KLIPAL 300 mg/25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: Patient information
2. Klipal, 300 mg + 25 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Klipal and what is it used for
4. Important information before taking Klipal
   1. When not to take Klipal:
   2. Warnings and precautions
   3. This medicine contains paracetamol and codeine. You should make sure that you are not taking other medicines that contain paracetamol or codeine, including those available without a prescription.
   4. Children and adolescents
   5. Other medicines and Klipal
   6. Klipal and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Breastfeeding
   10. Fertility
   11. Driving and using machines
   12. Klipal also contains:
5. How to take Klipal
   1. Dosage
   2. Recommended dose:
   3. Method and route of administration
   4. Use of a higher than recommended dose of Klipal
   5. Missing a dose of Klipal
   6. Stopping treatment with Klipal
6. Possible side effects
   1. DATA ON CODEINE
   2. Side effects with unknown frequency (frequency cannot be estimated from the available data):
   3. DATA ON PARACETAMOL
   4. Rare (may occur in less than 1 in 1000 people):
   5. Very rare (may occur in less than 1 in 10,000 people):
   6. Reporting side effects
7. How to store Klipal
8. Contents of the packaging and other information
   1. What Klipal contains
   2. What Klipal looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Other sources of information

Leaflet attached to the packaging: Patient information

Klipal, 300 mg + 25 mg, tablets

Paracetamol+ Codeine phosphate hemihydrate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Klipal and what is it used for

This medicine contains paracetamol and codeine.
Paracetamol has analgesic and antipyretic effects.
Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. This medicine may be used alone or in combination with other analgesics, such as paracetamol.
This medicine is used in patients over 15 years of age for short-term treatment of moderate pain that has not responded to other analgesics, such as paracetamol or ibuprofen used alone.

2. Important information before taking Klipal

When not to take Klipal:

• in children under 15 years of age,
• in children and adolescents (from 0 to 18 years) after tonsillectomy or adenoidectomy as part of the treatment of obstructive sleep apnea syndrome,
• in case of hypersensitivity (allergy) to the active substance (codeine and/or paracetamol) or to any of the other ingredients of this medicine listed in section 6.,
• in patients with severe liver disease,
• in patients with asthma,
• in patients with respiratory disorders (respiratory failure),
• in patients who rapidly metabolize codeine to morphine,
• in breastfeeding women (see section on breastfeeding),
• in combination with a medicine used to treat narcolepsy, which contains sodium oxybate.

In case of doubt, you should consult a doctor or pharmacist.

Warnings and precautions

Taking codeine (an active ingredient of this medicine) regularly and for a long time can lead to dependence and misuse, which can cause overdose and/or death. This medicine should not be taken for longer than necessary. It should not be taken for more than 3 days without consulting a doctor. This medicine should not be given to other people.
Before starting treatment with Klipal, you should consult a doctor or pharmacist:

• if the patient is or has been addicted to opioids, alcohol, prescription drugs, or illegal substances,
• if the patient has liver disease (including acute viral hepatitis) or kidney disease,
• if the patient has a respiratory disease (such as asthma),
• if the patient has a condition with excessive mucus in the airways (cough with expectoration),
• if the patient has had their gallbladder removed, as codeine may cause acute abdominal pain,
• if the patient drinks large amounts of alcohol or has done so in the past,
• if the patient has nutritional problems (malnutrition),
• if the patient is dehydrated,
• if the patient has increased intracranial pressure (intracranial hypertension), this medicine may further increase the pressure,
• if the patient weighs less than 50 kg,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (enzyme deficiency),
• if the patient has a severe infection; this may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid breathing, difficulty breathing, nausea, vomiting, loss of appetite. You should contact your doctor immediately if you experience a combination of these symptoms.

This medicine contains paracetamol and codeine. You should make sure that you are not taking other medicines that contain paracetamol or codeine, including those available without a prescription.

They should not be taken at the same time, to avoid exceeding the recommended daily dose (see section 3: How to take Klipal.
Neuropathic pain does not respond to the combination of codeine and paracetamol.
In the treatment of pain, especially in adolescents, the administration of codeine requires close monitoring by a doctor.
Monitoring should include supervision of the adolescent as follows: before administering the medicine, you should make sure that these patients do not have excessive or abnormal drowsiness.
Codeine is converted in the liver by an enzyme to morphine. Morphine is a substance that relieves pain. In some people, this enzyme occurs in a changed form, which means that the medicine may affect patients differently. In some people, morphine is not produced or is produced in very small amounts, which means that it does not provide sufficient analgesic effect. In other people, serious side effects associated with the production of a large amount of morphine may occur. If you notice any of the following side effects, you should stop taking the medicine and consult your doctor immediately: slowed or shallow breathing, disorientation, drowsiness, pinpoint pupils, constipation, loss of appetite, nausea, or vomiting.
In the event of a test for uric acid or blood glucose levels, the patient or their caregiver should inform the doctor that they are taking this medicine.
Athletesshould be aware that although Klipal contains codeine (which is not a banned substance), codeine can be converted in some people's bodies to a substance that can cause a positive result in doping tests. You should strictly follow the recommended dosage for this medicine, and the use of Klipal should be reported during doping tests.

Children and adolescents

This medicine should not be used in children under 15 years of age (see section 2 "When not to take Klipal"). You should consult a doctor or pharmacist.
Use in children and adolescents after surgery:
Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy as part of the treatment of obstructive sleep apnea syndrome (sleep disorders caused by breathing pauses).
Use in children with respiratory disorders:
Codeine is not recommended for children with respiratory disorders, as the symptoms of morphine toxicity in these children can be more severe.

Other medicines and Klipal

You should 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, including those available without a prescription.
In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines before starting treatment with Klipal or during treatment with Klipal:

• paracetamol: a pain reliever, you should not take other medicines that contain paracetamol. There is a risk of overdose.
• codeine: a pain reliever and cough suppressant. You should not take other medicines that contain codeine. There is a risk of overdose.
• opioids: pain relievers, cough suppressants, or used in substitution therapy (in case of addiction). There is a risk of overdose.
• hydroxyapatite sodium: used in the treatment of narcolepsy (see also section 2 "When not to take Klipal" above).
• flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

It is not recommended to take Klipal with:

• medicines that prevent blood clotting,
• medicines that contain alcohol,
• certain pain relievers (buprenorphine, nalbuphine, or pentazocine),
• medicines used to treat addiction to alcohol or drugs (buprenorphine, naltrexone, nalmefene),
• atropine-like medicines (including imipramine-like medicines, phenothiazine neuroleptics, anticholinergic anti-parkinsonian medicines, certain antihistamines that block H1 receptors, anticholinergic medicines),
• other medicines with a sedative and hypnotic effect (neuroleptics, anxiolytics other than benzodiazepines, hypnotics, antidepressants with a sedative effect, antihistamines that block H1 receptors with a sedative effect, centrally acting antihypertensive medicines, baclofen, and thalidomide) (see below),
• other opioid analgesics.

Taking Klipal with sedative medicines, such as benzodiazepines and related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
If, however, your doctor prescribes Klipal with sedative medicines, their dose and duration of concurrent use should be limited by your doctor.
You should inform your doctor about all sedative medicines you are taking and strictly follow their instructions. It may be helpful to inform your family and friends about the possible occurrence of the above symptoms. If these symptoms occur, you should contact your doctor.

Klipal and alcohol

It is not recommended to consume alcohol, alcoholic beverages, or medicinal products that contain alcohol during treatment, due to the risk of sedation and respiratory depression.
In the case of chronic alcoholism, there is an increased risk of liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

If the pain does not decrease and before starting to take this medicine, you should consult your doctor and strictly follow the recommended dose.
If clinically necessary, your doctor may consider occasional use of this medicine in the lowest effective analgesic dose for the shortest possible time and with the lowest possible frequency. You should avoid long-term use of the medicine.
Codeine taken at the end of pregnancy may cause toxic effects on the newborn.

Breastfeeding

You should not take this medicine while breastfeeding, as it contains codeine. Codeine and morphine (derived from codeine) pass into breast milk and may pose a risk to the child.

Fertility

Paracetamol may cause changes in fertility in women, which are reversible after stopping treatment.

Driving and using machines

Drivers and machine operators should be aware of the risk of drowsiness associated with the use of this medicine due to the codeine it contains.
Additionally, this effect is enhanced after consuming alcoholic beverages.

Klipal also contains:

• an azo dye - orange yellow, lake (E 110), which may cause allergic reactions,
• less than 1 mmol (23 mg) of sodium per tablet, which means that the product is considered "sodium-free".

3. How to take Klipal

This medicine should always be taken according to your doctor's instructions. In case of doubt, you should consult your doctor or pharmacist.

Dosage

The medicine is intended for use only in adults and adolescents over 15 years of age.
The dosage should be adjusted by your doctor according to the severity of the pain. The medicine should be taken in the smallest effective dose for the shortest possible time.
The treatment period with this medicine should be limited to 3 days. If after 3 days the pain does not decrease, you should consult your doctor.
To avoid the risk of overdose, you should check that other medicines you are taking, including those available without a prescription, do not contain codeine and paracetamol.

Recommended dose:

• Adults:1 tablet; if necessary, the dose can be repeated every 6 hours. The daily dose should not exceed 6 tablets. In case of severe pain, 2 tablets can be taken at once. The dose should not exceed 8 tablets per day.
• Children and adolescents:Children under 15 years of age: Klipal should not be used in children under 15 years of age due to the risk of severe respiratory disorders. Adolescents between 15 and 18 years of age: You should strictly follow your doctor's instructions. The dosage should be strictly followed based on the adolescent's body weight. The dose will be determined by your doctor, taking into account the body weight and severity of the pain.

Informationally: dosage in adolescents over 15 years of age:
To avoid the risk of overdose:

• you should make sure that you are not taking other medicines that contain paracetamol or codeine, including those available without a prescription.
• you should not take doses higher than the maximum recommended doses (unless your doctor instructs you otherwise), taking into account other medicines that contain paracetamol.
• Elderly patients and patients with liver failureThe initial dose should be half of the usual recommended dose for adults. Your doctor may then increase the dose depending on tolerance and needs.
• Patients with kidney failureIn the case of kidney disease (kidney failure), there is a risk of accumulation of codeine and paracetamol. Therefore, your doctor may reduce the dose of the medicine. The interval between doses should not be less than 8 hours.

Adolescents over 15 years of age with kidney failure should be under close medical supervision. If unusual symptoms occur (such as dizziness or breathing difficulties), you should contact your doctor.

• Other situationsThe maximum total daily dose of paracetamol should not exceed 60 mg/kg body weight/day (not exceeding 2 g of paracetamol/day) in the following situations:
• if the patient weighs less than 50 kg,
• if the patient has severe kidney or liver disease,
• if the patient drinks large amounts of alcohol or has done so in the past,

• if the patient has nutritional problems (malnutrition),
• if the patient is dehydrated.

If you feel that the effect of Klipal is too strong or too weak, you should inform your doctor or pharmacist.

Method and route of administration

Oral administration.
The tablets should be swallowed whole, washed down with a glass of water.

Use of a higher than recommended dose of Klipal

You should stop treatment and contact your doctor or emergency services immediately.
Overdose can be fatal.Within the first 24 hours, the main symptoms of poisoning are: vomiting, abdominal pain, slowed breathing, drowsiness.
Paracetamol overdose, even if the patient feels well, can cause a risk of delayed serious liver damage.

Missing a dose of Klipal

You should not take a double dose to make up for a missed tablet. You should continue treatment according to the instructions.

Stopping treatment with Klipal

In the case of long-term use of this medicine, sudden withdrawal may cause withdrawal syndrome.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

DATA ON CODEINE

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• In the case of long-term use:
• abuse, dependence
• withdrawal symptoms in case of sudden cessation of use
• withdrawal symptoms in a newborn born to a mother who regularly took the medicine during pregnancy
• Allergic skin reactions such as itching, hives, or skin rash. If such symptoms occur, you should stop taking the medicine and immediately inform your doctor.
• Pancreatitis, acute abdominal pain, especially in patients after gallbladder removal. In such a case, you should consult your doctor.
• Feeling of drowsiness, drowsiness, dizziness.
• Breathing difficulties. If such symptoms occur, you should stop taking the medicine and immediately inform your doctor.
• Euphoria, mood disorders.
• Pupil constriction.
• Difficulty urinating.
• Constipation, nausea, vomiting.

DATA ON PARACETAMOL

Rare (may occur in less than 1 in 1000 people):

In rare cases, a rash or red spots or an allergic reaction in the form of rapidly progressing facial and neck swelling or sudden severe malaise accompanied by a drop in blood pressure may occur. If any of these symptoms occur, you should immediately stop taking the medicine, immediately contact your doctor, and never take medicines that contain paracetamol again.

Very rare (may occur in less than 1 in 10,000 people):

• Very rare cases of serious skin reactions have been reported. In such a case, you should immediately stop taking the medicine, immediately contact your doctor, and never take medicines that contain paracetamol again.
• Blood test changes that require a blood test: abnormally low levels of white blood cells or platelets in the blood, putting the patient at risk of infection and causing nosebleeds or gum bleeding. In such a case, you should consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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, you can help gather more information on the safety of the medicine.

5. How to store Klipal

The medicine should be stored in a place that is out of sight and reach of children.
You should not use this medicine after the expiry date stated on the blister pack after EXP. The expiry date refers to the last day of the given month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Klipal contains

• The active substances of the medicine in one tablet are:Paracetamol (Paracetamolum)........................................................................... 300.00 mg Codeine phosphate hemihydrate (Codeini phosphas hemihydricus)......................... 25.00 mg (which corresponds to 18.4 mg of codeine).
• Other ingredients are:microcrystalline cellulose, sodium croscarmellose (see section 2.), povidone (K30), orange yellow, lake (E 110) (see section 2.), talc, magnesium stearate.

What Klipal looks like and what the pack contains

This medicinal product is a light orange, convex, round tablet with a diameter of 11 mm. The packaging contains 6, 12, or 16 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

PIERRE FABRE MEDICAMENT
Les Cauquillous

• 81500 – Lavaur France

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION
Site Progipharm
Rue du Lycée
45500 Gien
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: KLIPAL
France: KLIPAL
Date of last revision of the leaflet:11/2022

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl.