Klipal

Patient Information Leaflet

Klipal, 300 mg + 25 mg, tablets
Paracetamolum + Codeini phosphas hemihydricus
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Klipal is and what it is used for

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

2. Important information before using Klipal

When not to use Klipal:

• in children under 15 years of age,
• in children and adolescents (from 0 to 18 years) after surgical removal of palatine or pharyngeal tonsils as part of treatment for obstructive sleep apnoea syndrome,
• in case of hypersensitivity (allergy) to the active substance (codeine and/or paracetamol) or to any of the other components of this medicine listed in section 6,
• in patients with severe liver disease,
• in patients with bronchial asthma,
• in patients with respiratory disorders (respiratory insufficiency),
• in patients who very rapidly metabolize codeine into morphine,
• in breastfeeding women (see section on breastfeeding),
• in combination with a medication used to treat narcolepsy containing sodium oxybate.

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Regular and long-term use of codeine (an active ingredient in this medicine) may lead to dependence and misuse, which in turn may result in overdose and/or death. Do not use this medicine longer than necessary. Do not use this medicine for longer than 3 days without consulting a doctor. Do not pass this medicine on to other people.
Before starting treatment with Klipal, consult a doctor or pharmacist:

• if the patient is or has ever been addicted to opioids, alcohol, prescription medicines, or illegal substances,
• if the patient has liver disease (including acute viral hepatitis) or kidney disease,
• if the patient has a respiratory disorder (e.g. asthma),
• if the patient has mucus retention in the bronchi (cough with expectoration),
• if the patient has undergone gallbladder removal, 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 pressure,
• if the patient weighs less than 50 kg,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (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. Contact a doctor immediately if a combination of these symptoms occurs.

This medicine contains paracetamol and codeine.
Ensure that no other medicines containing paracetamol or codeine are being taken, including
over-the-counter medicines.
Do not take them simultaneously, to avoid exceeding the recommended daily dose (see
section 3: How to take Klipal).
Neuropathic pain does not respond to codeine-paracetamol combination.
In pain treatment, especially in adolescents, codeine use requires strict medical supervision.
Monitoring should include supervision of adolescents as follows: before administering the medicine, ensure that these patients do not exhibit excessive or abnormal tendency to sleepiness.
Codeine is metabolized in the liver by an enzyme into morphine. Morphine is the substance responsible for pain relief. In some individuals, this enzyme is altered, causing the medicine to affect patients differently. In some people, morphine is not produced or is produced in very small amounts, resulting in insufficient analgesic effect. In others, serious adverse effects may occur due to the production of very large amounts of morphine. If any of the following adverse effects are observed, discontinue use of the medicine and consult a doctor immediately: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, constipation, loss of appetite, nausea or vomiting.
If undergoing tests for blood uric acid or blood glucose levels, the patient or caregiver should inform the doctor about taking this medicine.
Athletes should be aware that although Klipal contains codeine (which is not a prohibited substance), codeine may be rapidly converted in some individuals into substances that may cause a positive result in anti-doping tests. Strictly follow the dosing instructions for this medicine, and the use of Klipal should be declared during anti-doping controls.
Children and adolescents
This medicine should not be used in children under 15 years of age (see section 2 “When not to use 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 surgical removal of palatine or pharyngeal tonsils as part of treatment for obstructive sleep apnoea syndrome (sleep disorders caused by breathing pauses).
Use in children with respiratory disorders:
Codeine is not recommended in children with respiratory disorders, as morphine toxicity symptoms may be more severe in these children.
Other medicines and Klipal
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use, including over-the-counter medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines before starting or during treatment with Klipal:

• paracetamol: a pain-relieving medicine; do not take other medicines containing paracetamol. Risk of overdose exists.
• codeine: a pain-relieving and antitussive medicine. Do not take other medicines containing codeine. Risk of overdose exists.
• opioids: pain-relieving, antitussive medicines, or those used in substitution therapy (in case of addiction). Risk of overdose exists.
• sodium oxybate: used in the treatment of narcolepsy (see also section 2 “When not to use Klipal” above).
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorder (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in patients with severe kidney dysfunction, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.

Concomitant use of Klipal is not recommended with:

• anticoagulant medicines,
• medicines containing alcohol,
• certain pain-relieving medicines (buprenorphine, nalbuphine, or pentazocine),
• medicines used in the treatment of alcohol or drug addiction (buprenorphine, naltrexone, nalmefene),
• anticholinergic medicines (including imipramine-like medicines, phenothiazine neuroleptics, antispasmodics, certain H-receptor blocking antihistamines, anticholinergic antiparkinsonian medicines, disopyramide),
• other medicines with sedative and hypnotic effects (neuroleptics, non-benzodiazepine anxiolytics, hypnotics, sedative antidepressants, sedative H-receptor blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide) (see below),
• other opioid pain-relieving medicines.

Concomitant use of Klipal with sedative medicines such as benzodiazepines and related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if other treatment options are not possible.
If, however, a doctor prescribes Klipal together with sedative medicines, the dose and duration of concomitant use should be limited by the doctor.
Inform the doctor about all sedative medicines being taken and strictly follow their instructions. Informing family and friends about the possible occurrence of the symptoms described above may be helpful. If these symptoms occur, contact a doctor.
Klipal and alcohol
Alcohol consumption, alcoholic beverages, or medicinal products containing alcohol are not recommended during treatment due to the risk of sedation and respiratory depression.
In cases of chronic alcoholism, there is an increased risk of liver damage.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
If pain does not subside, and before starting to take this medicine, medical advice should be sought and the recommended dose strictly followed.
If clinically necessary, a doctor may consider occasional use of this medicine at the lowest effective analgesic dose, for the shortest possible duration, and with the least possible frequency. Prolonged use of the medicine should be avoided.
Codeine taken towards the end of pregnancy may cause toxic effects in the newborn.
Breastfeeding
Do not take this medicine during breastfeeding, as it contains codeine. Codeine and morphine (derived from codeine) pass into breast milk and may pose a risk to the infant.
Fertility
Paracetamol may cause changes in fertility in women, which are reversible after discontinuation of treatment.
Driving and operating machinery
Drivers and machine operators should be aware of the risk of drowsiness associated with using this medicine due to its codeine content.
This effect is additionally intensified by consumption of alcoholic beverages.
Klipal also contains:

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

3. How to take Klipal

This medicine should always be taken exactly as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Dosage
This medicine is intended for use only in adults and adolescents aged over 15 years.
The dosage should be adjusted by the doctor according to the intensity of pain. Generally, the medicine should be used at the lowest effective dose for the shortest possible duration.
Treatment with this medicine should be limited to 3 days. If pain has not subsided after 3 days, medical advice should be sought.
To avoid the risk of overdose, check whether other medicines being taken, including over-the-counter medicines, contain codeine and paracetamol.
Recommended dosage:

• Adults: 1 tablet; if necessary, the dose may be repeated every 6 hours. It is not necessary to exceed a daily dose of 6 tablets. In case of severe pain, 2 tablets may be taken at once. The maximum dose of 8 tablets per day must not be exceeded.
• 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 aged 15 to 18 years: The doctor's instructions must be strictly followed. The dosage must be strictly based on the adolescent's body weight. The doctor will determine the dose according to body weight and severity of pain.

Informational: dosage for adolescents over 15 years of age:

To avoid the risk of overdose:

• ensure that no other medicines containing paracetamol or codeine are being taken, including those available without a prescription.
• do not take doses higher than the maximum recommended doses (unless otherwise directed by a doctor), taking into account other medicines containing paracetamol.
  • Elderly patients and patients with hepatic impairment: The initial dose should be half the usual recommended adult dose. The doctor may then increase the dose according to tolerance and need.
  • Patients with renal impairment: In kidney disease (renal failure), there is a risk of accumulation of codeine and paracetamol. For this reason, the doctor may reduce the dose. The interval between doses should not be less than 8 hours.

Adolescents over 15 years of age with renal impairment should be under strict
medical supervision. If unusual symptoms occur (e.g. dizziness or
difficulty breathing), contact a doctor.

• Other situations: The maximum total daily dose of paracetamol should not exceed 60 mg/kg body weight/day (must not exceed 2 g 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 consumes large amounts of alcohol or has a history of heavy alcohol use,
• 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, inform your
doctor or pharmacist.
Method and route of administration
Oral administration.
Tablets should be swallowed whole with a glass of water.
Use of a higher than recommended dose of Klipal
Stop treatment immediately and contact a doctor or emergency services without delay.
Overdose can be fatal. Within the first 24 hours, main symptoms of poisoning include: vomiting, abdominal pain, slowed breathing, drowsiness.
Paracetamol overdose, even if the patient feels well, may lead to a risk of delayed severe liver damage.
Missed dose of Klipal
Do not take a double dose to make up for a missed tablet. Continue treatment as recommended.
Discontinuation of Klipal
If this medicine has been taken for a prolonged period, abrupt discontinuation may cause withdrawal syndrome.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

DATA REGARDING CODEINE
Adverse effects occurring with unknown frequency (frequency cannot be estimated from
available data):

• With long-term use:
• abuse, dependence
• withdrawal symptoms if treatment is suddenly stopped
• withdrawal symptoms in a newborn baby born to a mother who regularly took the medicine during pregnancy
• Allergic skin reactions such as itching, urticaria, or skin rash. If such symptoms occur, discontinue use of this medicine immediately and inform your doctor without delay.
• Pancreatitis, acute abdominal pain, particularly in patients who have had their gallbladder removed. In such cases, consult your doctor.
• Drowsiness, feeling of sleepiness, dizziness.
• Breathing difficulties. If such symptoms occur, discontinue use of this medicine immediately and inform your doctor without delay.
• Euphoria, mood disturbances.
• Constricted pupils.
• Difficulty in urination.
• Constipation, nausea, vomiting.

DATA REGARDING PARACETAMOL
Rare (may occur in less than 1 in 1,000 people):
In rare cases, skin rash or red spots may occur, or an allergic reaction presenting as rapidly progressing facial and neck swelling or sudden malaise associated with a drop in blood pressure. If any of these symptoms occur, stop taking the medicine immediately, contact your doctor without delay, and do not take paracetamol-containing medicines in the future.

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

• Very rare cases of serious skin reactions have been reported. In such cases, discontinue the medicine immediately, contact your doctor without delay, and do not take paracetamol-containing medicines in the future.
• Blood morphology changes requiring blood tests have been observed: abnormally low levels of white blood cells or platelets, increasing the patient's susceptibility to infections and causing nosebleeds or gum bleeding. In such cases, consult your doctor.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Klipal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack following EXP. The expiry date refers to the last day of that month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Klipal contains

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

What Klipal looks like and contents of the pack
This medicinal product is a light orange, round, biconvex tablet, 11 mm in diameter.
The pack 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 European Economic Area countries under the following names:
Poland: KLIPAL
France: KLIPAL
Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl.