Calpol 6 Plus

Leaflet attached to the packaging: patient information

Calpol 6 Plus, 250 mg/5 ml, oral suspension

Paracetamol

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Calpol 6 Plus and what is it used for
• 2. Important information before using Calpol 6 Plus
• 3. How to use Calpol 6 Plus
• 4. Possible side effects
• 5. How to store Calpol 6 Plus
• 6. Contents of the packaging and other information

1. What is Calpol 6 Plus and what is it used for

Calpol 6 Plus oral suspension contains paracetamol as the active substance. Paracetamol has antipyretic and analgesic effects. Calpol 6 Plus is intended for children from 6 years of age and adults. Indications for use of Calpol 6 Plus: fever occurring in the course of:

• common cold,
• flu,
• childhood diseases, as well as pain of mild or moderate intensity, i.e.:
• headache,
• toothache,
• muscle, joint, and bone pain,
• pain after surgical and dental procedures.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Calpol 6 Plus

When not to use Calpol 6 Plus:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine

(listed in section 6),

• do not use in children under 6 years of age.

Warnings and precautions

Before starting to use Calpol 6 Plus, the patient should discuss it with their doctor or pharmacist. During the use of Calpol 6 Plus, the patient should not take other medicines containing paracetamol due to the risk of overdose. Taking higher doses than recommended (overdose) can cause life-threatening liver damage. In case of overdose, the patient should immediately seek medical help. Quick medical help is especially important, both in adults and children, even if no signs or symptoms of overdose are observed. The patient should be cautious when using paracetamol if they have a deficiency of glucose-6-phosphate dehydrogenase (G-6-PD). Patients with liver function disorders should consult their doctor before using paracetamol. The patient should be cautious when using paracetamol if they have kidney function disorders. In patients with chronic kidney failure, it is recommended to extend the intervals between paracetamol doses. In the case of patients undergoing hemodialysis, the doctor may consider administering additional doses of the medicine to maintain the therapeutic concentration of paracetamol in the blood (hemodialysis may reduce the concentration of paracetamol in the blood). During paracetamol treatment, the patient should not drink alcohol due to the increased risk of toxic liver damage. There is a particular risk of liver damage in people who are fasting and regularly drink alcohol. In patients taking paracetamol, there have been reports of severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4). Symptoms may include skin redness, rash, blisters, and ulcers on the skin, mouth, eyes, and genitals, large subepidermal blisters, extensive skin ulcers, peeling of large skin flakes, and fever. If skin reactions occur or symptoms worsen, the patient should stop using the medicine and seek medical help immediately. During the use of Calpol 6 Plus, the patient should immediately inform their doctor if they have severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and fluid disorder), when they used paracetamol in regular 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, feeling of nausea (nausea) and vomiting. The patient should stop using the medicine and consult their doctor if symptoms do not improve or worsen, or if new symptoms appear.

Calpol 6 Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, as well as any medicines they plan to take. Medicines that speed up stomach emptying (e.g., metoclopramide) speed up the absorption of paracetamol, while medicines that slow down stomach emptying (e.g., propantheline) may slow down the absorption of paracetamol. Concurrent use of paracetamol and medicines that increase liver metabolism, such as some sleeping pills or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (a medicine used to treat tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol. Drinking alcohol during paracetamol treatment may lead to liver failure due to cell necrosis. Using paracetamol simultaneously with zidovudine (AZT - an antiviral medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow. Regular, daily intake of paracetamol may enhance the effect of anticoagulant medicines (warfarin and other coumarin derivatives); sporadic doses do not have a significant impact. Paracetamol used simultaneously with monoamine oxidase inhibitors (medicines used, among others, in depression) may cause a state of excitement and high temperature. Using paracetamol may be the cause of false results of some laboratory tests performed by oxidation-reduction methods (e.g., glucose measurement). Concurrent administration of paracetamol may increase the concentration of chloramphenicol (a broad-spectrum antibiotic) in the blood. Concurrent use of paracetamol and non-steroidal anti-inflammatory medicines may increase the risk of kidney function disorders. Prolonged concurrent use of paracetamol and aspirin or other salicylates may increase the risk of kidney damage (such as analgesic nephropathy or renal papillary necrosis). The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the serious risk of blood and fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

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 using this medicine. Calpol 6 Plus can be used during pregnancy if it is clinically justified. The patient should take the smallest possible recommended dose that reduces pain and (or) fever, for the shortest time and as infrequently as possible. The patient should consult their doctor if pain and (or) fever do not decrease or if they need to take the medicine more frequently. Paracetamol passes into breast milk in small amounts. When used in recommended doses, it does not pose a risk to the breastfed child.

Driving and using machines

Calpol 6 Plus has no influence or negligible influence on the ability to drive and use machines.

Calpol 6 Plus contains 1894.687 mg of sorbitol (E420) (70% solution) in 5 ml

Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Calpol 6 Plus contains 2.1 g of sucrose in 5 ml

This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Calpol 6 Plus contains methyl parahydroxybenzoate (E218)

The medicine may cause allergic reactions (possible late-type reactions).

Calpol 6 Plus contains orange yellow (E110)

The medicine may cause allergic reactions.

In patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, there have been reports of hemolytic anemia associated with paracetamol overdose.

Missing a dose of Calpol 6 Plus

The medicine is used for acute treatment. If a dose of the medicine is missed and the symptoms persist, the patient should take the next dose of the medicine. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is presented according to the following scheme: Very rare: occurs in less than 1 in 10,000 patients Frequency not known: cannot be estimated from the available data Very rare The following have been reported: persistent rash, rash with itching, urticaria, severe skin reactions (see "Warnings and precautions", section 2), hypersensitivity (allergy), anaphylactic reaction (swelling of the face, lips, tongue, or throat, sometimes accompanied by difficulty breathing), increased activity of aminotransferases (enzymes involved in protein metabolism). Frequency not known A serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

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, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Calpol 6 Plus

The medicine should be stored out of sight and reach of children. Store in a temperature not exceeding 25°C, protect from light. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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 packaging and other information

What Calpol 6 Plus contains

• The active substance of the medicine is paracetamol. 5 ml of the oral suspension contains 250 mg of paracetamol.
• The other ingredients are: sucrose, sorbitol (E420) 70% (non-crystallizing), glycerol (E422), microcrystalline cellulose, and sodium carmellose, polysorbate 80, methyl parahydroxybenzoate (E218), sugar flavor DA 13780 (contains: propylene glycol (E1520) and anise alcohol), orange flavor 510652E (contains: benzyl alcohol (E1519), butylhydroxyanisole (E320), ethanol, propylene glycol (E1520), citral, citronellol, d-limonene, geraniol, and linalol), orange yellow (E110), purified water.

What Calpol 6 Plus looks like and what the pack contains

The medicine is an oral suspension in a 100 ml bottle made of orange glass, placed in a cardboard box with a measuring cup attached to the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder: McNeil Healthcare (Ireland) Limited Office 5, 6 & 7, Block 5 High Street, Tallaght Dublin 24, D24 YK8N Ireland Manufacturer: Delpharm Orléans 5, avenue de Concyr 45071 Orléans Cedex 2 France For more detailed information, please contact: email: [email protected]

Date of last revision of the leaflet: