Cetirizine Dihydrochloride 1mg/ml Oral Solution – patient leaflet, side effects, dosage

1. What Cetirizine Dihydrochloride 1mg/ml Oral Solution is and what it is used for

Cetirizine Dihydrochloride is the active ingredient of the is an antihistamine. It blocks the effects of a substance called

solution

histamine which occurs naturally in the body. Histamine is involved in allergic reactions.

Cetirizine Dihydrochloride 1mg/ml Oral Solution is used to treat adults and children aged 6 years and over who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like Cetirizine Dihydrochloride 1mg/ml Oral Solution relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

2. What you need to know before you take Cetirizine Dihydrochloride 1mg/ml Oral Solution

Do not take Cetirizine Dihydrochloride 1mg/ml Oral Solution

• if you have an end-stage kidney disease (severe renal failure requiring dialysis);

• if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to

  any piperazine derivatives (closely related active ingredients of other medicines).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Cetirizine Dihydrochloride 1mg/ml Oral Solution. 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 have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.

If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice. No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses.

However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking with

Cetirizine Dihydrochloride 1mg/ml Oral Solution alcohol.

If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Dihydrochloride 1mg/ml Oral Solution for several days before testing. This medicine may affect your allergy test results.

Other medicines and Cetirizine Dihydrochloride 1mg/ml Oral Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Cetirizine Dihydrochloride 1mg/ml Oral Solution with food and drink

Food does not affect absorption of .

Cetirizine Dihydrochloride 1mg/ml Oral Solution

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 for advice before taking this medicine.

Cetirizine Dihydrochloride 1mg/ml Oral Solution 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 medicine should only be administered if necessary and after medical advice. Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take during breast-feeding unless you

Cetirizine Dihydrochloride 1mg/ml Oral Solution

have contacted a doctor.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine Dihydrochloride 1mg/ml Oral Solution at the recommended dose. You should closely observe your response to the drug after you have taken if you are intending to drive, engage in potentially hazardous

Cetirizine Dihydrochloride 1mg/ml Oral Solution

activities or operate machinery. You should not exceed the recommended dose.

Cetirizine Dihydrochloride 1mg/ml Oral Solution contains sorbitol; This medicine contains 2250 mg sorbitol in each 5 ml which is equivalent to 450 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor befor you (or your child) take or receive this medicine. Cetirizine Dihydrochloride 1mg/ml Oral Solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate: that may cause allergic reactions (possibly delayed).

This medicine contains 125 mg propylene glycol in each 5 ml which is equivalent to 25 mg/ml.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.

3. How to take Cetirizine Dihydrochloride 1mg/ml Oral Solution

Always take this medicine exactly as described in this leaflet or your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

The solution can be swallowed as such.

Children aged 6 to 12 years:

The recommended dose is 5 mg twice daily as 5 ml (one full measuring spoon) twice daily.

Adults and adolescents over 12 years of age:

The recommended dose is 10 mg once daily as 10 ml oral solution (2 full measuring spoons).

Cetirizine Dihydrochloride 1mg/ml Oral Solution is not suitable for children under 6 years of age. Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly. If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child's needs.

If you feel that the effect of Cetirizine Dihydrochloride 1mg/ml Oral Solution 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. Please ask your doctor or pharmacist for advice.

If you take more Cetirizine Dihydrochloride 1mg/ml Oral Solution than you should

If you think you have taken an overdose of please inform your doctor. Your

Cetirizine Dihydrochloride 1mg/ml Oral Solution

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, mailaise (feeling unwell), dilating of pupil, itching, restlessness, sedation, somnolence (sleepiness), stupor, abnormal rapid heart rate, tremors and urinary retention (difficulty in completely emptying the bladder) have been reported.

If you forget to take Cetirizine Dihydrochloride 1mg/ml Oral Solution

Do not take a double dose to make up for a forgotten dose.

If you forget to take a dose, you should take one as soon as you remember, but wait at least 24 hours before taking the next dose. If you stop taking Cetirizine Dihydrochloride 1mg/ml Oral Solution

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Dihydrochloride 1mg/ml Oral Solution.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. Possible side effects

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

The following side effects are rare or very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice them:

• Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).

  These reactions may start soon after you first take the medicine, or it might start later.

  Common side effects (may affect up to 1 in 10 patients)

  -Somnolence (sleepiness)

  • Dizziness, headache
  • Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
  • Diarrhoea, nausea, dry mouth
  • Fatigue

Uncommon side effects (may affect up to 1 in 100 patients)

• Agitation
• Paraesthesia (abnormal feelings of the skin)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise (feeling unwell)

Rare side effects (may affect up to 1 in 1,000 patients)

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Convulsions
• Tachycardia (heart beating too fast)
• Liver function abnormal
• Urticaria (hives)
• Oedema (swelling)
• Weight increased

Very rare side effects (may affect up to 1 in 10,000 patients)

• Thrombocytopenia (low levels of blood platelets)
• Tics (habit spasm)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeu s i a (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes having uncontrolled circular movements)
• Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption (drug allergy)
• Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)

Not known frequency of side effects (frequency cannot be estimated from the available data)

• Increased appetite
• Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
• Amnesia, memory impairment
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria upon discontinuation
• Arthralgia (joint pain), myalgia (muscular pain)
• Acute generalized exanthematous pustulosis (rash with blisters containing pus)
• Hepatitis (inflammation of the liver)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse . side effects not listed in this

This includes any possible leaflet. You can also report side effects directly via the Yellow Card Scheme at Website: or search

www.mhra.gov.uk/yellowcard for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cetirizine Dihydrochloride 1mg/ml Oral Solution

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 carton and bottle. The expiry date refers to the last day of that month. Do not use after 3 months of first opening the bottle. This medicine does not require any special storage conditions. 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 Cetirizine Dihydrochloride 1mg/ml Oral Solution contains

The active substance is Cetirizine Dihydrochloride. 10 ml (equals to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride. The other ingredients are sorbitol liquid (E 420) (non-crystallising) , glycerol, propylene glycol, saccharin sodium, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), banana flavour, sodium acetate trihydrate, acetic acid glacial, purified water.

10 ml Cetirizine Dihydrochloride 1mg/ml Oral Solution (=2 measuring spoons) contain: 3.15 g glucose equivalents (sorbitol).

What Cetirizine Dihydrochloride 1mg/ml Oral Solution looks like and contents of the pack

It is a clear, colourless solution with slightly sweet taste and a banana flavour.

It is supplied in amber glass bottle containing 70 ml, 100ml, and 200 ml solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Indoco Remedies UK Limited

Alpha House, 296 Kenton Road,

Harrow, Middlesex

United Kingdom, HA3 8DD

Manufacturer:

Elara Pharmaservices Limited

Iron Farm 7 , Grimesgates,

Diseworth, Derby, DE74 2QD,

United Kingdom

This leaflet was last revised in { May 2024}

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