Vividrin Allergy Relief, 10 mg, film-coated tablets – patient leaflet, side effects, dosage

1. WHAT VIVIDRIN ALLERGY RELIEF IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride, the active ingredient of the tablets is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.

In adults and children aged 6 years and above, Vividrin Allergy Relief is used to treat people 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 Vividrin Allergy Relief 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 USE VIVIDRIN ALLERGY RELIEF

Do not take Vividrin Allergy Relief

• if you have end-stage kidney disease (severe renal failure requiring dialysis); ‐ if you are allergic to cetirizine dihydrochloride, to any of the other ingredients of this medicine (listed in section 6), to hydroxizine or to piperazine derivatives (closely related active ingredients of other medicines).

Warnings and precautions

Talk to your doctor or pharmacist before taking

Vividrin Allergy Relief.

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 Vividrin Allergy Relief with alcohol.

If you are scheduled for allergy testing, ask your

doctor if you should stop taking Vividrin Allergy

Relief for several days before testing. This

medicine may affect your allergy test results.

Children

Do not give this medicine to children below the

age of 6 years because the tablet formulation

does not allow the necessary dose adjustments.

Other medicines and Vividrin Allergy Relief

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines.

Vividrin Allergy Relief with food and drink

Food does not affect absorption of Vividrin Allergy Relief.

Pregnancy, breast-feeding and fertility

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.

Vividrin Allergy Relief should be avoided in pregnant women. Accidential 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 passess into breast milk. A risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take Vividrin Allergy Relief during breast-feeding unless you have contacted a doctor.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Vividrin Allergy Relief at the recommended dose.

You should closely observe your response to the drug after you have taken Vividrin Allergy Relief if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.

Vividrin Allergy Relief film-coated tablets contains lactose. 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.

3. HOW TO TAKE VIVDRIN ALLERGY RELIEF

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

The tablets need to be swallowed with a glass of liquid.

The tablet can be divided into 2 equal doses.

Do not take more than one tablet each day.

Children aged 6 to 12:

The recommended dose is 5 mg twice daily as

a half tablet twice a day.

Adults and adolescents aged 12 years and over:

The recommended dose is 10 mg once daily as

one tablet daily. If the tablets make you feel

drowsy or dizzy, taking half a tablet twice a day

may be better than taking one tablet once a day.

Other form(s) of this medicine may be more

suitable for children; ask your doctor or

pharmacist.

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 Vividrin Allergy

Relief 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 Vividrin Allergy Relief than you should

If you think you have taken an overdose of Vividrin Allergy Relief 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, malaise (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 Vividrin Allergy Relief

Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

If you stop taking Vividrin Allergy Relief

Rarely, pruritus (intense itching) and/or urticaria (hives) may return if you stop taking Vividrin Allergy Relief.

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

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
• paresthesia (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, hallucinations, 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, dysgeusia (altered taste)
  • blurred vision, accomodation disorder (difficulty focusing), oculogyration (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)
  • arthralgia (joint pain), myalgia (muscular pain) ‐ acute generalized exanthematous pustulosis (rash with blisters containing pus)
  • increased appetite
  • suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare ‐ amnesia (memory loss), 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
  • hepatitis (inflamation of the liver)

Reporting of side effects

If you get any side effects, talk to your doctor or 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 or search 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 VIVDRIN ALLERGY RELIEF

Keep this medicine out of the sight and reach of children. Store below 25˚C. Store in the original package to protect from light. Do not use this medicine after the expiry date which is stated on the carton and blister after: EXP. 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 Vividrin Allergy Relief contains

• The active substance of Vividrin Allergy Relief is: cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine

  dihydrochloride.

• The other ingredients are: lactose

  monohydrate, microcrystalline celulose,

  colloidal anhydrous silica, magnesium

  stearate, coating Opadry Y-1-7000 white: hypromellose, titanium dioxide (E 171),

  macrogol 400.

What Vividrin Allergy Relief looks like and contents of the pack

Vividrin Allergy Relief is white or almost white, round, biconvex film-coated tablets of

7.0-7.2 mm, with a score line on one side.

The tablet can be divided into equal doses.

Available packaging: 7, 10, 20 and 30 film-coated tablets in AL/PVDC/PVC foil blister in a cardboard box.

Not all pack sizes may be marketed.

Manufacturing Authorisation Holder

Bausch and Lomb UK Ltd.

106 London Road

Kingston-Upon-Thames

Surrey, KT2 6TN, UK

Manufacturer

ICN Polfa Rzeszów S.A.

ul. Przemysłowa 2

35-959 Rzeszów

The leaflet was last revised in January 2025.

P1UK01