AERINAZE 2.5 mg/120 mg Модифицированные таблетки

Содержание инструкции

1. Aerinaze 2.5 mg/120 mg modified release tablets
   1. What is Aerinaze and what is it for
   2. What you need to know before taking Aerinaze
   3. How to take Aerinaze
   4. Possible side effects
   5. How to store Aerinaze
   6. Contents of the pack and other information

Aerinaze 2.5 mg/120 mg modified release tablets

desloratadine/pseudoephedrine sulfate

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Aerinaze and what is it for

What is Aerinaze
Aerinaze tablets contains a combination of two active ingredients, desloratadine which is an
antihistamine and pseudoephedrine sulfate which is a decongestant.

How Aerinaze works
Antihistamines help to reduce allergy symptoms by preventing the effects of a substance called
histamine which is produced by the body. Decongestants help to relieve nasal congestion
(blocked/stuffy nose).

When should Aerinaze be used
Aerinaze tablets relieves the symptoms associated with seasonal allergic rhinitis (hay fever)
such as: sneezing, runny nose, itching of the nose and eyes, when accompanied by nasal congestion
in adults and adolescents aged 12 years and over.

2. What you need to know before taking Aerinaze

Do not take Aerinaze

• if you are allergic to desloratadine, pseudoephedrine sulfate, adrenergic medicines, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension treated with medication, suffer from a heart or vascular disease, or have had a stroke
• if you suffer from glaucoma, have difficulty urinating, suffer from a blockage of the urinary tract, or have hyperthyroidism
• if you are taking monoamine oxidase inhibitors (MAOIs) (a class of antidepressant medicines) or have stopped taking these medicines in the last 14 days
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.

Warnings and precautions
The presence of certain conditions may make you particularly sensitive to the decongestant
pseudoephedrine sulfate contained in this medicine. Ask your doctor, pharmacist or
nurse before taking Aerinaze:

• if you are 60 years of age or older. Older patients may be more sensitive to the effects of this medicine
• if you have diabetes
• if you have gastric ulcers that cause a narrowing of the stomach, small intestine or esophagus (stenosing peptic ulcer)
• if you have an intestinal blockage (pyloric or duodenal obstruction)
• if you have a blockage of the bladder neck (vesical cervical obstruction)
• if you have a history of breathing difficulties due to a narrowing of the muscles of the lung (bronchospasm)
• if you have problems with the liver, kidneys, or bladder.

Furthermore, if you have experienced or been diagnosed with any of the following conditions, you should inform
your doctor, pharmacist or nurse as they may advise you to stop taking
Aerinaze:

• high blood pressure
• fast or pounding heartbeat
• irregular heartbeat
• nausea and headache or worsening of headache while taking Aerinaze
• if you have a medical or family history of seizures
• severe skin reactions, including signs and symptoms such as skin redness, numerous small pimples, with or without fever.

If you are about to undergo surgery, your doctor may advise you to stop taking
Aerinaze 24 hours before.
One of the active ingredients of Aerinaze, pseudoephedrine sulfate, can potentially lead to abuse and high
doses of pseudoephedrine sulfate can be toxic. Prolonged use can lead to taking
more than the recommended dose of Aerinaze to obtain the desired effect, with a consequent increase
in the risk of overdose. If you suddenly stop treatment, depression may occur.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing
pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood supply
to the brain. Stop using Aerinaze immediately and seek immediate medical attention if
you develop symptoms that may be signs of PRES or RCVS (see section 4 “Possible side
effects” for symptoms).

Laboratory tests
Stop treatment with Aerinaze at least 48 hours before a skin test as antihistamines
may affect the result.
Athletes taking Aerinaze may test positive for doping.

Use in children and adolescents
Do not give this medicine to children under 12 years of age.

Other medicines and Aerinaze
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. It is particularly important if you are taking:

• digoxin, a medicine used to treat certain heart problems
• medicines for blood pressure (e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine)
• oral or nasal decongestants (such as phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline)
• diet pills (medicines that reduce appetite)
• amphetamines
• medicines for migraine e.g. ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine)
• medicines for Parkinson's disease or infertility e.g. bromocriptine, cabergoline, lisuride and pergolide
• antacids for indigestion or stomach problems
• a medicine for diarrhea called kaolin
• tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine, fexofenadine).

Aerinaze with alcohol
Ask your doctor, pharmacist or nurse if you can drink alcohol while taking Aerinaze. It is not
recommended to drink alcohol while taking Aerinaze.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor, pharmacist or nurse for advice before taking this
medicine.
Aerinaze is not recommended during pregnancy.
A decrease in milk production has been reported with pseudoephedrine sulfate, a component of Aerinaze, in mothers who are breastfeeding. Desloratadine and pseudoephedrine sulfate are excreted into
breast milk. If you are breastfeeding, taking Aerinaze is not recommended.

Fertility
No data are available on male/female fertility.

Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or
use machines. Although most people do not experience drowsiness, it is recommended to
avoid activities requiring mental alertness, such as driving or using machines, before
verifying your response to the medicine.

3. How to take Aerinaze

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, consult your doctor, pharmacist or nurse.

Adults and adolescents aged 12 years and over
The recommended dose is one tablet twice a day with a glass of water, during or
away from meals.
This medicine is for oral use.
Swallow the tablet whole without crushing, breaking or chewing it before swallowing.
Do not take more tablets than recommended in the instructions for use. Do not take the tablets
more often than recommended.
Do not take this medicine for more than 10 days continuously unless your doctor has
prescribed it.

If you take more Aerinaze than you should
If you should take more Aerinaze than prescribed, contact your doctor, pharmacist or
nurse immediately.

If you forget to take Aerinaze
If you should forget to take the dose at the prescribed times, take it as soon as possible, then
continue treatment as usual. Do not take a double dose to compensate for forgetting
the dose.

If you stop taking Aerinaze
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately stop treatment with Aerinaze and urgently seek medical advice if you develop symptoms that could be signs of reversible posterior encephalopathy syndrome
(PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset
• nausea
• vomiting
• confusion
• convulsions
• changes in vision

The following side effects have been observed in studies:

• fatigue
• headache
• sleep disturbances
• nervousness
• drowsiness
• fast heartbeat
• restlessness with increased body movements
• dry mouth
• dizziness
• sore throat
• decreased appetite
• constipation

Not common: the following side effects may affect up to 1 in 100 people

• heavy heartbeat or • dry throat
• stomach pain
• flu-like gastrointestinal disturbances
• nausea
• abnormal stools
• pain or difficulty urinating
• sugar in the urine
• increased blood sugar
• thirst
• problems with urination
• variations in frequency
• itching
• chills
• decreased sense of smell
• alteration of liver function tests
• agitation
• anxiety
• irregular irritability
• increased body movements
• skin redness
• hot flashes
• confusion
• blurred vision
• dry eye
• nosebleeds
• irritated nose
• inflammation of the nose
• runny nose
• inflammation of the nasal sinuses of urination

Very rare: the following other side effects reported during the marketing of
desloratadine, may affect up to 1 in 10000 people

• severe allergic reactions • vomiting
• diarrhea
• hallucinations
• muscle pain
• convulsions
• liver inflammation
• alteration of liver function tests (difficulty breathing, wheezing, itching, hives and swelling)
• skin rashes

Not known: the frequency cannot be defined on the basis of the available data

• serious conditions that • abnormal behavior
• aggressiveness
• changes in the way the heart beats
• weight gain, increased appetite
• depressed mood

Cases of severe skin reactions, including signs and symptoms such as fever, skin redness or
numerous small pimples, have been reported with medicines containing pseudoephedrine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Aerinaze

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 pack after SCAD. and on the
blister after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Keep the blisters in the pack to protect the
medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aerinaze contains

• The active ingredients are desloratadine and pseudoephedrine sulfate.
• Each tablet contains 2.5 mg of desloratadine and 120 mg of pseudoephedrine sulfate.
• The other ingredients are:
• Ingredients in the blue immediate-release layer:corn starch, microcrystalline cellulose, sodium edetate, citric acid, stearic acid and colorant (Indigotine aluminum lake E132).
• Ingredients in the white sustained-release layer:hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide and magnesium stearate.

Description of Aerinaze and contents of the pack
Aerinaze is an oval, modified-release tablet with two layers, blue and white, with “D12” imprinted on the
blue layer. Aerinaze tablets are supplied in packs of 2, 4, 7, 10, 14, or 20 tablets in blisters
consisting of a laminate film with a closing foil.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
Manufacturer:
Organon Heist bv Industriepark 30
2220 Heist-op-den-Berg
Belgium
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

Lietuva
Organon Pharma B.V. Lithuania representative
Tel.: +370 52041693
[email protected]

България
Органон (И.А.) Б.В. - клон България
Тел.: +359 2 806 3030
[email protected]

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Deutschland
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Nederland
N.V. Organon
Tel: 00800 66550123
(+32 2 2418100)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

Österreich
Organon Austria GmbH
Tel: +43 (0) 1 263 28 65
[email protected]

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353
[email protected]

Slovenija
Organon Pharma B.V., Oss, podružnica
Ljubljana
Tel: +386 1 300 10 80
[email protected]

Ísland
Vistor hf.
Sími: +354 535 70 00

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88
[email protected]

Italia
Organon Italia S.r.l.
Tel: +39 90259059
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ: +357 22866730
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

Latvija
Ārvalsts komersanta “Organon Pharma B.V.”
pārstāvniecība
Tel: +371 66968876
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu .

Annex IV
Scientific conclusions
Scientific conclusions
Pseudoephedrine is an alpha-adrenergic receptor agonist. Its mechanism of action as a
decongestant is based on the constriction of dilated arterioles in the nasal mucosa and the reduction
of blood flow, resulting in a decrease in rhinorrhea and nasal congestion. Following
oral administration of a single dose of pseudoephedrine, nasal decongestion occurs
within 30 minutes and lasts for 4-6 hours.
Medicinal products containing pseudoephedrine are used for the symptomatic treatment of nasal or sinus
congestion caused by the common cold, influenza, sinusitis, allergic rhinosinusitis, vasomotor rhinitis and
aerotitis (barotrauma otitis). In numerous authorised medicinal products containing
pseudoephedrine available in the EU, pseudoephedrine is combined with other active ingredients, such as
antihistamines, analgesics and/or antitussives. These combinations treat multiple symptoms
simultaneously in respiratory conditions. Medicinal products containing pseudoephedrine are
approved for several decades as prescription and over-the-counter (OTC) medicines. Medicinal products
containing pseudoephedrine are available in the majority of EU Member States; the majority of such
medicines have been authorised at national level and one via the centralised procedure: Aerinaze
(desloratadine 2.5 mg/pseudoephedrine 120 mg). Medicinal
products containing pseudoephedrine are widely used, to the extent that reported exposure is millions of
patients per year.
The efficacy of medicinal products containing pseudoephedrine in the authorised indications is considered
established in reducing short-term nasal congestion. In terms of safety, medicinal products containing
pseudoephedrine are known to be associated with cardiovascular risks such as hypertension,
arrhythmias, heart failure, ischaemic risks (transient ischaemic attack, myocardial infarction,
stroke, ischaemic colitis and ischaemic optic neuropathy) or haemorrhagic stroke. Such
adverse events are indicated to varying degrees in the product information. Several levels of limitations and
warnings are included in the product information of some medicinal products containing pseudoephedrine to
reduce these risks. The extent of information relating to cardiovascular and
cerebrovascular risks varies depending on the individual medicinal products.
In the context of the PSUSA procedure for pseudoephedrine in combination with ibuprofen
(PSUSA/00001711/202207) concluded in February 2023, the PRAC identified new safety data
relating to ischaemic cerebrovascular adverse reactions, in particular spontaneous cases of
PRES (posterior reversible encephalopathy syndrome) and RCVS (reversible cerebral vasoconstriction
syndrome) in the EudraVigilance data analysis system (EVDAS) and in the literature. These ischaemic events
contributed to the accumulation of serious ischaemic risks observed in association
with products containing pseudoephedrine. It was therefore considered necessary to carry out a thorough
assessment to examine the impact of these concerns on the benefit-risk balance of products
containing pseudoephedrine. A referral procedure was therefore initiated.
In the context of this review, the PRAC requested the marketing authorisation holders of medicinal products
containing pseudoephedrine to conduct a literature review
focused on publications relating to serious ischaemic neurological disorders (with particular attention
to PRES/RCVS events) following the administration of pseudoephedrine and to propose risk mitigation measures
to prevent or mitigate the risks of cerebrovascular and other known ischaemic events. The PRAC also
considered an EudraVigilance (EV) analysis carried out by the EMA and consulted experts in the context of a
meeting with an ad hoc expert group, in order to gather further information and their opinions on the matter. A
communication from a third party was also received in the context of this
procedure.
On 30 November 2023, the PRAC adopted a recommendation, which was then reviewed by the
CHMP (Committee for Medicinal Products for Human Use), pursuant to Article 107 duodeciesof
Directive 2001/83/EC.

Summary of the PRAC scientific assessment
The PRAC considered that the data reviewed in the context of this referral procedure do not
question the efficacy of products containing pseudoephedrine, as no new data have become
available to alter the already established benefit of these medicines in their respective
approved indications. The therapeutic position of medicines containing pseudoephedrine as
symptomatic treatment for the common cold/flu and allergic rhinitis was also confirmed
by the experts consulted during the procedure. Regarding safety, the PRAC
examined all the data presented during the review in relation to the risks of PRES and RCVS
in the context of the overall safety profile of medicines containing pseudoephedrine. The
causal relationship between pseudoephedrine and PRES and RCVS was assessed and considered at least
reasonably possible. This causality assessment was supported by a total of 34 serious cases of PRES and
RCVS considered as probably or possibly related to pseudoephedrine, by articles in the
literature describing pseudoephedrine as a trigger for PRES and RCVS, together with
the plausible mechanism of action of pseudoephedrine in the development of PRES and RCVS.
PRES is a neurological disorder caused by dysregulation of cerebral perfusion. RCVS
is a medical condition in which cerebral vasculature is characterized by multifocal arterial
constriction and dilation. Pseudoephedrine is described in the literature as a precipitating
factor for the development of PRES and RCVS along with other vasoactive agents. Clinical data indicate
furthermore that pseudoephedrine can cause a dose-dependent increase in blood pressure, which
is a standard risk factor for cardiovascular and cerebrovascular complications, including PRES and
RCVS.
The number of reports of cases of PRES or RCVS identified as related to pseudoephedrine
(n = 34) was not considered high when compared with the high exposure of patients to this
substance. This opinion was agreed upon by the experts consulted during the procedure. However, the
PRAC observed that all reported cases with pseudoephedrine were serious, required
hospitalization and in five of them, recovery with sequelae was reported. The PRAC also
noted that PRES and RCVS are serious conditions, although generally reversible or resolved with
timely diagnosis and management. Although no cases of irreversible or fatal PRES were observed among the cases examined
in association with the use of pseudoephedrine, cases of potentially fatal forms of RCVS with several strokes and uncontrolled massive cerebral edema (not in association with pseudoephedrine) have been reported. Early recognition and
intervention are therefore crucial to achieve a favorable clinical outcome
of reversible posterior encephalopathy syndrome and reversible cerebral vasoconstriction syndrome. Consequently, given the severity of these syndromes, it is important to minimize their
occurrence in patients treated with medicines containing pseudoephedrine, given the reasonable possible
association between the use of pseudoephedrine and the development of PRES and RCVS as described above. The
product information of medicines containing pseudoephedrine must therefore be updated
to inform healthcare professionals and patients about PRES and RCVS, their signs and
symptoms and how to act if related reactions occur (paragraph 4.4 of the adverse reactions summary must be added with an estimated frequency of “not known” to the product information (paragraph 4.8 of the summary of product characteristics and corresponding paragraph of the
In particular, with regard to risk factors for PRES and RCVS, the PRAC noted the
established link between severe hypertension and the risk of reversible posterior encephalopathy and reversible cerebral vasoconstriction syndrome, as well as the known hypertensive effects of pseudoephedrine. Patients with severe hypertension or uncontrolled hypertension treated with medicines containing
pseudoephedrine are considered to be at higher risk of developing PRES and RCVS. Separately, in
several articles, impairment of renal function (kidney disease, acute kidney injury,
renal failure, end-stage renal disease and renal impairment) is reported as
a significant risk factor for PRES and RCVS. Pseudoephedrine is mainly excreted
by the kidneys. It is known that renal impairment increases plasma levels of pseudoephedrine and that
the latter should not be administered to patients with severe renal impairment. Therefore, patients with kidney disease/renal failure are at greater risk of PRES and RCVS
during the intake of medicines containing pseudoephedrine. In conclusion, the PRAC considered that
patients with severe or uncontrolled hypertension and patients with severe acute or
chronic kidney disease/renal failure should not be treated with medicines based on pseudoephedrine and that,
consequently, a contraindication should be added (paragraph 4.3 of the summary of the
A direct communication to healthcare professionals was also agreed upon, together with a communication plan, to inform relevant healthcare professionals about the risks of PRES and RCVS with
medicines containing pseudoephedrine and the agreed changes to the product information. During the assessment, the PRAC discussed further measures to minimize the risks, including the
distribution of informational material, the creation of a patient card and awareness campaigns aimed at
healthcare professionals. These measures were also discussed by the clinical experts consulted during the procedure and some of the measures were proposed by a stakeholder. After careful examination of the available evidence regarding the risks of PRES and RCVS, these
supplementary measures were not considered proportionate in light of the magnitude of the risks. No new evidence was identified regarding other known risks associated with medicines containing pseudoephedrine
that could induce the PRAC to recommend a further measure to minimize the risks
beyond those described above. In light of the above, the committee considered that the
risk/benefit ratio of medicines containing pseudoephedrine in its authorized indications
remains favourable, subject to the recommended changes to the product information.

Reasons for the PRAC recommendation
Considering that:

• the PRAC has examined the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data on medicines containing pseudoephedrine;
• the PRAC has examined all available data for medicines containing pseudoephedrine in relation to the risks of PRES and RCVS in the context of the overall safety profile of the medicines. This included data available in EudraVigilance, in the literature, as well as responses to questions from the PRAC submitted by the marketing authorisation holders. The PRAC also took into consideration the outcome of the consultation with an ad hoc expert group and the documents submitted by a stakeholder;
• the PRAC concluded that the efficacy of medicines containing pseudoephedrine in its approved indications is established;
• it has also concluded that serious PRES and RCVS reactions are important identified risks in relation to the use of medicines containing pseudoephedrine;
• the PRAC considered that the data examined raise concerns regarding the use of medicines containing pseudoephedrine in patients with severe or uncontrolled hypertension and in patients with severe acute or chronic kidney disease/renal failure; it therefore concluded that the use of medicines containing pseudoephedrine should be contraindicated in these patient populations;
• furthermore the PRAC concluded that there is a need to update the product information of these medicines to reflect the current knowledge on the occurrence of the reactions in question and the measures to be followed in case of symptoms or signs of PRES or RCVS. In light of the above, the PRAC concluded that the benefit/risk ratio remains favourable for medicines containing pseudoephedrine, subject to the changes to the product information, as described above. The committee therefore recommended the variation of the terms of the marketing authorizations for medicines containing pseudoephedrine. It also agreed on the content of a communication to healthcare professionals together with a communication plan for its distribution.

CHMP opinion
Considering the PRAC recommendation, the CHMP agrees with the general conclusions of
the latter and with the reasons for its recommendation.
The CHMP therefore considers that the risk/benefit ratio for medicines containing pseudoephedrine remains
favourable, subject to the changes to the product information as above. It
therefore recommends the variation of the terms of the marketing authorizations for
medicines containing pseudoephedrine.