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PARACETAMOL 500 MG CAPSULES SOFT

Active substance(s): PARACETAMOL / PARACETAMOL

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PACKAGE LEAFLET

Package leaflet: Information for the patient
Paracetamol 500 mg capsules, soft
Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Paracetamol 500 mg capsules, soft is and what it is used for
What you need to know before you take Paracetamol 500 mg capsules, soft
How to take Paracetamol 500 mg capsules, soft
Possible side effects
How to store Paracetamol 500 mg capsules, soft
Contents of the pack and other information

What Paracetamol 500 mg capsules, soft is and what it is used for

Paracetamol 500 mg capsules, soft is used for the relief of headache, tension headache, migraine, backache,
rheumatic and muscular pain, toothache and period pain. Paracetamol 500 mg capsules, soft also relieves
sore throat and the fever, aches and pains of colds and flu and are recommended for the relief of pain due to
mild arthritis.
The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have
a fever.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2.

What you need to know before you take Paracetamol 500 mg capsules, soft

Do not take Paracetamol 500 mg capsules, soft:
- If you have ever had an allergic reaction to paracetamol or to any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol 500 mg capsules, soft:
- if you have liver or kidney disease, including alcoholic liver disease. Patients should talk to a doctor at
once if they take too much of this medicine even if they feel well. This is because too much paracetamol
can cause delayed, serious liver damage;
- if you suffer from mild arthritis and need to take painkillers every day;
- if you are taking other medicines containing paracetamol.
If the symptoms for which you take Paracetamol 500 mg capsules, soft persist talk to your doctor.
Children and adolescents
This medicine is not indicated for use in children under 12 years.
Other medicines and Paracetamol 500 mg capsules, soft
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor or pharmacist before taking Paracetamol 500 mg capsules, soft if you are taking
metodopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to
lower blood cholesterol).
If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily
basis, talk to you doctor because of the risk of bleeding. But you can still take occasional doses of
Paracetamol 500 mg capsules, soft at the same time as anticoagulants.
If you take epilepsy drugs (anticonvulsants e.g. carbamazepine, phenobarbital, phenytoin, primidone), certain
antibiotics (rifampicin) or the anti-depressant St. John’s Wort, you need to talk to your doctor because of the
risk of liver damage.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Paracetamol 500 mg capsules, soft can be used during pregnancy. You should use the lowest possible dose
that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or
midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines
It is unlikely that taking Paracetamol 500 mg capsules, soft in the recommended doses will affect your ability
to drive or use machines.

3.

How to take Paracetamol 500 mg capsules, soft

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Children aged 12 to 15 years:
- Give 1 capsule every 4 to 6 hours as needed.
- Do not give more than 6 capsules in 24 hours.
Do not give to children under 12 years.
Adults and children aged 16 years and over:
- Swallow 2 capsules every 4 hours as needed.
- Do not take more than 8 capsules in 24 hours.
Do not take more frequently than every 4 hours.
Do not take more than the recommended dose.
If you take more Paracetamol 500 mg capsules, soft than you should
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the
risk of delayed, serious liver damage.
If your symptoms continue or your headache becomes persistent, see your doctor.
If you forget to take Paracetamol 500 mg capsules, soft
If you forget a dose, give or take the next dose when needed, provided that the last dose was taken at least 4
hours ago. Do not give/take a double dose to make up for a forgotten dose.
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.
A small number of people have had side effects.
Stop taking this medicine and tell your doctor immediately if you experience:
- Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the
mouth or face or shortness of breath.
- Skin rash or peeling, or mouth ulcers.
- Breathing problems. These are more likely if you have experienced them before when taking other
painkillers such as ibuprofen and aspirin.
- Unexplained bruising or bleeding.
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
- Very rare cases of serious skin reactions have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme,
website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.

5.

How to store Paracetamol 500 mg capsules, soft

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Paracetamol 500 mg capsules, soft contains
The active substance is paracetamol. One capsule contains 500 mg paracetamol.
The other ingredients (excipients) are macrogol, purified water, propylene glycol, povidone, silica,
colloidal anhydrous, gelatin, sorbitol, liquid, partially dehydrated, glycerol, titanium dioxide (E171)
and the printing ink (black iron oxide, propylene glycol, hypromellose).
What Paracetamol 500 mg capsules, soft looks like and contents of the pack
- Paracetamol 500 mg capsules, soft is a white, oblong soft gelatin capsule with printing in black ink.
- Paracetamol 500 mg capsules, soft is supplied in a PVDC/PVC//Alu/PET blister. Each pack contains 2,
4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 or 32 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Banner Pharmacaps Europe
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
Manufacturer
Patheon Softgels B.V.
De Posthoornstraat 7

5048 AS Tilburg
The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
FR: Paracétamol Banner 500 mg, capsule molle
This leaflet was last revised in August 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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