Zatotabs

Leaflet attached to the packaging: patient information

ZATOTABS

400 mg + 60 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is ZATOTABS and what is it used for

ZATOTABS has a combined effect of two components: ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, a sympathomimetic drug.
Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract. It clears the nose and sinuses, reducing the amount of discharge.

Indications for use

The drug is intended for temporary use to relieve symptoms of nasal congestion and sinusitis with accompanying headache, pain related to sinusitis, and fever in the course of flu or cold.
If there is no improvement after 3 days or if the patient feels worse, they should consult a doctor.

2. Important information before taking ZATOTABS

When not to take 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 had allergic symptoms after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as nasal congestion, urticaria, or bronchial asthma,
• in patients with active or recurrent peptic ulcer disease of the stomach and/or duodenum, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients with a bleeding disorder (tendency to bleed),
• in patients with severe liver, kidney, or heart failure,
• in pregnancy,
• during breastfeeding,
• in patients with severe cardiovascular disorders, tachycardia (rapid heart rate), hypertension, angina pectoris,
• in patients who have had urinary retention,
• in patients with hyperthyroidism,
• in patients with narrow-angle glaucoma,
• in patients who have had a hemorrhagic stroke or have risk factors that may increase the risk of a hemorrhagic stroke, for example, due to taking vasoconstrictor medications or other decongestant medications used orally or nasally (see "ZATOTABS and other medicines").

Warnings and precautions

Before starting treatment with ZATOTABS, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking ZATOTABS in patients:

• with systemic lupus erythematosus and mixed connective tissue disease - due to the increased risk of developing aseptic meningitis,
• with gastrointestinal diseases (ulcerative colitis, Crohn's disease) - due to the possibility of exacerbating the disease,
• with kidney function disorders - due to the risk of further deterioration of kidney function,
• with liver function disorders,
• with heart rhythm disorders, hypertension, myocardial infarction, or heart failure in their medical history,
• with active or previously diagnosed bronchial asthma and allergic diseases - due to the possibility of bronchospasm,
• in the elderly - due to the risk of increased side effects,
• taking medications listed in the "ZATOTABS and other medicines" section ,
• with diabetes,
• with benign prostatic hyperplasia,
• with glaucoma,
• with pyloric stenosis,
• with urethral stricture,
• taking other NSAIDs, including COX-2 inhibitors (increased risk of side effects).

Patients who have ever had hypertension and/or heart failure should be particularly cautious and consult their doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and edema.
Taking anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking ZATOTABS, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries) or if they have had a stroke (including a mini-stroke or transient ischemic attack - TIA).

if they have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if they smoke.

• they have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if they smoke.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients who have had such warning signs. If bleeding or ulceration of the gastrointestinal tract occurs, the medicine should be stopped immediately, and a doctor should be consulted. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Such patients should use the lowest effective dose.

Caution should be exercised when taking the medicine in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications, such as warfarin (acenocoumarol) or antiplatelet agents, such as acetylsalicylic acid.
Concomitant, long-term use of analgesic medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Skin reactions
Severe skin reactions have been reported with the use of ZATOTABS.
If the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of an allergic reaction, the patient should stop taking ZATOTABS and seek medical help immediately, as these may be the first signs of a severe skin reaction. See section 4.

• 4.

Similar to other central nervous system stimulants, there is a risk of abuse when taking pseudoephedrine. When taking increased doses, toxic effects may occur. Long-term use may lead to the development of tachyphylaxis (loss of sensitivity to the drug) with an increased risk of overdose. After sudden withdrawal of the medicine, depression may occur.
The medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic medications (vasoconstrictor medications), appetite suppressants, amphetamine-like psychostimulants.
Effect on fertility in women
ZATOTABS belongs to a group of medications that may adversely affect fertility in women.
There is evidence that cyclooxygenase inhibitors (prostaglandin synthesis), including ibuprofen, may cause fertility disorders in women by affecting ovulation.
This effect is temporary and disappears after the end of treatment.
Children and adolescents
Do not give to children under 12 years of age.
In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.
Elderly patients
In elderly patients, there is an increased risk of side effects.
To minimize the risk of side effects, the medicine should be taken for the shortest period necessary to relieve symptoms.
Warning for athletes: after taking pseudoephedrine, a positive result may be obtained in doping tests.
Consult a doctor, even if the above warnings refer to past situations.

ZATOTABS and other medicines

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
ZATOTABS may affect the action of other medications or other medications may affect the action of ZATOTABS. For example:

• anticoagulant medications (e.g., blood thinners, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or corticosteroids (e.g., prednisolone or dexamethasone); concomitant use of these medications with ibuprofen may increase the risk of gastrointestinal side effects;
• blood pressure-lowering medications (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan);
• antihypertensive and diuretic medications: ibuprofen (like other NSAIDs) may reduce the effect of these medications;
• lithium (an antidepressant medication): there is evidence of a potential increase in lithium levels in the blood when taken with ibuprofen (like other non-steroidal anti-inflammatory drugs);
• methotrexate (an anticancer medication): there is a risk of increased methotrexate levels in the blood when taken with ibuprofen (like other non-steroidal anti-inflammatory drugs);
• zydovudine (an antiviral medication): there is evidence of an increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zydovudine and ibuprofen;
• medications that neutralize stomach acid increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate of pseudoephedrine.

Some other medications may also be affected or have an effect on ZATOTABS treatment.
Therefore, before taking ZATOTABS with other medications, the patient should always consult their doctor or pharmacist.
ZATOTABS should not be taken with the following medications:
monoamine oxidase inhibitors and for 14 days after stopping the inhibitor. When taking monoamine oxidase inhibitors and sympathomimetic medications, hypertensive crises may occur.
Due to the increased risk of vasoconstriction and increased blood pressure, it is not recommended to take ZATOTABS (due to the presence of pseudoephedrine) with the following medications:
dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
vasoconstrictor dopaminergic medications - dihydroergotamine, ergotamine, methylergometrine;
linezolid;
medications that reduce congestion of the nasal mucosa (taken orally or nasally)

• phenylephrine, ephedrine, phenylpropanolamine.

It is not recommended to take the following medications with pseudoephedrine:
appetite suppressants (pseudoephedrine may increase their effect);
psychostimulant medications of the amphetamine type (pseudoephedrine may increase their effect);
antihypertensive medications, alpha-methyldopa, mecamylamine, reserpine, ergot alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
tricyclic antidepressant medications (pseudoephedrine may theoretically increase the risk of hypertension and heart rhythm disorders).
When taking halogenated anesthetics, general inhalation anesthetics, in combination with pseudoephedrine, a severe hypertensive reaction may occur during the perioperative period, similar to when these medications are taken with other medications with indirect sympathomimetic action. Therefore, it is recommended to discontinue ZATOTABS 24 hours before scheduled general anesthesia.

Taking ZATOTABS with food

The medicine should be taken after meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy and breastfeeding
Taking ZATOTABS in pregnant or breastfeeding women is contraindicated.
Fertility
Taking ZATOTABS may adversely affect fertility in women. See "Warnings and precautions".

Driving and using machines

While taking ZATOTABS, the patient should be cautious when driving vehicles and operating machinery.

ZATOTABS contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take ZATOTABS

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally. The recommended dose is:
Adults and adolescents over 12 years:1 tablet every 4 hours after meals. The dose should not exceed 3 tablets per day (maximum daily dose of 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses).
The single dose should be reduced to ½ tablet if it is sufficient to relieve symptoms.
Elderly patients:no dose adjustment is required unless kidney or liver function is impaired. If kidney or liver function is impaired, the doctor should determine the dose individually.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. This minimizes the risk of side effects.
The patient should consult their doctor if it is necessary to take the medicine for more than 3 days or if symptoms worsen.

Use in children

The medicine should not be given to children under 12 years of age.

Taking a higher dose of ZATOTABS than recommended

If the patient has taken a higher dose of ZATOTABS than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur.
There may also be an increase in blood pressure and heart rate.
The doctor will provide symptomatic and supportive treatment. Within one hour of taking the medicine, it is recommended to administer activated charcoal (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, electrolyte levels should be checked, and an electrocardiogram should be performed.

Missing a dose of ZATOTABS

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ZATOTABS can cause side effects, although not everybody gets them.
Uncommon(affects 1 to 10 people in 1,000):
headache, indigestion, stomach pain, nausea, urticaria, and itching.
Rare(affects 1 to 10 people in 10,000):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, excitement, irritability, and fatigue
• edema resulting from kidney and urinary disorders.

Very rare(affects less than 1 person in 10,000):

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease
• peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, and perforation, sometimes fatal, especially in the elderly
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis
• dysuria (difficulty urinating), decreased urine output, kidney failure, renal papillary necrosis, increased urea levels in the blood
• liver function disorders, especially during long-term use
• blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds)
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
• severe hypersensitivity reactions, such as: facial edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Frequency not known:

• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• A red, scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking ZATOTABS and seek medical help immediately. See also section 2.

NSAID treatment has been associated with edema, hypertension, and heart failure.
Taking medications like ZATOTABS may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Side effects due to the presence of pseudoephedrine in the medicine:

indigestion, gastrointestinal disorders, redness, and rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, arrhythmia, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
tel.: 22 49 21 301, fax: 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ZATOTABS

Store in a temperature below 25°C. Store in the original packaging.
The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ZATOTABS contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride. 1 tablet contains 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride.
• The other ingredients (excipients) are: tablet core: lactose monohydrate, microcrystalline cellulose, microcrystalline cellulose silanized (ProSolv HD 90 - a mixture of microcrystalline cellulose and anhydrous colloidal silica), sodium carboxymethylcellulose (type A), anhydrous colloidal silica, magnesium stearate, coating Opadry II 85F18422 White: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What ZATOTABS looks like and what the pack contains

ZATOTABS coated tablets are white, oval, and biconvex with a dividing line on both sides.
The packaging consists of PVC/PVDC/Aluminum blisters in a cardboard box. One pack of the medicine contains 6 or 12 tablets.

Marketing authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A.
51-131 Wrocław, Żmigrodzka 242E

Information about the medicine

tel.: 22 742 00 22
e-mail: [email protected]
Date of last update of the leaflet:11-2019