Tillomed Allergy and Hayfever 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 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 Tillomed Allergy and Hayfever Relief 10mg Tablets is and what it is used for
2. What you need to know before you take Tillomed Allergy and Hayfever Relief 10mg Tablets
3. How to take Tillomed Allergy and Hayfever Relief 10mg Tablets
4. Possible side effects
5. How to store Tillomed Allergy and Hayfever Relief 10mg Tablets
6. Content of the pack and further information

• 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).

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.

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 Tillomed Allergy and Hayfever Relief 10mg Tablets.

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.

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.

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.

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

The recommended dose is 5 mg twice daily as a half tablet twice daily.

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.

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 Tillomed Allergy and Hayfever Relief 10mg Tablets 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 pupils, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.

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

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

• 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)

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 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 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 (E171), polydextrose (E1200) and macrogol (E1521).

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