PARACETAMOL/CAFFEINE PHARMACLAN 500 MG/65 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol/Caffeine Pharmaclan 500 mg/65 mg film-coated tablets EFG

paracetamol/caffeine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Paracetamol/Caffeine Pharmaclan is and what it is used for
2. What you need to know before you take Paracetamol/Caffeine Pharmaclan
3. How to take Paracetamol/Caffeine Pharmaclan
4. Possible side effects
5. Storage of Paracetamol/Caffeine Pharmaclan
6. Contents of the pack and other information

1. What Paracetamol/Caffeine Pharmaclan is and what it is used for

This medicine contains a combination of two active substances, paracetamol and caffeine, and is effective for pain and fever.

Paracetamol relieves pain and reduces fever. Caffeine increases the analgesic effect of paracetamol.

Paracetamol/Caffeine Pharmaclan is indicated for the short-term symptomatic treatment of mild to moderate pain, such as headache, back pain, and toothache.

Paracetamol/Caffeine Pharmaclan also reduces fever.

This medicine is indicated in adults and adolescents ≥12 years (from 40 kg body weight).

You should consult a doctor if the fever persists for more than 3 days or worsens or does not improve, or if the pain persists for more than 5 days.

2. What you need to know before you take Paracetamol/Caffeine Pharmaclan

Do not take Paracetamol/Caffeine Pharmaclan

• if you are allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver failure
• if you have hepatitis

Warnings and precautionsThis medicine contains paracetamol. Do not take it with other medicines that contain paracetamol, such as medicines for flu and colds. Taking higher doses than recommended can lead to a risk of severe liver damage.

Do not take more than the recommended dose of the medicine. The time interval between individual doses should be at least 4 hours.

Do not drink alcohol during treatment with this medicine.

Consult your doctor or pharmacist before taking Paracetamol/Caffeine Pharmaclan:

• if you have liver disease;
• if you regularly drink alcohol;
• if you have kidney disease;
• if you have hemolytic anemia (anemia due to the destruction of red blood cells);
• if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
• if you are underweight or malnourished.

Caution is required if:

• you have a severe infection (sepsis), are underweight, or are malnourished, or have regular problems with alcohol consumption, as this may increase the risk of metabolic acidosis. The symptoms of metabolic acidosis are:
• difficulty breathing, rapid and deep breathing;
• nausea (feeling unwell), vomiting;
• loss of appetite.

If you experience a combination of these symptoms, contact your doctor immediately.

Children and adolescents

This medicine is not indicated in children under 12 years or adolescents with a body weight below 40 kg.

Other medicines and Paracetamol/Caffeine Pharmaclan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Do not take Paracetamol/Caffeine Pharmaclan in combination with other medicines that contain paracetamol.

The effects of Paracetamol/Caffeine Pharmaclan may interact with the effects of other medicines used at the same time.

Before using Paracetamol/Caffeine Pharmaclan, consult your doctor or pharmacist if you are taking:

? anticoagulant medicines (e.g., warfarin);

? medicines for nausea and vomiting (e.g., metoclopramide, domperidone);

? medicines to lower cholesterol levels in the blood (cholestyramine);

? medicines that contain acetylsalicylic acid or other pain and fever medicines that belong to a class of medicines called non-steroidal anti-inflammatory drugs;

? some antibiotics (rifampicin, chloramphenicol);

? some medicines for the treatment of gout (probenecid);

? some medicines for the treatment of epilepsy (phenobarbital, lamotrigine);

? antiretrovirals for the treatment of HIV (zidovudine);

? medicines for the treatment of tuberculosis (isoniazid);

? lithium for the treatment of some mental illnesses;

? flucloxacillin for the treatment of bacterial infections.

If you are going to have laboratory tests, you should inform your doctor that you are taking this medicine, as it may affect the results of the tests. Paracetamol alters glucose and uric acid concentrations in the blood.

Taking Paracetamol/Caffeine Pharmaclan with food, drink, and alcohol

Alcohol should not be consumed during treatment. Prolonged alcohol consumption significantly increases the risk of liver damage. If you have problems with alcohol consumption, talk to your doctor before starting treatment.

Paracetamol/Caffeine Pharmaclan contains caffeine, so you should avoid excessive consumption of caffeinated beverages while taking this medicine (e.g., tea, coffee, or other caffeinated beverages). High caffeine intake can cause sleep problems, tremors, and chest pain (caused by rapid heartbeats).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Due to the caffeine content, the use of this medicine is not recommended during pregnancy and breastfeeding.

Caffeine may increase the risk of spontaneous abortion during pregnancy. Caffeine in breast milk may have a stimulating effect on a breastfed baby.

Driving and using machines

Paracetamol/Caffeine Pharmaclan has no influence on the ability to drive or use vehicles and operate machines.

Paracetamol/Caffeine Pharmaclan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is almost "sodium-free".

3. How to take Paracetamol/Caffeine Pharmaclan

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not exceed the recommended dose. The time interval between individual doses should be at least 4 hours.

Take the lowest effective dose for the shortest possible time to improve the symptoms of the disease.

Do not take with other medicines that contain paracetamol.

If the pain persists for more than 5 days or if the fever persists for more than 3 days, or the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.

High daily doses of paracetamol should be avoided during prolonged periods, as this increases the risk of adverse effects such as liver damage.

Adults and adolescents from 15 years (from 50 kg body weight)

The recommended dose is 1 tablet per intake. The interval between two doses should be at least 4 hours. A dose of 2 tablets at the same time is recommended only in patients with a body weight above 60 kg if pain relief is not sufficient with 1 tablet or if a higher dose is required due to more intense pain. The maximum daily dose is 6 tablets, which should not be exceeded within a 24-hour period.

Adolescents from 12 to 15 years (from 40 kg body weight)

The recommended dose is 1 tablet per intake, as needed, up to 5 times a day with an interval of at least 4 to 6 hours. The maximum dose per intake is 1 tablet. The maximum daily dose is a total of 5 tablets, which should not be exceeded within a 24-hour period.

Children under 12 years and adolescents with a body weight below 40 kg

The medicine is not indicated in children under 12 years or adolescents with a body weight below 40 kg.

If you have liver or kidney disease, consult your doctor before starting treatment. Your doctor will indicate if you need to reduce the dose or prolong the interval between doses. Do not take this medicine if you have severe liver failure.

Method of administration

For oral use only. Take the tablet with plenty of water.

Paracetamol/Caffeine Pharmaclan can be taken with or without food.

If you take more Paracetamol/Caffeine Pharmaclan than you should

In case of overdose or accidental ingestion by a child, consult your doctor or pharmacist or the nearest medical center immediately and inform them exactly how many tablets you have taken. Show them the used packaging and this leaflet. Paracetamol overdose can cause severe liver damage. In case of overdose or accidental ingestion, you can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Paracetamol/Caffeine Pharmaclan

DO NOT take a double dose to make up for forgotten doses. Take the usual dose as soon as you remember. Maintain a minimum interval of 4 hours between doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and inform your doctor immediately if:

• you have allergic reactions, such as skin rash or itching, or have breathing problems, problems, or inflammation of the lips, tongue, throat, or face;
• you have a skin rash with peeling or blisters in the mouth;
• you have had previous breathing problems after taking acetylsalicylic acid or other pain and fever medicines that belong to a class of medicines called non-steroidal anti-inflammatory drugs, and if you have similar problems after taking this medicine;
• you have bruising or bleeding of unknown origin.
• These side effects are rare (affect 1 in 1000 people).

Very rare cases of severe skin reactions (affect 1 in 10,000 people) have been reported.

Other side effects

Rare side effects (may affect 1 in 1000 people)

• abdominal pain, discomfort (nausea), vomiting, diarrhea;
• liver problems, liver failure, jaundice;
• changes in blood counts;
• sweating, purpura (multiple pinpoint bleeding on the skin);
• swelling.

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

• dizziness, headache;
• insomnia, agitation, anxiety, irritability, nervousness;
• palpitations (abnormal heartbeats).

These side effects may increase with the combination with caffeinated beverages.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. Even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https//www.notificaRam.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol/Caffeine Pharmaclan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging or on the blister after 'EXP'. The expiry date is the last day of the month stated.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice visible signs of deterioration.

• 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

C

• The active substances are: paracetamol 500 mg and caffeine 65 mg in a film-coated tablet.
• The other ingredients are microcrystalline cellulose, pregelatinized starch (corn), povidone K-30, croscarmellose sodium, stearic acid, magnesium stearate, hypromellose, macrogol 400.

A

Film-coated tablets are oval, white to off-white, scored with 'G55' on one side and smooth on the other side.

The tablets are packaged in blisters (PVC/aluminum) containing 10 or 20 film-coated tablets in a box.

Not all pack sizes may be marketed.

Marketing authorization holder:

Pharmaclan s.r.o.

Trtinová 260/1

Prague 9, 19600

Czech Republic

Manufacturer

Pharmazet Group s.r.o.

Trtinová 260/1, Cakovice

Prague 9, 19600

Czech Republic

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

Date of last revision of this leaflet: May 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/