivin Comp into or around the eye. If Otrivin Comp still comes into contact with your eyes, rinse thoroughly with cold water. You may experience temporary blurred vision, irritation, pain, redness of the eyes. Contact a doctor for advice if this occurs. Deterioration of glaucoma can also develop.

Children and young people

Otrivin Comp is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.

Other medicines and Otrivin Comp

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must mention the following:

Monoamine oxidase inhibitors (for depression). If you take or have taken these medicines in the last two weeks, your blood pressure may rise to dangerous levels.
Tri- and tetracyclic antidepressants. If you take or have taken these medicines in the last two weeks, your blood pressure may rise to dangerous levels.
Medicines for motion sickness (anticholinergics).

Medicines used to treat intestinal diseases (especially medicines for abnormal bowel movements) (medicines containing anticholinergic substances).
Medicines used to treat respiratory disorders (beta-2 agonists ) such as asthma or chronic obstructive pulmonary disease (COPD) as it may aggravate glaucoma if you have a history of narrow-angle glaucoma .

If you are taking any of the above medicines, talk to your doctor before using Otrivin Comp.

Pregnancy, breastfeeding and fertility

Otrivin Comp should be used during pregnancy only on the advice of a doctor.

Otrivin Comp should be used during breastfeeding only if the doctor considers that the benefits outweigh the potential risks to the baby.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Visual disturbances (including blurred vision and pupillary enlargement ), dizziness, and fatigue have been reported with Otrivin Comp. If you are affected, avoid driving, operating machinery, or engaging in activities where these symptoms may put yourself or others at risk.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Otrivin Comp

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults: A spray dose in each nostril if necessary up to 3 times daily for a maximum of 7 days. Let at least 6 hours pass between two doses. Do not exceed 3 sprays daily in each nostril.

Do not exceed the indicated dose one. Use the lowest dose needed to achieve the desired effect for the shortest possible treatment time.

Duration of treatment: Do not use this medicine for more than 7 days. To reduce the risk of side effects, it is recommended that you stop taking Otrivin Comp when your symptoms improve; even if less than 7 days have elapsed. Ask your doctor if the symptoms worsen or do not get better within 7 days.

If you have the impression that the effect of Otrivin Comp is too strong or too weak, talk to your doctor or pharmacist.

Instructions for use:

Remove the protective cap.
Do not cut off the tip. The spray bottle is ready to be used.
Before first use, prepare the pump by pumping 4 times. When the pump is prepared, it stays charged throughout the treatment period. If the spray is not delivered when the pump is compressed to the maximum, or if the product has not been used for more than 6 days, the pump needs to be prepared again with 4 pumps in the same way as before the pump was used for the first time.

Sniff your nose.
Hold the bottle vertically with your thumb under the bottom and the tip between two fingers.
Bend your head slightly forward and insert the tip of the spray into one nostril.
Push the pump down and at the same time inhale gently through the nose.
Repeat the procedure (steps 1-4) in the other nostril.
Clean and dry the tip of the nasal spray before putting on the protective cap again immediately after use.

To avoid the possible spread of infection, the spray should only be used by one person. Avoid spraying Otrivin Comp in or around the eyes.

The effect comes within 5-15 minutes.

If you use more Otrivin Comp

If you, or someone else, have ingested too much medicine or if e.g. if a child has ingested the medicine by mistake, contact a doctor or hospital to assess the risk. Feel free to bring this leaflet, bottle, or carton with you in case of medical contact. This is especially important in children who develop side effects more easily than adults.

The symptoms of overdose are severe dizziness, sweating, very low body temperature, headache, slow heartbeat, palpitations, impaired breathing, coma, seizures, high blood pressure that can be followed by low blood pressure. Other symptoms may include dry mouth, difficulty focusing with the eyes, and hallucinations.

If you forget to use Otrivin Comp

Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects are nosebleeds and dry nasal mucosa. Many of the side effects reported are also symptoms of the common cold.

Very common side effects (affects more than 1 user in 10):

Nasal blood

Common side effects (affects more than 1 user in 100):

Irritated nasal mucosa, nasal congestion, dry nasal mucosa, pain in the nose
Dry mouth , dry and irritated throat
altered taste, headache, dizziness, local burning sensation
nausea

Uncommon side effects (affects up to 1 in 100 people):

Nasal ulcers, sneezing, sore throat, cough, hoarseness
stomach upset
altered sense of smell, tremors
feeling uncomfortable, tired
insomnia
eye irritation, dry eyes, swelling of the eyes, red eyes
palpitations, increased heart rate

Rare side effects (affects up to 1 in 1000 people):

Rinnsnuva

Very rare (affects up to 1 in 10,000 people):

Reaction to the medicine such as swelling, rash and itching
Impaired vision

Has been reported (occurs in an unknown number of users):

hives
discomfort around the nose
difficulty swallowing
chest discomfort, thirst
sudden spasm in the neck muscle, swelling in the throat
irregular heartbeat
difficulty focusing with the eyes, pupil dilation, flashing light, increased eye pressure, glaucoma , blurred vision, contours around bright light and pain in the eyes
difficulty emptying the bladder

To reduce the risk of side effects such as nosebleeds and other effects affecting the nose, it is recommended that you stop treatment with Otrivin Comp when your symptoms improve; even if less than 7 days have elapsed.

How to store Otrivin Comp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month. This date also applies when the package has been opened.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

– The active substances are xylometazoline hydrochloride and ipratropium bromide.

1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratroprium bromide.

1 spray dose contains 70 micrograms of xylometazoline hydrochloride and 84 micrograms ipratropium bromide.

The other ingredients are disodium edetate, glycerol (85%), purified water, sodium hydroxide, and hydrochloric acid.

What the medicine looks like and contents of the pack

Otrivin Comp is a clear solution.

The package contains approximately 70 spray doses.

Otrivin Comp is available as a 10 ml nasal spray with a dosing spray pump.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline Consumer Healthcare ApS, PO Box 61, 2610 Rødovre, Denmark

Manufacturer

GlaxoSmithKline Consumer Healthcare ApS, Delta Park 37, 2665 Vallensbæk Strand, Denmark

Otrivin Comp – Xylometazoline hydrochloride / Ipratroprium bromide uses, dose and side effects

What Otrivin Comp is and what it is used for