Retersic 10 mg Capsules

Retersic contains the active substance cetirizine dihydrochloride. Retersic is an anti-allergic medicine. In adults and children aged 6 years and above, Retersic is indicated for:

• Allergic rhinitis, hay fever.
• Allergic skin condition associated with pruritus e.g., urticaria.

Do not take Retersic:

• if you are hypersensitive (allergic) cetirizine dihydrochloride, hydroxyzine, piperazine or to any of the other ingredients of Retersic (listed in section 6);
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 30 ml/min);
• if you are pregnant or breastfeeding your baby.

The use of Retersic is not recommended in children less than 6 years since this formulation does not allow for appropriate dose adaptation.

Warnings and precautions

Take special care with Retersic:

• If you are drinking alcohol. It is not advised to drink alcohol while taking Retersic.
• If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
• If you have factors that may cause urinary retention e.g., spinal cord lesion, enlarged prostrate (prostatic hyperplasia), you must be careful using Retersic since it can increase the symptoms.
• Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported very rarely with cetirizine-containing products, such as Retersic. This acute skin reaction may start to show early or delayed signs with numerous small liquid filled blisters arising on a widespread red, inflamed part of the skin, localised on the skin folds, upper body, and upper limbs, which may be accompanied by fever. You will be closely monitored.

If your symptoms persist or worsen, or if new symptoms occur, you should stop taking Retersic and consult your doctor.

If you have a pre-existing liver disease.

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

The usual dose is:

• Adults or children 12 years of age or older: One 10 mg soft gelatine capsule daily
• Children 6 to 12 years old: One 10 mg soft capsule daily

Your doctor will tell you how long your treatment with Retersic will last. Do not stop treatment with Retersic unless your doctor tells you too.

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

If you take more Retersic than 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 use Retersic

If you forget to take your medicine, take it as soon as you remember. Then take the next dose at the usual time. Do not take a double dose or extra capsule to make up for your forgotten dose.

If you stop taking Retersic

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Retersic. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

If any of the following happens, stop taking Retersic 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.

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

• Less urine than is normal for you, or difficulty urinating, swelling of hands, lower legs or feet, a fever with pain in your lower back. It may mean that you have serious kidney problems.
• You notice your heart beating faster than normal.

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

Tell your doctor if you notice any of the following:

• Frequent
• Sleepiness
• Headache, dizziness
• Sore throat, difficulty swallowing
• Dry mouth, feeling sick
• Feeling tired
• Less frequent
• Increased appetite
• Stomach pain
• Feeling frustrated, aggressiveness, feeling confused or feeling very down, seeing or hearing things that are not real, not being able to fall asleep
• An abnormal sensation, typically tingling or pricking (‘pins and needles’), involuntary spasms of muscles (convulsions), weak muscles, shaking, memory loss or difficulty remembering
• Blurred eyesight, struggling to focus with your eyes, uncontrolled eye-rolling
• Spinning sensation in your head
• Rash, hives, itching
• Joint pain
• Abnormal physical weakness or lack of energy, a general feeling of discomfort or illness, swelling of hands or feet
• Increased weight

In children 6 months to 12 years the following side effects have been noticed:

• Frequent
• Sleepiness
• Runny noise
• Loose/runny stomach
• Feeling tired.

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 Retersic.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Store in the original package.
• There are no special storage instructions for Retersic
• Do not store in a bathroom
• Do not use after the expiry date stated on the carton.

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