Cirrus 5mg Cetirizine 120 mg Pseudoephedrine 14 Film Tablets Chiesi

Cirrus 5mg Cetirizine 120 mg Pseudoephedrine 14 Film Tablets Chiesi

Brand:CHIESI Pharmaceuticals
Product Code:290
Availability:In Stock

Package leaflet: Information for the user
Cirrus 5 mg/120 mg prolonged-release tablets
(5 mg cetirizine dihydrochloride - 120 mg pseudoephedrine hydrochloride)
<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 to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.>
<Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has 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 any possible
side effects not listed in this leaflet.
- You must talk to a doctor if you do not feel better or if you feel worse after 7 days.>
What is in this leaflet:
1. What Cirrus is and what it is used for
2. What you need to know before you take Cirrus
3. How to take Cirrus
4. Possible side effects
5. How to store Cirrus
6. Contents of the pack and other information

1. What Cirrus is and what it is used for
Cirrus 5mg/120mg prolonged release tablets contains two active substances: cetirizine
dihydrochloride which is an antihistamine and pseudoephedrine hydrochloride which is a
decongestant. 

Cirrus is a medicine that is used to relieve allergic symptoms, especially when the antiallergy
properties of cetirizine are combined with the effects of pseudoephedrine in reducing
swelling of the mucous membranes inside the nose.
Cirrus is indicated for the treatment of symptoms such as blocked nose, sneezing, runny nose,
itchy nose or itchy eyes, which occur in seasonal allergic rhinitis (hay fever) or perennial
allergic rhinitis (house-dust allergy).
Cirrus is indicated for adults and children above 12 years. 

2. What you need to know before you take Cirrus
Do not take Cirrus
- if you are allergic to cetirizine, ephedrine or any of the other ingredients of this medicine
(listed in section 6) or to any piperazine derivative (closely related active sustances of
other medicines).
- if you have high blood pressure or coronary heart disease.
- if you suffer from impaired kidney function, impaired thyroid function or a tumour called
a phaeochromocytoma, if you have serious disturbances of heart rhythm, increased
intraocular pressure (inside the eye) or urination problems.
- if you are taking medication for high blood pressure such as beta-blockers,
sympathomimetics (medicines that reduce swelling), dihydroergotamine (for problems
with the circulation) or amphetamines (stimulants).
- if you are receiving treatment with MAO inhibitors (antidepressants) or have taken these
within the last two weeks.
- if you have had a cerebrovascular event (stroke) or display risk factors that increase the
risk of a cerebrovascular haemorrhage, due to the blood-vessel-narrowing action of Cirrus
in combination with medicines such as bromocriptine, pergolide, lisuride, cabergoline,
ergotamine, dihydroergotamine or any other medicines that reduce swelling.
(phenylpropanolamine, phenylephrine, ephedrine etc.), irrespective of the method of
administration.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cirrus:
- if you are over 50 years of age.
- if you are a diabetic or suffer from hyperthyroidism (overactive thyroid) or heart
problems (too fast or irregular rhythm, angina pectoris).
- if you suffer from moderate liver or kidney impairment.
- if your prostate is enlarged or you have problems urinating.
- if you regularly consume alcohol or take medication that depresses the central nervous
system.

- if you are taking/using medicines that belong to the class of drugs called
sympathomimetics (medicines that reduce swelling, appetite suppressants, stimulants
such as amphetamines).
- if you are at risk of excessive blood clotting e.g. from chronic inflammatory bowel
disease.
- if you are taking medications for depression (tricyclic antidepressants), digitalis
preparations (for the heart), linezolide (antibiotic), guanethidine, reserpine, phenothiazine
or antihypertensives.
- if you suffer from high blood pressure and are taking non-steroidal anti-inflammatory
drugs, your blood pressure may increase.
- if you are already taking other medicines, please read the section “Other medicines and
Cirrus”.
- if you have had a cerebrovascular event (stroke) or have risk factors for experiencing such
an event.
- this medicine may act as a cerebral stimulant and make insomnia, nervousness, fever,
tremors and epileptic seizures worse. 

Other medicines and Cirrus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
- Combination with the following medicines should be avoided: bromocriptine,
cabergoline, lisuride, pergolide, dihydroergotamine, ergotamine, methylergometrine and
other vasocontricting substances for oral use or local use in the nose (phenylpropanolamine,
ephedrine, phenylephrine etc).
- Caution is advised with simultaneous administration of sedatives (tranquillisers),
theophylline (anti-asthma medication), ritonavir (HIV medication), certain
antidepressants (MAO inhibitors, even if you have not been taking them in the last two
weeks) and tricyclic antidepressants), antihypertensives (alpha-blockers and betablockers,
methyldopa), medicines for the circulation (dihydroergotamine), antibiotics
containing linezolide, medications for the heart that contain digitalis.
- Some antacids may increase the effect of Cirrus, others may reduce it (kaolin).
- If you are scheduled for allergy testing, ask your doctor if you should stop taking Cirrus
for several days before testing. This medicine may affect your allergy test results.
Cirrus with food and drink
Cirrus may be taken with or without food.
Pregnancy, breast-feeding, and fertility
Cirrus is not recommended during pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice.
Driving and using machines
Cirrus does not normally cause drowsiness. However, in rare cases Cirrus may reduce
alertness. If you are affected by this reduction in alertness, or if you suffer from tiredness or
somnolence (drowsiness), you must not drive or use machines.
Cirrus contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine. 

3. How to take Cirrus
<Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.>
<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 recommended dose is: 1 tablet twice daily (one in the morning and one in the evening).
Use in children:
Children older than 12 years: 1 tablet twice daily (one in the morning and one in the evening).
Cirrus is not recommended for children younger than 12 years.
If you suffer from kidney or liver disease, please inform your doctor or pharmacist, who may
adjust your dose.
Method of administration and duration of treatment:
Oral use. The tablet must be swallowed whole with a little liquid with or without food and
must not be crunched or chewed.
After the allergy-induced symptoms have been relieved, it is often recommended that
treatment is continued in the pollen season with a medication that contains only an antiallergy
substance.
If symptoms have not subsided after 7 days, ask your doctor for advice. 

If you have taken or used more Cirrus than you should, contact your doctor or pharmacist
immediately.
A significant overdose can cause the following symptoms: vomiting, dilated (abnormally
large) pupils, disturbances of heart rhythm, high blood pressure, depression of the central
nervous system (sedation, breathing difficulties, loss of consciousness, cyanosis (bluish
discolouration due to oxygen deficiency), cardiovascular collapse (circulatory failure)) or
stimulation of the central nervous system (insomnia, hallucinations, tremor, seizures) which
may prove fatal.
There is no specific antidote. Treatment should take place in a hospital. If the person affected
does not vomit spontaneously, an attempt can be made to induce vomiting.
Read also the section for healthcare professionals.
If you forget to take Cirrus
If you forget to take a tablet, take it as soon as you remember. However, the subsequent
tablets must be spaced 12 hours apart.
Do not take more than two tablets in 24 hours.
If you stop taking Cirrus
Only take this medicine if you suffer from allergy symptoms.
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 are known side effects:

Common side effects (may affect up to 1 in 10 patients): rapid heart rate, dry mouth, nausea,
weakness (asthenia), dizziness, somnolence, headache, vertigo, nervousness, insomnia
Uncommon side effects (may affect up to 1 in 100 patients): agitation, anxiety
Rare side effects (may affect up to 1 in 1000 patients): disturbances of heart rhythm, pallor,
arterial hypertension, vomiting, abnormal liver function (increase in certain enzymes),
hypersensitivity reactions (allergy), convulsions, tremor, hallucinations, urination difficulties,
dry skin, eruption, sweating, urticaria 

Very rare side effects (may affect up to 1 in 10000 patients): circulatory collapse
(circulatory disorder), ischaemic colitis, altered taste (dysgeusia), cerebrovascular event
(stroke), psychosis (in isolated cases), angioedema (serious allergic reaction which causes
swelling of the face or throat), fixed drug eruption
Not known frequency of side effects (frequency cannot be estimated from the available
data): blurred vision, accommodation disorder (difficulty focusing), prolonged abnormal
dilation of the pupil of the eye (mydriasis), eye pain, visual impairment, abnormal eye
sensitivity or intolerance to the light (photophobia), difficulty in breathing (dyspnoea).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store Cirrus
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister pack
after {abbreviation used for expiry date}. 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 Cirrus contains
- The active substances are cetirizine dihydrochloride and pseudoephedrine
hydrochloride. Each prolonged release tablet contains 5 mg cetirizine dihydrochloride
and 120 mg pseudoephedrine hydrochloride.
- The other ingredients are: tablet: hypromellose, microcrystalline cellulose, colloidal
anhydrous silica, magnesium stearate, lactose monohydrate, croscarmellose-sodium;
coating: Opadry Y-1-7000 (= hypromellose, titanium dioxide (E171), Macrogol 400).
See section 2 “Cirrus contains lactose”.
What Cirrus looks like and contents of the pack?

Cirrus is a prolonged-release tablet, i.e. the contents are released slowly in order to allow for
an effective treatment over a period of approximately 12 hours.
Each round, biconvex tablet has a round logo engraved on one side.
Cirrus is available in boxes containing a blister with 10 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For more information about the medicine please contact your doctor or pharmacist.
If you wish, you can also contact the local representative of the Marketing Authorisation
Holder (pharmaceutical company):
[To be completed nationally]
Manufacturer:
<Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy>
<UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom>
This medicinal product is authorised in the Member States of the EEA under the
following names:
Belgium: Cirrus
Cyprus: Zyrtec-D
Ireland: Zirtek Plus Decongestant
Malta: Cirrus
This leaflet was last revised in {MM/YYYY}

The following information is intended for healthcare professionals only:
Simultaneous administration of halogenated anaesthetics such as chloroform, enflurane,
isoflurane, cyclopropane, halothane can trigger or exacerbate ventricular arrhythmia.
In the event of an overdose cetirizine and pseudoephedrine are hardly eliminated at all by
haemodialysis.

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