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Package leaflet: Information for the user

Manseldem 60/1000mg
Film-coated Tablets
Codeine phosphate hemihydrate/paracetamol
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 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.

What is in this leaflet
1 What Manseldem is and what it is used for
2 What you need to know before you take
3 How to take Manseldem
4 Possible side effects
5 How to store Manseldem
6 Contents of the pack and other information
1 What Manseldem is and what it is used for
The name of your medicine is Manseldem.
Manseldem contains two different analgesics (painkillers) called
paracetamol and codeine (as codeine phosphate hemihydrate).
Codeine belongs to a group of medicines called opioid analgesics
which act to relieve pain.
Manseldem can be used in children over 16 years of age for the
short-term relief of moderate or severe pain that is not relieved by
other painkillers such as paracetamol or ibuprofen alone.

What you need to know before you take
Do not take Manseldem:

• if you are allergic to codeine, paracetamol or any of the other
ingredients of this medicine (listed in Section 6). Signs of an
allergic reaction include a rash and breathing problems. There
can also be swelling of the legs, arms, face, throat or tongue
• if you are allergic to soya or peanut
• if you have severe asthma attacks or severe breathing problems
• if you have recently had a head injury
• if you have severe liver problems
• if you have been told by your doctor that you have increased
pressure in your head. Signs of this include: headaches, being
sick (vomiting) and blurred eyesight
• if you have recently had an operation on your liver, gallbladder or
bile duct (biliary tract)
• if you are taking medicine to treat depression called MAOIs
(monoamine oxidase inhibitors) or have taken them in the last 2
weeks. MAOIs are medicines such as moclobemide, phenelzine
or tranylcypramine (see ‘Other medicines and Manseldem’)
• if you have acute alcoholism
• if you are a breastfeeding woman
• if you know that you metabolise codeine very rapidly into
Do not take Manseldem for longer than your doctor tells you to.
Do not use this product for pain relief in children and adolescents
(0-18 years of age) after removal of their tonsils or adenoids due to
obstructive sleep apnoea syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Manseldem:
• if you have severe kidney problems
• if you have liver problems
• if you have problems passing water or prostate problems
• if you have an underactive thyroid gland
• if you have an addiction to opioids
• if you have problems with your adrenal glands
• if you have a bowel problem such as colitis or Crohn’s disease or a
blockage of your bowel
• if you are elderly
• if you have anaemia (a reduced number of red blood cells)
• if you are malnourished or dehydrated
• if the person going to take the tablets is under 18 years of age
and has breathing problems.

Continued top of next column

Taking codeine regularly for a long time can lead to addiction,
which might cause you to feel restless and irritable when you stop
taking the tablets.
Taking a painkiller for headaches too often or for too long can make
them worse.
Never take more Manseldem than recommended. A higher dose
does not increase pain relief; instead it can cause serious liver
damage. The symptoms of liver damage occur first after a few days.
It is therefore very important that you contact your doctor as soon
as possible if you have taken more Manseldem than recommended
in this leaflet.
Codeine is transformed to morphine in the liver by an enzyme.
Morphine is the substance that produces pain relief. Some people
have a variation of this enzyme and this can affect people in
different ways. In some people, morphine is not produced or
produced in very small quantities, and it will not provide enough
pain relief. Other people are more likely to get serious side effects
because a very high amount of morphine is produced. If you
notice any of the following side effects, you must stop taking this
medicine and seek immediate medical advice: slow or shallow
breathing, confusion, sleepiness, small pupils, feeling or being sick,
constipation, lack of appetite.

Children and adolescents

Manseldem should not be taken by children under 16 years of age.
Use in children and adolescents after surgery.
Codeine should not be used for pain relief in children and
adolescents after removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.
Use in children and adolescents with breathing problems.
Codeine is not recommended in children or adolescents with
breathing problems, since the symptoms of morphine toxicity may
be worse in these children.

Other medicines and Manseldem

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
This is especially important in the case of:
• Medicines to treat depression.
• Medicines which make you drowsy or sleepy (CNS depressants)
such as sleeping pills, medicines to treat anxiety or anaesthetics.
• Medicines used to thin the blood such as warfarin.
• Medicines for irregular heartbeats such as quinidine.
• Antibiotics used to treat infections (e.g. chloramphenicol,
• Metoclopramide or domperidone - used to stop you feeling sick
(nausea) or being sick (vomiting).
• Cholestyramine - for lowering blood cholesterol levels.
• Probenecid – used to treat gout.
• The herbal remedy ‘St John Wort’.
• Cimetidine – used to treat heartburn and peptic ulcers.
• Other painkillers.
• Barbiturates (e.g. phenobarbital).
• Medicines to treat epilepsy (e.g. phenytoin, carbamazepine).
• The oral contraceptive pill.
While taking Manseldem you should not take any other
medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It also
includes a wide range of other medicines available from your
doctor and more widely in shops.
Manseldem with food, drink and alcohol
You should not drink alcohol while you are taking these tablets. This
is because alcohol can increase the risk of serious side effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Manseldem should not be used during pregnancy unless
advised by your doctor. Regular use during pregnancy may cause
withdrawal symptoms in the newborn. If used, you should use the
lowest possible dose that reduces your pain and/or your fever and
use it for the shortest time possible.
Do not take Manseldem while you are breastfeeding, since it passes
into breast milk.

Continued over page

Driving and using machines
You may feel dizzy or sleepy while taking Manseldem. If this
happens, do not drive or use any tools or machines.

• You get swelling of the hands, feet, ankles, face, lips or throat
which may cause difficulty in swallowing or breathing. You
could also notice an itchy, lumpy rash (hives) or nettle rash
(urticaria). This may mean you are having an allergic reaction to
• You get serious skin reactions. Very rare cases have been

The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how it
affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental
problem and
- You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
- It was not affecting your ability to drive safely.


Talk to your doctor straight away if you notice the following
serious side effect
• Severe stomach pain, which may reach through to your
back. This could be a sign of inflammation of the pancreas
(pancreatitis). This is a very rare side effect.
Other side effects

Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

Common: may affect up to 1 in 10 people
Drowsiness, headache, abnormal sweating, feeling sick (nausea),
being sick (vomiting), constipation, tiredness.

Manseldem contains lecithin soya
If you are allergic to peanut or soya, do not take this medicine.

Uncommon: may affect up to 1 in 100 people
Dizziness, problems with vision, dryness of the mouth.
Rare: may affect up to 1 in 1,000 people
You get infections or bruise more easily than usual. This could be
because of a blood problem (such as agranulocytosis, neutropenia,
pancytopaenia, anaemia or thrombocytopenia). Difficulty
sleeping, breathlessness, yellowing of the skin or white of the eyes
(symptoms of liver damage), skin rash.

How to take Manseldem
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
• Do not take more than the recommended dose
• This medicine should not be taken for more than 3 days. If
the pain does not improve after 3 days, talk to your doctor
for advice

Very Rare: may affect up to 1 in 10,000 people
Kidney damage has been shown to occur very rarely in patients
receiving long term treatment with Manseldem.
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:

Take this medicine by mouth.
Swallow the tablets whole with a drink of water. If necessary, the
tablets may be broken in half to make them easier to swallow.
• The recommended dose of Manseldem is 1 tablet.
• Wait at least 4 hours before taking another dose.
• Do not take more than 4 tablets in any 24-hour period.
• Elderly people may be prescribed a lower dose.
• Patients with kidney problems may require longer intervals
between doses.


How to store Manseldem

Adolescents over 50kg of body weight aged 16 years and
• The recommended dose of Manseldem is 1 tablet.
• Wait at least 6 hours before taking another dose.
• Do not take more than 4 tablets in any 24-hour period.

Keep this medicine out of the sight and reach of children.

Children under 16 years
Manseldem 60/1000mg should not be given to children under
16 years of age.

This medicine does not require any special storage conditions.

If you take more Manseldem than you should
• Talk to your doctor at once if you take too much of this medicine
even if you feel well. This is because too much paracetamol can
cause delayed, serious liver damage.
• Remember to take any remaining tablets and the pack with you.
This is so the doctor knows what you have taken.
If you forget to take Manseldem
If you forget to take a dose at the right time, take it as soon as you
However, if it is almost time for your next dose, skip the missed
dose. Do not take a double dose to make up for a forgotten dose.
Remember to leave at least 4 hours between doses for adults and 6
hours between doses for adolescents over 16 years.
If you stop taking Manseldem
Changing or stopping treatment
Long term usage of Manseldem may lead to tolerance and
dependence. If you have taken regular daily doses of Manseldem
for a long time, you may experience withdrawal symptoms if you
suddenly stop treatment. Contact your doctor for advice on how to
stop taking the tablets gradually to avoid withdrawal symptoms.


By reporting side effects you can help provide more information on
the safety of this medicine.

Do not use this medicine after the expiry date which is stated on
the carton or label after ‘EXP’. 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.

Contents of the pack and other information
What Manseldem contains
The active substances are codeine phosphate hemihydrate and
paracetamol. Each film-coated tablet contains 60mg of codeine
phosphate and 1000mg of paracetamol.
The other ingredients are povidone (K29/32), magnesium stearate,
silica colloidal anhydrous, talc, sodium croscarmellose, copovidone
(25.2-30.8), cellulose microcrystalline, hydroxypropylated starch
(E1440), mannitol, lecithin soya (E322) and titanium dioxide (E171).
What Manseldem looks like and contents of pack
Manseldem 60/1000mg film-coated tablets are white, oval, 10.7
x 21.4mm, biconvex tablets, marked ’10 6’ on one side with a
scoreline on the other side and side scores.
Pack Sizes: 100 film-coated tablets
Not all pack sizes may be marketed.

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

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Possible side effects

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Important side-effects you should know about
• Taking a painkiller for headaches too often or for too long can
make them worse.
• Taking codeine regularly for a long time can lead to addiction,
which might cause you to feel restless and irritable when you
stop the tablets.
Stop taking Manseldem and see a doctor or go to a hospital
straight away if
• You have difficulty in breathing or you feel dizzy.
Continued top of next column

This leaflet was last revised in April 2015

If you would like a
leaflet with larger text,
please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

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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.