Orimox - Mometasone furoate uses, dose and side effects

Orimox nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids ( cortisone ). When mometasone furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation of the nose), sneezing, itching, nasal congestion, or runny nose.

What is Orimox used for?

Orimox is used to treat the symptoms of allergic rhinitis: hay fever (also called seasonal allergic rhinitis ) and perennial rhinitis ( allergy to eg mites and fur animals) in adults over 18 years of age.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grass, weeds or mold, and fungal spores. Perennial rhinitis occurs throughout the year and the symptoms can be caused by a sensitivity to a variety of things such as house dust mites, animal hair (or skin deposits), feathers, and certain foods. Orimox reduces swelling and irritation in the nose and thus relieves sneezing, itching, nasal congestion, or runny nose caused by hay fever or perennial rhinitis.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

Mometasone furoate contained in Orimox may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Orimox

Do not use Orimox

if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
if you have an untreated infection in your nose. Use of Orimox in an untreated infection of the nose, such as herpes , may aggravate an infection . You should wait until infection has healed before using the nasal spray.
if you have recently undergone nose surgery or have a nose injury. You must then wait until your nose has healed before you start using the nasal spray.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Orimox

if you have or have ever had tuberculosis .
if you have any other infection .
if you are taking other medicines containing corticosteroids ,
if you have cystic fibrosis .

Talk to your doctor while you are using Orimox

if your immune system is weakened (if you have difficulty fighting infection ) and you come in contact with someone who has measles or chickenpox. You should avoid contact with anyone who has these infections .
if you get a nose or throat infection .
if you are taking the medicine for several months or longer.
if you have persistent irritation of the nose or throat.

When nasal sprays containing corticosteroids are used in high doses for a long time, side effects may occur due to the drug being absorbed into the body.

Contact a doctor if you experience blurred vision or other visual disturbances.

Other medicines and Orimox

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

If you are taking other medicines containing corticosteroids for your allergy, either by mouth or by injection, your doctor may decide that you should stop taking them when you take Orimox. When you stop taking corticosteroids, either by mouth or by injection, you may experience symptoms such as joint or muscle pain, weakness, and depression. You may also have other types of allergies, such as itchy, watery eyes or spotty red and itchy skin. If these symptoms occur, consult your doctor.

Some medicines may increase the effects of Orimox and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

There is no or limited amount of information from the use of Orimox in pregnant women. It is unknown whether mometasone furoate is excreted in human milk.

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

There is no known information on whether the effect of Orimox affects the ability to drive or use machines.

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.

Orimox contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride per dose. Benzalkonium chloride may irritate and swell inside the nose, especially with prolonged use of the medicine.

How to use Orimox

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Dosage for adults from 18 years is 2 sprays in each nostril once daily. When a good effect has been achieved, the dose can be reduced to 1 spray in each nostril once a day. Do not exceed this dosage.

In some patients, Orimox may begin to relieve symptoms within 12 hours of the first dose. However, it may take up to two days before the full effect of the treatment is seen. If you have previously had severe problems with hay fever, treatment may need to be started a few days before the pollen season begins.

If you get any effect within 14 days, consult a doctor. Do not use Orimox for more than 3 months without consulting a doctor.

Please note that Orimox should only be given to children on the prescription of a doctor.

How to prepare your nasal spray for use

Your Orimox nasal spray has a plastic cover that protects the spout and keeps it clean. Remember to remove the plastic cover before using the spray and to put it back after use.

If you are using the spray for the first time, you must prepare the bottle by pumping the spray 10 times until a fine spray shower is obtained:

Gently shake the bottle.
Place the index finger and middle finger on opposite sides of the spout and thumb under the bottle.
Turn the spout away from you and then press down with your fingers to pump the spray 10 times until a fine spray shower is obtained.

How to use your nasal spray

1. Shake the bottle gently and remove the plastic cover (Figure 1).

(Figure 1)

2. Cheat carefully.

Hold one nostril and insert the spout into the other nostril shown

(Figure 2). Bend your head slightly forward while holding the bottle upright.

(Figure 2)

4. Slowly and gently begin to inhale through your nose as you spray

a nice shower into the nose by pressing down ONCE with your fingers.

5. Exhale through your mouth. Repeat step 4 to inhale the second

spraying in the same nostril, depending on the dose you have.

6. Remove the spout from the nostril and exhale through the mouth.

7. Repeat steps 3 to 6 for the second nostril (Figure 3).

(Figure 3).

After using the spray, wipe the pipe thoroughly with a clean handkerchief or soft paper and put the plastic cover back on.

How to clean your nasal spray

It is important to clean your nasal spray regularly, otherwise it may not work properly.
Remove the plastic cover and carefully pull off the spout.
Clean the spout and plastic cover in warm water and then rinse under running water.
Do not try to clean the spout by inserting a needle or other sharp object as this will damage the spout, which will prevent you from getting the correct dose of the medicine.
Let the plastic cover and spout dry in a warm place.
Put the spout back on the bottle and put on the plastic cover.
The spray will need to be pushed back on with 2 sprays the first time it is used after cleaning.

If you use more Orimox than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you use steroids for a long time or in large amounts, they can in rare cases affect some of your hormones.

If you forget to use Orimox

If you forget to use your nasal spray at the right time, use it as soon as you remember, then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Orimox

In some patients, Orimox may begin to relieve symptoms 12 hours after the first dose. However, it may take up to two days before the full effect of the treatment is seen. You must use your nasal spray regularly.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Sudden hypersensitivity reactions (allergic reactions) may occur when using this medicine. These reactions can be very serious. Stop taking Orimox and contact a doctor immediately if you get symptoms such as:

swelling of the face, tongue or throat
difficulty swallowing
hives
wheezing or difficulty breathing.When nasal sprays containing corticosteroids are used in high doses for a long time, side effects may occur due to the drug being absorbed into the body.
Other side effectsMost people have no problem using the nasal spray. Some people who have used Orimox or other nasal sprays containing corticosteroids may experience the following side effects:
Common side effects (may affect up to 1 in 10 people):
headache
nosebleed
nasal or throat irritation
sores in the nose
upper respiratory tract infection.
Has been reported (occurs in an unknown number of users):
increased pressure in the eye ( glaucoma ) and / or cataracts that cause changes in vision
damage to the septum of the nose that separates the nostrils
change of taste and smell
difficulty breathing and / or wheezing
dimsyn.

How to store Orimox

Do not freeze.

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 and carton after EXP. The expiration date is the last day of the specified month.

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 pack and other information

Content declaration

The active substance is mometasone furoate. Each spray with the pump emits mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
The other ingredients are benzalkonium chloride, microcrystalline cellulose and carmellose sodium, glycerol , sodium citrate, citric acid monohydrate, polysorbate 80, purified water.

What the medicine looks like and contents of the pack

Orimox is a nasal spray, suspension.

Each bottle contains 60 doses (10 g) or 140 doses (18 g).

Bottles containing 60 doses or 140 doses are delivered in packs of 1 nasal spray.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm

info@orifarm.com

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Orimox – Mometasone furoate uses, dose and side effects

What Orimox is and what it is used for