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CETIRIZINA NARGORAN
10mg film-coated tablets
CETIRIZINE DIHYDROCHLORIDE
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 need any clarification or advice, ask your pharmacist.
• If you get any side effects, including possible side effects non listed in this leaflet, talk to your doctor or pharmacist. Consult section 4.
• If you don’t feel better or if you get worse, you must go to a doctor.
1. WHAT CETIRIZINA NARGORAN IS AND WHAT IT IS USED FOR
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 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINA NARGORAN
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 3. HOW TO TAKE CETIRIZINA NARGORAN
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 4. POSSIBLE SIDE EFFECTS
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 5. HOW TO STORE CETIRIZINA NARGORAN
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 6. CONTENTS OF THE PACK AND OTHER INFORMATION
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1. WHAT CETIRIZINA NARGORAN IS AND WHAT IT IS USED FOR

The active substance of Cetirizina Nargoran is cetirizine dihydrochloride.
Cetirizina Nargoran is an antihistamine medicine.
On adults and children over 6 years old, Cetirizina Nargoran 10 mg film-coated tablets is indicated to:
• relieve the seasonal and permanent allergic rhinitis nose and eye symptoms;
• relieve idiopathic chronic hives.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINA NARGORAN

DO NOT TAKE CETIRIZINA NARGORAN
• if you suffer from severe renal disease (severe kidney failure with creatinine depuration bellow 10 ml/min);
• if you are allergic (hyper sensibility) to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed on section 6), to hydroxyzine or to piperazine derivatives (active substances related to other medicines).

WARNINGS AND PRECAUTIONS
If you suffer from renal failure, talk to your doctor; if necessary, you shall take a smaller dose. The new dose shall be determined by your doctor.
If you suffer from bladder problems (such as problems on the spine, prostate or bladder), talk to your doctor to receive advice.
If you are epileptic or a patient with an accrued convulsions risk, talk to your doctor.
No clinically significant interactions between alcohol (for an alcohol content of 0.5 g/l, corresponding to a glass of wine) and cetirizine used on the recommended doses were observed. Nevertheless, there is no available data on the safety when high doses of cetirizine and alcohol are taken at the same time. Therefore, like all antihistaminic, you should avoid taking Cetirizina Nargoran with alcohol.
If you are to take an allergy test, ask your doctor if you should stop taking this medicine many days before its execution. This medicine may affect your test results.

CHILDREN
Cetirizina Nargoran should not be taken by children under 6 years of age, as it doesn’t allow the necessary dosage adjustment.

OTHER MEDICINES AND CETIRIZINA NARGORAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

CETIRIZINA NARGORAN WITH FOOD AND DRINKS
Food doesn’t affect the absorption of Cetirizina Nargoran.

PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Like other medicines, Cetirizina Nargoran should be avoided on pregnant women. The accidental administration by a pregnant woman might not cause damaging effects on the unborn child. However, this medicine should only be administrated if necessary and after medical advice.
Cetirizine is absorbed by breast milk. Therefore, you should not take Cetirizina Nargoran while breast-feeding, except if indicated by your doctor.

DRIVING AND USING MACHINES
The clinical studies do not prove the decrease of concentration, alert state or the driving capability after taking Cetirizina Nargoran on the recommended doses.
You should carefully monitor your response to the medicine after taking Cetirizina Nargoran if you intend to drive, perform potentially dangerous activities or drive machines. Do not exceed the recommended dose.

CETIRIZINA NARGORAN CONTAINS LACTOSE
If you have been informed by your doctor that you are intolerant to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE CETIRIZINA NARGORAN

Always take this medicine exactly as described in this leaflet or accordingly to your doctor or pharmacist’s indications. Talk to your doctor or pharmacist if you have any doubts.
The tablets must be ingested with a glass of liquids.
The tablet may be divided in equal doses.

ADULTS AND ADOLESCENTS OVER 12 YEARS OLD:
The recommended dose is 10 mg, once a day (1 tablet).
There may be a more appropriate alternative of this medicine for children. Ask your doctor or pharmacist.
USE ON CHILDREN AGED BETWEEN 6 AND 12 YEARS OLD:
The recommended dose is 5 mg, twice a day (half a tablet, twice a day).
There may be a more appropriate alternative of this medicine for children. Ask your doctor or pharmacist.
PATIENTS WITH RENAL FAILURE:
The recommended dose for patients with moderate renal failure is 5 mg, once a day.
If you suffer from severe kidney disease, contact your doctor so they may adjust the dose accordingly to your problem.
If your child suffers from kidney disease, contact your doctor so they may adjust the dose accordingly to your child’s needs.

Talk to your doctor if you feel that the Cetirizina Nargoran’s effect is too weak or too strong.

DURATION OF THE TREATMENT
The duration of the treatment depends of your complaint’s type, duration and evolution and is determined by your doctor.

IF YOU TAKE MORE CETIRIZINA NARGORAN THAN YOU SHOULD
If you took too many Cetirizina Nargoran tablets, tell your doctor. Your doctor shall decide the measures you should take, if necessary.
After an overdose, the following side effects may occur with an increased intensity. The following adverse effects had been reported: confusion, diarrhea, dizziness, tiredness, headache, discomfort, dilated pupils, itchiness, agitation, sedation, drowsiness, stupor, abnormally quick heart rate, tremors and urinary retention.

IF YOU FORGET TO TAKE CETIRIZINA NARGORAN
Never take a double dose to compensate a dose you missed.
If you have any doubts on the use of this medicine, talk to your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following side effects are considered rare or very rare, but you shall stop taking this medicine and consult a doctor immediately if you suffer from any of these effects:
allergic reactions, including severe reactions and angioedema (severe allergic reaction which causes the swelling of the face or throat). These reactions may start immediately after the administration of this medicine or later.

Frequent side effects (may affect up to 1 in every 10 patients)
• drowsiness
• dizziness, headache
• pharyngitis, rhinitis (on children)
• diarrhea, nausea, dry mouth
• fatigue.

Infrequent side effects (may affect up to 1 in every 100 patients)
• agitation
• paresthesia (abnormal sensations on the skin)
• abdominal pain
• pruritus (itchiness), skin rash
• asthenia (extreme fatigue), general discomfort

Rare side effects (may affect up to 1 in every 1.000 patients)
• allergic reactions, some severe (very rare)
• depression, hallucinations, aggressivity, confusion, insomnia
• convulsions
• tachycardia (heart beating too fast)
• altered liver function
• hives
• edema (swelling)
• increased weight

Very rare side effects (may affect up to 1 in every 10.000 patients)
• thrombocytopenia (decrease of the number of blood platelets)
• tics
• syncope (faint), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• blurred vision, accommodation perturbances (focusing difficulties), involuntary eye movement (circular involuntary eye movements)
• angioedema (severe allergic reaction which causes the swelling of the face or throat), fixed medical rash
• elimination of altered urine (urinate in bed, pain and/or bladder problems).

Unknown side effects (the frequency cannot be calculated from the available data)
• increased appetite
• suicidal thoughts (recurrent thoughts or concerns regarding suicide)
• amnesia, memory alterations
• vertigo (dizziness or movement sensation)
• urinary retention (inability to completely empty the bladder).

REPORTING OF SIDE EFFECTS
If you get any side effects, including possible side effects not included on this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly to the INFARMED, I.P., via the contacts below. By reporting side effects, you are helping to provide more data on the safety of this medicine.
INFARMED, I.P.
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel: +351 21 798 73 73
Medicine Hotline: 800 222 444 (free of charge)
Fax: +351 21 798 73 97
Website: http://www.infarmed.pt/web/infarmed/submissaoram
Email: farmacovigilancia@infarmed.pt

5. HOW TO STORE CETIRIZINA NARGORAN
Never store it above 25ºC.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tape or exterior package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

WHAT CETIRIZINA NARGORAN CONTAINS
The active substance is cetirizine dihydrochloride. A film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other components (excipients) are: gelatinized starch, monohydrated lactose, cornstarch, povidone, magnesium stearate, Opadry® Y-1-7000 White [hypromellose, macrogol and titanium dioxide (E171)].

WHAT CETIRIZINA NARGORAN LOOKS LIKE AND THE CONTENTS OF THE PACK
Cetirizina Nargoran is presented as film-coated white tablets, in the shape of capsules and with a groove on one its sides. Each package contains 20 film-coated tablets. Tablets packaged on PVC/PVDC-Aluminum blister packs.

MARKETING AUTHORIZATION HOLDER
toLife - Produtos Farmacêuticos, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

MANUFACTURER
Bluepharma – Indústria Farmacêutica, S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal

Detailed and updated information on this medicine is available through the scan of the 2D code included on the package with a smartphone. The same information is also available on the following URL: https://www.tolifeotc.com/nargoran.

This leaflet was last revised on July 2019.