Cetirizine Hydrochloride 5 Mg/5 Ml Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine hydrochloride 5 mg/5ml Solution
Cetirizine dihydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Cetirizine hydrochloride carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cetirizine hydrochloride is and what it is used for
2. Before you take Cetirizine hydrochloride
3. How to take Cetirizine hydrochloride
4. Possible side effects
5. How to store Cetirizine hydrochloride
6. Further Information
1. What Cetirizine hydrochloride is and what it is used for
Cetirizine dihydrochloride is the active ingredient of Cetirizine hydrochloride. Cetirizine hydrochloride is an antiallergic medication.
In adults and children aged 2 year and above, Cetirizine dihydrochloride is indicated
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- for the relief of chronic nettle rash (chronic idiopathic urticaria).
2. Before you take Cetirizine hydrochloride
Do not take Cetirizine hydrochloride
- if you have a severe kidney disease (severe renal failure with creatinine clearance below10 ml/min)
- if you are known to be hypersensitive to the active substance of Cetirizine hydrochloride, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
- if you have rare hereditary problems of fructose intolerance
Take special care with Cetirizine hydrochloride
If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
If you have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention. Allergy Testing
If you are due to have an allergy test, ask your doctor if you should stop taking Cetirizine dihydrochloride for several days before testing. This medicine may affect your allergy test results.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Due to the profile of cetirizine, no interactions with other drugs are expected.
Taking Cetirizine hydrochloride with food and drink
Food does not affect noticeabily the absorption of cetirizine.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
As with other drugs, use of Cetirizine hydrochloride should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.
You should not take Cetirizine hydrochloride during breast feeding because cetirizine passes into breast milk.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine hydrochloride at the recommended dose.
If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug.
If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Important information about some of the ingredients of Cetirizine hydrochloride
Cetirizine hydrochloride contains sorbitol; If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Cetirizine hydrochloride contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
3. How to take Cetirizine hydrochloride
How and when should you take Cetirizine hydrochloride?
These guidelines apply unless your Doctor has given you different instructions on how to use Cetirizine hydrochloride.
Please follow these instructions, otherwise Cetirizine hydrochloride may not be fully effective.
The solution can be swallowed as such.
Adults and adolescents above 12 years old:
10 mg once daily as 10 ml oral solution (2 full measuring spoon)
Children between 6 and 12 years old:
5 mg twice daily as 5 ml (one full measuring spoon) twice daily..
Children between 2 and 6 years old
2.5 mg twice daily as 2.5 ml oral solution (a half measuring spoon) twice daily Patients with moderate to severe renal impairment
Patients with moderate renal impairment are recommended to take 5 mg as once daily.
If you feel that the effect of Cetirizine hydrochloride is too weak or too strong, please consult your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
If you take more Cetirizine hydrochloride than you should
If you think you have taken an overdose of Cetirizine hydrochloride please inform your doctor.
Your doctor will then decide what measures, if any, should be taken.
After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take Cetirizine hydrochloride
Do not take a double dose to make up for forgotten dose
If you stop taking Cetirizine hydrochloride
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cetirizine hydrochloride can cause side effects, although not everybody gets them.
The following side effect is very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice these symptoms:
• A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you first take the medicine, or it might start later.
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Pain in the abdomen
• Headache
• Dizziness
• Dry mouth
• Sore throat
• Nausea
• Cold-like symptoms of the nose (children only)
• Diarrhoea (children only)
Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Tingling in the hands and feet
• Diarrhoea
• Feeling agitated.
• Feeling weak or generally unwell
Rare side effects (affects less than 1 in 1000 people)
• Fast heart beat
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what to do)
• Convulsions
• Increased weight
• Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
• Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difficulty focussing
• Rotation of the eyes
• Bad taste in the mouth
• Fainting
• Bed wetting, pain and/or difficulty passing water
• Unusual bleeding or bruising
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face
• A recurring rash.
Not known side effects
• Increased appetite
• Vertigo
• Urinary retention
Some cases of memory loss and/or impairment have also been reported.
In very rare cases people have thought about committing suicide and if you feel this way then stop taking the oral solution and see your doctor. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cetirizine hydrochloride 5 mg/ 5 ml Solution
Keep out of the reach and sight of children.
The expiry date is stated on the label. “Exp” is short for expiry. Do not take your medicine after this date.
Once opened, the content of the bottle should be used within 2 months.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Cetirizine hydrochloride solution contain
The active substance of Cetirizine hydrochloride oral solution is Cetirizine.. 10 ml (equals to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride.
The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbitol, glycerol, sodium citrate, propylene glycol, monoammonium glycerrhizinate, pineapple flavour, sweet orange flavour and citric acid.
What Cetirizine hydrochloride solution looks like and contents of the pack
Cetirizine Hydrochloride 5 mg/5 ml Solution is a clear, colourless, pineapple and sweet orange flavoured solution with a sweet taste.
Cetirizine Hydrochloride 5 mg/5 ml Solution is available in 75 ml, 100 ml, and 200 ml bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is Chanelle Medical, Loughrea, Co Galway, Ireland.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
The distributor is Chanelle Medical UK Ltd.
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