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LASYNAC 200MG/30MG FILM COATED TABLETS

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lasynac 200 mg/30 mg film-coated tablets
Ibuprofen/Pseudoephedrine hydrochloride
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 5 days.
What is in this leaflet:
1.
What Lasynac is and what it is used for
2.
What you need to know before you take Lasynac
3.
How to take Lasynac
4.
Possible side effects
5.
How to store Lasynac
6.
Contents of the pack and other information
1.

What Lasynac is and what is used for

Lasynac film-coated tablets contains two active ingredients: ibuprofen and pseuoephedrine.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs provide relief by reducing pain and high temperature. Pseudoephedrine
belongs to a group of drugs called vasoconstrictors which act on the blood vessels in the nose
to relieve nasal congestion.
Lasynac film-coated tablets is indicated for the symptomatic relief of nasal congestion with
headache and/or fever in adults and adolescents aged 15 and above suffering from common
cold.
You should only take this combination product if you have a blocked nose with pain or fever.
If you have only one of these symptoms you should talk to your pharmacist or doctor about
using ibuprofen or pseudoehpedrine alone.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
2.

What you need to know before you take Lasynac

Do not take Lasynac:
• if you are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other
ingredients of this medicine (listed in section 6).


if you are younger than 15 years.



if you are pregnant or breast feeding.



if you have had a previous allergic reaction or asthma, skin rash, itchy runny nose or
facial swelling when previously taking this product, ibuprofen, acetylsalicylic acid or
similar medicines.



if you have a history of recurrent stomach or duodenal ulcers or have experienced
gastrointestinal bleeding related to taking NSAIDs previously.



if you have severe liver or kidney disease.



if you have heart problems (like coronary insufficiency).



if you have history of heart attack (myocardial infarction).



if you have uncontrolled high blood pressure.



if you have had a stroke or have previously been told you are at risk of having a stroke.



if you have history of seizures (fits).



if you have unexplained disorders in the formation of blood elements.



if you have an increased pressure in the eye (closed-angle glaucoma).



if you have difficulty in urinating related to prostate problems.



if you have been diagnosed with Systemic Lupus Erythematosus (SLE) an illness
affecting the immune system causing joint pain, skin changes and other problems.



if you are taking:


other nasal decongestants (vasoconstrictor drugs) administered orally or nasally
(e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or
oxymetazoline), or methylphenidate.



medicines for depression like non-selective Monoamine Oxidase Inhibitors
(known as MAOIs e.g. iproniazid) or have taken them in the last 14 days.

Warning and precautions
You should discuss your treatment with your doctor or pharmacist before taking Lasynac:
• if you have asthma; use of this drug can cause an asthma attack.
• if you have a history of gastro-intestinal disorders (such as hiatus hernia,
gastrointestinal bleeding, peptic or duodenal ulcer).
• if you have heart problems including heart failure, angina (chest pain), or if you have
had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the
legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘ministroke’ or transient ischaemic attack “TIA”).
• if you have high blood pressure, diabetes, high cholesterol, have a family history of
heart disease or stroke, of if you are a smoker.
• if you have hyperthyroidism (overactive thyroid gland).
• if you are taking medicinal drugs interacting with Lasynac, see the list below.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
the recommended dose or duration of treatment.
Interference with blood tests
Pseudoephedrine has the potential to interfere with some diagnostic blood tests. You should
tell your doctor that you are taking this medicine if you have a blood test.

Children and adolescents
Lasynac should not be given to children below 15 years.
There is a risk of renal impairment in dehydrated adolescents.
Other medicines and Lasynac
Tell your doctor or pharmacist if you are taking, have recently taken or might have taken or
might take any other medicines.
Invented name] may affect or be affected by some other medicines. For example:
-

medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)

-

medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as
losartan)

Some other medicines may also affect or be affected by the treatment of [Invented name].
You should therefore always seek the advice of your doctor or pharmacist before you use
[Invented name] with other medicines.
In particular tell your doctor or pharmacist if you are taking:














antiplatelet drugs and oral anticoagulants (thin blood/prevent clotting e.g.
acetylsalicylic acid, warfarin, ticlopidine),
other NSAIDs including high dose acetylsalicylic acid,
cardiac glycosides (eg. digoxin),
corticosteroids,
injectable heparin,
some medicines for depression (e.g.lithium, selective serotonin reuptake inhibitors
(SSRIs), monoamine oxidase A inhibitors (MAOIs)),
methotrexate in high doses (more than 20 mg per week),
quinolone antibiotics (used to treat a wide range of infections),
ciclosporin, tacrolimus and trimethoprim,
medicines for treatment of hypertension (high blood pressure),
any anti migraine drugs (including ergot alkaloid derivatives drugs),
zidovudine (a medicine for treating HIV/Aids),
preparations containing Ginkgo biloba.

Lasynac must not be used in combination with:


other vasoconstrictor agents used as nasal decongestants, whether administered orally
or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine), or
methylphenidate,non-selective monoamine oxidase inhibitors (MAOIs) (such as
iproniazid), which are prescribed for the treatment of certain depressive disorders.

Due to pseudoephedrine administration an acute hypertensive response may develop in the
perioperative period. Therefore, discontinue treatment with Lasynac several days before
surgery and inform your anaesthetist.
Lasynac with food, drink and alcohol

The tablets should not be taken with beverages containing alcohol.
Pregnancy, breast-feeding and fertility
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.
Lasynac is contraindicated during pregnancy and breastfeeding.
Athletes
Pseudoephedrine hydrochloride can lead to positive results in doping tests.
Driving and using machines
Lasynac could cause dizziness and/or blurred vision and therefore might temporarily affect
your ability to drive and use machines.
Lasynac contains Lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
3.

How to take Lasynac

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.
This product is for short term use only. You should take the lowest dose for the shortest time
necessary to relieve your symptoms. Do not take for longer than 5 days unless your doctor
tells you to.
The recommended dose is:
Adults and adolescents aged 15 years and older: 1 tablet every 6 hours if necessary. For more
severe symptoms, take 2 tablets every 6 hours, if necessary.
Never exceed the maximum daily dose of 6 tablets per day (equivalent to 1200 mg ibuprofen
and 180 mg pseudoephedrine hydrochloride).
The tablets should be taken without chewing with a glass of water, preferably during meals.
Use in children and adolescents
Lasynac should not be given to children and adolescents below 15 years.
If in adolescents this medicinal product is required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
If you take more Lasynac than you should
Stop treatment and consult your doctor immediately, even if you feel well.
4.

Possible side effects

Like all medicines, Lasynac can cause side effects, although not everybody gets them.
Stop taking Lasynac immediately and consult a doctor immediately if you experience:




Signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry
stools, vomiting blood or dark particles that look like coffee grounds.
Signs of a serious allergic reaction such as: severe skin rashes, peeling, flaking or
blistering skin, facial swelling, unexplained wheeziness, shortness of breath, easy
bruising.

Tell your doctor if you have any of the following side effects, they become worse or you
notice any effects not listed.
Common (affects 1 to 10 users in 100)
• indigestion, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation
Uncommon (affects 1 to 10 users in 1,000)
• Headache, dizziness, tiredness, difficulty in sleeping, agitation, irritability or tiredness
• Visual impairment
• Stomach or intestinal ulcers, sometimes with bleeding and perforation, worsening of
colitis and Crohn's disease
• Skin rashes
Rare (affects 1 to 10 users in 10,000)
• Tinnitus (ringing in the ears)
• Kidney damage
Very rare (affects less than 1 user in 10,000)
• Problems in blood cell production that might make you bruise more easily or make you
more susceptible to infections
• Severe allergic reactions
• Psychotic reactions and depression
• High blood pressure, palpitations, heart attack
• Liver damage
• Severe skin reactions
• Kidney damage, or difficulty passing urine
5.

How to store Lasynac

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or the blister

after (EXP). The expiry date refers to the last day of the month.
Store below 25°C.
Store in the original package. Keep blister in the outer cartoon.

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 you protect the
environment.
6.

Contents of the packs and other information

What Lasynac contains

- The active substances are:
ibuprofen……………………………………………..200 mg
pseudoephedrine hydrochloride………………………30 mg
- The other ingredients are:
Core
lactose monohydrate
cellulose microcrystalline
sodium starch glycolate (type A)
silica, colloidal anhydrous
magnesium stearate
Coating
polyvinyl alcohol
titanium dioxide (E 171)
macrogol type 3350
talc.
What Lasynac looks like and contents of the pack
Lasynac are round, white, film-coated tablets.
One pack contains 10 or 20 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Phone: +49 / 6132 / 77 0
Fax: +49 / 6132 / 72 0
Manufacturer:
Przedsiebiorstwo Produkcji Farmaceutycznej Hasco – Lek,
Żmigrodzka 242 E, 51-131 Wroclaw, Poland
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria
BoxaGrippal 200mg/30mg Filmtabletten
Belgium
Ibuprofen/Pseudoephedrine hydrochloride Boehringer
Ingelheim 200mg/30mg Comprimé pelliculé
Bulgaria
Mucogrip
Cyprus
Mucocold
France
Surbronc Rhume Ibuprofene Pseudoephedrine 200 mg/30
mg comprimé
Germany
BoxaGrippal 200mg/30mg Filmtabletten
Greece
Mucocold
Spain
Bisolfren 200mg/30mg comprimidos recubiertos con
película
Hungary
Mucogrip
Italy
Ibuprofene e pseudoefedrina Boehringer Ingelheim 200
mg/30mg compresse rivestite con film
Luxembourg
Lasynac
Portugal
Bisolgrip
Romania
Mucogrip 200mg/30mg comprimate filmate

Slovakia
United Kingdom

Mucogrip
Lasynac 200mg/ 30mg film coated tablets

This leaflet was last revised in September 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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