LLOYDS PHARMACY ANTIHISTAMINE HAYFEVER RELIEF 10 MG TABLETS, POLLENASE ALLERGY & HAYFEVER RELIEF 10 MG TABLETS, CAREWAY ANTIHISTAMINE HAYFEVER RELIEF 10 MG TABLETS, CETIRIZINE HYDROCHLORIDE 10 MG TABLETS, EM PHARMA ALLERGY AND HAYFEVER RELIEF 10 MG - patient leaflet, side effects, dosage

2. what you need to know before you take cetirizine hydrochloride tablets

Do not take Cetirizine Hydrochloride Tablets [

• 1 if you are allergic to cetirizine hydrochloride, or any of the ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
• 1 if you have a severe kidney disease (severe renal failure with creatinine clearance 1 below 10 ml/min).

[Warnings and precautions

• * If you have liver or kidney problems, please ask your doctor for advice; if necessary,1 you will take a lower dose. The new dose will be determined by your doctor.

i* If you have problems passing urine (like: spinal cord problems or prostate or bladder,

[---problems) please-ask your doctor for adATce-------------------------

? If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.

If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Hydrochloride Tablets for several days before testing. This medicine may i affect your allergy test results.

Children and Cetirizine Hydrochloride Tablets

The use of this medicine is not recommended in children aged less than 6 years since thisi formulation does not allow for appropriate dose adaptation.

pther medicines and Cetirizine Hydrochloride Tablets

Please tell your doctor or a pharmacist if you are taking, have recently taken or might i take any other medicines.

Cetirizine Hydrochloride Tablets with food and drink and alcohol

Food does not affect absorption of Cetirizine Hydrochloride Tablets.

[No clinically significant interactions have been observed between alcohol (at the blood [level of 0.5 g/1 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 Cetirizine Hydrochloride Tablets with alcohol.

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.

iCetirizine Hydrochloride 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. । iCetirizine passes into breast milk. Therefore you should not take Cetirizine [Hydrochloride Tablets if you are 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 Cetirizine Hydrochloride Tablets at the recommended dose. You [ shoukhclosely ob serve yourresponse lo the drug after you liave taken Cetirizine______l

[Hydrochloride Tablets if you are intending to drive, engage in potentially hazardous [activities or operate machinery. You should not exceed the recommended dose.

Cetirizine Hydrochloride Tablets contain lactose

if you have been told by your doctor that you have an intolerance to some sugars, contact [your doctor before taking these tablets.

3. how to take cetirizine hydrochloride tablets

[Always take this medicine exactly as described in this leaflet or as you doctor or [pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed with water.

Adults, -elderly patients and children' 12 years and oven 1 tablet daily [Children aged 6 to 12 years: Half a tablet twice daily.

Children under 6 years: Not recommended.

Patients with renal impairment: Patients with moderate renal impairment are [recommended to take 5 mg once daily. If you have severe kidney problems (or liver and kidney problems together) 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.

[Duration of treatment

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

If you take more than you should

[If you accidentally take too much medicine, contact your doctor or nearest casualty department at once.

If you forget to take Cetirizine Hydrochloride Tablets

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

If you stop taking Cetirizine Hydrochloride Tablets

(Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine [Hydrochloride Tablets.

'IhyouJiave-any further questions on the use of this medicine, ask your doctor______

or pharmacist.

Artwork

Brand:	Dr Reddy’s
Product Name:	Cetirizine
Strength	10 mg
Form:	Tablets
Component:	Leaflet
Pack Size:	N/A
Country:	UK
Date Created:	24/01/2018
Date Modified:	15/001/2019
Version:	1.4

Technical Information

	Die Cut		Guides

Printer: Chesapeke

Dimensions: 135 x390 mm

Colours

	Process Black

Dr. Reddy’s

Good Health Can’t Wait

Dr. Reddy’s Labora­tories (UK) Ltd 6 Riverview Road, Beverley, HU17 OLD, UK

4. possible side effects

[Like all medicines, this medicine can cause side effects, although not everybody gets them[. The following side effects are very rare but you must stop taking the tablets and Speak to your doctor immediately if you notice them:

• [ Allergic reactions including severe reactions and angioedema (serious allergic reaction[

1 which causes swelling of the face or throat)

i* Convulsions (fits)

• [ Thoughts about committing suicide.

_ _ These reactions may start soon after yon first take the medicine, or they might start later. J

1

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

• ? Somnolence, (sleepiness) Fatigue
• i* Dizziness, headache Pharyngitis, cold-like symptoms of the nose[

• * Diarrhoea, nausea, dry mouth (children only).

i

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

• i* Feeling agitated Pruritus (itchy skin), rash
• Parestheisa (abnormal feelings of Asthenia (extreme fatigue), malaise

। the skin) (feeling generally unwell).

i* Ab dominal p ain i

[Rare side effects (may affect up to 1 in 1000 patients)

• Depression, hallucination (hearing or seeing things), aggression, confusion, sleeplessness 1 i* Tachycardia (heart beating too fast)
• [ Abnormal liver function test results (your doctor will know what to do)
• ' Urticaria (hives)

i* Oedema (generalised swelling due to water retention)

• [ Weight increased.

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

• ' Low levels of blood platelets causing unusual bleeding or bruising

i* Tics (habit spasm)

---ty – Syncope; dyskmesia (invohmtary movements) – dystonia -(abnormal prolonged?---- 1 muscular contractions), tremor, dysgeusia (altered taste)

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

• ' Fixed drug eruption

i* Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).

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

• ' Increased appetite

i* Memory loss and forgetfulness

i* Vertigo (sensation of rotation or movement)

• [ Urinary retention (inability to completely empty die urinary bladder)

i* Pruritus (intense itching) and/or urticaria upon discontinuation

T Arthralgia (joint pain)

• [ Acute generalised exanthematous pustulosis (rash with blisters containing pus).

i* Nightmares.

Reporting of side effects

[If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via ithe Yellow Card Scheme at: 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 cetirizine hydrochloride tablets

Keep this medicine out of the sight and reach of children. Do not use this medicine after [the expity date, which is stated on the blister and carton. 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 Cetirizine Hydrochloride Tablets contain__________­__________ iEach tablet contains lOmg of cetirizine hydrochloride (the active ingredient). They also [contain: lactose, macrocrystalline cellulose, maize starch, colloidal anhydrous silica, (magnesium stearate, talc, hypromellose, titanium dioxide (El 71), macrogol 4000 and sodium citrate. 1

[What Cetirizine Hydrochloride Tablets look like and contents of the pack

The tablets are white circular bi-convex, film-coated tablets marked C on one side and a ibreakline on the other. 1

[Available in cartons containing 7, 14, 21, 28, 30 and 60 tablets.

Marketing authorisation holder Revision date January 2019

___'and manufacturer_________­____ Cetirizine Hydrochloride lOmg__________ t>r. Reddy’s Labora­tories (UK) Ltd Tablets PL 08553/0193

[6 Riverview Road, Beverley, © Ur. Reddy’s Labora­tories (UK)Ltd

East Yorkshire, HU 17 OLD