Patient Information Leaflet

ZATOTABS
400 mg + 60 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

Leaflet Contents

What ZATOTABS is and what it is used for
Important information before taking ZATOTABS
How to take ZATOTABS
Possible side effects
How to store ZATOTABS
Contents of the pack and other information

1. What ZATOTABS is and what it is used for

ZATOTABS has a combined effect of two active ingredients: ibuprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic agent.
Ibuprofen has analgesic, antipyretic and anti-inflammatory properties. Pseudoephedrine reduces nasal mucosal congestion. It clears the nose and sinuses and reduces mucus secretion.
Indications
The medicine is intended for short-term use to relieve symptoms of nasal and paranasal sinus congestion accompanied by headache, pain associated with sinus congestion, and fever in the course of influenza or common cold.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using ZATOTABS

When not to use ZATOTABS

if the patient is allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6),
in patients who have ever experienced allergic reactions such as rhinitis, urticaria or bronchial asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation (penetration) or bleeding, including those occurring after use of NSAIDs,
in patients with haemorrhagic diathesis (tendency to bleed),
in patients with severe liver failure, severe kidney failure or severe heart failure,
during pregnancy,
during breastfeeding,
in patients with severe cardiovascular disorders, tachycardia (rapid heartbeat), hypertension or angina pectoris,
in patients who have experienced urinary retention,
in patients with hyperthyroidism,
in patients with narrow-angle glaucoma,
in patients with a history of haemorrhagic stroke or risk factors increasing the risk of haemorrhagic stroke, for example due to use of vasoconstrictive drugs or other decongestants taken orally or nasally (see section "ZATOTABS with other medicines").

Warnings and precautions
Before starting treatment with ZATOTABS, discuss this with your doctor or pharmacist.
Special caution is required when using ZATOTABS in patients:

with systemic lupus erythematosus or mixed connective tissue disease – due to increased risk of aseptic meningitis,
with gastrointestinal disorders (ulcerative colitis, Crohn's disease) – due to possible exacerbation of the disease,
with impaired kidney function – due to risk of further deterioration of kidney function,
with impaired liver function,
with cardiac arrhythmias, hypertension, history of myocardial infarction or heart failure,
with active or past history of bronchial asthma or allergic diseases – due to possible occurrence of bronchospasm,
in elderly patients – due to increased risk of adverse effects,
taking medicines listed in section "ZATOTABS with other medicines",
with diabetes,
with benign prostatic hyperplasia,
with glaucoma,
with pyloric stenosis,
with bladder neck obstruction,
taking other NSAIDs simultaneously, including COX-2 inhibitors (increased risk of adverse effects).

Patients who have ever had hypertension and/or heart failure
should exercise particular caution and consult a doctor or pharmacist before
using ZATOTABS, as fluid retention, hypertension and oedema have been reported during NSAID therapy.
Use of anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a
slight increase in the risk of myocardial infarction or stroke, especially when used at high
doses. Do not exceed the recommended dose or duration of treatment.
Before using ZATOTABS, the patient should discuss treatment with a doctor or
pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischaemic attack – TIA).
the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or may occur in patients who previously experienced such warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact a doctor. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of therapy. Such patients should use the lowest effective dose of the medicine.
Caution is advised when using the medicine in patients taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants such as warfarin (acenocoumarol), or antiplatelet agents such as acetylsalicylic acid.
Concurrent, long-term use of analgesic medicines may lead to kidney damage with risk of kidney failure (post-analgesic nephropathy).
Skin reactions
Severe skin reactions associated with the use of ZATOTABS have been reported.
If any skin rash, mucosal changes, blisters or other allergic symptoms appear, discontinue use of ZATOTABS immediately and seek medical help without delay, as these may be the first signs of a very serious skin reaction. See section 4.
As with other medicines that stimulate the central nervous system, there is a risk of abuse during pseudoephedrine use. Toxic effects may occur with increased doses. Long-term use may lead to tachyphylaxis (loss of sensitivity to the drug's effect), increasing the risk of overdose. Depression may occur after abrupt discontinuation of the medicine.
The medicine should be used cautiously in patients taking tricyclic antidepressants and other sympathomimetic medicines (vasoconstrictive medicines acting on mucous membranes), appetite suppressants, or amphetamine-like psychotropic medicines.
Effect on fertility in women
ZATOTABS belongs to a group of medicines that may adversely affect fertility in women.
Evidence indicates that substances inhibiting cyclooxygenase (prostaglandin synthesis), including ibuprofen, may cause fertility disorders in women by affecting ovulation. This effect is transient and resolves after discontinuation of therapy.
Children and adolescents
Do not give to children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired kidney function.
Elderly patients
Elderly patients have an increased risk of adverse effects.
To reduce the risk of adverse effects, the medicine should be taken for the shortest duration necessary to relieve symptoms.
Note for athletes: After using pseudoephedrine, a positive result in doping tests may occur.
Consult a doctor even if the above warnings refer to conditions experienced in the past.
ZATOTABS with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
ZATOTABS may affect the action of other medicines or other medicines may affect the action of ZATOTABS. For example:

anticoagulant medicines (i.e. blood thinners preventing clot formation, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine);
acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs or corticosteroids (e.g. prednisolone or dexamethasone); use of these medicines in combination with ibuprofen may increase the risk of gastrointestinal adverse effects;
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
antihypertensive medicines and diuretics: ibuprofen (like other NSAIDs) may reduce the effectiveness of these medicines;
lithium (antidepressant medicine): evidence suggests a potential increase in serum lithium levels during concomitant use of ibuprofen (similar to other NSAIDs);
methotrexate (anticancer medicine): risk of increased methotrexate plasma concentration during concomitant use of ibuprofen (similar to other NSAIDs);
zidovudine (antiviral medicine): evidence suggests increased risk of joint haemorrhages and haematomas in haemophilia patients who are HIV-positive and taking zidovudine and ibuprofen simultaneously;
antacids increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate of pseudoephedrine.

Other medicines may also interact with or be affected by ZATOTABS treatment.
Therefore, always consult a doctor or pharmacist before using ZATOTABS with other medicines.
ZATOTABS must not be used simultaneously with:
monoamine oxidase inhibitors (MAOIs), or within 14 days after discontinuation of such inhibitors. Concurrent use of MAOIs and sympathomimetic medicines may cause hypertensive crises.
Due to increased risk of vasoconstriction and elevated blood pressure, simultaneous use of ZATOTABS (due to pseudoephedrine content) with the following medicines is not recommended:
dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide;
vasoconstrictive dopaminergic medicines – dihydroergotamine, ergotamine, methylergonovine;
linezolid;
decongestant medicines reducing nasal mucosal congestion (taken orally or nasally):

phenylephrine, ephedrine, phenylpropanolamine.

Concomitant use of the following medicines with pseudoephedrine is not recommended:
appetite suppressants (pseudoephedrine may enhance their effect);
psychostimulants of amphetamine-type (pseudoephedrine may enhance their effect);
antihypertensive medicines, methyldopa, guanethidine, reserpine, alkaloids of rauwolfia (pseudoephedrine may reduce their antihypertensive effect);
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and cardiac arrhythmias).
During use of halogenated gases and inhaled general anaesthetics, acute hypertensive reactions may occur in the perioperative period when used in combination with pseudoephedrine, similarly to other medicines with indirect sympathomimetic action. Therefore, it is recommended to discontinue ZATOTABS 24 hours before planned general anaesthesia.
Taking ZATOTABS with food
Take the medicine after meals.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy and breastfeeding
Use of ZATOTABS in pregnant and breastfeeding women is contraindicated.
Fertility
Use of ZATOTABS may adversely affect female fertility. See section "Warnings and precautions".
Driving and operating machinery
Exercise caution when driving vehicles or operating machinery during treatment with ZATOTABS.
ZATOTABS contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use ZATOTABS

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. The recommended dose is:
Adults and adolescents over 12 years of age: 1 tablet every 4 hours after meals. Do not exceed 3 tablets per day (maximum daily dose: 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses).
The single dose may be reduced to ½ tablet if this is sufficient to relieve symptoms.
Elderly patients: dose adjustment is not required unless renal or hepatic function is impaired. If renal or hepatic impairment is present, the doctor should determine the appropriate dose individually.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
This helps reduce the risk of adverse effects.
Consult a doctor if treatment with this medicine is needed for more than 3 days or if symptoms worsen.
Use in children
This medicine should not be given to children under 12 years of age.
Overdose of ZATOTABS
If a patient takes more than the recommended dose of ZATOTABS or if a child accidentally ingests the medicine, seek immediate medical advice from a doctor or go to the nearest hospital for assessment of potential health risks and guidance on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
Increased blood pressure and increased heart rate may also occur.
The doctor will provide symptomatic and supportive treatment. Activated charcoal should be administered within one hour of ingestion (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, electrolyte levels should be checked and an electrocardiogram (ECG) should be performed.
Missed dose of ZATOTABS
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Uncommon (in 1 to 10 patients out of 1,000):
headache, dyspepsia, abdominal pain, nausea, urticaria, and itching.

Rare (in 1 to 10 patients out of 10,000):

diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability, and feeling tired
oedema due to kidney and urinary tract disorders.

Very rare (occurring in less than 1 patient out of 10,000):

tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease
peptic ulceration of the stomach and/or duodenum, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients
in isolated cases: depression, psychotic reactions, tinnitus, aseptic meningitis
dysuria (difficulty in passing urine), decreased urine output, renal failure, renal papillary necrosis, increased serum urea concentration
liver function disorders, particularly during prolonged use
blood morphology abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds)
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, dyspnoea, tachycardia (rapid heartbeat), hypotension (sudden drop in blood pressure), shock; exacerbation of asthma and bronchospasm
in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms associated with aseptic meningitis have been observed during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

Frequency not known:

Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy (swollen lymph nodes), and increased eosinophil count (a type of white blood cell).
Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue taking ZATOTABS and seek immediate medical attention. See also section 2.

Treatment with NSAIDs at high doses has been associated with oedema, hypertension, and heart failure.
Use of medicines such as ZATOTABS may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

Adverse effects due to the presence of pseudoephedrine in the medicine:
dyspepsia, gastrointestinal disturbances, flushing and skin rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia (rapid heartbeat), cardiac arrhythmias, restlessness, insomnia, rarely - uncontrolled urination, muscle weakness, tremor, anxiety, disorientation, thrombocytopenia.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49 21 301, fax: 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store ZATOTABS

Store below 25°C. Keep in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ZATOTABS contains

The active substances in this medicine are ibuprofen and pseudoephedrine hydrochloride. Each tablet contains 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride.
The other ingredients (excipients) are: tablet core: monohydrate lactose, microcrystalline cellulose, silicified microcrystalline cellulose (ProSolv HD 90 – a mixture of microcrystalline cellulose and anhydrous colloidal silica), sodium carboxymethyl starch (type A), anhydrous colloidal silica, magnesium stearate; film coating Opadry II 85F18422 White: polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171).

What ZATOTABS looks like and contents of the pack
ZATOTABS coated tablets are white, oval-shaped, biconvex tablets with a break line on both sides.
The packaging consists of PVC/PVDC/Aluminium blisters in a cardboard box. One pack contains 6 or 12 tablets.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]