Levalbuterol 1,25 mg/3 ml Solution

LEVALBUTEROL CIPLA is an inhaled prescription medicine used for the treatment or prevention of asthma in patients 6 years and older.

Do not take LEVALBUTEROL CIPLA:

• If you are allergic to levalbuterol, racemic albuterol or any of the inactive ingredients of LEVALBUTEROL CIPLA.
• Do not give LEVALBUTEROL CIPLA to children under the age of 6 years.

Warnings and precautions:

Tell your doctor if you are suffering from any of the following medical conditions as treatment with LEVALBUTEROL CIPLA may deteriorate your health:

• Heart problems
• High blood pressure
• Fits
• Diabetes (condition due to increased sugar level in blood)
• Thyroid problems (increased or decreased function of the thyroid gland)

If you experience any of the following whilst on treatment with LEVALBUTEROL CIPLA, discontinue treatment and consult your doctor or health care provider immediately:

• Allergic reactions, may be characterised by rash and itching, swelling in the face, tongue and/or throat.
• Breathing difficulties
• Worsening of your asthma
• Heart-related complications such as chest pain (due to angina pectoris) and irregular heart rates.

Other medicines and LEVALBUTEROL CIPLA:

Always tell your health care provider if you are taking any other medicine. This includes complementary or traditional medicines. Taking LEVALBUTEROL CIPLA together with any of the below medicines may aggravate your health, please tell your doctor if you are taking any of the following:

• Other medicines for treating asthma.
• Diuretics (water tablets).
• Digoxin (used for treating heart conditions).
• Antidepressants (medicines used to treat depression).

Pregnancy breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking LEVALBUTEROL CIPLA. Do not take LEVALBUTEROL CIPLA if you are pregnant, planning to have a baby or breastfeeding as safety and efficacy have not been established.

Driving and using machines

LEVALBUTEROL CIPLA can cause dizziness and fainting, therefore it might impair your ability to drive and operate machinery. Caution is advised until you are fully aware of how LEVALBUTEROL CIPLA affects you.

Do not share medicines prescribed for you with any other person. Always take LEVALBUTEROL CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Children 6 to 11 years old: LEVALBUTEROL CIPLA 0,31/ 3 mL three times per day, by nebulisation.
• Adults and children aged 12 years and older: LEVALBUTEROL CIPLA 0,63 mg/ 3 mL three times per day, by nebulisation.

Do not exceed the recommended dose. If you have the impression that the effect of LEVALBUTEROL CIPLA is too strong or too weak, tell your doctor or pharmacist.

If you take more LEVALBUTEROL CIPLA you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take LEVALBUTEROL CIPLA: Do not take a double dose to make up for forgotten individual doses.

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Eczema
• Fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to LEVALBUTEROL 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:

Table 1: Frequent serious side effects in children and adults

Adults and children aged 12 years and older

• Flu - like illness
• Exacerbation of asthma
• Irregular or faster heart rhythm
• Chest pain
• High blood pressure (may be indicated by headaches, severe heartbeat and breathing difficulties)
• Low blood pressure (may be indicated by fainting and being pale)

Children aged 6 to 11 years

• Flu - like illness
• Viral infections, e.g. sore throat, blocked and/or runny nose, coughing (infections are accompanied by fever)
• Ear infection, indicated by ear pain
• Wheezing
• Exacerbation of asthma
• Diarrhoea

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

Table 2: Other frequent side effects that must be noted and reported to your healthcare provider:

Adults and children aged 12 years and older

• Severe headache
• Dizziness
• Tight/inflexible muscle
• Tremors
• Anxiety
• Nervousness
• A feeling of pins and needles
• Dry mouth
• Dry throat
• Bloatedness
• Nausea
• Vomiting
• Sleeplessness

Children aged 6 to 11 years

• Headache
• Extreme tiredness
• Fever
• Pain
• Accidental injury
• Abdominal pain (stomach pain)
• Muscle pain
• Leg cramps

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LEVALBUTEROL CIPLA. You may also report any suspected side effects (to Cipla Medpro (Pty) Ltd) by e-mail: [email protected] or telephone: 080 222 6662 (toll free).

Store in the original packages at or below 25 °C. STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).