KLIPAL 600 mg/50 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: Patient information
2. Klipal, 600 mg + 50 mg, tablets
   1. Read the leaflet carefully 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. Make sure that no other medicines containing paracetamol or codeine are taken at the same time.
   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. Taking a higher dose of Klipal than recommended
   5. Missing a dose of Klipal
   6. Stopping treatment with Klipal
6. Possible side effects
   1. CODEINE DATA
   2. Side effects with unknown frequency (frequency cannot be estimated from available data):
   3. PARACETAMOL DATA
   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, 600 mg + 50 mg, tablets

Paracetamol+ Codeine phosphate hemihydrate

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on 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 can be used alone or in combination with other analgesics, such as paracetamol.
This medicine is used in patients over 15 years of age with a body weight over 50 kg 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 metabolize codeine to morphine very quickly,
• in breastfeeding women (see the section on breastfeeding),
• in combination with a medicine used to treat narcolepsy, which contains sodium oxybate.

In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

Taking codeine (an active ingredient in this medicine) regularly and for a long time can lead to dependence and misuse, which can cause overdose and/or death. Do not take this medicine for longer than necessary. Do not take this medicine for more than 3 days without consulting a doctor. Do not give this medicine to others.
Before taking Klipal, consult a doctor or pharmacist:

• if the patient is or has ever been dependent on 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 production 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), as 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. Consult a doctor immediately if these symptoms occur together.

This medicine contains paracetamol and codeine. Make sure that no other medicines containing paracetamol or codeine are taken at the same time.

Do not take them at the same time, so as not to exceed the recommended daily dose (see section 3: How to take Klipal).
Neuropathic pain does not respond to 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, 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 pain relief. In other people, serious side effects associated with the production of a very large amount of morphine may occur. If any of the following side effects are noticed, stop taking the medicine and consult a 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 glucose levels in the blood, the patient or their caregiver should inform the doctor about 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. The dosage instructions for this medicine should be strictly followed, 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"). 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 cessation).
Use in children with respiratory disorders:
Codeine is not recommended for children with respiratory disorders, as the symptoms of morphine toxicity in these children may be more severe.

Other medicines and Klipal

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting or during treatment with Klipal:

• paracetamol: a pain reliever, do not take other medicines containing paracetamol. There is a risk of overdose.
• codeine: a pain reliever and cough suppressant. Do not take other medicines containing 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.
• sodium oxybate: used to treat narcolepsy (see also section 2 "When not to take Klipal" above).

It is not recommended to take Klipal at the same time as:

• blood-thinning medicines,
• medicines containing alcohol,
• certain pain relievers (buprenorphine, nalbuphine, or pentazocine),
• medicines used to treat addiction to alcohol or drugs (buprenorphine, naltrexone, nalmefene),
• anticholinergic medicines (including those similar to imipramine, phenothiazine neuroleptics, antispasmodics, certain antihistamines that block H1 receptors, anticholinergic anti-Parkinson's medicines, dyzopiramid),
• other sedative and hypnotic medicines (neuroleptics, anxiolytics other than benzodiazepines, sleeping pills, antidepressants with a sedative effect, antihistamines that block H1 receptors with a sedative effect, centrally acting antihypertensives, baclofen, and thalidomide) (see below),
• other opioid pain relievers.
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, 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 the maximum daily doses of paracetamol.

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, a doctor prescribes Klipal along with sedative medicines, their dose and duration of concurrent use should be limited by the doctor.
Inform your doctor about all sedative medicines being taken and strictly follow their instructions. It may be helpful to inform family and friends about the possible occurrence of the above symptoms. If these symptoms occur, consult a doctor.

Klipal and alcohol

It is not recommended to consume alcohol, alcoholic beverages, or medicinal products containing 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, consult a doctor or pharmacist before taking this medicine.

Pregnancy

If the pain does not decrease and before starting to take this medicine, consult a doctor and strictly follow the recommended dose.
If clinically necessary, a 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. Avoid long-term use of the medicine.
Codeine taken at the end of pregnancy may cause toxic effects on the newborn.

Breastfeeding

Do 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 taking this medicine due to the codeine it contains.
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 the product is considered "sodium-free".

3. How to take Klipal

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Dosage

This medicine is intended for use only in adults and adolescents over 15 years of age with a body weight over 50 kg.
The dosage should be adjusted by the doctor according to the severity of the pain. In principle, 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, consult a doctor.
To avoid the risk of overdose, check that other medicines being taken, 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. Do not exceed the dose of 4 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: Klipal should not be used in adolescents with a body weight less than 50 kg. The dosage instructions must be strictly followed. The dosage should be determined by the doctor based on the adolescent's body weight and pain severity. Informative: dosage in adolescents over 15 years of age:

To avoid the risk of overdose:

• make sure that no other medicines containing paracetamol or codeine are taken at the same time, including those available without a prescription,
• do not take doses higher than the maximum recommended doses (unless the doctor recommends otherwise), taking into account other medicines containing paracetamol.
• Elderly patients and patients with liver failureThe initial dose should be half the usual recommended dose for adults. The 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, the 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 (e.g., dizziness or breathing difficulties), consult a doctor.

• Other situationsThe maximum 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, tell your doctor or pharmacist.

Method and route of administration

Oral administration.
Swallow the tablets whole with a glass of water.
The dividing line is intended to facilitate swallowing and should not be used to adjust the dose.

Taking a higher dose of Klipal than recommended

Stop treatment and contact a 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

Do not take a double dose to make up for a missed tablet. Continue treatment as recommended.

Stopping treatment with Klipal

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

4. Possible side effects

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

CODEINE DATA

Side effects with unknown frequency (frequency cannot be estimated from 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, stop taking the medicine and consult a doctor immediately.
• Pancreatitis, acute abdominal pain, especially in patients after gallbladder removal. In such a case, consult a doctor.
• Feeling drowsy, drowsiness, and dizziness.
• Breathing difficulties. If such symptoms occur, stop taking the medicine and consult a doctor immediately.
• Euphoria, mood disorders.
• Pupil constriction.
• Difficulty urinating.
• Constipation, nausea, vomiting.

PARACETAMOL DATA

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 swelling of the face and neck or sudden severe illness accompanied by a drop in blood pressure may occur. If any of these symptoms occur, stop taking the medicine immediately, contact a doctor immediately, and never take medicines containing 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, stop taking the medicine immediately, contact a doctor immediately, and never take medicines containing paracetamol again.
• Blood test abnormalities have been observed: 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, consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Klipal

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after EXP. The expiry date refers to the last day of that month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. 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) .......................................................................... 600.00 mg Codeine phosphate hemihydrate (Codeini phosphas hemihydricus) ......................... 50.00 mg (which corresponds to 36.8 mg of codeine).
• The 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, oblong, biconvex tablet with a length of 18 mm and a width of 7.5 mm with a dividing line on one side to facilitate swallowing.
The packaging contains 12, 100, or 120 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.