Aspirin Complex 500 mg/30 mg - Granules for oral suspension

Aspirin Complex - Granules has analgesic, anti-inflammatory, antipyretic and nasal decongestant properties.

Application

1. what is aspirin complex granules and what are they used for?

Aspirin complex granules have analgesic, anti-inflammatory, antipyretic and nasal decongestant properties.
The white to yellowish granules contain two active ingredients, acetylsalicylic acid andpseudoephedrine hydrochloride.

Aspirin Complex - Granules is used for the symptomatic treatment of swelling of the mucous membranes in the nose and sinuses (rhinosinusitis) with cold-related pain and fever and/or flu-like symptoms.

If you have only one of the above-mentioned symptoms, treatment with a preparation containing only one active substance is preferred.

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How is it applied?

What is Aspirin Complex - Granules and what is it used for?

Aspirin Complex - Granules has analgesic, anti-inflammatory, antipyretic and nasal decongestant properties.
The white to yellowish granules contain two active ingredients, acetylsalicylic acid and
pseudoephedrine hydrochloride.

Aspirin Complex - Granules is used for the symptomatic treatment of swelling of the mucous membranes in the area of the nose and sinuses (rhinosinusitis) with cold-related pain and fever and/or flu-like symptoms.

If you have only one of the above signs of illness, treatment with
a preparation containing only one active ingredient is preferred.

If you do not feel better or even worse after 3 days, contact
your doctor.
ASPIRIN Complex is intended for adults and adolescents aged 16 years and over._______________________________________________________________________

.

What should you pay attention to before taking it?

What should you be aware of before taking Aspirin Complex - Granules?
Aspirin Complex - Granules must not be taken

if you are allergic to acetylsalicylic acid, pseudoephedrineor any of the other ingredients of this medicine listed in
section 6.

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. . drugs). . at the same time. .

	If you have a history of asthma caused by treatment with
Salicylates or substances with a similar effect (so-called non-steroidal
anti-inflammatory drugs).
	if you suffer from stomach ulcers.
	if you have an increased tendency to bleed.
	if you are pregnant or breastfeeding.
	if you have liver and kidney failure.
	if you suffer from severe heart failure (cardiac insufficiency).
	if you are taking 15 mg or more of methotrexate per week at the same time.
	If you have severe high blood pressure or severe coronary heart disease
suffer.
	If you are taking a medicine from the class of monoamine oxidase (MAO)-
Taking inhibitors (antidepressants) (or taken within the last 2 weeks
have).

Warnings and precautions.

Please talk to your doctor or pharmacist before taking Aspirin Complex - Granules.
take, . . . . . . . . . . . . . .

	If you are allergic to other painkillers (analgesics), rheumatism medicines
(anti-rheumatics) or anti-inflammatory agents (anti-inflammatories) are.
	if you suffer from allergies (e.g. with skin reactions, itching, hives), asthma,
Hay fever, swelling of the nasal mucosa (nasal polyps) or from chronic
Suffering from respiratory diseases.
	If you are taking blood-thinning and anticoagulant medicines at the same time
(Anticoagulants).
	if you have previously suffered from stomach ulcers or gastrointestinal bleeding.
	if you have impaired liver and kidney function.
	if you suffer from impaired cardiovascular function (e.g. if the blood
not sufficiently pumped through the body, loss of volume, greater
surgery, blood infection or major bleeding events).
	if you are about to have an operation (even minor procedures such as drawing a
tooth), as acetylsalicylic acid increases the risk of bleeding even at low doses.
	If you have hyperthyroidism, mild to moderately high blood pressure, diabetes
mellitus (diabetes), heart disease, increased intraocular pressure (glaucoma) or
Suffer from prostate enlargement or have a hypersensitivity to some ingredients
from cold medicines such as phenylephrine or ephedrine (sympathomimetics)
have.
	If you regularly take several different painkillers at the same time
(especially the combination of several analgesic medicines), sit down
the risk of kidney damage.
	if you are prone to gout. In low doses, acetylsalicylic acid lowers the
Uric acid excretion, which under certain circumstances can be observed in patients with
corresponding tendency can trigger a gout attack.
	if you have severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (a
Hereditary disease affecting red blood cells) suffer from high doses of
Acetylsalicylic acid could cause haemolysis (destruction of red blood cells)
	if you get a febrile generalised skin redness associated with pustules,
Stop taking Aspirin Complex - Granules and contact
immediately to a doctor. See section 4.
	When taking Aspirin Complex - Granules, as a result of inflammation of the
colon (ischaemic colitis) sudden abdominal pain or bleeding in the rectum
occur. If you experience these gastrointestinal symptoms, stop

946234_F_GI_19-04-10_AspirinComplex_IB-60G_BEC15257 2 / 8Ingestion of Aspirin Complex - Granules and consult your doctor immediately or
Get medical treatment immediately. See section 4.


The use of the medicinal product Aspirin Complex - Granules may lead to positive results in doping tests.

If you are unsure whether you are allowed to take Aspirin Complex - Granules, ask
please consult your doctor or pharmacist.

Use in elderly patients.
Older patients may be particularly sensitive to pseudoephedrine and may have
reacting with insomnia or experiencing things that do not seem real
(Hallucinations).

Children and adolescents
There is a possible link between acetylsalicylic acid and the Reye-
Syndrome when the drug is given to children and adolescents. Reye's syndrome is
a very rare but life-threatening disease. Therefore, Aspirin Complex - Granules should be
Not used without medical advice in children and adolescents under 16 years of age.
become.

Taking Aspirin Complex - Granules with other medicines.

Inform your doctor or pharmacist if you are taking other medicines,
have recently taken or intend to take other medicines.

The effect of the following medicines or classes of medicines may be affected,
when taken at the same time as Aspirin Complex - Granules.
Please inform your doctor so that a possible dose adjustment can be made.
can.

Aspirin Complex - Granules may increase the effect of the following remedies: . . .

	Medicines which thin the blood (anticoagulants) and which inhibit blood clotting
inhibit (platelet aggregation inhibitors), e.g. ticlopidine.
	Medicines such as cortisone or prednisolone, if taken or injected
become.
	Digoxin (for the treatment of heart failure or irregular heartbeat): the
Quantity of digoxin in the blood is increased.
	anti-inflammatory and analgesic medicines (non-steroidal
Analgesics/antiphlogistics).
	Blood sugar-lowering medicines (antidiabetics).
	Methotrexate: possibly increased risk of side effects.
	Valproic acid (medicinal product for the treatment of epilepsy).
	Antidepressants including MAO inhibitors.
	Salbutamol tablets: the heart may beat irregularly or faster. Bronchi
Expanding inhalation sprays may, however, continue to be used (as prescribed).
	Other medicinal products containing phenylephrine and ephedrine, or other sympatho-
mimetics as used in local nasal decongestants, e.g.
nasal drops, are included.

Aspirin Complex - Granules may weaken the effect of the following medicines:
dehydratingmedicines (aldosterone antagonists and loop diuretics).

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	Antihypertensive medicines (antihypertensives such as guathinidine, methyldopa, beta-
Blocker).
	Uric acid excreting gout agents (e.g. probenecid, sulfinpyrazone).

Taking Aspirin Complex - Granules. together with food, beverages
and alcohol
You can take the medicine independently of a meal. Before taking
you must add the granules to a glass of water and stir well.
Ingestion with alcohol increases the risk of gastrointestinal bleeding and impairs
Your responsiveness.

Pregnancy, lactation and fertility.
Due to a lack of experience with the combination of both active ingredients in Aspirin Complex -.
Granules, the product must not be used during pregnancy and breastfeeding.

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor before taking this medicine.
Your doctor or pharmacist.

Aspirin Complex - Granules belongs to a group of medicines (NSAIDs) which it
Women can make it difficult to get pregnant. This effect is only temporary
and recedes after the intake is finished.

Driving and ability to operate machinery.

Caution: This medicinal product may impair reactivity and

Affect the ability to drive.
During treatment with Aspirin Complex - Granules, your
Responsiveness may be impaired. The risk can be amplified,
if you drink alcohol at the same time. This must be taken into account in activities
become that require special attention, e.g. driving a car.

Aspirin Complex - Granules contains sucrose.
This medicine contains 2 g sucrose (sugar) per sachet (equivalent to 0.17 BE). This
You must take into account if you are diabetic. If you are known to
suffer from a sugar intolerance, please take this medicine only after consulting your doctor.

Aspirin Complex - Granules contains benzyl alcohol.
This medicinal product contains 3.78 mg of benzyl alcohol per sachet. Benzyl alcohol can
cause allergic reactions.
Consult your doctor or pharmacist if you have a liver or liver disease.
Suffering from kidney disease due to large amounts of benzyl alcohol accumulating in your body.
and can cause side effects (called "metabolic acidosis").

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How should the medicine be taken?

How to take Aspirin Complex - Granules?

Always take this medicine exactly as described in this leaflet
or exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.

946234_F_GI_19-04-10_AspirinComplex_IB-60G_BEC15257 4 / 8Unless otherwise prescribed by your doctor, the usual dose for adults and adolescents is
from 16 years of age:
age single dose total daily dose

adults and
1-2 sachets up to 6 sachets
Adolescents

If necessary, the single dose may be taken at 4 - 8 hour intervals
repeatedly.
A total daily dose of 6 sachets must not be exceeded.

Before taking, add the contents of one to two sachets of granules to a glass of
water and stir well. The resulting suspension has an orange flavour.
Drink the entire glass immediately. Note: The granules do not dissolve completely
.

Do not take the medicine for more than 3 days without medical advice.

Children and adolescents:
ASPIRIN Complex is intended for adults and adolescents aged 16 years and over.
Aspirin Complex - Granules must not be used in children and
adolescents under 16 years of age without a doctor's advice. Due to the limited experience
no dose recommendations can be given for adolescents.

If you have taken a larger amount of Aspirin Complex - Granules than
you should
take.In the event of an overdose, headache, dizziness, convulsions, vomiting,
arousal, palpitations (tachycardia), chest pain, agitation or
breathlessness may occur.
If you suspect an overdose, you must inform a doctor immediately. If
you have any further questions about taking this medicine, ask your doctor
or pharmacist.________________________________________________________________________

What are the possible side effects?

How to store Aspirin Complex - Granules?

946234_F_GI_19-04-10_AspirinComplex_IB-60G_BEC15257 6 / 8Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and sachets. The expiry date refers to the last day of the month indicated.

Do not store above 30º C.

Do not dispose of medicines in sewage or household waste. Ask your
pharmacist how to dispose of the medicine when you stop using it. You
are thus helping to protect the environment.________________________________________________________________________

Special instructions for storage

5 How to store Aspirin Complex - Granules?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and sachets. The expiry date refers to the last day of the month indicated.

Do not store above 30º C.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they help to protect the environment.________________________________________________________________________

Special notes on the content

Contents of the pack and other information
What Aspirin Complex - Granules contains
The active ingredients are acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg).

The other ingredients are: Citric acid, sucrose, hypromellose, saccharin,
Orange flavouring (with benzyl alcohol, acetic acid, alpha-tocopherol, modified starch and maltodextrin).

What Aspirin Complex - Granules looks like and contents of the pack
Aspirin Complex - Granules is a white to yellowish granule to be taken after
dissolving.
One pack of Aspirin Complex - Granules contains 10 or 20 sachets of granules.

Not all pack sizes may be marketed.