Package leaflet: Information for the user

Cetirizina Aurobindo 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Cetirizina Aurobindo is and what it is used for
2 What you need to know before taking Cetirizina Aurobindo
3 How to take Cetirizina Aurobindo
4 Possible side effects
5 How to store Cetirizina Aurobindo
6 Contents of the pack and other information

1. What Cetirizina Aurobindo is and what it is used for

Cetirizina Aurobindo contains the active substance cetirizine dihydrochloride.
Cetirizina Aurobindo is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizina Aurobindo is indicated:

for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
for the relief of urticaria.

2. What you should know before taking Cetirizine Aurobindo

Do not take Cetirizine Aurobindo

if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines);
if you have severe kidney disease (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions
If you have kidney impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you have problems with urination (such as spinal cord disorders, prostate, or bladder problems), consult your doctor.
If you are an epileptic patient or at risk of seizures, you must consult your doctor.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5‰ (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on the safety of concomitant intake of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid alcohol consumption while taking Cetirizine Aurobindo.
If you are planning to undergo allergy testing, ask your doctor whether you should stop taking this medicine for a few days before the test. This medicine may affect the results of allergy tests.
Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.
Other medicines and Cetirizine Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizine Aurobindo with food and drink
Food does not affect the absorption of cetirizine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Cetirizine Aurobindo should be avoided in pregnant women. Accidental use of the medicine during pregnancy is not expected to cause harmful effects on the fetus; however, treatment with Cetirizine Aurobindo should only be administered if necessary and under medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizine Aurobindo during breastfeeding unless advised by a doctor.
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or driving ability after taking cetirizine at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, you should carefully monitor your response to the medicine and must not exceed the recommended dose.
Cetirizine Aurobindo contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Cetirizina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet may be divided into two equal doses.

Adults and adolescents aged 12 years and older:
The recommended dose is 10 mg once daily, equivalent to 1 tablet.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily, equivalent to half a tablet twice daily.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you have severe renal impairment, contact your doctor or pharmacist, who will adjust the dose accordingly.
If your child suffers from kidney disease, contact your doctor or pharmacist, who will adjust the dose according to your child’s needs.

If you feel that the effect of Cetirizina Aurobindo is too weak or too strong, consult your doctor.

Duration of treatment:
The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor.

If you take more Cetirizina Aurobindo than you should
If you think you have taken an overdose of Cetirizina Aurobindo, inform your doctor. The doctor will decide what measures, if any, are necessary.
After an overdose, the undesirable effects listed below may occur with increased intensity.
Adverse effects reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormally rapid heart rate, tremors, and urinary retention.

If you forget to take Cetirizina Aurobindo
Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizina Aurobindo
If you stop treatment with Cetirizina Aurobindo, itching (intense pruritus) and/or urticaria may rarely return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects are rare or very rare, but if you notice them you must stop taking the
medicine and speak to your doctor immediately:

allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may start immediately after taking the medicine for the first time, or may develop later.
Common (may affect up to 1 in 10 people):
drowsiness
dizziness, headache
pharyngitis, rhinitis (in children)
dry mouth, nausea, diarrhoea
fatigue
Uncommon (may affect up to 1 in 100 people):
agitation
paraesthesia (abnormal skin sensation)
abdominal pain
itching, rash
asthenia (extreme fatigue), malaise
Rare (may affect up to 1 in 1,000 people):
allergic reactions, some severe (very rare)
depression, hallucinations, aggression, confusion, insomnia
seizures
tachycardia (increased heart rate)
abnormal liver function
urticaria
oedema (swelling)
weight gain
Very rare (may affect up to 1 in 10,000 people):
thrombocytopenia (low platelet levels)
tics (habitual spasms)
syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes with uncontrolled circular movements)
angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
abnormal urination (bedwetting, pain and/or difficulty passing urine)

Not known: (frequency cannot be estimated from the available data):

increased appetite
suicidal thoughts (recurring or persistent thoughts of suicide), nightmares
amnesia, memory impairment
vertigo (sensation of spinning or movement)
urinary retention (inability to completely empty the bladder)
pruritus (intense itching) and/or urticaria upon discontinuation of treatment
joint pain
rash with pus-filled blisters.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetirizina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cetirizina Aurobindo contains

The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of

cetirizine dihydrochloride.

The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hypromellose (5 cp), titanium dioxide (E171), macrogol 400.

Description of the appearance of Cetirizina Aurobindo and package contents
Film-coated tablets.
White to off-white film-coated tablets, rectangular in shape, marked with “10” on one side and smooth on the other side. A score line between “1” and “0”. The tablet can be divided into two equal parts.
Film-coated tablets of Cetirizina Aurobindo are available in blister packs and HDPE containers.
Pack sizes:
Blister packs: 20 film-coated tablets.
HDPE containers: 30 and 1,000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited HF26,
Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia,
Malta

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Cetirizina Aurobindo
Malta: Cetirizine Aurobindo 10 mg film-coated tablets
Portugal: Cetirizina Aurobindo
Spain: Cetirizina Aurobindo 10 mg comprimidos recubiertos con película EFG