Oxymetazoline Cipla Spray

OXYMETAZOLINE CIPLA (oxymetazoline) belongs to a class of medicines known as nasal decongestants. It is used to relieve a blocked nose due to the common cold (acute rhinitis), sinusitis (inflammation or swelling of the tissue lining the sinuses), hay fever (allergic rhinitis), or as an add-on treatment for middle ear infection.

Do not use OXYMETAZOLINE CIPLA:

• if you/your child are hypersensitive (allergic) to oxymetazoline hydrochloride, benzalkonium chloride (the preservative) or any of the other ingredients of OXYMETAZOLINE CIPLA (listed in section 6).
• if you/your child have rhinitis sicca (abnormally dry nose, and/or inflamed skin or mucous membranes of your nostrils or scabs in your nose).
• if you/your child recently had sinus surgery or nasal surgery, or had your pituitary gland removed.
• if you/your child are using other medicines for a blocked nose.
• if you/your child have been diagnosed with a tumour of the adrenal gland (phaeochromocytoma).

Do not give OXYMETAZOLINE CIPLA 0,05 to children below six years of age. OXYMETAZOLINE CIPLA is considered unsafe in patients with porphyria.

Do not share medicines prescribed for you with any other person. Always use OXYMETAZOLINE CIPLA exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.

OXYMETAZOLINE CIPLA 0,05 metered spray is indicated for adults and children over 6 years. OXYMETAZOLINE CIPLA 0,025 metered spray is indicated for children up to the age of 6 years. Do not use OXYMETAZOLINE CIPLA for more than 5 days (see Warnings and precautions). Do not exceed the recommended dosage. If symptoms persist, consult a health care provider.

The usual dose is as follows:

• OXYMETAZOLINE CIPLA 0,05: Adults: 1 - 2 sprays into each nostril 2 – 3 times a day. Children over 6 years: 1 spray into each nostril 2 - 3 times a day.
• OXYMETAZOLINE CIPLA 0,025: Children up to the age of 6 years: 2 to 3 sprays into each nostril 2 – 3 times a day.

How to use OXYMETAZOLINE CIPLA metered nasal spray: For best results keep both the head and spray bottle in an upright position. Remove the cap by pulling and insert the nozzle of the spray loosely into the nostril with the middle and forefinger around the bottom of the nozzle and the thumb on the base of the bottle. Depress the spray mechanism (as shown in the diagram) thus producing a fine mist. Sniff in to ensure an even distribution of the spray. Withdraw from nostril and release the spray mechanism. Repeat for the other nostril.

Prevention of contamination:

• Wipe the tip of the applicator with a clean, damp tissue and replace the cap directly after use.
• Do not share your bottle of OXYMETAZOLINE CIPLA 0,05 with other people. Do not use one bottle of OXYMETAZOLINE CIPLA 0,025 for more than one child.

If you have the impression that the effect of OXYMETAZOLINE CIPLA is too strong or too weak, please speak to your doctor or pharmacist.

OXYMETAZOLINE CIPLA can have side effects. Not all side effects reported for OXYMETAZOLINE CIPLA are included in this leaflet. Should you/your child’s general health worsen or if you experience any untoward effects while using OXYMETAZOLINE CIPLA, please consult your health care provider for advice.

If any of the following happens, stop using OXYMETAZOLINE CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, rash or itching.
• Fits or seizures (convulsions).
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to OXYMETAZOLINE CIPLA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Fast, irregular or pounding heartbeat.
• High blood pressure.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Aqueous nasal secretions (runny nose), crusted nose.

Less frequent side effects:

• Nervousness, anxiety, irritability.
• Tremor (shaking), headache or light-headedness, nervousness, anxiety, irritability.
• Eye irritation, dryness, discomfort or redness.
• Discomfort, irritation, or dryness of the nose, mouth or throat, sneezing.

Side effects with unknown frequency:

• Trouble sleeping (insomnia), restlessness.
• Dizziness, sleepiness, sleep or calm induced by medication (sedation), seeing or hearing things that are not real, uncontrolled body moments.
• Rebound low blood pressure.
• Nasal discomfort (burning or stinging of the nasal mucosa), irritation, rebound congestion, nasal dryness and sneezing, swelling of the lining of the nasal mucosa, bleeding from the nostril.
• Fatigue or tiredness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website, or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of OXYMETAZOLINE CIPLA.

Store at or below 25 °C. Keep tightly closed. Protect from light. Store all medicines out of reach of children. Keep in the outer carton until required for use. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).