Texamer 5 mg Film-Coated Tablets

TEXAMER contains levocetirizine dihydrochloride, an anti-allergic medicine. TEXAMER is indicated for the relief of symptoms associated with the following allergic conditions in adults:

• Seasonal allergic irritation and inflammation of the nose.
• Allergic irritation and inflammation of the nose throughout the year.
• Daily, long term allergic irritation of the skin (chronic nettle rash of unknown origin - chronic idiopathic urticaria).

Do not take TEXAMER:

• if you are hypersensitive (allergic) to levocetirizine or any of the other ingredients of TEXAMER (see section 6)
• if you or your child are hypersensitive to medicines containing a substance derived from piperazine. These substances could be in heart medicines, antidepressants, antipsychotic medicines or sexual enhancement medicines. Refer to your doctor for advice
• if you or your child have a severe kidney disease
• if you or your child are on dialysis
• if you are pregnant or breastfeeding your baby
• do not give TEXAMER to children under the age of 6 years.

Warnings and precautions

Take special care with TEXAMER:

• TEXAMER may make you sleepy
• caution is advised if TEXAMER is taken at the same time as alcohol. In sensitive patients, the simultaneous use of TEXAMER and alcohol or medicines affecting the central nervous system may have effects on alertness and ability to drive and use machines
• if you have predisposing factors of urinary retention (inability to completely empty your bladder) (e.g. spinal cord lesions, prostatic hyperplasia (enlarged prostate)) as TEXAMER may increase the risk of urinary retention
• if you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of TEXAMER may cause seizure aggravation
• if you are scheduled for allergy testing, ask your doctor if you should stop taking TEXAMER for several days before testing. This medicine may affect your allergy test results
• if you stop taking TEXAMER, pruritus (intense itching) and/or urticaria may occur
• TEXAMER is not suitable for children under the age of 6 (see Do not take TEXAMER).

Children aged less than 6 years

TEXAMER is not recommended in children less than 6 years since the film coated tablets do not allow for dose adaptation.

Other medicines and TEXAMER

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Caution is advised if TEXAMER is taken at the same time as alcohol (see Take special care).

Do not share medicines prescribed for you with any other person. Always take/use TEXAMER exactly as described in this leaflet or as your doctor/pharmacist or nurse has/have told you. Check with your doctor/pharmacist or nurse if you are not sure.

The film coated tablet must be taken orally, swallowed with liquid and it is recommended to take the daily dose in one single intake.

Adults or children 12 years of age or older

The usual dose is one 5 mg tablet.

Patients with liver disease

No change in dosage is needed in patients with liver disease.

Patients with kidney disease (speak to your doctor for advice)

Patients with mild or moderate kidney disease may take TEXAMER only every second or third day respectively. If you have a severe kidney disease you should not take TEXAMER at all. (See Do not take TEXAMER.)

Elderly patients

No adjustment of the dose is necessary in elderly patients with normal kidney function, however, in those elderly patients with moderate or severe kidney disease, your doctor will adjust your dose.

Children

Children 6 - 12 years: The recommended daily dose is one 5 mg tablet. Children 2 - 6 years: TEXAMER is not indicated in children under the age of 6 (see Do not take).

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

If you take more TEXAMER 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
• overdosage in children may produce restlessness or agitation followed by drowsiness

If you forget to take TEXAMER

If you forget to take TEXAMER, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TEXAMER

Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking TEXAMER, 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 can have side effects. Not all side effects reported for TEXAMER are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using TEXAMER, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using TEXAMER 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. 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:

• irregular and/or fast heartbeat
• shortness of breath or difficulty breathing
• if your liver function test came back abnormal or if your liver is inflamed (symptoms may include stomach pain or yellowing of the skin and whites of the eyes (jaundice)
• serious skin reactions (hives and/or itchy skin)
• convulsions (fits)
• hallucinations (seeing or hearing things that are not there), depression, suicidal thoughts
• inability to completely empty the bladder

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:

• difficulty sleeping
• headaches, sleepiness
• dry mouth, diarrhoea, constipation
• fatigue
• sore throat, common cold

Less frequent side effects:

• nausea, stomach pains or discomfort
• feeling tired, weak or generally unwell, abnormal physical weakness or lack of energy
• hives or skin eruptions in the same place, itching

The following side effects have been reported but the frequency for them to occur is not known:

• increased weight, increased appetite
• feeling aggressive, agitated, nightmares
• tingly or numbness sensation of the skin, dizziness, distortion of the sense of taste
• blurry vision or visual disturbances (difficulty to see), uncontrolled circular movements of the eyes
• vertigo (sensation of whirling and loss of balance)
• vomiting
• muscle aches
• hives or skin eruptions in the same place, itching
• painful urination
• swelling caused by excess fluid trapped in your body's tissues (generally in the hands, arms, feet, ankles and legs)

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TEXAMER. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 30 °C. Keep blisters in carton until required for use. 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).