Patient leaflet - Tillomed Allergy and Hayfever Relief 10 mg film-coated tablets

1. WHAT TILLOMED ALLERGY AND HAYFEVER RELIEF 10MG TABLETS IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is the active ingredient of Tillomed Allergy and Hayfever Relief 10mg Tablets. Tillomed Allergy and Hayfever Relief 10mg Tablets is an antiallergic medication.

In adults and children aged 6 years and above, Tillomed Allergy and Hayfever Relief 10mg are indicated

for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hayfever, dust allergies, pet allergies).
for the relief of symptoms of urticaria (skin allergies).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TILLOMED ALLERGY AND HAYFEVER RELIEF 10MG TABLETS

Do not take Tillomed Allergy and Hayfever Relief 10mg Tablets

if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min);

if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines).

Warning and precautions

Talk to your doctor or pharmacist before taking Tillomed Allergy and Hayfever Relief 10mg Tablets.

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 (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

Tillomed Allergy and Hayfever Relief 10mg Tablets with alcohol.

If you are scheduled for allergy testing, ask your doctor if you should stop taking Tillomed Allergy and Hayfever Relief 10mg Tablets 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 Tillomed Allergy and Hayfever Relief 10mg Tablets

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

Tillomed Allergy and Hayfever Relief 10mg Tablets with food and drink

Food does not affect absorption of Tillomed Allergy and Hayfever Relief 10mg Tablets. 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. Tillomed Allergy and Hayfever Relief 10mg Tablets 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 Tillomed Allergy and Hayfever Relief 10mg Tablets 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 Tillomed Allergy and Hayfever Relief 10mg Tablets at the recommended dose.

You should closely observe your response to the drug after you have taken Tillomed Allergy and Hayfever Relief 10mg Tablets if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.

Tillomed Allergy and Hayfever Relief 10mg Tablets 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 TILLOMED ALLERGY AND HAYFEVER RELIEF 10MG TABLETS

Always take this medicine exactly as described in this leaflet or 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.

Adults and adolescents above 12 years old:

The recommended dose is 10 mg once daily as 1 tablet.

Use in children between 6 and 12 years old:

The recommended dose is 5 mg twice daily as a half tablet twice daily. 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 Tillomed Allergy and Hayfever Relief 10mg Tablets 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 Tillomed Allergy and Hayfever Relief 10mg Tablets than you should

If you think you have taken an overdose of Tillomed Allergy and Hayfever Relief 10mg Tablets please inform your doctor. Your doctor will then decide what measures, if any, should be taken.

Cetirizine 10 mg Tabs

Package leaflet

2014469

TW235009 (launch)

[All]

9 points (Reg text)

TW226492 (MAT) 25/11/2025 01/12/2025

Black C

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 Tillomed Allergy and Hayfever Relief 10mg Tablets

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

If you stop taking Tillomed Allergy and Hayfever Relief 10mg Tablets

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Tillomed Allergy and Hayfever Relief 10mg Tablets.

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, rhinitis (in children)

Diarrhea, 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

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, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)

Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)

Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption

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 Joint pain

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: 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 TILLOMED ALLERGY AND HAYFEVER RELIEF 10MG TABLETS

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 box and blister. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tillomed Allergy and Hayfever Relief 10mg Tablets contains

The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, lactose, magnesium stearate, Hypromellose (E 464), titanium dioxide (E 171), Polydextrose (E1200) and macrogol (E1521). What Tillomed Allergy and Hayfever Relief 10mg Tablets looks like and contents of the pack

White to off White, film coated capsule shaped tablet, with score on one face of the tablet.

Pack containing 7, 14, or 30 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer