Apap Pzheziembienie Caps

Leaflet attached to the packaging: patient information

APAP Cold CAPS

(500 mg + 6.1 mg), hard capsules
Paracetamol+ Phenylephrine 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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is APAP Cold CAPS and what is it used for
• 2. Important information before taking APAP Cold CAPS
• 3. How to take APAP Cold CAPS
• 4. Possible side effects
• 5. How to store APAP Cold CAPS
• 6. Package contents and other information

1. What is APAP Cold CAPS and what is it used for

APAP Cold CAPS is a combination medicine.
It contains two active substances: paracetamol and phenylephrine.
Paracetamol acts as an antipyretic and analgesic, while phenylephrine reduces swelling and congestion of the nasal mucosa and sinuses. APAP Cold CAPS is a medicine intended for the treatment of adults and adolescents over 12 years of age.
APAP Cold CAPS is a medicine intended for occasional use to relieve symptoms of flu and colds such as rhinitis (runny nose), headache (including sinusitis), sore throat, fever, and musculoskeletal pain.

2. Important information before taking APAP Cold CAPS

When not to take APAP Cold CAPS:

• if the patient is allergic to the active substances or other sympathomimetic amines or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has cardiovascular disorders,
• if the patient has heart rhythm disorders,
• if the patient has hypertension,
• if the patient has diabetes,
• if the patient has a pheochromocytoma of the adrenal gland,
• if the patient has angle-closure glaucoma,
• if the patient has hyperthyroidism,
• if the patient has prostatic hyperplasia,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• in the case of taking monoamine oxidase inhibitors (MAOIs) and for 14 days after stopping their use,
• in the case of taking tricyclic antidepressants or zidovudine,
• do not use in children under 12 years of age,
• do not use during pregnancy and breastfeeding.

Warnings and precautions

Before starting to take APAP Cold CAPS, the patient should discuss it with their doctor or pharmacist if they:

• have liver or kidney failure (should monitor liver enzyme activity and kidney function),
• have arteriosclerotic disease,
• have Raynaud's syndrome,
• have stable coronary artery disease,
• have respiratory failure,
• have asthma,
• are taking beta-adrenergic receptor antagonist drugs,
• are taking anticoagulant drugs (it is recommended to adjust their dose based on blood coagulation tests). The medicine contains paracetamol. Due to the risk of overdose, it should be checked if other medicines taken do not contain paracetamol.

During the use of APAP Cold CAPS, the patient should immediately inform their doctor if:

• they experience severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in standard doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

During the use of the medicine, the patient should not drink alcohol. Taking the medicine by people with liver failure, alcohol abuse, or starvation poses a risk of toxic liver damage.

Children and adolescents

The medicine should not be used in children under 12 years of age.

APAP Cold CAPS and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The interaction of APAP Cold CAPS with other medicines results from the interaction of the active substances contained in the medicine:
Paracetamol:

• The medicine should not be taken at the same time as other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol.
• MAOI inhibitors (used to treat, among other things, depression and within 2 weeks after the end of treatment) may cause a state of excitement and fever.
• Concomitant use of paracetamol with zidovudine (AZT, a medicine used to treat HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Concomitant use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic drugs, such as phenobarbital, phenytoin, carbamazepine, as well as rifampicin (used to treat, among other things, tuberculosis), may lead to liver damage, even when using recommended doses of paracetamol. Therefore, before using APAP Cold CAPS, the patient should always consult their doctor.
• Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that causes liver cell necrosis, which can lead to liver failure.
• Cholestyramine reduces the absorption of paracetamol and should not be taken within the first hour after paracetamol administration.
• Probenecid prolongs the half-life of paracetamol.

The patient should inform their doctor or pharmacist if they are taking:
flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).
Phenylephrine:

• MAOIs may enhance the effect of phenylephrine. The patient should avoid taking them at the same time as phenylephrine or take phenylephrine at least 14 days after discontinuing tricyclic antidepressants.
• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants.
• Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, and reserpine.
• Phenylephrine taken at the same time as indomethacin, beta-adrenergic receptor antagonists, or methyldopa may cause a hypertensive crisis.

The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 capsule), which means the medicine is considered "sodium-free".

APAP Cold CAPS with food, drinks, and alcohol

Food does not significantly affect the absorption of the medicine.
During the use of the medicine, the patient should not drink alcohol.

Pregnancy, breastfeeding, and fertility

The medicine should not be used during pregnancy and breastfeeding.
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.

Driving and using machines

When taking APAP Cold CAPS, the patient should be cautious while driving vehicles and operating machinery.

3. How to take APAP Cold CAPS

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
APAP Cold CAPS should be taken orally.
Adults and adolescents over 12 years of age: 1 to 2 capsules, 3 to 4 times a day.
The patient should not take more than 8 capsules per day.

Taking a higher dose of APAP Cold CAPS than recommended

Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, and may lead to nystagmus, increased blood pressure, convulsions, difficulty urinating, and shortness of breath. These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, which will then become apparent with abdominal distension, return of nausea, and jaundice. In case of overdose, the patient should immediately call their doctor.
Treatment should be carried out in a hospital and involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. In case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missing a dose of APAP Cold CAPS

In case of missing a dose and persistence of symptoms, the patient should take the next dose of APAP Cold CAPS. The patient should not take a double dose to make up for the missed dose.

Stopping the use of APAP Cold CAPS

In case of further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, APAP Cold CAPS can cause side effects, although not everybody gets them.
If the following symptoms occur, the patient should not take the medicine and should immediately contact their doctor. These are life-threatening conditions.
Occurring with unknown frequency:

• anaphylactic shock (pallor, blood pressure drop, sweating, oliguria, laryngeal edema, tachypnea, weakness)
• a serious disease that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2)
• rarely occurring:
• allergic reactions, such as urticaria, rash, itching, facial, lip, tongue, and throat edema (angioedema), bronchospasm making breathing difficult,
• bleeding,
• liver failure, liver necrosis, jaundice, manifested by yellowing of the eyes and skin, abdominal pain, loss of appetite;
• acute pancreatitis (severe pain in the middle and upper abdomen, vomiting, abdominal distension, often with gas and stool retention, high fever);
• kidney damage (nephropathy or tubulopathy) manifested by fever, lumbar pain, skin rash, hematuria, renal colic, urinary retention, occurring very rarely:
• severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome (pustular polymorphic erythema), toxic epidermal necrolysis, which manifest as follows: initially in the form of red spots on the torso, often with blisters in the center, rash with pustules all over the body or erosions in the mouth, eyes, genitalia, and skin, or bursting large blisters, exfoliation of large skin flakes, accompanied by weakness, fever, and joint pain;

Due to the presence of paracetamol, the medicine may cause side effects.

Side effects occurring rarely (may occur less frequently than in 1 in 1,000 people):

• anemia, bone marrow depression, thrombocytopenia, agranulocytosis (lack of granulocytes in the blood), leukopenia (decreased number of leukocytes), neutropenia (decreased number of neutrophils);
• edema,
• chronic pancreatitis; abdominal pain, diarrhea, nausea,
• sweating, purpura.

Side effects whose frequency cannot be determined based on available data:

Available data:

• polymorphic erythema, dizziness.

The medicine rarely has toxic effects on the kidneys, except in cases of chronic use, and no relationship has been found with therapeutic doses, except in cases of chronic use of the medicine.
Due to the presence of phenylephrine, the medicine may cause side effects.

Side effects occurring frequently (may occur less frequently than in 1 in 10 people):

• nausea, vomiting, digestive disorders, anorexia.

Side effects occurring rarely (may occur less frequently than in 1 in 1,000 people):

• increased blood pressure, tachycardia (too frequent heartbeat), arrhythmias, palpitations, pallor.

Side effects occurring very rarely (may occur less frequently than in 1 in 10,000 people):

• anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations.

Side effects whose frequency cannot be determined based on available data:

• kidney and urinary tract disorders in the form of urinary retention.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 (22) 492-13-01, fax: +48 (22) 492-13-09
website: https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store APAP Cold CAPS

Store in a temperature below 25°C.
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 and blister pack (month/year).
The labeling used for the blister is: EXP - expiry date, BN - batch number.
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. Package contents and other information

What APAP Cold CAPS contains

• The active substances of the medicine are: paracetamol and phenylephrine hydrochloride.
• One hard capsule contains
• The other ingredients are: cornstarch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, talc; Capsule shell:gelatin, erythrosine (E 127), titanium dioxide (E 171), indigo carmine (E 132); Body:gelatin, indigo carmine (E 132).

What APAP Cold CAPS looks like and what the package contains

Dark blue and/or light blue hard capsules, gelatin, packaged in PVC/Aluminum blisters, in a carton box.

Packaging:6 capsules; 8 capsules; 10 capsules; 12 capsules; 16 capsules; 24 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław

Manufacturer

Wrafton Laboratories Limited
Exeter Road, Wrafton, Braunton, Devon; EX33 2DL, United Kingdom
To obtain more detailed information about this medicine, the patient should contact USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: