Sinutab Nasal 0,1 % Solution

Sinutab Nasal Spray contains xylometazoline which helps to open up and clear your nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size. Sinutab Nasal Spray is for use in your nose to provide relief from nasal congestion (blocked nose) accompanying hay fever, allergies, colds and sinusitis.

Do not use Sinutab Nasal Spray:

• If you are hypersensitive (allergic) to xylometazoline hydrochloride or any of the other ingredients of Sinutab Nasal Spray (see What Sinutab Nasal Spray contains).
• In children under the age of 12 years.
• For long periods if you suffer from chronic rhinitis (inflammation and swelling of your nasal mucous membranes, causing blocked or runny nose).
• If you are taking medicines for high blood pressure called adrenergic neuron blockers or you stopped taking them within the last 10 days.
• If you are taking medicines for depression called monoamine oxidase inhibitors (MAOIs) or stopped taking them within the last 10 days.
• If you recently had neurosurgery.

Warnings and precautions

Take special care with Sinutab Nasal Spray:

• If you have high blood pressure.
• If you suffer from cardiovascular disease.
• If you have an overactive thyroid gland (hyperthyroidism).
• If you suffer from narrow angle glaucoma.
• If you have diabetes mellitus.
• If you have previously had a strong reaction to stimulant medicines, resulting in symptoms such as sleeplessness or dizziness.

Sinutab Nasal Spray should not be used for longer than 7 consecutive days.

Do not share medicines with any other person.

Adults and children over the age of 12 years:

One spray in each nostril 2 – 3 times a day, as required. (Maximum daily dose: 3 sprays).

Children under 12 years of age: Not recommended.

Do not use for more than 7 days. Do not exceed the recommended dosage. Always use Sinutab Nasal Spray exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Method of administration:

1. Remove the plastic cap from the nozzle.
2. On first use, press the plunger downwards, and release until a single spray is delivered.
3. Hold the bottle upright and place nozzle into one nostril. Depress the plunger and at the same time breathe in through your nose. Release the plunger and remove nozzle from the nostril. Repeat this procedure for the other nostril.
4. To keep clean, wipe the nozzle and replace the plastic cap after use.

If you have the impression that the effect of Sinutab Nasal Spray is too strong or too weak, tell your doctor or pharmacist.

If you use more Sinutab Nasal Spray than you should

In the event of an overdosage or accidental ingestion, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining Sinutab Nasal Spray with you so the doctor will know what you have taken.

If you forget to use Sinutab Nasal Spray

Do not use a double dose to make up for forgotten individual doses.

Sinutab Nasal Spray can have side effects. Not all side effects reported for Sinutab Nasal Spray are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Sinutab Nasal Spray, please consult your health care provider for advice.

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

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash, hives or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Sinutab Nasal Spray. 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:

• changes in the way your heart beats.

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

Tell your doctor if you notice any of the following:

Less frequent side effects:

• burning sensation in your nose or throat;
• irritation or dryness of your nose.

Side effects with an unknown frequency:

• visual disturbance;
• difficulty sleeping or sleepiness;
• nausea;
• headache;
• sneezing;
• nosebleeds.

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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Sinutab Nasal Spray.

• Store at or below 25 °C.
• Store in a cool place.
• Protect from light and keep container tightly closed.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the bottle / carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).