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Clarinaze Allergy Control 0.05% Nasal Spray

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Mometasone furoate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Mometasone furoate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for What is Clarinaze Allergy Control?

Clarinaze Allergy Control nasal spray contains mometasone furoate, one of a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose.

What is Clarinaze Allergy Control used for?

Clarinaze Allergy Control is used to treat the nasal symptoms of hayfever (also called seasonal allergic rhinitis) and perennial allergic rhinitis in adults aged 18 years and older. Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores. Perennial allergic rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods. Clarinaze Allergy Control reduces the swelling and irritation in your nose thereby relieving sneezing, itching and a blocked-up or runny nose caused by hayfever or perennial allergic rhinitis.

What you need to know before you take it

e Clarinaze Allergy Control Do not use Clarinaze Allergy Control

  • if you are allergic (hypersensitive) 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 Clarinaze Allergy Control during an untreated infection in your nose, such as herpes, can worsen the infection. You should wait until the infection is resolved before you start using the nasal spray.
  • if you have recently had an operation on your nose or you have injured your nose. You should not use the nasal spray until your nose has healed.
  • if you are under 18 years of age.
  • if you are pregnant or breastfeeding without talking to your doctor first.
  • for more than 3 months without consulting your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before using Clarinaze Allergy Control

  • if you have or have ever had tuberculosis.
  • if you have any other infection.
  • if you are taking other corticosteroid medicines, either by mouth or by injection.
  • if you have cystic fibrosis. While you are using Clarinaze Allergy Control, talk to your doctor or pharmacist
  • if your immune system is not functioning well (you have difficulty fighting infection) and you come into contact with anyone with measles or chickenpox. You should avoid coming into contact with anyone who has these infections.
  • if you have an infection of the nose or throat.
  • if you have persistent irritation to the nose or throat.
  • if you experience blurred vision or other visual disturbances. When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may occur due to the drug being absorbed in the body.

Other medicines and Clarinaze Allergy Control

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines whilst using Clarinaze Allergy Control, including medicines obtained without a prescription. Some medicines may increase the effects of Clarinaze Allergy Control and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Talk to your pharmacist before using this medicine if you are taking any prescribed corticosteroid medicines (including eczema creams, asthma inhalers, injections, nasal sprays and eye or nose drops). A few people may find that once they discontinue oral or injected corticosteroids they suffer from some undesirable effects, such as joint or muscular pain, weakness and depression. You may also seem to develop other allergies, such as itchy, watering eyes or patches of red and itchy skin. If you develop any of these effects, you should contact your doctor or pharmacist.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using Clarinaze Allergy Control if you are pregnant, trying to become pregnant or are breast-feeding.

Driving and using machines

There is no known information on the effect of Clarinaze Allergy Control on the ability to drive or use machinery. Clarinaze Allergy Control contains benzalkonium chloride Clarinaze Allergy Control contains 0.02mg benzalkonium chloride per spray which is equivalent to 0.2mg/g. This ingredient may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Clarinaze Allergy Control Always use Clarinaze Allergy Control according to the instructions in this leaflet. You should check with your doctor or pharmacist if you are not sure. Do not use a larger dose or use the spray more often or for longer than instructed.

Treatment of Symptoms of Hayfever and Perennial Allergic Rhinitis Adults (aged 18 years and over)

The usual dose is two sprays into each nostril once a day.

  • Once your nasal symptoms are under control, you may reduce the dose to one spray into each nostril once a day.
  • Use the lowest possible dose to control your symptoms.
  • Do not use more than four sprays in a day.
  • Do not use more than the recommended dose. If your symptoms have not improved within 14 days, you should see your doctor or pharmacist. In some patients Clarinaze Allergy Control begins to relieve nasal symptoms within 12 hours after the first dose; however full benefit of treatment may not be seen in the first two days. Therefore, you should continue regular use to achieve the full benefit of treatment. If you suffer badly from hayfever, you can start using Clarinaze Allergy Control some days before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring. Children or adolescents under 18 years Do not use in children and adolescents under 18 years.

Preparing your nasal spray for use

Your Clarinaze Allergy Control Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray and to replace it after use. If you are using the spray for the first time you need to "prime" the bottle by pumping the spray 10 times until a fine mist is produced: 1. Gently shake the bottle. 2. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Do Not pierce the nasal applicator. 3. Point the nozzle away from you and then press down with your fingers to pump the spray 10 times until a fine mist is produced. If you have not used the spray for 14 days or more, you need to "re-prime" the bottle by pumping the spray 2 times until a fine mist is produced.

How to take it

your nasal spray

Figure 1

1. Shake the bottle gently and remove the dust cap. (Figure 1) 2. Gently blow your nose. 3. Close one nostril and put the nozzle into the other nostril as shown. (Figure 2) Tilt your head forward slightly, keeping the bottle upright. 4. Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers. 5. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril if applicable. 6. Remove the nozzle from this nostril and breathe out through the mouth. 7. Repeat steps 3 to 6 for the other nostril (Figure 3).

Figure 2

Figure 3

After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the dust cap. Cleaning your nasal spray

  • It is important to clean your nasal spray regularly, otherwise it may not work properly.
  • Remove the dust cap and gently pull off the nozzle.
  • Wash the nozzle and dust cap in warm water and then rinse under a running tap.
  • Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.
  • Allow the dust cap and nozzle to dry in a warm place.
  • Push the nozzle back onto the bottle and replace the dust cap.
  • The spray will need to be primed again with 2 sprays when first used after cleaning.

If you use more Clarinaze Allergy Control than you should Tell your doctor or pharmacist if you accidentally use more than this leaflet recommends. If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.

If you forget to use Clarinaze Allergy Control If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop using Clarinaze Allergy Control In some patients Clarinaze Allergy Control should begin to relieve symptoms 12 hours after the first dose; however full benefit of treatment may not be seen for up to two days. It is very important that you use your nasal spray regularly. If you stop treatment before the end of the allergy season your symptoms may reoccur. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Immediate hypersensitivity (allergic) reactions may occur after use of this product. These reactions may be severe. You should stop taking Clarinaze Allergy Control and get immediate medical help if you experience symptoms such as:

  • swollen face, tongue or pharynx
  • trouble swallowing
  • hives
  • wheezing or trouble breathing Stop taking the medicine and tell your doctor if you experience:
  • eye problems such as pain or blurred vision.
  • nasal problems such as pain and/or persistent bleeding. When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may occur due to the drug being absorbed in the body. The following side effects may occur: Common side effects (may affect up to 1 in 10 people):
  • headache
  • sneezing
  • nose bleeds [occurred very commonly (may affect more than 1 in 10 people) in people with nasal polyps receiving two sprays in each nostril twice a day]
  • sore nose or throat
  • ulcers in the nose
  • respiratory tract infection Not known (frequency cannot be estimated from the available data):
  • increase in pressure in the eye (glaucoma) and/or cataracts causing visual disturbances
  • damage to the partition in the nose which separates the nostrils
  • changes in taste and smell
  • difficulty in breathing and/or wheezing
  • blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Clarinaze Allergy Control

  • Do not store the nasal spray above 25°C. Do not freeze it.
  • The bottle should be used within 2 months of first opening.
  • 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 bottle and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Clarinaze Allergy Control contains

  • The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate, as the monohydrate.
  • The other ingredients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.

What Clarinaze Allergy Control looks like and contents of the pack Clarinaze Allergy Control is a nasal spray suspension. Each 10g bottle contains 60 sprays, each 18g bottle contains 140 sprays. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer The holder of the Marketing Authorisation is: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK

The manufacturer is: Schering-Plough Labo NV, Heist-op-den Berg, Belgium

This leaflet was last revised in November 2021.

7008969700 2/2

Frequently asked questions about Clarinaze Allergy Control 0.05% Nasal Spray

How do I take Clarinaze Allergy Control 0.05% Nasal Spray?

Clarinaze Allergy Control 0.05% Nasal Spray comes as nasal spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Clarinaze Allergy Control 0.05% Nasal Spray?

The active substance in Clarinaze Allergy Control 0.05% Nasal Spray is mometasone furoate.

Are there equivalent medicines to Clarinaze Allergy Control 0.05% Nasal Spray?

Medicines with the same active substance, strength and form include: Clarinaze Hayfever Relief 0.05% w/w Nasal Spray. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Clarinaze Allergy Control 0.05% Nasal Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Clarinaze Allergy Control 0.05% Nasal Spray without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Mometasone furoate (16 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Clarinaze Nasal Spray is indicated for use in adults to treat the symptoms of seasonal or perennial allergic rhinitis.

4.2. Posology and method of administration

After initial priming of the Clarinaze Nasal Spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.

Posology

Seasonal or Perennial Allergic Rhinitis

Adults aged 18 years and over (including older patients): The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance. Dose reduction is recommended following control of symptoms.

Children under 18 years of age: Should not be used by children and adolescents under 18 years of age.

Clarinaze Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be achieved in the first 48 hours. Therefore, the patient should continue regular use to achieve full therapeutic benefit.

Treatment with Clarinaze Nasal Spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.

Method of administration

Prior to administration of the first dose, shake container well and actuate the pump 10 times (until a uniform spray is obtained). If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed, before next use.

Shake container well before each use. The bottle should be discarded after the labelled number of actuations or within 2 months of first use.

If symptoms have not improved after 14 days medical advice must be sought.

4.3. Contraindications

Hypersensitivity to the active substance, mometasone furoate, or to any of the excipients listed in section 6.1.

Clarinaze Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa, such as herpes simplex.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.

4.4. Special warnings and precautions for use

Treatment should be stopped or the advice of a doctor sought if an improvement is not seen within 14 days. Advice of a doctor or pharmacist should also be sought if symptoms have improved but are not adequately controlled. This medicines should not be used continuously for more than 3 months without consulting a doctor.

Immunosuppression

Clarinaze Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, or systemic viral infections.

Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.

Local Nasal Effects

Following 12 months of treatment with Clarinaze Nasal Spray in a study of patients with perennial rhinitis, there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype. Nevertheless, patients using Clarinaze Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localised fungal infection of the nose or pharynx develops, discontinuance of Clarinaze Nasal Spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Clarinaze Nasal Spray.

Clarinaze is not recommended in case of nasal septum perforation (see section 4.8).

In clinical studies, epistaxis occurred at a higher incidence compared to placebo. Epistaxis was generally self-limiting and mild in severity (see section 4.8).

Clarinaze Nasal Spray contains benzalkonium chloride which may cause irritation or swelling inside the nose, especially if used for a long time.

Systemic Effects of Corticosteroids

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Following the use of intranasal corticosteroids, instances of increased intraocular pressure have been reported (see section 4.8).

Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Patients who are transferred from long-term administration of systemically active corticosteroids to Clarinaze Nasal Spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted. Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Non-nasal Symptoms

Although Clarinaze Nasal Spray will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.

4.5. Interaction with other medicinal products and other forms of interaction

(See 4.4 Special warnings and special precautions for use with systemic corticosteroids)

A clinical interaction study was conducted with loratadine. No interactions were observed.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). As with other nasal corticosteroid preparations, Clarinaze Nasal Spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

Lactation

It is unknown whether mometasone furoate is excreted in human milk. As with other nasal corticosteroid preparations, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Clarinaze Nasal Spray therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effects on fertility (see section 5.3).

The leaflet and label will include a warning that medical opinion should be sought, before using this medicine, in the case of pregnancy and breastfeeding.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Summary of the safety profile

Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis. The incidence of all other adverse events was comparable with that of placebo.

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

Tabulated list of adverse reactions

Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented in Table 1. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100). The frequency of post-marketing adverse events are considered as “not known (cannot be estimated from the available data)”.

Table 1: Treatment-related adverse reactions reported by system organ class and frequency

Very common

Common

Not known

Infections and infestations

Pharyngitis

Upper respiratory tract infection†

Immune system disorders

Hypersensitivity including anaphylactic reactions, angioedema, bronchospasm, and dyspnoea

Nervous system disorders

Headache

Eye disorders

Glaucoma

Increased intraocular pressure

Cataracts

Vision blurred (see also section 4.4)

Respiratory, thoracic and mediastinal disorders

Epistaxis*

Epistaxis

Nasal burning

Nasal irritation

Nasal ulceration

Nasal septum perforation

Gastrointestinal disorders

Throat irritation*

Disturbances of taste and smell

*recorded for twice daily dosing for nasal polyposis

†recorded at uncommon frequency for twice daily dosing for nasal polyposis

Paediatric population

In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.

Management

Because the systemic bioavailability of Clarinaze Nasal Spray is <1%, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.

💬 Ask about this leaflet

Ask anything about Clarinaze Allergy Control 0.05% Nasal Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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