PANADOL 500 mg/10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Panadol Femina
   2. 500 mg + 10 mg, coated tablets
   3. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   4. Table of Contents of the Package Leaflet
2. What is Panadol Femina and what is it used for
3. Important information before taking Panadol Femina
   1. Panadol Femina contains paracetamol.
   2. When not to take Panadol Femina
   3. Warnings and precautions
   4. Panadol Femina and other medicines
   5. It is not recommended to take several medicines containing paracetamol at the same time, as this may lead to paracetamol overdose.
   6. Panadol Femina and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Panadol Femina contains sorbitol
4. How to take Panadol Femina
   1. Use in adults and adolescents over 12 years of age
   2. Duration of treatment
   3. Use in children under 12 years of age
   4. Taking a higher dose of Panadol Femina than recommended
   5. Missing a dose of Panadol Femina
5. Possible side effects
   1. Stop taking Panadol Femina and seek medical attention immediately if you experience:
   2. Reporting side effects
6. How to store Panadol Femina
7. Contents of the pack and other information
   1. What Panadol Femina contains
   2. What Panadol Femina looks like and contents of the pack
   3. Marketing authorisation holder
   4. Manufacturer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Panadol Femina

500 mg + 10 mg, coated tablets

Paracetamol + Hyoscine butylbromide

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

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the package leaflet, inform your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

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

1. What is Panadol Femina and what is it used for

Panadol Femina contains paracetamol (also known as acetaminophen) and hyoscine butylbromide.
Paracetamol is used to relieve pain and reduce fever. Hyoscine butylbromide relieves spasms in the gastrointestinal and genitourinary tracts.
Panadol Femina is used in adults and adolescents over 12 years of age to prevent and treat disorders associated with:

• painful menstruation,
• renal colic, biliary colic,
• irritable bowel syndrome.

2. Important information before taking Panadol Femina

Panadol Femina contains paracetamol.

When not to take Panadol Femina

Do not take Panadol Femina if you have:

• hypersensitivity to paracetamol, atropine, hyoscine butylbromide, or any other component of this medicine (listed in section 6);
• gastrointestinal obstruction;
• megacolon;
• severe liver failure (mainly in patients with alcoholic liver damage); The medicine contains paracetamol
• severe kidney failure;
• alcoholic disease;
• anemia;
• congenital deficiency of the enzyme called glucose-6-phosphate dehydrogenase (favism);
• myasthenia (muscle weakness);
• glaucoma (eye disease with progressive damage to the optic nerve);
• prostatic hyperplasia causing urinary retention;
• gastrointestinal stenosis;
• heart rhythm disorders with accelerated heart rate.

Warnings and precautions

Before taking Panadol Femina, the patient should discuss with the doctor if the following circumstances apply.

• Heart problems (mitral valve stenosis, coronary artery disease) or recent myocardial infarction.
• Intestinal ulcers (the medicine may weaken intestinal movements and cause constipation).
• Gastroesophageal reflux (regurgitation of stomach contents into the esophagus) or other chronic disorders of the motility of the smooth muscles of the upper gastrointestinal tract or pyloric stenosis.
• Older age (over 65 years), as the medicine may cause central nervous system disorders, dry mouth, and urinary retention (especially in men).
• Liver and/or kidney function disorders.
• The patient is fasting or regularly drinks alcohol, as they are particularly at risk of liver damage.
• Hypersensitivity to acetylsalicylic acid derivatives (aspirin derivatives), as there may also be hypersensitivity to paracetamol.
• Severe infection (e.g., sepsis), as it may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: rapid, deep, and difficult breathing, nausea, vomiting, and loss of appetite. If these symptoms occur, seek medical attention immediately(see information below).
• Taking other medicines containing paracetamol (may lead to paracetamol overdose).
• The patient is taking antihistamine medicines(medicines used for allergies and motion sickness), quinidine or disopyramide(medicines controlling heart function), ipratropium, tiotropium(medicines used in respiratory diseases).
• the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). In these situations, severe metabolic acidosis (a blood and body fluid disorder) has been reported in patients taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Taking too high a dose of paracetamol can lead to severe liver damage.
Do not take this medicine if you are taking other medicines containing paracetamol, used to treat: pain, fever, cold and flu symptoms, or sleep disorders.
If you experience any vision disturbances or eye pain caused by increased pressure, stop taking the medicine and consult a doctor.
Do not drink alcohol while taking Panadol Femina.
Stop using this product and seek medical attention immediately if you experience persistent or severe unexplained abdominal pain, with fever and blood in the stool, and/or feel weak.
The medicine should be stored out of sight and reach of children.

Panadol Femina and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

It is not recommended to take several medicines containing paracetamol at the same time, as this may lead to paracetamol overdose.

• Paracetamol enhances the effect of anticoagulant medicines from the coumarin group (e.g., warfarin) and indandione (phenindione). Prolonged, daily use of paracetamol with anticoagulant medicines may increase the risk of bleeding; occasional use of the medicine does not have this effect.
• Caffeinemay increase the effect of paracetamol.
• Metoclopramide(an antiemetic) accelerates, and scopolamine(used in ophthalmology to dilate the pupil) delays the absorption of paracetamol from the gastrointestinal tract.
• Salicylamide(an anti-inflammatory, antipyretic, and analgesic) prolongs the elimination time of paracetamol.
• MAO inhibitors(medicines used to treat depression and Parkinson's disease), tricyclic antidepressants, quinidine, disopyramide(antiarrhythmic medicines), amantadine(an antiviral medicine, also used to treat Parkinson's disease), and butyrophenone(an antipsychotic) used with paracetamol may cause excitement and high fever. Rifampicin(an antibiotic used to treat tuberculosis), antiepileptic medicines, sedatives, and alcoholused with paracetamol may cause liver damage.
• Paracetamol used simultaneously with nonsteroidal anti-inflammatory medicines (NSAIDs)(such as diclofenac, ibuprofen, acetylsalicylic acid) may exacerbate kidney disease in patients with kidney failure.
• Hyoscine butylbromide, by weakening intestinal movements and secretion in the gastrointestinal tract, may reduce the absorption and therapeutic effect of other orally administered medicines.
• Medicines from the group called dopamine antagonists, such as metoclopramide, may reduce the effect of Panadol Femina on the gastrointestinal tract.

Consult a doctor if you are taking:

• warfarin or other anticoagulant medicines
• medicines used to treat depression, so-called tricyclic antidepressants
• antihistamine medicines and medicines used for motion sickness
• medicines controlling heart rate
• antipsychotic medicines
• medicines usually used for breathing problems, such as tiotropium or ipratropium
• medicines used for Parkinson's disease or flu treatment
• 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).

If you have any doubts whether the above statements apply to you, consult a doctor or pharmacist.

Panadol Femina and alcohol

Do not drink alcohol while taking Panadol Femina.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Do not take Panadol Femina tablets in pregnant women unless, in the doctor's opinion, the benefits of taking the medicine outweigh the risk to the fetus. In this case, use the smallest effective dose for the shortest possible time.
Panadol Femina can be used in breastfeeding women only if, in the doctor's opinion, the benefits of taking the medicine outweigh the risk to the child; in this case, consider the lowest effective dose and the shortest treatment duration.

Driving and using machines

Panadol Femina may cause central nervous system symptoms and impair vision (accommodation process), so do not drive vehicles or operate machines while taking it.

Panadol Femina contains sorbitol

The medicinal product contains 15 mg of sorbitol in each tablet.
If you have previously been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine.
Sorbitol is a source of fructose. If you or your child have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, consult a doctor before taking the medicine or giving it to your child.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Panadol Femina

Always take this medicine exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is for oral use.
Do not take a higher dose than recommended.

Use in adults and adolescents over 12 years of age

• 1 or 2 tablets (i.e., 500 mg or 1000 mg of paracetamol and 10 mg or 20 mg of hyoscine butylbromide).
• If necessary, take a maximum of 3 times a day, every 8 hours.

Do not take more than 6 tablets per day (which corresponds to 3000 mg of paracetamol and 60 mg of hyoscine butylbromide).
Maintain an interval of at least 8 hours between doses.
The maximum daily dose of paracetamol for adults during short-term treatment is 4000 mg, and during long-term treatment, it is 2600 mg.
Do not take Panadol Femina with other medicines containing paracetamol.
Use the lowest effective dose of the medicine for the shortest possible time. Do not use to treat pain caused by irritable bowel syndrome (IBS) unless IBS has been diagnosed by a doctor.

Duration of treatment

If after 3 days there is no improvement or you feel worse, consult a doctor.

Use in children under 12 years of age

Do not use the medicine in children under 12 years of age.

Taking a higher dose of Panadol Femina than recommended

Symptoms of overdose

• Paracetamol overdose may cause liver damage and failure, which can lead to the need for a liver transplant or death. Within a few or several hours, symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur. These symptoms may resolve the next day, despite the fact that liver damage has begun, which then manifests as abdominal distension, return of nausea, and jaundice [yellowing of the skin and/or eyes].
• Hyoscine butylbromide overdose in oral form may cause symptoms such as dry mouth, rapid heartbeat, slight drowsiness, or transient vision disturbances.

Procedure in case of overdose
In case of single ingestion of a dose higher than 8 tablets, even if the above symptoms do not occur, seek medical attention immediately, as urgent medical intervention is necessary due to the risk of liver damage.
As a first aid measure, if the patient is conscious, vomiting can be induced (best within the first hour after oral ingestion of the medicine). It is recommended to administer 60 to 100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of Panadol Femina

Do not take a double dose to make up for a missed dose.
Continue taking the medicine without increasing the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the medicine is taken in the recommended doses, the following side effects may occur:
Very rare(occurring in less than 1 in 10,000 people taking the medicine):

• methemoglobinemia (presence of oxidized hemoglobin in the blood), agranulocytosis (decrease in white blood cell count), thrombocytopenia (decrease in platelet count);
• anaphylactic reactions (severe allergic reactions causing breathing difficulties or dizziness), skin hypersensitivity symptoms, such as: rashes, angioedema (severe allergic reaction causing swelling of the face or throat, which can make breathing and swallowing difficult), Stevens-Johnson syndrome (blisters and painful ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain), toxic epidermal necrolysis, hypersensitivity, shortness of breath;
• bronchospasm in patients sensitive to aspirin or other nonsteroidal anti-inflammatory medicines;
• liver function disorders;
• glaucoma, eye accommodation disorders (eye adaptation to viewing objects at different distances);

Uncommon(occurring in less than 1 in 100 people taking the medicine):

• dizziness;
• diarrhea, vomiting, nausea, and dry mouth;
• skin reactions, abnormal sweating, itching, and dry skin;
• fatigue;

Rare(occurring in less than 1 in 1,000 people taking the medicine):

• tachycardia (rapid heartbeat);
• flushing;
• urination disorders;

Frequency not known(cannot be estimated from the available data):

• anaphylactic shock, anaphylactic reaction, hypersensitivity, and shortness of breath;
• urticaria and rash;
• urinary retention.
• metabolic acidosis - a serious condition that can cause blood and body fluid disorders in patients with severe disease taking paracetamol (see section 2).

Stop taking Panadol Femina and seek medical attention immediately if you experience:

• -symptoms of an allergic reaction, such as: itching, rash, flushing, facial swelling, tongue or throat swelling, breathing difficulties,
• -skin peeling, bruising, bleeding, oral ulcers, vomiting, stomach irritation,
• -difficulty urinating, more common in people with prostate enlargement.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, inform your doctor, pharmacist, or nurse. 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. Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Panadol Femina

Store in a temperature below 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month.
Medicines should 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 Panadol Femina contains

The active substances of the medicine are paracetamol and hyoscine butylbromide.
One coated tablet contains 500 mg of paracetamol and 10 mg of hyoscine butylbromide.
The other ingredients are: microcrystalline cellulose, potato starch, povidone K30, sorbitol, talc, magnesium stearate, silica colloidal anhydrous, sodium carboxymethylcellulose, hypromellose, macrogol 6000.

What Panadol Femina looks like and contents of the pack

Panadol Femina is a white to cream-colored, oblong tablet.
The single pack contains 10 tablets.

Marketing authorisation holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer

Delpharm Poznań S.A.
ul. Grunwaldzka 189
60-322 Poznań

Date of last revision of the package leaflet:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.