Acuzyrt 1 mg/1 ml Syrup

ACUZYRT SYRUP is an antihistamine used to treat allergic conditions affecting the:

• Respiratory system such as allergic rhinitis (runny nose) and hay fever and,
• Allergic skin conditions associated with pruritus (severe itching of the skin) or hives.

Do not take / administer ACUZYRT SYRUP:

• If you are hypersensitive (allergic) to cetirizine, or any other ingredients of ACUZYRT SYRUP.
• If you are allergic to hydroxyzine (an antihistamine similar to cetirizine).
• If you have severe problems with your kidneys.
• If you are pregnant and/or breastfeeding your baby.
• To children under 2 years of age.

Warnings and precautions

Take special care with ACUZYRT SYRUP:

• ACUZYRT SYRUP may cause drowsiness in a small number of patients.
• Before you take ACUZYRT SYRUP, inform your doctor if you have problems with infrequent urination, or you have been diagnosed with an enlarged prostate gland, increased pressure in the eye (glaucoma), obstruction in the gut, epilepsy, or heart problems.
• You should avoid taking alcohol while using ACUZYRT SYRUP.
• If you are elderly, you are more likely to experience side effects of ACUZYRT SYRUP.
• You should stop taking ACUZYRT SYRUP several days before going for any allergy skin tests as this medicine may suppress positive skin test results.
• Hypersensitivity reactions, including skin reactions, may occur, when ACUZYRT SYRUP is stopped.
• If you are an epileptic patient (have fits), or a patient at risk of convulsions.

Other medicines and ACUZYRT SYRUP

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Taking ACUZYRT SYRUP with other medicines may cause undesirable interactions. Always consult with your healthcare professional before taking ACUZYRT SYRUP with any other medicine.

Please inform your doctor if you are taking medicines for anxiety, medicines used to treat psychosis (such as schizophrenia), opioid analgesics (strong painkillers), sleeping tablets (hypnotics) and barbiturates. Do not take ACUZYRT SYRUP with alcohol and other sedating medication, as it can lead to impaired concentration and drowsiness.

Please inform your doctor if you are taking antimuscarinic medicines such as atropine, tricyclic antidepressants and monoamine oxidase inhibitors. Please inform your doctor if you are taking aminoglycoside antibiotics such as tobramycin or gentamycin.

ACUZYRT SYRUP with food, drink and alcohol

ACUZYRT SYRUP can be taken with or without meals, as food does not affect the extent of absorption. Alcohol should be avoided.

Pregnancy, breastfeeding and fertility

Do not take ACUZYRT SYRUP if you are pregnant or breastfeeding your child. 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 professional for advice before taking ACUZYRT SYRUP.

Driving and using machines

ACUZYRT SYRUP may cause drowsiness. Do not drive or operate machinery if you feel drowsy/sleepy after taking ACUZYRT SYRUP. It is not always possible to predict to what extent ACUZYRT SYRUP may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which ACUZYRT SYRUP affects them.

Important information about some of the ingredients of ACUZYRT SYRUP

The preservatives methyl parahydroxybenzoate and propyl hydroxybenzoate included in ACUZYRT SYRUP may cause allergic reactions (possibly delayed). ACUZYRT SYRUP contains sorbitol. If you have been told that you have an intolerance to some sugars, you should not take ACUZYRT SYRUP.

Do not share medicines intended for you with any other person. Always take ACUZYRT SYRUP exactly as your doctor, pharmacist or nurse has instructed you. You should check with your doctor, pharmacist or nurse if you are unsure.

If you have problems with your kidneys or liver, your doctor may reduce the dose of ACUZYRT SYRUP. ACUZYRT SYRUP should not be given to children under 2 years of age.

Adults and children 12 years or older: Take 10 mL (two medicine measures) once a day.

Children 6 to 12 years of age: Give 10 mL (two medicine measures) once daily as a single dose OR 5 mL (one medicine measure) in the morning and 5 mL (one medicine measure) in the evening.

Children 2 to 6 years of age: Give 5 mL (one medicine measure) once a day as a single dose OR 2,5 mL (half a medicine measure) in the morning and 2,5 mL (half a medicine measure) in the evening.

If you have a kidney or liver disorder, you should take half the recommended dose.

If you take more ACUZYRT SYRUP than you should

In the event of overdosage, or if someone else has taken your medicine by mistake, you, or this person, may experience any of the side effects listed below. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ACUZYRT SYRUP

If you forget to take a dose of ACUZYRT SYRUP, take the missed dose as soon as you remember, then wait 24 hours to take the following dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ACUZYRT SYRUP

When stopping treatment with ACUZYRT SYRUP, you may experience severe itching or raised bumps on the skin. If this occurs, restart treatment with ACUZYRT SYRUP, and the side effects should stop.

ACUZYRT SYRUP can have side effects. Not all side effects reported for ACUZYRT SYRUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• allergic reactions, which may include swelling of eyelids, face or lips,
• severe hives with blister formation or purple/red inflamed spots on your skin,
• difficulty in swallowing or breathing,
• wheezing or shortness of breath.

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

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

• yellowing of the skin and eyes, also called jaundice,
• convulsions (fits),
• fast pounding or uneven heartbeat,
• tremors (uncontrolled shaking),
• thoughts of killing yourself (suicidal ideation),
• memory impairment (loss), or
• loss of consciousness.

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 include:
1. feeling dizzy or drowsy,
2. sore throat,
3. headaches,
4. dry mouth,
5. runny and/or itchy nose,
6. nausea,
7. feeling tired,
8. diarrhoea.

• Less frequent side effects include:
1. feeling weak and or generally unwell,
2. anaemia with symptoms such as fatigue, pale skin, abnormal blood test results,
3. stomach pain,
4. hallucinations (seeing and/or hearing things that are not real) and nightmares,
5. tingling or pricking feeling in your extremities (pins and needles) e.g. fingers and feet,
6. feeling agitated,
7. bleeding and bruising easily,
8. a wheezing sound when you inhale, thickening of mucous (phlegm),
9. hair loss, sweating,
10. itchy rash,
11. confusion, depression, insomnia (problems sleeping),
12. sensitivity to light,
13. distorted sense of taste,
14. problems with eye sight,
15. abnormal liver function,
16. problems (pain or difficulty) urinating,
17. bed - wetting,
18. twitching, muscle spasms, unusual limb movements,
19. weight gain,
20. swelling or fluid retention.

• Side effects with unknown frequency:
1. in-coordination,
2. nervousness,
3. feeling light-headed,
4. constipation, vomiting, increased appetite,
5. rash with blisters containing pus,
6. muscle and joint pain,
7. vertigo (feeling unbalanced),
8. irritability,
9. euphoria,
10. memory impairment (loss).

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 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 ACUZYRT SYRUP.

Store in a cool dry place at or below 25 ºC. Protect from light. Do not use after the expiry date stated on the bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Store in the original container. Keep the container in the outer carton. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.