Cetrine 10 mg Film-coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Cetirizine hydrochloride
Available from:
Rowex Ltd
ATC code:
R06AE; R06AE07
INN (International Name):
Cetirizine hydrochloride
Dosage:
10 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Piperazine derivatives; cetirizine
Authorization status:
Marketed
Authorization number:
PA0711/075/001
Authorization date:
2004-08-06

Package leaflet: Information for the user

Cetrine 10 mg Film-coated Tablets

cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on the others. It may harm them even

if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

3. H

What is in this leaflet:

1. What Cetrine is and what it is used for

2. What you need to know before you take Cetrine

3. How to take Cetrine

4. Possible side effects

5. How to store Cetrine

6. Contents of the pack and other information

1. What Cetrine is and what it is used for

.

The active ingredient of Cetrine is cetirizine dihydrochloride. Cetrine is an anti-allergy medicine. It

helps control your allergic reaction and its symptoms.

In adults and children aged 6 years and above: Cetrine relieves symptoms associated with, for

example, hay fever, allergy to dust mites (allergic rhinitis) such as:

sneezing,

runny or itchy nose,

itchy palate,

itchy, red or tearing eyes.

Cetrine is also used to relieve symptoms such as itching and hives (associated with chronic urticaria

of unknown cause).

2. What you need to know before you take Cetrine

Do not take Cetrine:

- if you are allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6),

to hydroxyzine or piperazine derivatives (closely related active substances of other medicines)

- if you have severe kidney problems.

Warnings and precautions

- Talk to your doctor or pharmacist before taking Cetrine:

- if you have

kidney problems

. Your treatment may need to be adjusted.

- if you have predisposition factors of urinary retention (e.g. spinal cord lesions or prostatic

hyperplasia)

- 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 Cetrine for several

days before testing. This medicine may affect your allergy test results.

Children and adolescents

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 Cetrine

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

medicines, including medicines obtained without a prescription.

Cetrine with food, drink and alcohol

Please be careful if you drink alcohol during use of this medicine, as it may increase the effects of

alcohol. Food does not affect the absorption of Cetrine.

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 or pharmacist for advice before taking this medicine.

Cetrine 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.

Breast-feeding: You should avoid using this medicine if you are breastfeeding an infant, as cetirizine

hydrochloride is excreted in human milk.

Driving and using machines

At the recommended dose, Cetrine is not expected to cause you to be drowsy or less alert. However, if

you are a sensitive patient, simultaneous use of alcohol and other nervous depressant agents may

additionally affect your ability to drive and use machines.

Cetrine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicinal product.

3. How to take Cetrine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults and adolescents aged 12 years and over:

The usual dose is one tablet once a day.

Children aged between 6-12 years:

The usual dose is half a tablet twice a day (morning and evening).

These tablets are not intended for children under the age of 6 years.

Patients with kidney problems:

if you have moderate kidney problems your doctor may reduce your

dose to half a tablet once a day. If you have severe kidney problems your doctor may reduce your

dose to half a tablet every 2 days.

Swallow the tablets with a glass of water.

The tablet can be divided into equal doses.

You may take this medicine with or without food.

Duration of treatment:

The duration of the treatment may vary depending on the symptoms.

If you take more Cetrine than you should

The following symptoms may occur after an overdose of Cetrine:

Confusion, diarrhoea, dizziness, fatigue, headache, weakness, dilatation of the pupils, itching,

restlessness, sedation, drowsiness, unresponsiveness, fast heart rhythm, involuntary trembling and

inability to pass water.

If you have accidentally taken more of this medicine than you should please contact your doctor or

pharmacist immediately.

If you forget to take Cetrine

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

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.

Some very rare side effects could be serious:

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to

the casualty department at your nearest hospital:

allergic reactions such as sudden difficulty in breathing, speaking and swallowing, swelling of the

lips, face and neck, extreme dizziness or collapse, itchy, raised skin rash

unusual bruising or bleeding caused by low blood platelets.

Other possible side effects:

Tell your doctor if any of the following side effects bother you:

Common:

may affect up to 1 in 10 people

headache, dizziness, dry mouth, fatigue, feeling sick, diarrhoea, drowsiness, sore throat, runny nose.

Uncommon:

may affect up to 1 in 100 people

stomach upset, extreme fatigue, feeling weak, tingling or numbness in the hands and feet, agitation,

itchiness, rash.

Rare:

may affect up to 1 in 1,000 people

rapid heart beat, swelling, allergic reactions, changes in liver function, weight increase, convulsions,

aggression, confusion, depression, hallucination, difficulty in sleeping, red and/or blotchy skin rash.

Very rare:

may affect up to 1 in 10,000 people

difficulty focusing, blurred vision, unusual eye movements, fainting, tremor, altered taste, tics, pain

and/or difficulty passing water, fixed drug eruption.

Not known:

frequency cannot be estimated from the available data

increased appetite, impairment or loss of memory, vertigo, urinary retention, joint pain, nightmare,

hepatitis, rash with blisters containing pus.

After stopping treatment with Cetrine, pruritus (intense itching) and/or urticaria have been reported.

In very rare cases people have thought about committing suicide, if you feel this way stop taking the

tablets and see your doctor.

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 HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

4.

5. How to store Cetrine

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 carton after EXP. The expiry date

refers to the last day of that month.

Do not store above 25°C.

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. Further information

What Cetrine contains:

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

dihydrochloride.

- The other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous

silica, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 4000.

What Cetrine looks like and contents of the pack:

Cetrine are white, oblong film-coated tablets with a score line on one side.

The tablets can be divided into equal halves.

PVC/Aluminium blister: 30 film-coated tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Rowex Ltd., Bantry, Co. Cork, Ireland

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany

Rowa Pharmaceuticals Ltd., Bantry, Co. Cork.

This leaflet was last revised in 02/2019

5.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cetrine 10 mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

Excipients with known effect: Also contains 81.8mg lactose monohydrate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets

White, oblong film-coated tablet, scored on one side.

The scoreline is to allow the tablet to be divided into equal halves.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Cetrine is indicated in adults and paediatric patients 6 years and above:

- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- for the relief of symptoms of chronic idiopathic urticaria.

4.2 Posology and method of administration

Posology

Children aged from 6 to 12 years: 5mg twice daily (a half a tablet twice daily)

Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet).

Elderly patients: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is

normal.

Patients with moderate to severe renal impairment: there are no data to document the efficacy/safety ratio in patients with renal

impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used,

the dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as

indicated. To use the dosing table an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr

(ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula;

Dosing adjustments for adult patients with impaired renal function

Group

Creatinine Clearance (ml/min)

Dosage and frequency

Normal

≥80

10mg once daily

Mild

50 – 79

10mg once daily

Moderate

30 – 49

5mg once daily

Severe

<30

5 mg once every 2 days

End Stage Renal Disease –

Patients undergoing dialysis

<10

Contraindicated

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In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into

account the renal clearance of the patient and the body weight.

Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.

Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to

severe renal impairment above).

Method of administration

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

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine

derivatives.

Patients with severe renal impairment of less than 10ml/min creatinine clearance.

4.4 Special warnings and precautions for use

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of

0.5g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic

hyperplasia) as cetirizine may increase the risk of urinary retention.

Caution in epileptic patients and patients at risk of convulsions is recommended.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment

initiation. In some cases, the symptoms may be intense and may require treatment to be re-started. The symptoms should

resolve when the treatment is restarted.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

Paediatric population

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation

does not allow for appropriate dose adaptation.

4.5 Interaction with other medicinal products and other forms of interactions

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this

antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug

interactions studies performed, notably with pseudoephedrine or theophylline (400mg/day).

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and

impairment of performance, although cetirizine does not potentiate the effect of alcohol (0.5g/l blood levels).

4.6 Fertility, pregnancy and lactation

Pregnancy

For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic

toxicity above background rates. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,

embryonal/foetal development, parturition or postnatal development (see 5.3).

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Caution should be exercised when prescribing to pregnant women.

Breast-feeding

Cetirizine is excreted in human milk at concentrations representing 25% to 90% those measured in plasma, depending on

sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

Fertility

Limited data is available on human fertility but no safety concern has been identified.

Animal data show no safety concern for human reproduction.

4.7 Effects on ability to drive and use machines

Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically

relevant effects at the recommended dose of 10mg.

However, patients who experience somnolence should refrain from driving, engaging in potentially hazardous activities or

operating machinery should not exceed the recommended dose and should take their response to the medicinal product into

account.

4.8 Undesirable effects

Clinical Studies

Overview

Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including

somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

Although cetirizine is a selective antagonist of peripheral H

-receptors and is relatively free of anticholinergic activity, isolated

cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported.

Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.

Listing of ADR's

Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage

(10mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.

From this pooling, the following adverse reactions were reported for cetirizine 10mg in the placebo-controlled trials at rates of

1.0% or greater:

Adverse event

(WHO-ART)

Cetirizine 10mg

(n=3260)

Placebo

(n=3061)

General disorders and administration site conditions

Fatigue

1.63%

0.95%

Nervous system disorders

Dizziness

Headache

1.10%

7.42%

0.98%

8.07%

Gastro-intestinal disorders

Abdominal pain

Dry mouth

Nausea

0.98%

2.09%

1.07%

1.08%

0.82%

1.14%

Psychiatric disorders

Somnolence

9.63%

5.00%

Respiratory, thoracic and mediastinaldisorders

Pharyngitis

1.29%

1.34%

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Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective

tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily

dose in healthy young volunteers.

Paediatric population

Adverse reactions at rates of 1% or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical

trials are:

Adverse event

(WHO-ART)

Cetirizine 10mg

(n=1656)

Placebo

(n=1294)

Gastro-intestinal disorders

Diarrhoea

1.0%

0.6%

Psychiatric disorders

Somnolence

1.8%

1.4%

Respiratory, thoracic and mediastinal disorders

Rhinitis

1.4%

1.1%

General disorders and administration site disorders

Fatigue

1.0%

0.3%

Post-marketing experience

In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have

been reported in post-marketing experience.

Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on

postmarketing experience.

Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10) uncommon (≥ 1/1,000 to < 1/100); rare

(≥1/10,000 to <1/1,000); very rare (<1/10,000) not known (cannot be estimated from the available data)

Blood and lymphatic disorders

Very rare: thrombocytopenia

Immune system disorders

Rare: hypersensitivity

Very rare: anaphylactic shock

Metabolism and nutrition disorders

Not known: increased appetite

Psychiatric disorders

Uncommon: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very rare: tics

Not known: suicidal ideation, nightmare

Nervous system disorders

Uncommon: paraesthesia

Rare: convulsions

Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia

Not known: amnesia, memory impairment

Eye disorders

Very rare: accommodation disorder, blurred vision, oculogyration

Ear and labyrinth disorders

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Not known: vertigo

Cardiac disorders

Rare: tachycardia

Gastro-intestinal disorders

Uncommon: diarrhoea

Hepatobiliary disorders

Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)

Not known: hepatitis

Skin and subcutaneous tissue disorders

Uncommon: pruritus, rash

Rare: urticaria

Very rare: angioneurotic oedema, fixed drug eruption

Not known: acute generalised exanthematous pustulosis

Musculoskeletal and connective tissue disorders

Not known: arthralgia

Renal and urinary disorders

Very rare: dysuria, enuresis

Not known: urinary retention

General disorders and administration site conditions

Uncommon: asthenia, malaise

Rare: oedema

Investigations

Rare: weight increased

Description of selected adverse reactions

After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie

4.9 Overdose

a) Symptoms

Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an

anticholinergic effect.

Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness,

fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary

retention.

b) Management

There is no known specific antidote to cetirizine.

Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following

ingestion of the medicinal product.

Cetirizine is not effectively removed by haemodialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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ATC code : R06A E07: Antiallergic Agent

Pharmacotherapeutic group: Antihistamines for systemic use. Piperazine derivatives

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H

-receptors. In vitro receptor

binding studies have shown no measurable affinity for other than H

-receptors.

In addition to its anti-H

effect, cetirizine was shown to display anti-allergic activities: at a dose of 10mg once or twice daily, it

inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen

challenge.

Studies in healthy volunteers show that cetirizine, at doses of 5 and 10mg strongly inhibits the wheal and flare reactions

induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.

In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of

cetirizine was found. When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal

reactivity to histamine within 3 days.

In a six week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma,

cetirizine 10mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of

administering cetirizine to allergic patients with mild to moderate asthma.

In a placebo-controlled study, cetirizine given at the high daily dose of 60mg for seven days did not cause statistically

significant prolongation of QT interval.

At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and

seasonal allergic rhinitis.

5.2 Pharmacokinetic properties

The steady-state peak plasma concentrations is approximately 300ng/ml and is achieved within 1.0 ± 0.5h. No accumulation is

observed for cetirizine following daily doses of 10mg for 10 days. The distribution of pharmacokinetic parameters such as peak

plasma concentration (C

) and area under curve (AUC), is unimodal in human volunteers.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. The extent of

bioavailability is similar when cetirizine is given as solutions, capsules or tablets.

The apparent volume of distribution is 0.50l/kg. Plasma protein binding of cetirizine is 93 ± 0.3%. Cetirizine does not modify

the protein binding of warfarin.

Cetirizine does not undergo extensive first pass metabolism. About two third of the dose are excreted unchanged in urine. The

terminal half-life is approximately 10 hours.

Cetrizine exhibits linear kinetics over the range of 5 to 60 mg.

Special populations

Elderly: Following a single 10mg oral dose, half-life increased by about 50% and clearance decreased by 40% in 16 elderly

subjects compared to the normal subjects. The decrease in cetirizine clearance in these elderly volunteers appeared to be

related to their decreased renal function.

Children, infants and toddlers: the half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6

years. In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.

Renally impaired patients: The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance

higher than 40ml/min) and healthy volunteers. Patients with moderate renal impairment had a 3-fold increase in half-life and

70% decrease in clearance compared to healthy volunteers.

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Patients on hemodialysis (creatinine clearance less than 7ml/min) given a single oral 10mg dose of cetirizine had a 3-fold

increase in half-life and a 70% decrease in clearance compared to normal. Cetirizine was poorly cleared by haemodialysis.

Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).

Hepatically impaired patients: Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or

20mg of cetirizine as a single dose had a 50% increase in half-life along with 40% decrease in clearance compared to healthy

subjects.

Dosing adjustment is only necessary in hepatically impaired patients if concomitant renal impairment is present.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose

toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Monohydrate

Microcrystalline Cellulose

Silica, Colloidal Anhydrous

Magnesium Stearate

For film-coating

Lactose Monohydrate

Titanium Dioxide (E171)

Hypromellose

Macrogol 4000

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Cetrine 10 mg tablets are packed into PVC/Al strips and inserted into a carton.

Cetrine 10 mg tablets are available in packs of 30 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Rowex Ltd

Bantry

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Co. Cork

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0711/075/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06 August 2004

Date of last renewal: 06 August 2009

10 DATE OF REVISION OF THE TEXT

April 2019

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