Vividrin Allergy Relief 10 mg film-coated tablets

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

1. What Vividrin Allergy Relief is and what it is used for
2. What you need to know before you take Vividrin Allergy Relief
3. How to take Vividrin Allergy Relief
4. Possible side effects
5. How to store Vividrin Allergy Relief
6. Contents of the pack and other information

• 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).

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.

Do not give this medicine to children below the age of 6 years because the tablet formulation does not allow the necessary dose adjustments.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Food does not affect absorption of Vividrin Allergy Relief.

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.

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.

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.

The duration of treatment depends on the type, duration and course of your complaints . Please ask your doctor or pharmacist for advice.

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.

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.

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

• 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)

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.

• 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.

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.