Texamer Oral Solution

TEXAMER SYRUP contains levocetirizine dihydrochloride, which is an allergic agent. TEXAMER SYRUP is used to treat symptoms associated with allergic conditions such as:

• hayfever
• year - round allergies such as dust or pet allergies
• nettle rash (urticaria).

Do not take TEXAMER SYRUP:

• if you are hypersensitive (allergic) to levocetirizine, or to other antihistamines called piperazine derivatives (such as buclizine, cetirizine, cyclizine), or any of the other ingredients of TEXAMER SYRUP (see section 6)
• if you are pregnant, intend to become pregnant, or are breastfeeding your baby
• if you suffer from severe kidney failure (with creatinine clearance below 10 ml/min)
• Do not give TEXAMER SYRUP to children younger than 2 years.

Warnings and precautions

Take special care with TEXAMER SYRUP:

• if you are likely to be unable to empty your bladder (due to conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice
• if you suffer from epilepsy or are at risk of convulsions, ask your doctor for advice as use of TEXAMER SYRUP may cause seizure to be severe or occur more frequently
• if you are going for allergy testing, you should stop taking TEXAMER SYRUP for at least 3 days before testing as TEXAMER SYRUP will affect your allergy test results

When you stop taking TEXAMER SYRUP, you may experience itchy skin, even if it was not present before starting treatment. The itching may stop on its own, but in some cases, you experience intense itching and may need to restart treatment with TEXAMER SYRUP.

Children

Do not give TEXAMER SYRUP to children less than 2 years because it is unlikely to be safe.

Other medicines and TEXAMER SYRUP

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Please consult your healthcare provider for advice if you are taking any of the following medicine:

• theophylline, used to treat asthma and lung conditions, and ritonavir, used to treat HIV. These may increase the amount of TEXAMER SYRUP in your body which increases the risk of side effects.

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

Adults and children from the age of 6 years

The usual dose is 10 ml solution once daily.

Children from the age of 2 to 6 years

The usual dose is 2,5 ml solution twice daily. Do not give TEXAMER SYRUP to infants and toddlers aged less than 2 years.

Special dosage instructions for specific populations

If you have impaired kidney function you may be given a lower dose according to the severity of your kidney condition. Your doctor or pharmacist will determine the dose. If you have only impaired liver function you should take the usual prescribed dose. If you have both impaired liver and kidney function you may be given a lower dose depending on the severity of the kidney condition. The dose in children will also be chosen on the basis of body weight by your doctor.

No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.

How and when should you take TEXAMER SYRUP

This medicine is for oral use only. A dosing syringe is provided with the pack. You can take TEXAMER SYRUP with or without food.

Handling of the dosing syringe

Place the dosing syringe into the bottle and draw the plunger up to the mark which corresponds to the dose in millilitres (ml) prescribed by your doctor. Remove the dosing syringe from the bottle and empty its contents into a spoon by pressing the plunger down. Rinse the plunger with water after every use.

If you take more TEXAMER SYRUP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• drowsiness can occur in adults
• children may initially show a sense of excitement (agitation) and restlessness followed by drowsiness.

If you forget to take TEXAMER SYRUP

If you forget to take TEXAMER SYRUP, take your next dose at your normal time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TEXAMER SYRUP

Stopping treatment should have no negative effects. However, rarely, you may experience intense itching (pruritus) if you stop taking TEXAMER SYRUP, even if those symptoms were not present before you started treatment. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

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

If any of the following happens, stop taking TEXAMER SYRUP 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
• fainting.

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

• thinking about or feeling like you want to take your own life
• strong or irregular heartbeat, abnormally rapid heart rate
• difficulty breathing
• painful or difficult urination, passing less urine than is normal for you
• seizures (fits)
• liver infection (hepatitis) characterized by abdominal pain especially on the upper right side beneath your lower rib, dark urine, fever, yellowing of skin and eyes, which is sore when you press it (tenderness) on the right side just below your ribs and clay-coloured stool
• intense itching upon discontinuation.

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

• headache
• sleepiness or drowsiness
• dry mouth
• diarrhoea
• constipation
• tiredness
• sleep disorders.

Less frequent side effects

• nausea, abdominal pain
• abnormal physical weakness or lack of energy
• general feeling of discomfort

Side effects with unknown frequency

• weight gain, increased appetite
• aggression, agitation, seeing or hearing things that are not there (hallucination), depression, difficulty in falling and staying asleep (insomnia), nightmares
• tingling or prickling sensation (pins and needles), involuntary shaking (tremors), dizziness, distortion of sense of taste (dysgeusia)
• changes in vision, blurred vision
• sensation of spinning or feeling off balance
• vomiting
• swelling, redness and itchiness of the skin (urticaria)
• muscle pain, joint pain
• general swelling of ankles, feet and legs (oedema).

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 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 TEXAMER SYRUP.

Store all medicines out of reach of children. Store at or below 25 °C. Keep the bottle tightly closed. Store in the original package to protect from light. Do not use 3 months after first opening. 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).