Ceticit 10 mg Film-Coated Tablets

CETICIT (cetirizine dihydrochloride 10mg). The active substance cetirizine dihydrochloride, is part of a group of molecules with antihistaminic activity. CETICIT is used for symptomatic relief of allergic conditions such as allergic rhinitis (hay fever), and allergic skin conditions, associated with pruritus (severe itching), such as urticarial (hives or itchy areas of the skin).

Do not take CETICIT

• If you are hypersensitive (allergic) to cetirizine dihydrochloride or hydroxyzine, any piperazine derivatives, or any of the other ingredients of CETICIT.
• If you are pregnant, as the safety of this medicine in pregnant women has not been determined.
• If you are breastfeeding, since cetirizine dihydrochloride passes into the breast milk.
• If the child you are caring for is under the age of 2 years, as it is not yet known whether this medicine is safe or effective in this age group.
• If you suffer from severe renal impairment (kidney disease).
• If you suffer from asthma, as it may cause obstruction of the airways (tight chest) if you have previously experienced adverse reactions to this type of medicine.

Warnings and precautions

Take special care with CETICIT

• If you are going to perform hazardous activities or if you are driving or operating machinery; as your mental alertness and physical coordination may be impaired.
• If you are taking alcohol, as this may lead to drowsiness when taken with CETICIT.
• If you suffer from conditions that may increase the risk of urinary retention (unable to empty your bladder), e.g., spinal cord lesion, prostatic hyperplasia (prostate gland enlargement).
• If you suffer from epilepsy and or convulsions (spasms / seizures).
• if you are advised by your doctor to have an allergy skin test done, as CETICIT interferes with the outcome of the test results. You should stop taking CETICIT 3 days prior to a scheduled allergy skin test.
• When you stop taking CETICIT, pruritus (severe itching) and/or urticaria (itchy, raised red areas on the skin) may occur when CETICIT is stopped, even if those symptoms were not present before you started taking CETICIT. The symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
• If you suffer from the rare hereditary (inherited) condition of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance as CETICIT contains lactose.
• If you suffer from diabetes mellitus, as lactose may have an effect on your sugar control.
• If you suffer from porphyria (a metabolic disease of blood components, affecting the skin and nervous system).

The usual dose is as follows:

Adults or children 12 years of age or older:

• One 10 mg tablet daily once daily.

Children 6 to 12 years old:

• 10 mg (one tablet) once daily or 5 mg (half a tablet) twice daily.

Dosage in patients with kidney impairment (deficiency / disease)

In patients with kidney disease, half the recommended daily dose of cetirizine should be taken.

Dosage in liver impairment (deficiency / disease)

In patients with liver disease, half the recommended daily dose should be taken.

Dosage in the elderly

No dose adjustment is necessary.

If you use more CETICIT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Drowsiness (sleepiness) may be expected with an overdosage of CETICIT. Overdosage may produce agitation, confusion, diarrhoea, dizziness, headache, mydriasis (dilation of the pupil), restlessness, somnolence (a state of drowsiness), stupor (a state of near-unconsciousness), pruritus (severe itching) sleepiness, itching, skin rash, difficulty in urinating, exhaustion, tremor and an increased heart rate.

If you forget to take CETICIT

Do not take a double dose to make up for forgotten individual doses. Take CETICIT as soon as possible after the forgotten dose and then continue with the normal dose.

If you stop taking CETICIT

When you stop taking CETICIT, pruritus (severe itching) and/or urticaria (itchy, raised red areas on the skin) may occur even if these symptoms were not present before starting treatment with CETICIT. The symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

CETICIT can have side effects. Not all side effects reported for CETICIT 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 health care professional for advice.

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in breathing;
• rash or itching;
• fainting.

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

Tell your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the following:

• you pass less urine than normal;
• a tight chest or difficulty in breathing;
• increase in epileptic seizures (if you are an epileptic patient);
• abdominal pain, muscle weakness, -cramping or -pain, darkening of the skin, skin rashes, skin blisters, increased heart rate, confusion which may be symptoms of porphyria problems (if you are a porphyria patient).

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

CETICIT. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:

Frequent side effects:

• Pharyngitis (sore throat), rhinitis (a congested, itchy, and runny nose).

Less frequent side effects:

• Urticaria (itchy, raised red areas on the skin), skin rash, pruritus (severe itching), angioedema (an allergic skin disease characterised by swelling of the surrounding skin and the mucous membranes).
• Somnolence (a state of drowsiness), depression, confusion, agitation, aggression, hallucinations (visions and imaginations), insomnia (suffering to fall asleep).
• Drowsiness, fatigue, malaise (general feeling of discomfort, illness, or lack of well-being), asthenia (weakness; lack of energy and strength), tics.
• Blurred vision, oculogyration (uncontrolled and repetitive movement of the eye).
• Tinnitus (ringing sound in ear), vertigo (feeling off-balance).
• Palpitations (a rapid and irregular heartbeat), dysrhythmias (abnormal heartbeat), tachycardia (increased heart rate).
• Hypotension (low blood pressure).
• Thickening of mucous, bronchospasm (tight chest / shortness of breath).
• Nausea, gastrointestinal (stomach) discomfort, diarrhoea (runny stomach), constipation, dry mouth.
• Jaundice (a condition in which the skin and whites of the eyes become yellow).
• Fixed drug-eruption (hyperpigmentation of the skin), photosensitivity (increased sensitivity of the skin to light), hair loss, sweating.
• Myalgia (muscle aches and pains).
• Dysuria (discomfort or burning with urination), enuresis (bed-wetting), urinary retention (unable to emptying your bladder).
• Oedema (build-up of fluid in the body which causes the affected tissue to become swollen).
• Weight increase.

Frequency unknown side effects:

• Increased appetite.
• Suicidal ideation (thinking about suicide), nightmares.
• Headaches, dizziness, anxiety, nervousness, paraesthesia (tingling or pins-and-needles), convulsions (spasms / seizures), movement disorders, dysgeusia (a distortion of the sense of taste), syncope (temporary loss of consciousness), tremor, dystonia (a state abnormal of muscle tone), dyskinesia (writhing movements of the face), amnesia (forgetfulness), memory loss.
• Hepatitis (inflammation in the liver).
• Acute generalised exanthematous pustulosis (a skin reaction related to medication).
• Arthralgia (pain in a joint).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C. Keep tablets in dry place. Protect from light. Do not remove the blisters from the carton until required for use. KEEP OUT OF REACH AND SIGHT OF CHILDREN.